Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, is pleased to announce the Company has filed a preliminary prospectus supplement (the "Supplement") to its short form base shelf prospectus dated July 12, 2024 (the "Base Prospectus") in connection with a proposed public offering (the "Offering") of Class A common shares (the "Common Shares"). The Supplement was also filed with the U.S. Securities Exchange and Commission (the "SEC"), as part of a registration statement on Form-10, as amended, which was declared effective by the SEC on July 16, 2024, in accordance with the Multijurisdictional Disclosure System established between Canada and the United States.
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Potent Ventures Secures Partnership with Influencer Michelle Cehn in Advance of Launch of The Gummy Project
Potent Ventures Inc. (CSE: POT) (FSE: 0OS) (OTCQB: POTVF) ("Potent" or the "Company") is thrilled to announce that the Company has established a partnership with Michelle Cehn's World of Vegan lifestyle media platform.
- Michelle Cehn brings 1,100,000+ followers on Instagram
- World of Vegan Media Platform to deliver widespread exposure for The Gummy Project through its brand and product launch
- Partnership to include extensive campaign deploying Instagram Features, In-depth articles, Social Media features on Facebook, Twitter and Pinterest and E-newsletter features from Michelle Cehn's World of Vegan
"Building on our significant partnership announcements with OCEARCH (www.ocearch.org), and the Bee Conservancy (www.thebeeconservancy.org), The Gummy Project and World of Vegan have established a partnership that will significantly raise brand awareness directly to one of our target markets, further aligning the brand as one of substance and purpose," said Mr. Charlie Lamb, CEO of The Gummy Project.
Deploying its World of Vegan media platform, The Gummy Project's brand, products and purpose driven marketing strategy will be featured prominently on Instagram (1.1 million plus followers), with articles on www.worldofvegan.com, through e-newsletters aimed at the Company's target market and extensively throughout the World of Vegan's social media platforms including Pinterest, Twitter and Facebook. Over the course of the media campaign, from March 2022 through January 2023, World of Vegan/Michelle Cehn, will receive $3950 USD per month from Potent.
"I couldn't be more thrilled about the launch of The Gummy Project, and I know the world is more than ready for consciously crafted vegan gummies! People are eagerly looking for ways to align their food choices and purchases with their values and it's always a double-win when a brand like The Gummy Project goes beyond just being vegan, and truly establishes their business as a business for good," said Michelle Cehn, Founder, World of Vegan. "I've always had a soft spot in my heart for sharks and I'm thrilled they are speaking out for a species that is underrepresented (and mis-represented) in the media."
ABOUT WORLD OF VEGAN
World of Vegan is a vegan food and lifestyle website founded in 2015 by longtime animal advocate, tree-hugger, and wellness warrior Michelle Cehn. Here at World of Vegan we're on a mission to make vegan living accessible, delicious, and fun! Why? Because living in a way that's gentle on our planet, kind to animals, and supportive of our health and longevity should feel good. And we're here to support you every step of the journey. https://www.worldofvegan.com/
About Potent Ventures
We are a growing community of individuals and organizations who believe small contributions can add up to something big. We sell low sugar, plant based gummy products while raising money (and awareness) to support endangered keystone species. We are the only "better for you" candy company that is built to support our planet's most precious species and ecosystems, while educating our future generations on the steps we must take today, to ensure a viable tomorrow.
Charlie Lamb, President & CEO, Director
Telephone: 1(236) 317-2812 - Toll free 1(888) 556-9656
E-mail: investors@potent-ventures.com
www.shopgummies.com
Neither the Canadian Securities Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.
Forward-Looking Statements
Certain information set forth in this news release may contain forward-looking statements that involve substantial known and unknown risks and uncertainties. All statements other than statements of historical fact are forward-looking statements, including, without limitation, statements regarding future financial position, business strategy, use of proceeds, corporate vision, proposed acquisitions, partnerships, joint-ventures and strategic alliances and co-operations, budgets, cost and plans and objectives of or involving the Company. Such forward-looking information reflects management's current beliefs and is based on information currently available to management. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "expects", "is expected", "budget", "scheduled", "estimates", "forecasts", "predicts", "intends", "targets", "aims", "anticipates", "may" or "believes" or variations (including negative variations) of such words and phrases or may be identified by statements to the effect that certain actions "may", "could", "should", "would", "might" or "will" be taken, occur or be achieved. A number of known and unknown risks, uncertainties and other factors may cause the actual results or performance to materially differ from any future results or performance expressed or implied by the forward-looking information. These forward-looking statements are subject to numerous risks and uncertainties, certain of which are beyond the control of the Company including, but not limited to, the impact of general economic conditions, industry conditions, risks relating to epidemics or pandemics such as COVID-19, including the impact of COVID-19 on the Company's business, financial condition, and results of operations. Readers are cautioned that the assumptions used in the preparation of such information, although considered reasonable at the time of preparation, may prove to be imprecise and, as such, undue reliance should not be placed on forward-looking statements. The Company does not assume any obligation to update or revise its forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by securities laws.
Cardiol Therapeutics Files Preliminary Prospectus Supplement for Proposed Public Offering of Common Shares
The Company intends to use the net proceeds from the Offering to support the clinical development of CardiolRx for the treatment of recurrent pericarditis, and for general and administrative expenses, working capital and other expenses.
Canaccord Genuity is acting as the sole bookrunner in connection with the Offering.
The Offering is expected to be priced in the context of the market, with the final terms of the Offering to be determined at the time of pricing. There can be no assurance as to whether or when the Offering may be completed, or as to the actual size or terms of the Offering. The closing of the Offering will be subject to customary closing conditions, including the listing of the Common Shares on the Toronto Stock Exchange (the "TSX") and the Nasdaq Capital Market (the "Nasdaq") and any required approvals of the TSX and Nasdaq.
The Supplement and accompanying Base Prospectus contain important detailed information about the Offering. The Supplement and accompanying Base Prospectus can be found on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Copies of the Supplement and accompanying Base Prospectus may also be obtained from Canaccord Genuity LLC, 1 Post Office Square, Suite 3000, Boston, Massachusetts 02109, Attn: Syndicate Department, or by email at prospectus@cgf.com. Prospective investors should read the Supplement and accompanying Base Prospectus and the other documents the Company has filed before making an investment decision.
This news release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any province, state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such province, state or jurisdiction.
About Cardiol Therapeutics
Cardiol Therapeutics Inc. is a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease.
Cautionary statement regarding forward-looking information:
This news release contains "forward-looking information" within the meaning of applicable securities laws. All statements, other than statements of historical fact, that address activities, events, or developments that Cardiol believes, expects, or anticipates will, may, could, or might occur in the future are "forward-looking information". Forward looking information contained herein may include, but is not limited to statements regarding the Offering, the anticipated size and terms of the Offering, and the anticipated use of proceeds from the Offering. Forward-looking information contained herein reflects the current expectations or beliefs of Cardiol based on information currently available to it and is based on certain assumptions and is also subject to a variety of known and unknown risks and uncertainties and other factors that could cause the actual events or results to differ materially from any future results, performance or achievements expressed or implied by the forward looking information, and are not (and should not be considered to be) guarantees of future performance. These risks and uncertainties and other factors include the risks and uncertainties referred to in the Company's Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission and Canadian securities regulators on April 1, 2024, as well as the risks and uncertainties associated with product commercialization and clinical studies. These assumptions, risks, uncertainties, and other factors should be considered carefully, and investors should not place undue reliance on the forward-looking information, and such information may not be appropriate for other purposes. Any forward-looking information speaks only as of the date of this press release and, except as may be required by applicable securities laws, Cardiol disclaims any intent or obligation to update or revise such forward-looking information, whether as a result of new information, future events, or results, or otherwise. Investors are cautioned not to rely on these forward-looking statements and are encouraged to read the Supplement, the accompanying Base Prospectus and the documents incorporated by reference therein.
For further information, please contact:
Trevor Burns, Investor Relations +1-289-910-0855
trevor.burns@cardiolrx.com
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/226067
News Provided by Newsfile via QuoteMedia
Strategic Acquisition and Capital Raising - Investor Presentation | 3 October 2024
Elixinol Wellness Ltd. (”EXL”) has entered into a binding agreement to acquire 100% of the business assets from the entities ("Acquisition") that together form The Healthy Chef business ("Healthy Chef").
ACQUISITION PURCHASE PRICE
- The aggregate total Purchase Price will be between $3.1 million - $5.5 million, with the final amount determined on1st March 2028(Final Settlement). ThePurchase Price willbe calculated on a sliding scale with a minimum of $3.1 million and a maximum of $5.5 million if the grossrevenue generated by Healthy Chef in Financial Year 2027 is over $10 million.
- ThePurchase Price comprises:
a) Ordinary Shares in EXLto the valueof $400,000 (Consideration Shares), calculated at 30-day VWAP on 10 September, subject to shareholder approval and under a 12-month escrow period
b) The remainder of the Purchase Price to be paid incash according tothe agreed Deferred Payment Schedule
DEFERRED PAYMENT SCHEDULE
- EXL agrees to pay Healthy Chef:
a) $600,000 in upfront cash at the closing of the proposed Transaction (Completion)
b) $450,000 in cash on the 1st annual anniversary of Completion
c) $600,000 in cash on the 2nd annual anniversary of Completion
d) The remainder of the Purchase Price to be paid in cash on the Final Settlement date
FUNDING
- Funding of the Acquisition will consist of:
a) A single-tranche placement of $1.1 millionand Share PurchasePlan (SPP) to raise up to $0.5 million
b) Canaccord Genuity is acting as Lead Manager to the Equity Raising, see Pg. 25 for details
c) Deferred consideration is anticipated to be funded from operational cashflow
Click here for the full ASX Release
This article includes content from Elixinol Wellness 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.
Significant Progress with B7-H3 Targeting Radio-Antibody (BetaBart)
Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, is pleased to announce regulatory and manufacturing progress for its B7-H3 targeting radio-antibody, BetaBart.
- Pre-IND meeting request with FDA submitted
- First GMP batch of antibody + chelator successfully produced
The strong preclinical data package combined with GMP quality production, supported the pre-IND submission to the US Food and Drug Administration (FDA). Preparations are on track to prepare the IND submission with the FDA and subsequently start the Phase I/II First-In-Human (FIH) therapeutic trial with BetaBart in multiple tumour types in the US, expected for mid-2025.
B7-H3 is an immune checkpoint molecule that is overexpressed in several tumour types, and represents a highly attractive target for antibody-based cancer immunotherapy. Deregulated B7-H3 expression is linked with tumour aggressiveness and poor outcomes. BetaBart is the first and only targeted radiopharmaceutical in development against the 4Ig subtype of B7-H3, which is the most common subtype expressed on human tumours.
Multiple preclinical studies with BetaBart show tumour shrinkage and prolonged survival in animals treated with this radiotherapeutic agent. The monoclonal antibody, invented at MDACC, has been specifically engineered with a shorter blood circulation time and reduced affinity for on-target off- tissue toxicity, leading to a final molecule that is highly promising for human use in clinical settings.
BetaBart will be used in the planned FIH clinical trial as a 177 Lutetium-conjugated therapeutic. The supply chain of the isotope Lu177 has been secured by multiple contracts.
Radiopharm’s Managing Director and CEO Riccardo Canevari said: "We are extremely pleased with the strong collaboration with MD Anderson and the early results we saw with BetaBart (RV-01) are impressive, so we’re looking forward to developing this further."
Dr David Piwnica-Worms of the MDACC Department of Cancer Systems Imaging said: "It has been an exciting and rewarding journey for our research team to be working with our strong partners at RAD to bring this antibody through the regulatory steps required for human testing."
About Radiopharm Theranostics
Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm has been listed on ASX (RAD) since November 2021. The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer, in pre-clinical and clinical stages of development from some of the world’s leading universities and institutes. The pipeline has been built based on the potential to be first-to-market or best-in-class. Learn more at Radiopharmtheranostics.com.
Click here for the full ASX Release
This article includes content from Radiopharm Theranostics, 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.
Completion of Divesture of Non-US Assets
Hydration solutions company The Hydration Pharmaceuticals Company Limited (ASX: HPC) (“Hydralyte US” or “the Company”) refers to its announcement released pre-open on 2 October 2024 regarding entry into an Intellectual Property Sales Agreement (the ‘Agreement’) and related documents with Prestige Consumer Healthcare Inc. and associated subsidiaries.
Hydralyte US is pleased to announce that the Agreement has completed and the sale proceeds of approximately US$9.45m (A$13.7m) have been received.
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.
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.
LA LA ANTHONY PARTNERS WITH AMGEN TO SHARE CANDID, BEHIND-THE-SCENES LOOK AT HOW PLAQUE PSORIASIS AFFECTS HER LIFE
Campaign Encourages Open Dialogue With Doctor About Unmanaged Symptoms to Find the Right Treatment Option
Amgen (NASDAQ: AMGN) has partnered with multi-talented actress, producer and entrepreneur La La Anthony to share her personal journey living with plaque psoriasis, and to inspire people to be open with their doctors about how the disease affects their daily lives. As one of the more than 6 million people in the United States living with plaque psoriasis, La La understands the frustrations of living with this disease. Symptoms can distract from everyday moments, big and small, even influencing clothing or makeup choices. 1,2
Experience the full interactive Multichannel News Release here: https://www2.multivu.com/amgen/9292951-en-la-la-anthony-amgen-partner-to-encourage-open-dialogue-about-plaque-psoriasis
In a new interactive video , La La offers an intimate, behind-the-scenes look at how plaque psoriasis has affected her personal and professional life – and her realization of how important it is to advocate for treatment options that work well for her, and to help others do the same.
"I have spent so much time and energy trying different methods to manage my plaque psoriasis that were often messy or inconvenient to apply, like a prescription shampoo for my scalp psoriasis. It required daily hair washing, which is not practical for my hair," said La La. "I was hesitant to tell my doctor that some treatments didn't work with my lifestyle, but I realized that doctors can only help if they know the full picture. I want to encourage people living with plaque psoriasis to be vocal about how the disease and treatments are impacting their daily lives."
Although common, plaque psoriasis is a frequently misunderstood disease. Many people think it is a skin condition, but it is an autoimmune disease that starts as inflammation inside the body. 1 The inflammation presents as itchy, flaky patches that may cover large portions of the skin or only a few areas. 1
Research shows that people with plaque psoriasis and their doctors aren't always on the same page about how severe their condition is – with patients believing their symptoms to be more severe than their doctor's assessment. 3
Many people are prescribed topical treatments for plaque psoriasis patches, like creams or ointments. While these topical medications may provide relief, they are only treating the symptoms of the disease – not a root cause of inflammation – and are often viewed by patients as messy to apply. 4-7
"Plaque psoriasis is a chronic inflammatory condition and each patient's experience is unique," said board-certified dermatologist Meagen McCusker M.D ., M.S., FAAD. "The good news is advances in the field have given us a multitude of treatment options. For many patients who struggle with topical therapies, or who feel like their symptoms are not well managed by their current routine, I suggest talking to your doctor about a treatment option that helps reduce the underlying inflammation. Disease severity and lifestyle are key factors that influence a patient's choice for treatment – there is no one-size-fits all approach."
To interact with La La in her new video, access resources to help facilitate an open conversation about plaque psoriasis treatment with your doctor and learn about Otezla ® (apremilast), an oral treatment option, visit MomentsWithLaLa.com . La La is not currently on treatment or taking Otezla.
Amgen is committed to supporting plaque psoriasis patients to ensure that appropriate patients have affordable access to Otezla. For more information, please visit Otezla.com .
About Psoriasis
Psoriasis is a chronic disease where skin cells build up quickly, typically causing red or discolored, scaly, and itchy patches on the skin. 1 Approximately 125 million people worldwide have psoriasis, including more than 8 million people in the United States . 8,9 About 80% of those patients have plaque psoriasis. 2
About Otezla ® (apremilast)
Otezla ® (apremilast) is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels, which is thought to indirectly modulate the production of inflammatory mediators. The specific mechanism(s) by which Otezla exerts its therapeutic action in patients is not well defined.
Since its initial FDA approval in 2014, Otezla has been prescribed to more than 1 million patients worldwide.
INDICATIONS
Otezla ® (apremilast) is indicated for the treatment of:
- Adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy
- Pediatric patients 6 years of age and older and weighing at least 20 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
- Adult patients with active psoriatic arthritis
- Adult patients with oral ulcers associated with Behçet's Disease
IMPORTANT SAFETY INFORMATION
Contraindications
- Otezla is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation
Warnings and Precautions
- Hypersensitivity: Hypersensitivity reactions, including angioedema and anaphylaxis, have been reported during postmarketing surveillance. If signs or symptoms of serious hypersensitivity reactions occur, discontinue Otezla and institute appropriate therapy
- Diarrhea, Nausea, and Vomiting: Cases of severe diarrhea, nausea, and vomiting were associated with the use of Otezla. Most events occurred within the first few weeks of treatment. In some cases, patients were hospitalized. Patients 65 years of age or older and patients taking medications that can lead to volume depletion or hypotension may be at a higher risk of complications from severe diarrhea, nausea, or vomiting. Monitor patients who are more susceptible to complications of diarrhea or vomiting; advise patients to contact their healthcare provider. Consider Otezla dose reduction or suspension if patients develop severe diarrhea, nausea, or vomiting
- Depression: Carefully weigh the risks and benefits of treatment with Otezla for patients with a history of depression and/or suicidal thoughts/behavior, or in patients who develop such symptoms while on Otezla. Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and they should contact their healthcare provider if such changes occur
- Plaque Psoriasis : Treatment with Otezla is associated with an increase in depression. During clinical trials in adult patients with moderate to severe plaque psoriasis, 1.3% (12/920) of patients reported depression compared to 0.4% (2/506) on placebo. Depression was reported as serious in 0.1% (1/1308) of patients exposed to Otezla, compared to none in placebo-treated patients (0/506). Suicidal behavior was observed in 0.1% (1/1308) of patients on Otezla, compared to 0.2% (1/506) on placebo. One patient treated with Otezla attempted suicide; one patient on placebo committed suicide
- Psoriatic Arthritis : Treatment with Otezla is associated with an increase in depression. During clinical trials, 1.0% (10/998) reported depression or depressed mood compared to 0.8% (4/495) treated with placebo. Suicidal ideation and behavior was observed in 0.2% (3/1441) of patients on Otezla, compared to none in placebo-treated patients. Depression was reported as serious in 0.2% (3/1441) of patients exposed to Otezla, compared to none in placebo-treated patients (0/495). Two patients who received placebo committed suicide compared to none on Otezla
- Behçet's Disease : Treatment with Otezla is associated with an increase in depression. During the clinical trial, 1% (1/104) reported depression or depressed mood compared to 1% (1/103) treated with placebo. No instances of suicidal ideation or behavior were reported in patients treated with Otezla or treated with placebo
- Weight Decrease: Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of Otezla
- Plaque Psoriasis : Body weight loss of 5-10% occurred in 12% (96/784) of adult patients with moderate to severe plaque psoriasis treated with Otezla and in 5% (19/382) of patients treated with placebo. Body weight loss of ≥10% occurred in 2% (16/784) of adult patients treated with Otezla compared to 1% (3/382) of patients treated with placebo. Body weight loss of 5%-10% occurred in 12% (19/163) of pediatric patients with moderate to severe plaque psoriasis treated with Otezla compared to 2.5% (2/80) with placebo. Body weight loss of ≥ 10% occurred in 1% (1/163) of pediatric patients treated with Otezla twice daily compared to 0% (0/80) of patients with placebo. Closely monitor growth (height and weight) in Otezla-treated pediatric patients. Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted
- Psoriatic Arthritis : Body weight loss of 5-10% was reported in 10% (49/497) of patients taking Otezla and in 3.3% (16/495) of patients taking placebo
- Behçet's Disease : Body weight loss of >5% was reported in 4.9% (5/103) of patients taking Otezla and in 3.9% (4/102) of patients taking placebo
- Drug Interactions: Apremilast exposure was decreased when Otezla was co-administered with rifampin, a strong CYP450 enzyme inducer; loss of Otezla efficacy may occur. Concomitant use of Otezla with CYP450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended
Adverse Reactions
- Plaque Psoriasis : The most common adverse reactions (≥ 5%) are diarrhea, nausea, upper respiratory tract infection, and headache, including tension headache. Overall, the safety profile of Otezla in adult patients with mild to moderate plaque psoriasis and pediatric patients with moderate to severe plaque psoriasis was consistent with the safety profile established in adult patients with moderate to severe plaque psoriasis
- Psoriatic Arthritis : The most common adverse reactions (≥ 5%) are diarrhea, nausea, and headache
- Behçet's Disease : The most common adverse reactions (≥ 10%) are diarrhea, nausea, headache, and upper respiratory tract infection
Use in Specific Populations
- Otezla has not been studied in pregnant women. Advise pregnant women of the potential risk of fetal loss
Please click here for the full Prescribing Information for Otezla.
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.
For more information, visit Amgen.com and follow Amgen on X , LinkedIn , Instagram , TikTok , YouTube and Threads .
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 and 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. 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. We or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market. 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. 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, 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)
Breen Weir , 415-535-9814 (media)
Justin Claeys , 805-313-9775 (investors)
References
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