Through a curated team of the world's most experienced and qualified dieticians, performance coaches, scientists, and medical professionals who are subject matter experts in their respective fields, Cizzle Brands is building a house of brands in the sports nutrition industry that serves the world's most elite athletes and leverages that knowledge to make products for everyday people looking to live healthy, active lifestyles. Cizzle Brands' ambassadors will not only assist in product development and formulation but they will also help to expand knowledge and adoption of Cizzle Brands' products around the world.
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Divesture of Non-US Assets for ~US$9.5M (~A$13.7M) Allowing for Payoff of A$8.2M Debt Facility while Funding Expansion of US Business
Hydration solutions company The Hydration Pharmaceuticals Company Limited (ASX: HPC) (“Hydralyte North America” or “the Company”) is pleased to announce that it has entered into an Intellectual Property Sales Agreement (the ‘Agreement’) with Prestige Consumer Healthcare Inc. and associated subsidiaries (together, ‘Prestige’). Pursuant to the Agreement and associated arrangements, the Company will assign and transfer the exclusive right to sell Hydralyte products, and associated intellectual property rights, to Prestige in all relevant jurisdictions other than the United States of America.1
HIGHLIGHTS
- Divestiture of Hydralyte’s non-US assets to Prestige Consumer Healthcare Inc and associated subsidiaries.
- Total proceeds of ~US$9.5m includes US$8.3m for all non-US territories plus US$1.2m for stock and inventory (subject to final adjustments).
- The sale price of ~A$13.7m represents a significant premium over HPC’s market capitalisation of A$2.7m at 30 September 2024.
- Company retains full ownership of US-based operations, which are achieving annualised revenue of US$3.8m (unaudited, based on Q2 FY24 annualised) – US assets have considerable scope to grow.
- Divesture allows for the full repayment of debt and provides new capital to drive sales and margin growth from continuing US operations.
- Near-term US market growth strategy will focus on scalable ecommerce channels and products – follows recent momentum on Amazon USA, which has generated five consecutive months of positive net contribution margin.
- Divesting the non-US territories greatly simplifies the business structure and allows for a significantly reduced cost base with a deleveraged balance sheet.
- Additional cost efficiencies will be implemented with a focus on achieving cashflow breakeven.
Under the terms of the Agreement (which is dated 1 October 2024), Hydralyte US will receive consideration of US$8.25m plus the value of stock and prepaid inventory in the relevant jurisdictions, valued at approximately US$1.2m (subject to post-completion adjustments). The final cash consideration, including stock and prepaid inventory, is expected to be approximately US$9.5m (A$13.7m).
All conditions precedent to completion of the Agreement have been satisfied and the Agreement will complete in the coming days.
The Company has also agreed a Transition Services Agreement with Prestige, which covers the period of operational transition, and certain other related agreements.
With the funds received from the sale, the Company will repay its existing A$8.2m debt facility owed to Pure Asset Management (refer ASX announcement: 27 March 2024), with the remaining cash at bank to be used towards closing and restructure costs and advancing operations in the US market. The Company is focussed on achieving scale and cashflow breakeven in the US, targeting profitability in the future.
Use of Funds:
*Unaudited management estimate. Final balance will be determined post-completion.
Rationale:
On 27 March 2024 the Company announced that it intended to seek a sale transaction. Since that time, the Board has considered a range of options to divest part or all of the Company’s business.
The Board considers that the Prestige transaction will effectively deleverage the Company’s balance sheet and provide Hydralyte US with an opportunity to pursue its growth strategy in the potentially lucrative US market for the benefit of shareholders. This US growth strategy will be underpinned by a significant increase in balance sheet strength, with no debt and a stronger cash position to flexibly pursue targeted opportunities for sales and margin growth.
Streamlined operations:
Hydralyte US will focus on driving growth and unlocking value from its US-based assets. At present, Hydralyte US’s operations are annualising net revenues of approximately US$3.8m on an unaudited basis based on Q2 FY24.
The Company will maintain a presence with American bricks and mortar retail outlets but its targeted growth strategy in the US market will focus on ecommerce channels, where it already has an established footprint.
Most recently, the Company has achieved considerable net margin growth since Q1 CY23. Further, Amazon USA has achieved five consecutive months of positive net contributions and margin growth.
Click here for the full ASX Release
This article includes content from The Hydration Pharmaceuticals Company Limited, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
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Hydralyte International
Overview
Hydralyte International (ASX:HPC) is an ASX-listed rapid hydration solutions business focused on the lucrative North American market. With an established supply chain in Canada and the United States, the company consolidated its market position in FY23 with a 10 percent increase in net sales to $10 million. The impressive increase in group sales was achieved with a disciplined cost focus which flowed through to a significant US$5.7 million in cash savings. And there was ongoing momentum in the first quarter of FY24, with consistent growth in net sales to US$2.17 million on strong gross margins of 56 percent.
Hydralyte’s multi-channel distribution strategy includes a targeted growth through ecommerce. Its rapid rehydration product has been the number one SKU in the hydration category on Amazon Prime Day in Canada, where it's the number two hydration brand overall with a 21 percent market share. Starting on Prime Day, Hydralyte delivered ~US$140,000 in gross sales over 48 hours.
It's also worth noting that all this revenue growth – alongside a partnership with Shay Mitchell – occurred with an ongoing reduction in marketing expenditure. In 2024, marketing costs as a percentage of net revenue decreased to 37 percent from 48 percent in Q1 2023. This is due in part to the company's solid leadership team, featuring professionals with decades of expertise in health and wellness, as well as heavy brand investments which have been made throughout 2022.
In Australia, New Zealand and parts of Southeast Asia, Prestige Consumer Healthcare (NYSE:PBH) holds the exclusive sales and distribution rights to Hydralyte products. PBH is an American over-the-counter healthcare marketing and distribution company, dating back more than 100 years.
Hydralyte International's robust supply chain, sales trajectory, manufacturing approach and product strategy are far from the only reasons it shows such promise as an investment. Current market trends also significantly favor the company's core value proposition. Valued at US$1.68 billion in 2023, the global electrolyte hydration drinks market is expected to reach US$2.78 billion by 2033 as consumers turn away from high-sugar, low-electrolyte drinks and towards more clinical hydration products.
Roughly 75 percent of Americans are dehydrated at any given time. The reasons are many and varied, ranging from travel and exercise to alcohol and illness. Its symptoms are something many of us have simply learned to live with – irritability, brain fog, dizziness, increased thirst, dry mouth and fatigue, to name just a few.
Hydralyte fits the bill perfectly for these consumers. Founded with the goal of making a difference through better hydration, Hydralyte is able to treat dehydration more effectively than the majority of sports drinks on the market. Thanks to its proprietary formula – which uses a precise ratio of water, electrolytes and glucose based on the World Health Organization's recommended formula for rapid rehydration.
Hydralyte is available in three forms: ready-to-drink, tablet and dissolvable powder stick. All three are widely accepted in the medical community. Hydralyte is also frequently used by professional athletes as an alternative to sports drinks.
In short, thanks to its market position, strong leadership and science-based formula, Hydralyte represents the perfect opportunity for investors to enter the lifestyle sports market.
Company Highlights
- Hydralyte International is a rapid hydration drink business with a focus on North America and established supply chains in both the United States and Canada.
- The company’s latest financials show a consistent upward trajectory with respect to its key growth targets:
- 10 percent increase in FY2023 net sales to US$10 million
- 2ppt increase in gross margin to 54 percent resulting in a 15 percent increase in gross profit from US$4.7 million to $5.4 million
- Net sales of US$2.17 million in Q1 2024, up 2 percent on in Q4 2023 with an uplift in gross margins to 56% (adjusted for one-off items)
- Strong momentum in FY24 with underlying sales growth for Q1 2024 of US$2.62 million, an increase of 23 percent from the previous quarter.
- Appointment of leading health and wellness products broker LeBeau Excel as new national sales broker for Canada, giving Hydralyte the ability to significantly expand its footprint in the Canadian market.
- Ongoing product development with a focus on high-margin growth channels, including Hydralyte Rapid Rehydration, a unique formula to take advantage of the lucrative ready-to-drink category for hydration products
- In addition to a solid manufacturing base and supply chain, Hydralyte is supported by leaders with decades of experience in health and wellness.
- Hydralyte products are widely accepted in both the medical and athletic communities. As a result, the company is well-positioned to leverage the fast-growing electrolyte hydration drinks market.
Core Product Offering
Hydralyte Rapid Rehydration
Hydralyte is based on the World Health Organization's recommended formula for rapid rehydration. Made from all-natural ingredients, it contains the precise ratio of glucose and electrolytes necessary to rehydrate. Its innovative formula contains up to 75 percent less sugar and four times more electrolytes than the majority of sports drinks.
Highlights:
- Multiple SKUs: Available as a tablet, powder and premade drink, Hydralyte comes in a range of different flavors and formulations, including:
- Liver Support: 7 key electrolytes, six antioxidants, ginger, turmeric, milk thistle and prickly pear.
- Apple Cider Vinegar: 4 key electrolytes, apple cider vinegar, vitamins B12, B6 and C.
- Collagen: 5 key electrolytes, Verisol collagen, vitamin C and zinc.
- Immunity with Elderberry: 7 key electrolytes, vitamin C, magnesium and zinc.
- SPORT: Launched in 2022, these tablets are designed with the needs of athletes in mind.
- Under development: Hydralyte Rapid Rehydration, a unique formula with inherent advantages in comparison to competitor products in the lucrative ready-to-drink product category
- Promising Partnerships: In December 2022, Hydralyte launched a brand partnership with Shay Mitchell, a Canadian actress and entrepreneur with over 36 million Instagram followers. The two parties launched a co-branded product through HPC eCommerce channels and Amazon USA to leverage Ms Mitchell’s high profile in the North American wellness market.
- Strategic Agreements: Recently appointed LeBeau Excel as its new sales broker to significantly expand Hydralyte’s footprint in the Canadian market. Along with a strong sales team and in-store support, the Lebeau Excel appointment is expected to generate additional margin growth through more streamlined distribution.
Management Team
Oliver Baker – CEO
Oliver Baker is the former general manager of Swisse Wellness USA, a vitamin, supplement and skincare brand that in 2015 sold for US$1.7 billion. During his tenure at Swisse, Baker employed a dedicated eCommerce strategy that enabled a successful US launch. He also led the integration team in Guangzhou, migrating ~US$73 million in sales and building a local team in the Chinese market.
Prior to his position at Swisse, Baker worked in multiple global and national sales and marketing roles with a focus on sports sponsorships.
Adem Karafili – Independent, Non-executive Chairman
A registered CPA and business professional with more than 15 years of experience, Adem Karafili has operated in leadership positions across a range of different sectors and industries. Most recently, he spent several years at Swisse Wellness, beginning as chief financial officer before becoming chief operating officer and managing director. While there, he helped to establish Swisse as a leading global health and wellness brand. Karafili holds a Bachelor of Business Administration in accounting and is chairman of multiple health and wellness corporations.
Chris Kavanaugh – CFO
Chris Kavanaugh has over 20 years of experience running finance and operations for growing startups from inception to US$30M+ in revenue. He has worked with Hydralyte for over five years, starting as a controller before being promoted to chief financial officer in 2021. Prior to his position at Hydralyte, he served as a director of finance for companies including Fullbridge, Education Incorporated and OneVision Resources. Kavanaugh has a bachelor's degree in accounting and management with a double major in information systems from Indiana University of Pennsylvania.
Nick Berry – Non-executive Director
Nick Berry brings over 19 years of experience in the Australian finance industry, specialising in equity and debt capital markets, mergers and acquisitions and strategic planning. With a proven track record in raising capital and structuring and negotiating complex financial transactions, Nick has demonstrated extensive expertise and leadership in the field. He previously served as an Executive Director at Nomura Australia and is currently a Director of PURE Asset Management Pty Ltd.
Margaret Hardin – Independent, Non-executive Director
Margaret Hardin has served as CEO and CFO for numerous major product companies in the United States including Baby Super Brands, ERGObaby Carrier Incorporated and Munchkin. With over two decades of experience, Hardin has a well-established reputation for driving growth through innovation, strategic acquisitions and geographic expansion. She holds a BBA from New Mexico State and an MBA from the Booth Graduate School of Business at the University of Chicago.
Brandon Fishman – US Advisor
Brandon Fishman is the Founder and CEO of VitaCup, a vitamin-infused functional coffee and tea brand that surpassed US$20 million in sales in five years. Fishman has worked with multiple Fortune 500 brands in a range of different capacities, in the process building up considerable entrepreneurial wisdom. Other companies founded by Fishman include NewCondosOnline and Internet Marketing Incorporated. Fishman holds a Bachelor of Business Administration and Finance from Emory University and a Master's in Real Estate & Business from the University of San Diego.
Cizzle Brands Unveils its Team of Ambassadors to Accelerate North American Commercialization Initiatives
Cizzle Brands Corporation (Cboe Canada: CZZL) ( the "Company or "Cizzle Brands") , today unveiled the lineup of subject matter experts ("SMEs") who will underpin the Company's product commercialization efforts for 2025 and drive awareness for its lineup of sports nutrition brands. The Company's roster of SMEs includes some of the world's most experienced and respected strength and performance coaches, dieticians, and medical professionals.
In its Market Introduction press release, Cizzle Brands detailed the performance of CWENCH Hydration™ following its launch in late May of 2024, following which more than one million ready-to-drink units of the beverage have been sold across North America. On January 14, 2025 , Cizzle Brands also announced the launch of Spoken Nutrition , a brand of athlete-grade supplements and nutraceuticals primarily sold through trainers and coaches.
As Cizzle Brands continues to commercialize these product offerings alongside upcoming additional brands to be launched, the Company expects its SMEs to play a key role in product innovation and generating broad-scale awareness in product categories that tend to have very nuanced and knowledge-driven exploration journeys prior to trial or purchase.
Cizzle Brands' current roster of SMEs includes:
Carl Bergstrom: Carl is the Director of Performance for Stephen Curry and former Performance Coach of the Golden State Warriors, White Caps FC, and Canada Soccer.
Dr. Matt Frakes: Dr. Matt Frakes, Assistant Athletic Director of Sports Nutrition at LSU, has prior experience at Notre Dame and the University of Louisville, and holds a PhD in Nutrition and Hospitality Management from the University of Mississippi, along with a Master's and Bachelor's in Food and Nutrition.
Todd Herman: Todd Herman, with over 28 years of experience coaching elite athletes, entrepreneurs, and business teams on inner game, strategy, and performance, is a leading expert on mental game and peak performance, authoring books, building programs, and creating tools to help ambitious individuals succeed across various fields. Todd is the renowned performance coach who helped Kobe Bryant create the Black Mamba.
Ben Prentiss: Ben Prentiss, a strength coach with over 20 years of experience, has worked with professional and Olympic hockey players, including Stanley Cup winners and NHL All-Stars, and currently serves as a Strength and Conditioning Consultant for the New York Rangers.
Carley Patterson: Carley Patterson is a Registered Holistic Nutritionist with a Bachelor of Applied Science, with an expertise in providing nutritional advice to families with young athletes living a competitive and active lifestyle.
Matt Price: Matt Price is the Director of Strength & Performance Science for the Los Angeles Kings and was formerly the lead strength and conditioning coach for Alpine Canada.
Brianne Brown: Brianne Brown, Head of Women's Basketball Strength & Conditioning at the University of Miami, has over seven years of experience, including positions at the University of Pittsburgh and Racing Louisville FC, and holds a Master's in Exercise Science and Human Performance from Utah State University.
David Lawrence: David Lawrence is a renowned strength coach who has trained NFL athletes, including six Super Bowl champions, to enhance their body composition, speed, and performance, with his work featured in Sports Illustrated, ESPN, and The Athletic.
Dr. Jordan Shallow: Dr. Jordan Shallow is a strength coach, powerlifter, chiropractor, and founder of Pre-Script.com, specializing in innovative strategies to improve human performance for elite athletes and corporations.
Mark Fitzgerald: Mark Fitzgerald has 15 years of experience working with athletes at all levels, including CWENCH's very own Gavin McKenna. Mark founded Elite Training Systems in Ontario, served as Head of Performance for the Anaheim Ducks, and is the lead training advisor for Under Armour Canada, while consulting for various health and performance organizations.
Dan Noble: Dan Noble is the Director of Hockey at Upper Canada College, the Director of Performance for the Oshawa Generals, owns and runs Noble Sport & Performance, and is a Family Coach and Speaker.
Alan Bishop: Alan Bishop, Director of Sports Performance for the University of Houston Men's Basketball program, is a highly regarded coach known for his pragmatic approach and leadership in strength and conditioning, driving impressive physical development in his teams year after year. Alan is considered a godfather in NCAA basketball, placing many of his disciples into programs across the country.
Doug Crashley: Doug Crashley trains world class athletes through Crash Conditioning, a premier training destination for elite hockey players that offers individualized training programs and intuitive coaching based on sports science research.
Dr. Sachin Patel: Dr. Sachin Patel, a functional medicine coach, international speaker, and author, founded The Living Proof Institute to transform healthcare through patient-centered practices and lifestyle changes, while mentoring practitioners globally to provide affordable, inspired care.
Derrell Levy: Derrell Levy trains world class athletes through In-Tech High Performance Training. With over 12 years of on-ice coaching experience, Derrell has developed strength and conditioning programs for elite basketball and hockey teams, as well as NBA, NHL, OHL, and AHL athletes.
Sam Davis: Sam Davis is a Fitness Business Consultant, Women's Health Advisor, and the Founder of Powerfully Fit Training. Sam if a former NCAA athlete, and provides coaching for other well-known fitness influencers and helps them develop their own programs.
Ryan Vigneau: Ryan Vigneau is an Athlete Development Coach and runs RVX Performance, an elite training facility that works with NHL athletes in Edmonton.
Cizzle Brands' Chief Performance Officer Andy O'Brien is also one of the Company's SMEs. Andy was nicknamed "The Muscle Whisperer" by Sportsnet in 2015, highlighting his work as a trainer to NHL superstar Sidney Crosby, MVP and CWENCH's very own Nathan MacKinnon, Olympic medallist figure skater Patrick Chan, women's hockey legend Hayley Wickenheiser, and Olympic swimmer Dara Torres. Andy has also held coaching and consultancy roles for the Pittsburgh Penguins and Florida Panthers.
Additionally, Don Saladino will be an ambassador specifically for CWENCH Hydration™. Earlier this week, Cizzle Brands announced that it was engaging Mr. Saladino as an advisor, which will enable the Company to leverage his insights, expertise, and professional network as a well-known personal trainer to Hollywood's A-List, professional athletes, and award-winning musicians. Mr. Saladino has a high-profile social media presence, with over 432,000 followers on his Instagram channel .
Cizzle Brands Chairman and Chief Executive Officer, John Celenza, commented, "In an era when product competition is fierce, we believe that the best way to stand out is by working with the world's most experienced subject matter experts to develop products of unparalleled quality and performance, like we have with CWENCH Hydration™ and Spoken Nutrition. There are very few companies out there that have as much knowledge, reach, and fire power as the team of SMEs that are behind Cizzle Brands' products. Not only are they helping us to develop our amazing lineup of products, they are also our loudest evangelists. Furthermore, anyone in the sports nutrition industry will understand that when Cizzle Brands' SMEs speak, people who matter pay attention, which can drive accelerated growth for the Company."
About Cizzle Brands Corporation
Cizzle Brands Corporation is elevating the game in health and wellness. Through extensive collaboration and testing with leading athletes and trainers across several elite sports, Cizzle Brands has launched two leading product lines in the sports nutrition category: (i) CWENCH Hydration, a better-for-you sports drink that is now carried in over 1,200 stores in Canada, the United States, and Europe; and (ii) Spoken Nutrition, a premium brand of athlete-grade nutraceuticals that carry the prestigious NSF Certified for Sport® qualification. All Cizzle Brands products are designed to help people achieve their best in both competitive sports and in living a healthy, vibrant, active lifestyle.
For more information about Cizzle Brands, please visit: https://www.cizzlebrands.com/
Notice Regarding Images and Links: This press release may contain images and/or links to outside web pages, which could play an important role in providing the full context of the news update being conveyed through this press release. Some news aggregation services may remove these images and/or links at their discretion. Therefore, readers are encouraged to access SEDAR+ or the News section of the Cizzle Brands Corporation website to view this press release containing all images and/or links as originally published.
On behalf of the Board of Directors of the Company,
"John Celenza"
John Celenza, Chairman and Chief Executive Officer
CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION
This news release contains "forward-looking information" which may include, but is not limited to, information with respect to the activities, events or developments that the Company expects or anticipates will or may occur in the future, such as, but not limited to: new products of the Company and potential sales and distribution opportunities. Such forward-looking information is often, but not always, identified by the use of words and phrases such as "plans", "expects", "is expected", "budget", "scheduled", "estimates", "forecasts", "intends", "anticipates", or "believes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Various assumptions or factors are typically applied in drawing conclusions or making the forecasts or projections set out in forward-looking information. Those assumptions and factors are based on information currently available to the Company.
Forward looking information involves known and unknown risks, uncertainties and other risk factors which may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information. Such risks include risks related to increased competition and current global financial conditions, access and supply risks, reliance on key personnel, operational risks, regulatory risks, financing, capitalization and liquidity risks. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking information. The Company undertakes no obligation, except as otherwise required by law, to update these forward-looking statements if management's beliefs, estimates or opinions, or other factors change.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250123730912/en/
For further information, please contact:
Setti Coscarella
Head of Corporate Development
investors@cizzlebrands.com
1-844-588-2088
News Provided by Business Wire via QuoteMedia
Biotech Market Forecast: Top Trends for Biotech in 2025
The biotech sector in 2025 presents a landscape brimming with both opportunities and challenges.
The industry is being shaped by a confluence of factors, all of which are driving exciting innovations in healthcare.
Drawing from insights gained at the JP Morgan Healthcare Conference (JPMHC), held in San Francisco from January 13 to 16, the Investing News Network examines the key trends taking shape in biotech in 2025.
M&A and the future of therapy
Following a period of market stagnation, Evaluate's 2025 Market Preview suggests cautious optimism for the biotech sector in 2025. Industry experts anticipate increased mergers and acquisitions (M&A) and improved access to capital fueled in part by a looming US$300 billion patent cliff.
Companies facing steep revenue losses will be seeking to refill their pipelines, creating a ripe environment for “the biotech innovation engine” as noted in a market report authored by Dr. Arda Ural, EY Americas Life Sciences sector leader, at the end of December. Promising biotech companies could become attractive acquisition targets.
Acquisitions announced this week at JPMHC underscore this trend, with several significant deals announced. The day before the conference, Gilead (NASDAQ:GILD) signaled its intent with a US$1.7 billion investment in Leo Pharma's preclinical inflammation drugs.
The first day of JPMHC saw even more action. Johnson & Johnson (J&J) (NYSE:JNJ) made one of the largest biotech acquisitions in recent memory when it announced it would acquire Intra-Cellular Therapies for US$14.6 billion. Intra-Cellular Therapies is the maker of Caplyta, an atypical antipsychotic approved to treat schizophrenia and bipolar depression. This acquisition expands J&J's presence in the neuroscience market.
GSK (NYSE:GSK) also announced a strategic acquisition at JPMHC, striking a US$1.15 billion buyout deal for IRDx, a company developing non-invasive diagnostics for gastrointestinal (GI) cancers.
Vera Therapeutics (NASDAQ:VERA) later announced a licensing agreement with Stanford University for VT-109, a fusion protein designed to treat B cell diseases by targeting two proteins involved in overactive immune cell activity.
Inflammation and immunology (I&I) were indeed two prominent areas of interest at the conference. AbbVie's (NYSE:ABBV) CEO, Rob Michael, highlighted the company's strong performance in this area, driven by the success of Skyrizi (risankizumab) and Rinvoq (upadacitinib), which he said have effectively offset the revenue decline from Humira's patent expiration during a discussion at the conference. The company’s acquisition of Nimble Therapeutics for its preclinical IL-23 inhibitor highlights the ongoing search for innovative treatments for inflammatory diseases
Meanwhile, Kyverna Therapeutics (NASDAQ:KYTX) presented its ambitious goal of developing the first chimeric antigen receptor T-cell (CAR-T) therapy for autoimmune diseases.
Insight released by JPM senior analyst of large-cap biotechnology Jess Fye ahead of the conference also cited oncology as another therapeutic area of focus. That was evidenced by Eli Lilly's (NYSE:LLY) US$2.5 billion purchase of Scorpion Therapeutics on January 13, positioning them as a potential leader in the development of a new class of cancer drugs with their acquisition of STX-678, an experimental drug undergoing clinical trials.
This focus on oncology was further underscored by several partnerships and developments announced before and during the conference, including Boehringer Ingelheim licensing Lonza's antibody-drug conjugate (ADC) technology, Chugai (OTCPINK:CHGCF) and Araris's research collaboration to develop ADC treatments and Ginkgo Bioworks (NYSE:DNA) collaborating with Astellas (OTCPINK:ALPMF) to optimize next-generation cancer treatments. GSK highlighted its upcoming ADC Blenrep, and Novartis (NYSE:NVS) emphasized the potential of its breast cancer drug Kisqali.
Beyond oncology and I&I, the conference highlighted the continued interest in gene and cell therapy, with the US Food & Drug Administration (FDA) Center for Biological Evaluation and Research director Peter Marks saying his agency is aiming to accelerate approvals of gene therapies like CRISPR medicine Casgevy, Pfizer’s (NYSE:PFE) Beqvez and PTC Therapeutics (NASDAQ:PTC) Kebilidi. Denali Therapeutics (NASDAQ:DNLI) also shared an update on its leading asset to treat Hunter syndrome, DNL310 (tividenofusp alfa), announcing its intent to file for regulatory approval in 2025.
The company also said it expects to have one or two new drugs ready to bring to the clinic every year for the next three years thanks to its Transport Vehicle platform, a molecule capable of passing the blood-brain barrier.
Neurology also garnered attention. Apart from J&J’s acquisition, Bayer (OTCPINK:BAYRY) announced that it was moving onto Phase II trials of an allogeneic cell therapy to treat Parkinson’s disease. Earlier in Q1 2025, Biogen's (NASDAQ:BIIB) pursuit of Sage Therapeutics (NASDAQ:SAGE) and their jointly developed mood-stabilizing medicine Zurzuvae caused Sage’s stock price to surge more than 38 percent over the weekend.
Furthermore, Vertex Pharmaceuticals (NASDAQ:VRTX) awaits an FDA decision on its novel non-opioid pain treatment, suzetrigine, which is expected by January 30.
While M&A is on the rise, companies in biopharma have signaled a cautious approach to
the funding environment that could still be challenging for early-stage companies. Roche (OTCQX:RHHBF) recently decided to pull about 30 percent of its pipeline and, at JPMHC, said it has US$10 billion for M&A this year but will only spend it on "transformative assets" complementary to its portfolio or that "change the game" in important diseases.
AbbVie CEO Rob Michaels shared this sentiment in Oppenheimer’s 2024-25 Biopharma M&A and Strategic Collaboration Insight report. “Our main focus is our five key growth areas...immunology, oncology, neuroscience, aesthetics and eye care...So far this year, we’ve executed 15 deals along those lines, really focus(ing) more on early‐stage opportunities to drive growth in the next decade. So, that’s our primary focus.”
Impact of AI on biotech R&D
When AlphaFold, a groundbreaking artificial intelligence (AI) system with revolutionary protein structure prediction capabilities developed by Google’s (NASDAQ:GOOGL) DeepMind, was awarded the prestigious Nobel Prize in Chemistry in October 2024, the potential for AI to play an increasingly critical role in drug discovery and development became a more prominent topic of conversation.
AI applications like AlphaFold could reduce development costs, lessening biotech's reliance on partnerships or acquisitions from Big Pharma to secure funding. This would allow smaller companies to better protect their intellectual property and introduce more innovative drugs.
The FDA's release of draft guidance on AI in drug development further underscores the growing importance of AI in the biotech sector, signaling a shift towards greater acceptance and adoption of AI-based tools in the regulatory process.
Biotech under Trump: A new regulatory era?
Policy can either promote or hinder growth in a sector by affecting factors such as market access, the cost of compliance and funding for research. Regulatory changes and leadership appointments under President Trump have the potential to significantly impact the biotech industry. As Daphne Zohar, CEO of Seaport Therapeutics and former head of PureTech Health (NASDAQ:PRTC), noted in an email to Biopharma Dive, a change in FTC leadership could have a positive effect.
Current Federal Trade Commission (FTC) chairwoman Lina Khan's policies have been unfavorable to the healthcare industry and included heavy scrutiny of M&As. Trump’s picks – Andrew Ferguson as FTC chair and Mark Meador as a commissioner – are seen as likely to be less restrictive in their approach to dealmaking.
However, uncertainty around the confirmation of key health department appointments and an evolving tariff situation may contribute to market volatility in the short term. “Uncertainty always creates volatility, and volatility is not great for the public markets,” said Rebecca Stevenson, according to BioPharmaDive’s coverage of JPMHC. “Ultimately the dust needs to settle before we see generalist [investors] back in. Is that happening in the next six months? Probably not.”
On the other hand, it's important to consider that any potential policy shifts may take time to emerge, as the confirmation process for President-elect Trump's cabinet picks could take until mid-2025, as noted by the Evaluate authors.
Trump’s choice for FDA Commission, Johns Hopkins University pancreatic surgeon Dr. Marcus Makary, was well-received by the industry, who sees him as a more conventional pick than Trump’s choice to lead the Department of Health and Human Services, Robert F. Kennedy Jr.
Kennedy has stated that the high prevalence of chronic diseases in the US necessitates significant changes to the healthcare system. Financial disclosures from Stat+ indicate a vested interest in biotech investments, and his oversight could also breathe new life into stem cell research. In the aforementioned post, Kennedy wrote that he would support unconventional medical fields, including stem cell injections and nutraceuticals. In a post to X after his October nomination, Kennedy issued a warning: “FDA’s war on public health is about to end.”
Investor takeaway
The biotech sector in 2025 is at a crossroads, presenting a dynamic landscape of opportunities and challenges. As the sector navigates these complexities, collaboration between academia, industry and government will be crucial to unlocking its full potential and addressing the pressing healthcare challenges of the 21st century. Investors will need to closely monitor both clinical data and regulatory developments.
Don’t forget to follow @INN_LifeScience for real-time updates!
Securities Disclosure: I, Meagen Seatter, hold no direct investment interest in any company mentioned in this article.
Editorial Disclosure: Radiopharm Theranostics and Sirona Biochem are clients of the Investing News Network. This article is not paid-for content.
Don Saladino, Personal Trainer to Hollywood's A-List, Joins Cizzle Brands as an Advisor
Hollywood actors, professional athletes, and award-winning musicians alike have all relied on Don Saladino, coach and trainer of over 20 years, to reach their full potential in physical fitness. As an advisor to Cizzle Brands, Mr. Saladino will provide his insights, expertise, and access to his vast professional network for the commercialization and promotion of Cizzle Brands' product lines at a global scale.
Cizzle Brands Corporation (Cboe Canada: CZZL) ( the "Company or "Cizzle Brands") , is pleased to announce that Don Saladino, a renowned coach and fitness expert to many A-List celebrities, professional athletes, and award-winning musicians has been engaged as an advisor to Cizzle Brands to help guide the Company's commercialization journey in the health and wellness space. Under his agreement with Cizzle Brands, Mr. Saladino will provide sales, marketing, and promotional support for Cizzle Brands' offerings, including through his TikTok (165k followers) and Instagram (432k followers) social media channels.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250121943080/en/
Don Saladino's one-minute Intro Reel video can be viewed on YouTube: https://www.youtube.com/watch?v=5L57AYEjZF4 (Photo: Business Wire)
Mr. Saladino has developed a reputation for training several A-List Hollywood stars, including Ryan Reynolds, Blake Lively, Anne Hathaway, John Krasinski, Emily Blunt, Liev Schreiber, Hugh Jackman and Joanna Gaines. In 2020, Mr. Saladino pivoted from running a brick-and-mortar gym in New York City to operating a global online fitness business which includes workout programs and challenges, an e-commerce portal for supplements, the Don Saladino App (available on the Apple App Store and Google Play), and yearly fitness retreats. Mr. Saladino has an extensive network of celebrity personalities to whom he will be supplying Cizzle Brands' products throughout the course of their training programs.
Additionally, Mr. Saladino has received extensive media coverage. Magazines such as Men's Health , Women's Health , and Muscle & Fitness have cited Mr. Saladino as a fitness expert. Muscle & Fitness has also featured Mr. Saladino on its print magazine cover in March 2018, October 2021, and November 2023. Other publications have featured Mr. Saladino including People , US Weekly , Cosmo , and Shape . Additionally, Mr. Saladino has done live fitness demonstrations on The Golf Channel , The Today Show , Good Morning America , Page Six TV , People NOW , E News , Fox News , and WebMD .
More information about Don Saladino can be found on his website at the following link: https://donsaladino.com/
Cizzle Brands Chairman and Chief Executive Officer, John Celenza, commented, "We are keen to be working with Don, as he is one of the most recognized names in the fitness world with a highly engaged following, a well-earned reputation for generating results, and a broad network of highly influential executives. Cizzle Brands is only getting started with building out its presence in the world of health and wellness. With Don's knowledge of what the world's most elite athletes, entrepreneurs, and actors are demanding, we expect he will prove to be extraordinarily valuable to us as an advisor."
Regarding his appointment as an advisor to Cizzle Brands, Don Saladino commented, "In today's marketplace, very few companies truly have what it takes to formulate and produce athlete-grade products for training, nutrition, hydration, and overall wellness while also being appropriate for active people of all ages. The proven team behind Cizzle Brands has already demonstrated their ability to meet this standard with the recent successful launch of CWENCH Hydration™ which has already sold more than one million ready-to-drink units in less than a year on the market, with even more exciting offerings set to hit the market soon. As someone who personally incorporates Cizzle Brands' products into nutrition regimes for myself, my wife, and our two children, I am honoured to be part of the Cizzle Brands team, and there are exciting times to be had for all of us in 2025!"
Cizzle Brands also announced the issuance of 455,645 common shares (the "Settlement Shares") of the Company at a deemed price of $0.31 in settlement of $141,250 in debt. The Settlement Shares were issued to a provider who elected to receive part of their service fee in shares as opposed to cash. The Settlement Shares will be subject to a statutory hold period expiring four months and one day after the date of issuance pursuant to National Instrument 45-102 – Resale of Securities .
Celenza added: "I've always sought to have our key partners invested in our success, so I was pleased when one of our key professional advisers opted to receive part of their fee in equity. To me, it is one of the highest endorsements we've received to date."
About Cizzle Brands Corporation
Cizzle Brands Corporation is elevating the game in health and wellness. Through extensive collaboration and testing with leading athletes and trainers across several elite sports, Cizzle Brands has launched two leading product lines in the sports nutrition category: (i) CWENCH Hydration, a better-for-you sports drink that is now carried in over 1,200 stores in Canada, the United States, and Europe; and (ii) Spoken Nutrition, a premium brand of athlete-grade nutraceuticals that carry the prestigious NSF Certified for Sport® qualification. All Cizzle Brands products are designed to help people achieve their best in both competitive sports and in living a healthy, vibrant, active lifestyle.
For more information about Cizzle Brands, please visit: https://www.cizzlebrands.com/
Notice Regarding Images and Links: This press release may contain images and/or links to outside web pages, which could play an important role in providing the full context of the news update being conveyed through this press release. Some news aggregation services may remove these images and/or links at their discretion. Therefore, readers are encouraged to access SEDAR+ or the News section of the Cizzle Brands Corporation website to view this press release containing all images and/or links as originally published.
On behalf of the Board of Directors of the Company,
"John Celenza"
John Celenza, Chairman and Chief Executive Officer
CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION
This news release contains "forward-looking information" which may include, but is not limited to, information with respect to the activities, events or developments that the Company expects or anticipates will or may occur in the future, such as, but not limited to: new products of the Company and potential sales and distribution opportunities; the role of Mr. Saladino with Cizzle Brands; the supply of Cizzle Brands' products through Mr. Saladino's training programs; the building of Cizzle Brands' presence in the world of health and wellness; and the value of Mr. Saladino as an advisor to Cizzle Brands. Such forward-looking information is often, but not always, identified by the use of words and phrases such as "plans", "expects", "is expected", "budget", "scheduled", "estimates", "forecasts", "intends", "anticipates", or "believes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Various assumptions or factors are typically applied in drawing conclusions or making the forecasts or projections set out in forward-looking information. Those assumptions and factors are based on information currently available to the Company.
Forward looking information involves known and unknown risks, uncertainties and other risk factors which may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information. Such risks include risks related to increased competition and current global financial conditions, access and supply risks, reliance on key personnel, operational risks, regulatory risks, financing, capitalization and liquidity risks. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking information. The Company undertakes no obligation, except as otherwise required by law, to update these forward-looking statements if management's beliefs, estimates or opinions, or other factors change.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250121943080/en/
For further information, please contact:
Setti Coscarella
Head of Corporate Development
investors@cizzlebrands.com
1-844-588-2088
News Provided by Business Wire via QuoteMedia
FDA APPROVES LUMAKRAS® IN COMBINATION WITH VECTIBIX® FOR CHEMOREFRACTORY KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER
Pivotal Study Demonstrated the Combination More Than Doubled Progression-Free Survival Compared to Investigated SOC
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved LUMAKRAS ® (sotorasib) in combination with Vectibix ® (panitumumab) for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. Approval is based on the pivotal Phase 3 CodeBreaK 300 study, which demonstrated that LUMAKRAS plus Vectibix is the first and only targeted treatment combination for chemorefractory KRAS G12C-mutated mCRC to show superior progression-free survival (PFS) compared to the investigated standard-of-care (SOC). 1*
"Colorectal cancer is the third leading cause of cancer-related deaths in the United States , and fewer than one in five people diagnosed with metastatic disease survive beyond five years after diagnosis," said Jay Bradner , M.D., executive vice president of Research and Development at Amgen. 2 "LUMAKRAS plus Vectibix offers a targeted, biomarker-driven combination therapy that helps delay disease progression more effectively than the investigated standard of care. This new option validates our combination approach to improve outcomes for patients living with advanced KRAS G12C-mutated metastatic colorectal cancer."
The CodeBreaK 300 clinical trial compared LUMAKRAS at two different doses (960 mg daily or 240 mg daily) in combination with Vectibix to the investigator's choice of SOC (trifluridine and tipiracil or regorafenib) in patients with chemorefractory KRAS G12C-mutated mCRC. Study results demonstrated that LUMAKRAS 960 mg daily plus Vectibix (n=53) showed an improved median PFS of 5.6 months (4.2, 6.3) compared to 2 months (1.9, 3.9) on investigator's choice of care (n=54), with a hazard ratio (HR) of 0.48 (95% Confidence Interval [CI]: 0.3, 0.78) and a p -value of 0.005. The study demonstrated an improved overall response rate (ORR) of 26% (95% CI: 15, 40) compared to 0% with investigator's choice (95% CI: 0, 7). The study was not statistically powered for overall survival (OS). The median overall survival (mOS) for patients treated with LUMAKRAS plus Vectibix was not reached (NR) (8.6, NR), and mOS for patients treated with investigator's choice was 10.3 months (7, NR), with a HR of 0.7 (95% CI: 0.41, 1.18); the final analysis of OS was not statistically significant. Safety profiles were consistent with those historically observed for LUMAKRAS and Vectibix. The most common adverse reactions (≥20%) are rash (87%), dry skin (28%), diarrhea (28%), stomatitis (26%), fatigue (21%) and musculoskeletal pain (21%). PFS of LUMAKRAS 240 mg daily plus Vectibix (n=53) compared to investigator's choice was not statistically significant.
The KRAS G12C mutation is present in approximately 3-5% of colorectal cancers as determined by an FDA-approved biomarker test. 3-5 This emphasizes the important role of comprehensive biomarker testing in mCRC. By detecting an actionable mutation, eligible patients are now able to receive a corresponding targeted therapy that may lead to improved responses.
"In metastatic colorectal cancer, KRAS mutations are historically associated with worse mortality rates and inferior outcomes compared to non-mutated tumors, and standard treatment options have shown minimal benefit," said Marwan G. Fakih , M.D., primary study investigator and co-director of the Gastrointestinal Cancer Program, City of Hope. 3-6 "Designed for dual blockade of KRAS G12C and EGFR pathways, the combination of sotorasib plus panitumumab provides a needed new treatment option to better overcome cancer's escape mechanisms. The CodeBreaK 300 study showed superior progression-free survival compared to the investigated standard of care and represents a clinically meaningful benefit for patients with KRAS G12C-mutated metastatic colorectal cancer."
"There is an immense need for continued innovation and precision medicine to help address metastatic colorectal cancer," said Michael Sapienza , Chief Executive Officer of the Colorectal Cancer Alliance. "This new combination approach is an important breakthrough for patients with KRAS G12C-mutated metastatic colorectal cancer, offering a new beneficial treatment option for patients living with this devastating and challenging disease."
* Investigator's choice for SOC included trifluridine/tipiracil or regorafenib.
About CodeBreaK 300
The CodeBreaK 300 trial enrolled 160 participants and compared LUMAKRAS ® (sotorasib) at doses of 960 mg and 240 mg in combination with Vectibix ® (panitumumab) to investigator's choice of standard of care (trifluridine/tipiracil or regorafenib) in patients with chemorefractory KRAS G12C-mutated metastatic colorectal cancer (mCRC). The study met its primary endpoint showing improved progression-free survival (PFS), and the key secondary endpoints of overall survival (OS) and overall response rate (ORR) also favored the combination.
About mCRC and the KRAS G12C Mutation
Colorectal cancer (CRC) is the second leading cause of cancer deaths worldwide, comprising 11% of all cancer diagnoses. 7 It is also the third most commonly diagnosed cancer globally. 8
Patients with previously treated mCRC need more effective treatment options. For patients in the third-line setting, standard therapies yield median OS times of less than one year, and patients' response rates are less than 10%. 9
KRAS mutations are among the most common genetic alterations in CRC, with the KRAS G12C mutation present in approximately 3-5% of CRC cases as determined by a U.S. Food and Drug Administration (FDA)-approved biomarker test. 3-5
About LUMAKRAS ® (sotorasib) in Combination with Vectibix ® (panitumumab)
In the U.S., LUMAKRAS is now approved in combination with Vectibix ® (panitumumab) for the treatment of adult patients with KRAS G12C-mutated mCRC, as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. This targeted therapy combines LUMAKRAS, a KRAS G12C inhibitor, with Vectibix, a monoclonal anti-EGFR antibody. The recommended dose of LUMAKRAS is 960 mg daily, and the recommended dose of Vectibix is 6 mg/kg IV q2 weeks.
About LUMAKRAS ® /LUMYKRAS ® (sotorasib)
LUMAKRAS received accelerated approval from the FDA on May 28, 2021 . The FDA completed its review of Amgen's supplemental New Drug Application (sNDA) seeking full approval of LUMAKRAS on December 26, 2023 , which resulted in a complete response letter. In addition, the FDA concluded that the dose comparison postmarketing requirement (PMR) issued at the time of LUMAKRAS accelerated approval, to compare the safety and efficacy of LUMAKRAS 960 mg daily dose versus a lower daily dose, has been fulfilled. The company said LUMAKRAS at 960 mg once-daily will remain the dose for patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC) under accelerated approval. The FDA also issued a new PMR for an additional confirmatory study to support full approval that will be completed no later than February 2028.
About Vectibix ® (panitumumab)
Vectibix is the first and only human monoclonal anti-EGFR antibody fully approved by the FDA for the treatment of mCRC. Vectibix was approved in the U.S. in September 2006 as a monotherapy for the treatment of patients with EGFR-expressing mCRC following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemotherapy.
In May 2014, the FDA approved Vectibix for use in combination with FOLFOX as first-line treatment in patients with wild-type KRAS (exon 2) mCRC. With this approval, Vectibix became the first-and-only anti-EGFR biologic therapy indicated for use with FOLFOX, one of the most commonly used chemotherapy regimens, in first-line treatment of mCRC for patients with wild-type KRAS mCRC.
In June 2017, the FDA approved a refined indication for Vectibix for use in patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) mCRC, specifically as first-line therapy in combination with FOLFOX and as monotherapy following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemotherapy.
LUMAKRAS ® (sotorasib) in Combination with Vectibix ® (panitumumab) U.S. Indication
Vectibix ® in combination with sotorasib, is indicated for the treatment of adult patients with KRAS G12C -mutated mCRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
LIMITATIONS OF USE
Vectibix ® is not indicated for the treatment of patients with RAS- mutant mCRC unless used in combination with sotorasib in KRAS G12C-mutated mCRC. Vectibix ® is not indicated for the treatment of patients with mCRC for whom RAS mutation status is unknown.
IMPORTANT SAFETY INFORMATION FOR LUMAKRAS ® (SOTORASIB)
Hepatotoxicity
- LUMAKRAS ® can cause hepatotoxicity and increased ALT or AST which may lead to drug-induced liver injury and hepatitis.
- In the pooled safety population of NSCLC patients who received single agent LUMAKRAS ® 960 mg hepatotoxicity occurred in 27% of patients, of which 16% were Grade ≥ 3. Among patients with hepatotoxicity who required dosage modifications, 64% required treatment with corticosteroids.
- In this pooled safety population of NSCLC patients who received single agent LUMAKRAS ® 960 mg, 17% of patients who received LUMAKRAS ® had increased alanine aminotransferase (ALT)/increased aspartate aminotransferase (AST); of which 9% were Grade ≥ 3. The median time to first onset of increased ALT/AST was 6.3 weeks (range: 0.4 to 42). Increased ALT/AST leading to dose interruption or reduction occurred in 9% of patients treated with LUMAKRAS ® . LUMAKRAS ® was permanently discontinued due to increased ALT/AST in 2.7% of patients. Drug-induced liver injury occurred in 1.6% (all grades) including 1.3% (Grade ≥ 3).
- In this pooled safety population of NSCLC patients who received single agent LUMAKRAS ® 960 mg, a total of 40% patients with recent (≤ 3 months) immunotherapy prior to starting LUMAKRAS ® had an event of hepatotoxicity. An event of hepatotoxicity was observed in 18% of patients who started LUMAKRAS ® more than 3 months after last dose of immunotherapy and in 17% of those who never received immunotherapy. Regardless of time from prior immunotherapy, 94% of hepatotoxicity events improved or resolved with dosage modification of LUMAKRAS ® , with or without corticosteroid treatment.
- Monitor liver function tests (ALT, AST, alkaline phosphatase and total bilirubin) prior to the start of LUMAKRAS ® , every 3 weeks for the first 3 months of treatment, then once a month or as clinically indicated, with more frequent testing in patients who develop transaminase and/or bilirubin elevations. Withhold, reduce the dose or permanently discontinue LUMAKRAS ® based on severity of the adverse reaction. Consider administering systemic corticosteroids for the management of hepatotoxicity.
Interstitial Lung Disease (ILD)/Pneumonitis
- LUMAKRAS ® can cause ILD/pneumonitis that can be fatal.
- In the pooled safety population of NSCLC patients who received single agent LUMAKRAS ® 960 mg ILD/pneumonitis occurred in 2.2% of patients, of which 1.1% were Grade ≥ 3, and 1 case was fatal. The median time to first onset for ILD/pneumonitis was 8.6 weeks (range: 2.1 to 36.7 weeks). LUMAKRAS ® was permanently discontinued due to ILD/pneumonitis in 1.3% of LUMAKRAS ® -treated patients. Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold LUMAKRAS ® in patients with suspected ILD/pneumonitis and permanently discontinue LUMAKRAS ® if no other potential causes of ILD/pneumonitis are identified.
Most Common Adverse Reactions
- The most common adverse reactions ≥ 20% were diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity, and cough.
Drug Interactions
- Advise patients to inform their healthcare provider of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, dietary and herbal products.
- Inform patients to avoid proton pump inhibitors and H2 receptor antagonists while taking LUMAKRAS ® .
- If coadministration with an acid-reducing agent cannot be avoided, inform patients to take LUMAKRAS ® 4 hours before or 10 hours after a locally acting antacid.
Please see accompanying LUMAKRAS ® full Prescribing Information .
IMPORTANT SAFETY INFORMATION FOR VECTIBIX ® (PANITUMUMAB)
BOXED WARNING: DERMATOLOGIC TOXICITY
Dermatologic Toxicity: Dermatologic toxicities occurred in 90% of patients and were severe (NCI-CTC Grade 3 and higher) in 15% of patients receiving Vectibix ® monotherapy
- Vectibix ® can cause dermatologic toxicity, which may be severe. Clinical manifestations included, but were not limited to, acneiform dermatitis, pruritus, erythema, rash, skin exfoliation, paronychia, dry skin, and skin fissures.
- Among 229 patients who received Vectibix ® as monotherapy, dermatologic toxicity occurred in 90% including Grade 3 (15%). Among 585 patients who received Vectibix ® in combination with FOLFOX, dermatologic toxicity occurred in 96% including Grade 4 (1%) and Grade 3 (32%). In 126 patients receiving Vectibix ® in combination with sotorasib across clinical studies, dermatologic toxicities occurred in 94%, including Grade 3 (16%) of patients.
- Monitor patients who develop dermatologic or soft tissue toxicities while receiving Vectibix ® for the development of inflammatory or infectious sequelae. Life-threatening and fatal infectious complications including necrotizing fasciitis, abscesses, and sepsis have been observed in patients treated with Vectibix ® . Life-threatening and fatal bullous mucocutaneous disease with blisters, erosions, and skin sloughing has also been observed in patients treated with Vectibix ® . It could not be determined whether these mucocutaneous adverse reactions were directly related to EGFR inhibition or to idiosyncratic immune-related effects (eg, Stevens Johnson syndrome or toxic epidermal necrolysis). Withhold or discontinue Vectibix ® for dermatologic or soft tissue toxicity associated with severe or life-threatening inflammatory or infectious complications. Dose modifications for Vectibix ® concerning dermatologic toxicity are provided
- Vectibix ® monotherapy or in combination with oxaliplatin-based chemotherapy is not indicated for the treatment of patients with colorectal cancer that harbor somatic RAS mutations in exon 2 (codons 12 and 13), exon 3 (codons 59 and 61), and exon 4 (codons 117 and 146) of either KRAS or NRAS and hereafter is referred to as " RAS. "
- Retrospective subset analyses across several randomized clinical trials were conducted to investigate the role of RAS mutations on the clinical effects of anti-EGFR-directed monoclonal antibodies (panitumumab or cetuximab). Anti-EGFR antibodies in patients with tumors containing RAS mutations resulted in exposing those patients to anti-EGFR related adverse reactions without clinical benefit from these agents. Additionally, in Study 20050203, 272 patients with RAS -mutant mCRC tumors received Vectibix ® in combination with FOLFOX and 276 patients received FOLFOX alone. In an exploratory subgroup analysis , OS was shorter (HR = 1.21, 95% CI: 1.01-1.45) in patients with RAS -mutant mCRC who received Vectibix ® and FOLFOX versus FOLFOX alone.
- Vectibix ® can cause progressively decreasing serum magnesium levels leading to severe (Grade 3 or 4) hypomagnesemia. Among 229 patients who received Vectibix ® as monotherapy, hypomagnesemia occurred in 38% including Grade 4 (1.3%) and Grade 3 (2.6%). Among 585 patients who received Vectibix ® in combination with FOLFOX, hypomagnesemia occurred in 51% including Grade 4 (5%) and Grade 3 (6%). In 126 patients receiving Vectibix ® in combination with sotorasib across clinical studies, decreased magnesium occurred in 69%, including Grade 4 (2.4%) and Grade 3 (14%).
- Monitor patients for hypomagnesemia and hypocalcemia prior to initiating Vectibix ® treatment, periodically during Vectibix ® treatment, and for up to 8 weeks after the completion of treatment. Other electrolyte disturbances, including hypokalemia, have also been observed. Replete magnesium and other electrolytes as appropriate.
- In Study 20020408, 4% of patients experienced infusion reactions and 1% of patients experienced severe infusion reactions (NCI-CTC Grade 3-4). Infusion reactions, manifesting as fever, chills, dyspnea, bronchospasm, and hypotension, can occur following Vectibix ® administration. Fatal infusion reactions occurred in postmarketing experience. Terminate the infusion for severe infusion reactions.
- Severe diarrhea and dehydration, leading to acute renal failure and other complications, have been observed in patients treated with Vectibix ® . Among 229 patients who received Vectibix ® as monotherapy, acute renal failure occurred in 2% including Grades 3 or 4 (2%). Among 585 patients who received Vectibix ® in combination with FOLFOX, acute renal failure occurred in 2% including Grade 3 or 4 (2%). In 126 patients receiving Vectibix ® in combination with sotorasib across clinical studies, acute renal failure occurred in 3.2%, including Grade 3 (0.8%). Monitor patients for diarrhea and dehydration, provide supportive care (including anti-emetic or anti-diarrheal therapy) as needed, and withhold Vectibix ® if necessary.
- Fatal and nonfatal cases of interstitial lung disease (ILD) (1%) and pulmonary fibrosis have been observed in patients treated with Vectibix ® . Pulmonary fibrosis occurred in less than 1% (2/1467) of patients enrolled in clinical studies of Vectibix ® . Grade 1 ILD/pneumonitis occurred in 0.8% (1/126) of patients enrolled in clinical studies of Vectibix ® in combination with sotorasib. In the event of acute onset or worsening of pulmonary symptoms interrupt Vectibix ® therapy. Discontinue Vectibix ® therapy if ILD is confirmed.
- In patients with a history of interstitial pneumonitis or pulmonary fibrosis, or evidence of interstitial pneumonitis or pulmonary fibrosis, the benefits of therapy with Vectibix ® versus the risk of pulmonary complications must be carefully considered.
- Exposure to sunlight can exacerbate dermatologic toxicity. Advise patients to wear sunscreen and hats and limit sun exposure while receiving Vectibix ® .
- Serious cases of keratitis, ulcerative keratitis, and corneal perforation have occurred with Vectibix ® use. Among 585 patients who received Vectibix ® in combination with FOLFOX, keratitis occurred in 0.3%. In 126 patients receiving Vectibix ® in combination with sotorasib across clinical studies, keratitis occurred in 1.6%, ulcerative keratitis occurred in 0.8%, and vernal keratoconjunctivitis in 0.8% (all were Grade 1-2). Monitor for evidence of keratitis, ulcerative keratitis, or corneal perforation. Interrupt or discontinue Vectibix ® therapy for acute or worsening keratitis, ulcerative keratitis, or corneal perforation.
- In an interim analysis of an open-label, multicenter, randomized clinical trial in the first-line setting in patients with mCRC, the addition of Vectibix ® to the combination of bevacizumab and chemotherapy resulted in decreased OS and increased incidence of NCI-CTC Grade 3-5 (87% vs 72%) adverse reactions. NCI-CTC Grade 3-4 adverse reactions occurring at a higher rate in Vectibix ® -treated patients included rash/acneiform dermatitis (26% vs 1%), diarrhea (23% vs 12%), dehydration (16% vs 5%), primarily occurring in patients with diarrhea, hypokalemia (10% vs 4%), stomatitis/mucositis (4% vs ® -treated patients (7% vs 3%) and included fatal events in three ( ® -treated patients.
- As a result of the toxicities experienced, patients randomized to Vectibix ® , bevacizumab, and chemotherapy received a lower mean relative dose intensity of each chemotherapeutic agent (oxaliplatin, irinotecan, bolus 5-FU, and/or infusional 5-FU) over the first 24 weeks on study compared with those randomized to bevacizumab and chemotherapy.
- Based on data from animal studies and its mechanism of action, Vectibix ® can cause fetal harm when administered to a pregnant woman. When given during organogenesis, panitumumab administration resulted in embryolethality in cynomolgus monkeys at exposures approximately 1.25 to 5 times the recommended human dose. Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment, and for at least 2 months after the last dose of Vectibix ® .
- In monotherapy, the most commonly reported adverse reactions (≥ 20%) in patients with Vectibix ® were skin rash with variable presentations, paronychia, fatigue, nausea, and diarrhea.
- The most commonly reported adverse reactions (≥ 20%) with Vectibix ® + FOLFOX were diarrhea, stomatitis, mucosal inflammation, asthenia, paronychia, anorexia, hypomagnesemia, hypokalemia, rash, acneiform dermatitis, pruritus, and dry skin. Serious adverse reactions (≥ 2% difference between treatment arms) were diarrhea and dehydration.
- The most common adverse reactions (≥ 20%) in patients receiving Vectibix ® in combination with sotorasib 960 mg were rash, dry skin, diarrhea, stomatitis, fatigue and musculoskeletal pain.
Please see full Prescribing Information , including Boxed WARNING.
About Amgen
Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.
In 2024, Amgen was named one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes, among other external recognitions . Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average ® , and it is also part of the Nasdaq-100 Index ® , which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.
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References
- Fakih M, et al. N Engl J Med. 2023;389(23): 2125- 2139.
- Biller L, et al. JAMA . 2021;325(7):669-685.
- Neumann J, et al. Pathol Res Pract . 2009;205(12):858-862.
- Jones RP, et al. Br J Cancer . 2017;116(7):923-929.
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- Fakih M, et al. The Oncologist . 2022;27(8):663–674.
- Rawla P, et al. Prz Gastroenterol . 2019;14(2):89-103.
- World Health Organization. 2022 Statistics. https://www.who.int/en/news-room/fact-sheets/detail/cancer . Accessed on August 20, 2024 .
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FDA APPROVES LUMAKRAS® IN COMBINATION WITH VECTIBIX® FOR CHEMOREFRACTORY KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER
Pivotal Study Demonstrated the Combination More Than Doubled Progression-Free Survival Compared to Investigated SOC
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved LUMAKRAS ® (sotorasib) in combination with Vectibix ® (panitumumab) for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. Approval is based on the pivotal Phase 3 CodeBreaK 300 study, which demonstrated that LUMAKRAS plus Vectibix is the first and only targeted treatment combination for chemorefractory KRAS G12C-mutated mCRC to show superior progression-free survival (PFS) compared to the investigated standard-of-care (SOC). 1*
"Colorectal cancer is the third leading cause of cancer-related deaths in the United States , and fewer than one in five people diagnosed with metastatic disease survive beyond five years after diagnosis," said Jay Bradner , M.D., executive vice president of Research and Development at Amgen. 2 "LUMAKRAS plus Vectibix offers a targeted, biomarker-driven combination therapy that helps delay disease progression more effectively than the investigated standard of care. This new option validates our combination approach to improve outcomes for patients living with advanced KRAS G12C-mutated metastatic colorectal cancer."
The CodeBreaK 300 clinical trial compared LUMAKRAS at two different doses (960 mg daily or 240 mg daily) in combination with Vectibix to the investigator's choice of SOC (trifluridine and tipiracil or regorafenib) in patients with chemorefractory KRAS G12C-mutated mCRC. Study results demonstrated that LUMAKRAS 960 mg daily plus Vectibix (n=53) showed an improved median PFS of 5.6 months (4.2, 6.3) compared to 2 months (1.9, 3.9) on investigator's choice of care (n=54), with a hazard ratio (HR) of 0.48 (95% Confidence Interval [CI]: 0.3, 0.78) and a p -value of 0.005. The study demonstrated an improved overall response rate (ORR) of 26% (95% CI: 15, 40) compared to 0% with investigator's choice (95% CI: 0, 7). The study was not statistically powered for overall survival (OS). The median overall survival (mOS) for patients treated with LUMAKRAS plus Vectibix was not reached (NR) (8.6, NR), and mOS for patients treated with investigator's choice was 10.3 months (7, NR), with a HR of 0.7 (95% CI: 0.41, 1.18); the final analysis of OS was not statistically significant. Safety profiles were consistent with those historically observed for LUMAKRAS and Vectibix. The most common adverse reactions (≥20%) are rash (87%), dry skin (28%), diarrhea (28%), stomatitis (26%), fatigue (21%) and musculoskeletal pain (21%). PFS of LUMAKRAS 240 mg daily plus Vectibix (n=53) compared to investigator's choice was not statistically significant.
The KRAS G12C mutation is present in approximately 3-5% of colorectal cancers as determined by an FDA-approved biomarker test. 3-5 This emphasizes the important role of comprehensive biomarker testing in mCRC. By detecting an actionable mutation, eligible patients are now able to receive a corresponding targeted therapy that may lead to improved responses.
"In metastatic colorectal cancer, KRAS mutations are historically associated with worse mortality rates and inferior outcomes compared to non-mutated tumors, and standard treatment options have shown minimal benefit," said Marwan G. Fakih , M.D., primary study investigator and co-director of the Gastrointestinal Cancer Program, City of Hope. 3-6 "Designed for dual blockade of KRAS G12C and EGFR pathways, the combination of sotorasib plus panitumumab provides a needed new treatment option to better overcome cancer's escape mechanisms. The CodeBreaK 300 study showed superior progression-free survival compared to the investigated standard of care and represents a clinically meaningful benefit for patients with KRAS G12C-mutated metastatic colorectal cancer."
"There is an immense need for continued innovation and precision medicine to help address metastatic colorectal cancer," said Michael Sapienza , Chief Executive Officer of the Colorectal Cancer Alliance. "This new combination approach is an important breakthrough for patients with KRAS G12C-mutated metastatic colorectal cancer, offering a new beneficial treatment option for patients living with this devastating and challenging disease."
* Investigator's choice for SOC included trifluridine/tipiracil or regorafenib.
About CodeBreaK 300
The CodeBreaK 300 trial enrolled 160 participants and compared LUMAKRAS ® (sotorasib) at doses of 960 mg and 240 mg in combination with Vectibix ® (panitumumab) to investigator's choice of standard of care (trifluridine/tipiracil or regorafenib) in patients with chemorefractory KRAS G12C-mutated metastatic colorectal cancer (mCRC). The study met its primary endpoint showing improved progression-free survival (PFS), and the key secondary endpoints of overall survival (OS) and overall response rate (ORR) also favored the combination.
About mCRC and the KRAS G12C Mutation
Colorectal cancer (CRC) is the second leading cause of cancer deaths worldwide, comprising 11% of all cancer diagnoses. 7 It is also the third most commonly diagnosed cancer globally. 8
Patients with previously treated mCRC need more effective treatment options. For patients in the third-line setting, standard therapies yield median OS times of less than one year, and patients' response rates are less than 10%. 9
KRAS mutations are among the most common genetic alterations in CRC, with the KRAS G12C mutation present in approximately 3-5% of CRC cases as determined by a U.S. Food and Drug Administration (FDA)-approved biomarker test. 3-5
About LUMAKRAS ® (sotorasib) in Combination with Vectibix ® (panitumumab)
In the U.S., LUMAKRAS is now approved in combination with Vectibix ® (panitumumab) for the treatment of adult patients with KRAS G12C-mutated mCRC, as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. This targeted therapy combines LUMAKRAS, a KRAS G12C inhibitor, with Vectibix, a monoclonal anti-EGFR antibody. The recommended dose of LUMAKRAS is 960 mg daily, and the recommended dose of Vectibix is 6 mg/kg IV q2 weeks.
About LUMAKRAS ® /LUMYKRAS ® (sotorasib)
LUMAKRAS received accelerated approval from the FDA on May 28, 2021 . The FDA completed its review of Amgen's supplemental New Drug Application (sNDA) seeking full approval of LUMAKRAS on December 26, 2023 , which resulted in a complete response letter. In addition, the FDA concluded that the dose comparison postmarketing requirement (PMR) issued at the time of LUMAKRAS accelerated approval, to compare the safety and efficacy of LUMAKRAS 960 mg daily dose versus a lower daily dose, has been fulfilled. The company said LUMAKRAS at 960 mg once-daily will remain the dose for patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC) under accelerated approval. The FDA also issued a new PMR for an additional confirmatory study to support full approval that will be completed no later than February 2028.
About Vectibix ® (panitumumab)
Vectibix is the first and only human monoclonal anti-EGFR antibody fully approved by the FDA for the treatment of mCRC. Vectibix was approved in the U.S. in September 2006 as a monotherapy for the treatment of patients with EGFR-expressing mCRC following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemotherapy.
In May 2014, the FDA approved Vectibix for use in combination with FOLFOX as first-line treatment in patients with wild-type KRAS (exon 2) mCRC. With this approval, Vectibix became the first-and-only anti-EGFR biologic therapy indicated for use with FOLFOX, one of the most commonly used chemotherapy regimens, in first-line treatment of mCRC for patients with wild-type KRAS mCRC.
In June 2017, the FDA approved a refined indication for Vectibix for use in patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) mCRC, specifically as first-line therapy in combination with FOLFOX and as monotherapy following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemotherapy.
LUMAKRAS ® (sotorasib) in Combination with Vectibix ® (panitumumab) U.S. Indication
Vectibix ® in combination with sotorasib, is indicated for the treatment of adult patients with KRAS G12C -mutated mCRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
LIMITATIONS OF USE
Vectibix ® is not indicated for the treatment of patients with RAS- mutant mCRC unless used in combination with sotorasib in KRAS G12C-mutated mCRC. Vectibix ® is not indicated for the treatment of patients with mCRC for whom RAS mutation status is unknown.
IMPORTANT SAFETY INFORMATION FOR LUMAKRAS ® (SOTORASIB)
Hepatotoxicity
- LUMAKRAS ® can cause hepatotoxicity and increased ALT or AST which may lead to drug-induced liver injury and hepatitis.
- In the pooled safety population of NSCLC patients who received single agent LUMAKRAS ® 960 mg hepatotoxicity occurred in 27% of patients, of which 16% were Grade ≥ 3. Among patients with hepatotoxicity who required dosage modifications, 64% required treatment with corticosteroids.
- In this pooled safety population of NSCLC patients who received single agent LUMAKRAS ® 960 mg, 17% of patients who received LUMAKRAS ® had increased alanine aminotransferase (ALT)/increased aspartate aminotransferase (AST); of which 9% were Grade ≥ 3. The median time to first onset of increased ALT/AST was 6.3 weeks (range: 0.4 to 42). Increased ALT/AST leading to dose interruption or reduction occurred in 9% of patients treated with LUMAKRAS ® . LUMAKRAS ® was permanently discontinued due to increased ALT/AST in 2.7% of patients. Drug-induced liver injury occurred in 1.6% (all grades) including 1.3% (Grade ≥ 3).
- In this pooled safety population of NSCLC patients who received single agent LUMAKRAS ® 960 mg, a total of 40% patients with recent (≤ 3 months) immunotherapy prior to starting LUMAKRAS ® had an event of hepatotoxicity. An event of hepatotoxicity was observed in 18% of patients who started LUMAKRAS ® more than 3 months after last dose of immunotherapy and in 17% of those who never received immunotherapy. Regardless of time from prior immunotherapy, 94% of hepatotoxicity events improved or resolved with dosage modification of LUMAKRAS ® , with or without corticosteroid treatment.
- Monitor liver function tests (ALT, AST, alkaline phosphatase and total bilirubin) prior to the start of LUMAKRAS ® , every 3 weeks for the first 3 months of treatment, then once a month or as clinically indicated, with more frequent testing in patients who develop transaminase and/or bilirubin elevations. Withhold, reduce the dose or permanently discontinue LUMAKRAS ® based on severity of the adverse reaction. Consider administering systemic corticosteroids for the management of hepatotoxicity.
Interstitial Lung Disease (ILD)/Pneumonitis
- LUMAKRAS ® can cause ILD/pneumonitis that can be fatal.
- In the pooled safety population of NSCLC patients who received single agent LUMAKRAS ® 960 mg ILD/pneumonitis occurred in 2.2% of patients, of which 1.1% were Grade ≥ 3, and 1 case was fatal. The median time to first onset for ILD/pneumonitis was 8.6 weeks (range: 2.1 to 36.7 weeks). LUMAKRAS ® was permanently discontinued due to ILD/pneumonitis in 1.3% of LUMAKRAS ® -treated patients. Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold LUMAKRAS ® in patients with suspected ILD/pneumonitis and permanently discontinue LUMAKRAS ® if no other potential causes of ILD/pneumonitis are identified.
Most Common Adverse Reactions
- The most common adverse reactions ≥ 20% were diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity, and cough.
Drug Interactions
- Advise patients to inform their healthcare provider of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, dietary and herbal products.
- Inform patients to avoid proton pump inhibitors and H2 receptor antagonists while taking LUMAKRAS ® .
- If coadministration with an acid-reducing agent cannot be avoided, inform patients to take LUMAKRAS ® 4 hours before or 10 hours after a locally acting antacid.
Please see accompanying LUMAKRAS ® full Prescribing Information .
IMPORTANT SAFETY INFORMATION FOR VECTIBIX ® (PANITUMUMAB)
BOXED WARNING: DERMATOLOGIC TOXICITY
Dermatologic Toxicity: Dermatologic toxicities occurred in 90% of patients and were severe (NCI-CTC Grade 3 and higher) in 15% of patients receiving Vectibix ® monotherapy
- Vectibix ® can cause dermatologic toxicity, which may be severe. Clinical manifestations included, but were not limited to, acneiform dermatitis, pruritus, erythema, rash, skin exfoliation, paronychia, dry skin, and skin fissures.
- Among 229 patients who received Vectibix ® as monotherapy, dermatologic toxicity occurred in 90% including Grade 3 (15%). Among 585 patients who received Vectibix ® in combination with FOLFOX, dermatologic toxicity occurred in 96% including Grade 4 (1%) and Grade 3 (32%). In 126 patients receiving Vectibix ® in combination with sotorasib across clinical studies, dermatologic toxicities occurred in 94%, including Grade 3 (16%) of patients.
- Monitor patients who develop dermatologic or soft tissue toxicities while receiving Vectibix ® for the development of inflammatory or infectious sequelae. Life-threatening and fatal infectious complications including necrotizing fasciitis, abscesses, and sepsis have been observed in patients treated with Vectibix ® . Life-threatening and fatal bullous mucocutaneous disease with blisters, erosions, and skin sloughing has also been observed in patients treated with Vectibix ® . It could not be determined whether these mucocutaneous adverse reactions were directly related to EGFR inhibition or to idiosyncratic immune-related effects (eg, Stevens Johnson syndrome or toxic epidermal necrolysis). Withhold or discontinue Vectibix ® for dermatologic or soft tissue toxicity associated with severe or life-threatening inflammatory or infectious complications. Dose modifications for Vectibix ® concerning dermatologic toxicity are provided
- Vectibix ® monotherapy or in combination with oxaliplatin-based chemotherapy is not indicated for the treatment of patients with colorectal cancer that harbor somatic RAS mutations in exon 2 (codons 12 and 13), exon 3 (codons 59 and 61), and exon 4 (codons 117 and 146) of either KRAS or NRAS and hereafter is referred to as " RAS. "
- Retrospective subset analyses across several randomized clinical trials were conducted to investigate the role of RAS mutations on the clinical effects of anti-EGFR-directed monoclonal antibodies (panitumumab or cetuximab). Anti-EGFR antibodies in patients with tumors containing RAS mutations resulted in exposing those patients to anti-EGFR related adverse reactions without clinical benefit from these agents. Additionally, in Study 20050203, 272 patients with RAS -mutant mCRC tumors received Vectibix ® in combination with FOLFOX and 276 patients received FOLFOX alone. In an exploratory subgroup analysis , OS was shorter (HR = 1.21, 95% CI: 1.01-1.45) in patients with RAS -mutant mCRC who received Vectibix ® and FOLFOX versus FOLFOX alone.
- Vectibix ® can cause progressively decreasing serum magnesium levels leading to severe (Grade 3 or 4) hypomagnesemia. Among 229 patients who received Vectibix ® as monotherapy, hypomagnesemia occurred in 38% including Grade 4 (1.3%) and Grade 3 (2.6%). Among 585 patients who received Vectibix ® in combination with FOLFOX, hypomagnesemia occurred in 51% including Grade 4 (5%) and Grade 3 (6%). In 126 patients receiving Vectibix ® in combination with sotorasib across clinical studies, decreased magnesium occurred in 69%, including Grade 4 (2.4%) and Grade 3 (14%).
- Monitor patients for hypomagnesemia and hypocalcemia prior to initiating Vectibix ® treatment, periodically during Vectibix ® treatment, and for up to 8 weeks after the completion of treatment. Other electrolyte disturbances, including hypokalemia, have also been observed. Replete magnesium and other electrolytes as appropriate.
- In Study 20020408, 4% of patients experienced infusion reactions and 1% of patients experienced severe infusion reactions (NCI-CTC Grade 3-4). Infusion reactions, manifesting as fever, chills, dyspnea, bronchospasm, and hypotension, can occur following Vectibix ® administration. Fatal infusion reactions occurred in postmarketing experience. Terminate the infusion for severe infusion reactions.
- Severe diarrhea and dehydration, leading to acute renal failure and other complications, have been observed in patients treated with Vectibix ® . Among 229 patients who received Vectibix ® as monotherapy, acute renal failure occurred in 2% including Grades 3 or 4 (2%). Among 585 patients who received Vectibix ® in combination with FOLFOX, acute renal failure occurred in 2% including Grade 3 or 4 (2%). In 126 patients receiving Vectibix ® in combination with sotorasib across clinical studies, acute renal failure occurred in 3.2%, including Grade 3 (0.8%). Monitor patients for diarrhea and dehydration, provide supportive care (including anti-emetic or anti-diarrheal therapy) as needed, and withhold Vectibix ® if necessary.
- Fatal and nonfatal cases of interstitial lung disease (ILD) (1%) and pulmonary fibrosis have been observed in patients treated with Vectibix ® . Pulmonary fibrosis occurred in less than 1% (2/1467) of patients enrolled in clinical studies of Vectibix ® . Grade 1 ILD/pneumonitis occurred in 0.8% (1/126) of patients enrolled in clinical studies of Vectibix ® in combination with sotorasib. In the event of acute onset or worsening of pulmonary symptoms interrupt Vectibix ® therapy. Discontinue Vectibix ® therapy if ILD is confirmed.
- In patients with a history of interstitial pneumonitis or pulmonary fibrosis, or evidence of interstitial pneumonitis or pulmonary fibrosis, the benefits of therapy with Vectibix ® versus the risk of pulmonary complications must be carefully considered.
- Exposure to sunlight can exacerbate dermatologic toxicity. Advise patients to wear sunscreen and hats and limit sun exposure while receiving Vectibix ® .
- Serious cases of keratitis, ulcerative keratitis, and corneal perforation have occurred with Vectibix ® use. Among 585 patients who received Vectibix ® in combination with FOLFOX, keratitis occurred in 0.3%. In 126 patients receiving Vectibix ® in combination with sotorasib across clinical studies, keratitis occurred in 1.6%, ulcerative keratitis occurred in 0.8%, and vernal keratoconjunctivitis in 0.8% (all were Grade 1-2). Monitor for evidence of keratitis, ulcerative keratitis, or corneal perforation. Interrupt or discontinue Vectibix ® therapy for acute or worsening keratitis, ulcerative keratitis, or corneal perforation.
- In an interim analysis of an open-label, multicenter, randomized clinical trial in the first-line setting in patients with mCRC, the addition of Vectibix ® to the combination of bevacizumab and chemotherapy resulted in decreased OS and increased incidence of NCI-CTC Grade 3-5 (87% vs 72%) adverse reactions. NCI-CTC Grade 3-4 adverse reactions occurring at a higher rate in Vectibix ® -treated patients included rash/acneiform dermatitis (26% vs 1%), diarrhea (23% vs 12%), dehydration (16% vs 5%), primarily occurring in patients with diarrhea, hypokalemia (10% vs 4%), stomatitis/mucositis (4% vs ® -treated patients (7% vs 3%) and included fatal events in three ( ® -treated patients.
- As a result of the toxicities experienced, patients randomized to Vectibix ® , bevacizumab, and chemotherapy received a lower mean relative dose intensity of each chemotherapeutic agent (oxaliplatin, irinotecan, bolus 5-FU, and/or infusional 5-FU) over the first 24 weeks on study compared with those randomized to bevacizumab and chemotherapy.
- Based on data from animal studies and its mechanism of action, Vectibix ® can cause fetal harm when administered to a pregnant woman. When given during organogenesis, panitumumab administration resulted in embryolethality in cynomolgus monkeys at exposures approximately 1.25 to 5 times the recommended human dose. Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment, and for at least 2 months after the last dose of Vectibix ® .
- In monotherapy, the most commonly reported adverse reactions (≥ 20%) in patients with Vectibix ® were skin rash with variable presentations, paronychia, fatigue, nausea, and diarrhea.
- The most commonly reported adverse reactions (≥ 20%) with Vectibix ® + FOLFOX were diarrhea, stomatitis, mucosal inflammation, asthenia, paronychia, anorexia, hypomagnesemia, hypokalemia, rash, acneiform dermatitis, pruritus, and dry skin. Serious adverse reactions (≥ 2% difference between treatment arms) were diarrhea and dehydration.
- The most common adverse reactions (≥ 20%) in patients receiving Vectibix ® in combination with sotorasib 960 mg were rash, dry skin, diarrhea, stomatitis, fatigue and musculoskeletal pain.
Please see full Prescribing Information , including Boxed WARNING.
About Amgen
Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.
In 2024, Amgen was named one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes, among other external recognitions . Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average ® , and it is also part of the Nasdaq-100 Index ® , which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.
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Amgen Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or Kyowa Kirin Co., Ltd.), the performance of Otezla ® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), our acquisitions of Teneobio, Inc., ChemoCentryx, Inc., or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon's business, performance and opportunities, any potential strategic benefits, synergies or opportunities expected as a result of such acquisition, and any projected impacts from the Horizon acquisition on our acquisition-related expenses going forward), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on our business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future.
Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.
Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico , and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. There can be no guarantee that we will be able to realize any of the strategic benefits, synergies or opportunities arising from the Horizon acquisition, and such benefits, synergies or opportunities may take longer to realize than expected. We may not be able to successfully integrate Horizon, and such integration may take longer, be more difficult or cost more than expected. A breakdown, cyberattack or information security breach of our information technology systems could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our environmental, social and governance objectives. The effects of global climate change and related natural disasters could negatively affect our business and operations. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.
CONTACT: Amgen, Thousand Oaks
Elissa Snook , 609-251-1407 (media)
Justin Claeys , 805-313-9775 (investors)
References
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SOURCE Amgen
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Cizzle Brands Corporation Teams up with Hockey Influencer, Coach Chippy, to launch Tropical Flow, a Special Edition Coach Chippy Inspired Flavour of CWENCH Hydration
With a combined social media following of more than one million users, Coach Chippy is a leading influencer in youth hockey. Through his Tropical Flow flavour of CWENCH Hydration, which will be available for purchase at Pro Hockey Life, Source for Sports, Sports Excellence and other leading retailers, Coach Chippy will be creating greater visibility for CWENCH Hydration in a key demographic for the brand.
Cizzle Brands Corporation (Cboe Canada: CZZL) ( the "Company or "Cizzle Brands") , is pleased to announce that it has teamed up with famed Canadian hockey influencer Coach Chippy to launch Tropical Flow , a special edition Coach Chippy-inspired flavour of CWENCH Hydration. Tropical Flow , which will be available in ready-to-drink and hydration mix formats, is CWENCH Hydration's fifth flavour option, along with Rainbow Swirl, Blue Raspberry, Cherry Lime and Berry Crush.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250116330910/en/
Canadian hockey influencer Coach Chippy has teamed up with Cizzle Brands to launch Tropical Flow, a new flavour of CWENCH Hydration™. Through his social media channels and major presence within the Canadian hockey sphere, the Company expects to cultivate valuable awareness for the CWENCH brand. (Photo: Business Wire)
The launch of Tropical Flow further strengthens the market position of CWENCH Hydration™ in the sports nutrition market. In Cizzle Brands' most recent quarterly financial results, the Company reported CAD $2.8 million in revenue from sales of CWENCH Hydration™ beverages and mixes, with CAD $1.75 million in gross profit for a 62.5% gross margin. Since its launch in late May of 2024, more than one million ready-to-drink ("RTD") units of CWENCH Hydration™ have been sold.
Under the agreement with Coach Chippy, Cizzle Brands will release a special-edition tropical fruit flavour of CWENCH Hydration™ featuring images of Coach Chippy, as well as his Style & Flow tagline (pictured below). At launch, Tropical Flow will be available for purchase at Pro Hockey Life, Source for Sports, Sports Excellence, Canlan Ice Sports and Buckingham Sports Group with additional retailers expected to offer it soon.
Coach Chippy will be a key driver in creating awareness for CWENCH Hydration and Tropical Flow through his social media profiles, which include:
TikTok: @coachchippyy (736,000 followers)
Instagram: @coach.chippy (450,000 followers)
YouTube: @coachchippy (111,000 followers)
More information about Coach Chippy can be found on his website at the following link: https://coachchippy.ca/en-cad/
Following its launch at the end of May 2024, CWENCH Hydration™ has established a robust brand profile among professional athletes and fans of all ages. As detailed in Cizzle Brands' Market Introduction press release , NHL players including Nathan MacKinnon and Cole Caufield have endorsed CWENCH Hydration™ as well as NBA All-Star Andrew Wiggins, Canadian Olympian Adriana Leon and up-and-coming hockey stars Gavin McKenna, Chloe Primerano and Jade Iginla. Additionally, CWENCH Hydration™ is the named sponsor of a four-rink hockey arena in Toronto known as CWENCH Centre - a Canlan Sports Community as well as a sponsor of over 500 youth hockey teams, which has the CWENCH brand displayed on the hockey gear of more than 12,000 youth hockey players across North America.
Cizzle Brands Chairman and Chief Executive Officer, John Celenza, commented, "In many ways, Coach Chippy represents so much of what is great about youth hockey - passion, commitment and a great sense of joy. His message resonates with so many kids. As a dad myself, I hear about Coach Chippy all the time and know how much clout he has with one of our key demographics for CWENCH Hydration™. Chippy has been a part of the Cizzle Brands story since the early days of the Company, and we are thrilled to be deepening our partnership with him to further strengthen the profile of CWENCH Hydration™ in hockey communities across North America."
Coach Chippy added, "I've had a bunch of companies hit me up about product partnerships, but teaming up with the crew at Cizzle Brands was a no-brainer. When you're dialed in on being your best, CWENCH Hydration™ is the real deal. It's all-natural, sugar-free, and loaded with 6+ electrolytes. The product being healthy was a big deal for me—it's one of the main reasons I decided to put my name (and face) behind it. Staying hydrated the smart way is a huge part of the whole Style and Flow vibe. I'm really excited to bring Tropical Flow to the market."
About Cizzle Brands Corporation
Cizzle Brands Corporation is elevating the game in health and wellness. Through extensive collaboration and testing with leading athletes and trainers across several elite sports, Cizzle Brands has launched two leading product lines in the sports nutrition category: (i) CWENCH Hydration, a better-for-you sports drink that is now carried in over 1,200 stores in Canada, the United States, and Europe; and (ii) Spoken Nutrition, a premium brand of athlete-grade nutraceuticals that carry the prestigious NSF Certified for Sport® qualification. All Cizzle Brands products are designed to help people achieve their best in both competitive sports and in living a healthy, vibrant, active lifestyle.
For more information about Cizzle Brands, please visit: https://www.cizzlebrands.com/
For more information about CWENCH, please visit: https://cwenchhydration.com/
For more information about Spoken Nutrition, please visit: https://spokennutrition.com/
On behalf of the Board of Directors of the Company,
"John Celenza"
John Celenza, Chief Executive Officer
CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION
This news release contains "forward-looking information" which may include, but is not limited to, information with respect to the activities, events or developments that the Company expects or anticipates will or may occur in the future, such as, but not limited to: new products of the Company and potential sales and distribution opportunities. Such forward-looking information is often, but not always, identified by the use of words and phrases such as "plans", "expects", "is expected", "budget", "scheduled", "estimates", "forecasts", "intends", "anticipates", or "believes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Various assumptions or factors are typically applied in drawing conclusions or making the forecasts or projections set out in forward-looking information. Those assumptions and factors are based on information currently available to the Company.
Forward looking information involves known and unknown risks, uncertainties and other risk factors which may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information. Such risks include risks related to increased competition and current global financial conditions, access and supply risks, reliance on key personnel, operational risks, regulatory risks, financing, capitalization and liquidity risks. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking information. The Company undertakes no obligation, except as otherwise required by law, to update these forward-looking statements if management's beliefs, estimates or opinions, or other factors change.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250116330910/en/
For further information, please contact:
Setti Coscarella
Head of Corporate Development
investors@cizzlebrands.com
1-844-588-2088
News Provided by Business Wire via QuoteMedia
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