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Lexaria Bioscience secures U.S. patent for drug delivery technology
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BTV Highlights Promising Investment Opportunities
On Sat. Sept 25th at 5pm EST broadcast on FOX Business News - BTV-Business Television visits up-and-coming innovative investment opportunities.
Discover Companies to Invest In - Watch their TV feature!
Osisko Metals (TSXV: OM) (OTCQX:OMZNF) - As electric transportation rises in popularity, the zinc demand increases and Osisko is poised to take advantage with their advanced zinc projects.
Fobi AI (TSXV: FOBI) (OTCQB: FOBIF) - BTV showcases their innovative AI device that provides real time data connectivity to retailers for increased profitability.
Rritual Superfoods(CSE: RSF) - BTV visits a company aiming to be the premium brand in the superfood space with its mushrooms and herbal adaptogen products.
Desert Mountain Energy (TSXV: DME) (OTCQX: DMEHF) - From helping launch rockets to driving antibiotics deep into the lungs of COVID patients, helium has many uses and Desert Mountain is gearing up to meet this growing demand.
Giga Metals (TSXV: GIGA) (OTCQB: HNCKF) - With nickel as one of the key minerals required in EV batteries, Giga is on point with one of the world's largest undeveloped nickel-cobalt sulphide deposits.
Lexaria Bioscience (CSE: LXX) (NASDAQ: LEXX) - A leading bioscience company whose patented technology, DehydraTECH, provides a faster and more effective drug delivery method.
About BTV:
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120-Day Business Development Plan
The Board of BPH Global Ltd (ASX: BP8) (Company) announces that the Company’s CEO Matthew Leonard and CFO Chow Yee Koh are currently travelling in Malaysia and China for a series of meetings over a 2–3- week period commencing last week. The CEO and CFO will be joined by China-based Company Director Michael Huang for strategic meetings in Malaysia and China.
Highlights
- CEO & CFO in Malaysia & China to advance BP8’s APAC & China-based projects as part of a 120- day business plan.
- Wide and deep engagement with potential China-based cornerstone investors.
- Focus on securing supply agreements with a major supplier(s) to underpin further expansion of sales & distribution channels for Bird’s Nest products.
- Discussions regarding expanding the China Tobacco sales & distribution footprint.
- Re-activation of hemp business.
This visit to Malaysia and China represents a further major business development opportunity for the Company. This visit follows the completion of the acquisition of China-based Foshan Gedishi Biotechnology Co Ltd (Foshan) in December 2023 and the renewal in January 2024 of the sales & distribution agreements with the two (2) wholly owned subsidiaries of China Tobacco, Guangzhou Gold Leaves Franchise Co Ltd and Guangzhou City Twenty Sticks Commercial Franchise Co Ltd, based in Guangzhou City in the Province of Guangdong (Guangzhou Subsidiaries).
The visit by the Company’s CEO and CFO represents the Board’s confidence in the potential for the further expansion of the Company’s bird’s nest operations and the reactivation of the Company’s hemp operations in China. Activities to be explored/discussed by the CEO and CFO include:
- Bird’s nest supply arrangements: The Board recognises that the Company’s ability to secure the supply of quality bird’s products at competitive prices underpins its goal of growing its sales numbers. A principal focus of this current business visit to Malaysia and China is to enter into a supply agreement with one or more major suppliers of bird’s nest products. The Company’s CEO made several visits to Malaysia and China in 2023, and working with the Company’s director Michael Huang, sought to develop the Company’s options for the purchase of raw bird’s nests and bird’s nest products. The CEO, CFO and Michael Huang will leverage previous discussions regarding bird’s nest supply arrangements to drive further discussions and negotiations in Malaysia and China with the goal of securing new and expanded bird’s nest supply arrangements.
- China Tobacco and initial sales results: Following renewal of the two (2) sales and distribution agreements between the Company’s wholly owned subsidiary Foshan and the Guangzhou Subsidiaries, the Company’s immediate focus was on maximising sales of its bird’s next products during January and February prior to Chinese New Year (Initial Sales Period). The Company is currently working with China Tobacco and the Guangzhou Subsidiaries to finalise the sales numbers achieved by sale of Foshan’s bird’s nest products during the Initial Sales Period. The Company expects to be able to report those sales numbers to the market prior to the end of this month. The Company is aiming to leverage these trading results and increased brand awareness to negotiate with China Tobacco for an expansion of the Company’s operational footprint under the agreements with the Guangzhou Subsidiaries, initially by expanding the number of China Tobacco outlets in which it operates within Guangzhou City, then subsequently to China Tobacco outlets in the greater Guangdong Province. China Tobacco, via the Guangzhou Subsidiaries, operates approximately 370 stores in Guangzhou City.
- Chinese Autumn Festival: The next major seasonal bird’s nest retail opportunity for the Company is the Mid-Autumn Festival which this year will be celebrated in China from 15 to 17 September. The work that the Company is now undertaking to expand both its bird’s nest supply arrangements and its bird’s nest retail footprint will be crucial to maximising its sales performance in the period leading up to this festival. The Company will also work to ensure that it has in place arrangements with key opinion leaders (KOLs) to maximise its sales opportunities on Douyin (the Chinese equivalent of TikTok).
- Chinese banks – Bird’s nest corporate gifts program: The Company is seeking to enter bird’s nest products supply agreements with major Chinese banks. Corporate gift giving is an important feature of Chinese corporate culture. High-end bird’s nest products are commonly gifted by major banks to their corporate and high net worth clients. Company Director Michael Huang and the Foshan management team have already commenced discussions with major banks regarding potential bird’s nest supply arrangements with Foshan. These discussions will be further progressed during the CEO’s visit in China.
- Hemp business: The CEO and CFO will work with Michael Huang in China on reactivating and expanding the Company’s hemp business. The initial steps will be to source hemp-based cosmetic products from third party suppliers for on-sale in the Chinese market. The Company does not intend to leverage its Chinese hemp growing licence in the short term to commence cultivation and harvest activities. The farming of hemp is capital intensive. The Board will delay the commencement of hemp farming activities to a later time when the Board believes that the Company’s cash position is sufficiently sound to support such activity.
The goals of the new Board and management team over the four-months period ending 30 June and arising from this China-Malaysia visit are structured around timeline milestones as follows:
- March - The China visit: Conduct of the Malaysia and China business visits in accordance with the goals stated above. Finalisation and release of China Tobacco sales results from the Initial Sales Period.
- April - Completion of transactions: Negotiation of agreements regarding the investment and commercial operations opportunities that arise from the Malaysia-China visit.
- May: Return visit to Malaysia and China. Finalisation and execution of agreements regarding the investment and commercial operations opportunities that arise from the initial Malaysia-China visit.
- June: Commence and consolidate operations pursuant to the new commercial operations agreements. Preparation for Autumn Festival sales period.
The Board will constantly monitor these milestones and their timing and will adjust them as may be necessary to take advantage of opportunities that may arise and/or to provide for changed circumstances.
Click here for the full ASX Release
This article includes content from BPH Global Ltd, 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.
BP8 to Expand Seaweed R&D Activities into Essential Mineral Extraction Utilising AI Search Technology; Carbon Credits
The Board of BPH Global Ltd (ASX: BP8) (Company) is pleased to announce that the Company is expanding the nature of its business to include the following projects:
- Essential mineral extraction: The Company’s extraction of individual macro minerals and micro minerals from seaweed and sea plant biomass, to enable the sale of those macro and micro minerals to the commodities markets, and to industry specific markets such as the battery industry, and thereby create an additional revenue stream for the Company; and
- Seaweed and Blue Carbon Credits: The Company’s sale of seaweed cellulose fibre as a filler in biopolymer, bioplastic and battery electrolyte solution separator materials as revenue streams for the Company and to serve as a means of evidencing carbon sequestration and storage for the purposes of qualifying for blue carbon credits. On receipt of the blue carbon credits, the Company would seek to sell those blue carbon credits as an additional revenue stream. (Together, the New Projects)
- R&D program now includes:
- Essential Mineral Extraction: extraction of seaweed-based individual macro & micro minerals for sale into the commodities markets and industry specific markets like the battery and energy industries;
- Artificial Intelligence technology (AI): AI to be developed and deployed to enhance nutraceutical and essential mineral identification and extraction; and
- Carbon Credits: sale of seaweed cellulose fibre to the building materials and battery industries to attract Carbon Credits.
- R&D program focussed on potential commercialisation opportunities.
- Edible bird’s nest product enhancement by the infusion of seaweed-derived nutrients; and
- Creation of a range of prototypes for food products, dietary supplements, healthcare products, and cosmetic applications that incorporate seaweed-sourced and/or bird’s nest-sourced nutraceuticals.
ASX Listing Rule 11.1.2 doesn’t apply to the expanded “nature” of the Company’s business
Following its review of the Company’s submission letter, the Company has received notice from ASX that the expenditure of $250,000 to investigate the possibilities of the New Projects will not attract the application of Listing Rules 11.1.2. The Company will notify ASX once anything eventuates from the R&D on the New Projects, and if the Company decides to pursue further opportunities, to report to ASX on the size and scope of the further developments.
Essential Mineral Extraction
Seaweed in general has a chemical composition significant in polysaccharides (agar), essential minerals and trace elements, although the composition varies from species to species. The target compounds of interest to the Company will affect the choice of species selection for the sake of commercial production and will also affect the method of post-harvest treatment and extraction for specific compounds.
For essential mineral extraction for sale into the commodities markets and for use in the battery technology and energy production industries, the initial specific focus is on nickel and cobalt. The Company is also monitoring the results of published research regarding the use of seaweed-derived chemicals and cellulose micromaterials in enhancing battery performance. Examples of recently published studies include the improvement made by added cellulose micromaterials to battery separators in sodium-metal batteries and to a prototype battery electrode made from a combination of silicon and a seaweed-derived alginate which improved the electrode’s elasticity and ability to store energy. The Company regards itself as a potential supplier of essential minerals, including these seaweed-derived cellulose micromaterials and alginates, to the current and emerging battery technology and battery manufacturing industries.
Regarding essential mineral extraction for use in vitamin supplement manufacture, the Company’s specific focus is on trace metals that are established by science to occur in rich concentrations in seaweed: nickel, cobalt and manganese. These minerals are common trace elements in vitamin supplements.
Click here for the full ASX Release
This article includes content from BPH Global Ltd, 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.
Sirona Biochem Receives Commercial-Grade GlycoProteMim Based Anti-Aging Serum Formulations
Sirona Biochem Corp . (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) (" Sirona " or the " Company ") announces a significant achievement in its quest to transform the skincare industry. Its subsidiary, TFChem, has successfully received formulations for its eagerly awaited GlycoProteMim™ based anti-aging serum from its formulation partner, Global Beauty Consulting (GBC). This marks a crucial step in Sirona Biochem's plan to offer innovative skincare solutions.
The chosen formulation will not only define the brand but also lay the foundation for a broader range of products. The team is in the process of selecting the precise formulation that will undergo standard safety evaluations and be used in the upcoming clinical trial. This is in preparation for the planned product launch in early 2025, ensuring compliance with regulatory standards in the European, US, and Canadian markets.
‘We are thrilled to unveil these innovative formulations for our GlycoProteMim based anti-aging serum. Our mission at Sirona Biochem is to revolutionize skincare through science and these formulations represent a significant step towards achieving that goal." reports Sirona's Chief Scientific Officer Dr Geraldine Deliencourt-Godfrey. In line with our commitment to transparency and innovation, samples of the GlycoProteMim-based anti-aging serum formulations will be distributed to prospective key stakeholders in Asia, Europe, and North America.
About Sirona Biochem Corp.
Sirona is a cosmetic ingredient and drug discovery company with a proprietary platform technology. Sirona specializes in stabilizing carbohydrate molecules with the goal of improving efficacy and safety. New compounds are patented for maximum revenue potential.
Sirona's compounds are licensed to leading companies around the world in return for licensing fees, milestone fees and ongoing royalty payments. Sirona's laboratory, TFChem, is in France and is the recipient of multiple French national scientific awards and European Union and French government grants. For more information, please visit www.sironabiochem.com .
For more information regarding this press release, please contact:
Investor Enquiries:
Christopher Hopton
Chief Financial Officer
Phone: (604) 641-4466
Email: info@sironabioche.com
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Forward Looking Statements
This news release includes certain statements that may be deemed "forward-looking statements". All statements in this new release, other than statements of historical facts, that address events or developments that the Company expects to occur, are forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in the forward-looking statements. Factors that could cause the actual results to differ materially from those in forward-looking statements include market prices, continued availability of capital and financing, and general economic, market or business conditions. Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Forward-looking statements are based on the beliefs, estimates and opinions of the Company's management on the date the statements are made. Except as required by applicable securities laws, the Company undertakes no obligation to update these forward-looking statements in the event that management's beliefs, estimates or opinions, or other factors, should change.
News Provided by GlobeNewswire via QuoteMedia
5 Small Biotech ETFs to Watch (Updated 2024)
Thanks to exchange-traded funds (ETFs), investors don’t have to be tied to one specific stock. Biotech ETFs allow market participants to gain leverage in multiple biotech companies via one investment vehicle.
The life science sector can certainly be risky, and ETFs are a good way to enter more safely than by investing in standalone stocks. A key advantage is that even if one company in the ETF takes a hit, the impact will be less direct.
Below the Investing News Network takes a look at five small biotech ETFs for investors to consider. They were selected using ETFdb.com, and their total assets under management (AUM) were under US$100 million as of March 8, 2024. All other figures were also current as of that date. Read on to learn more about these investment vehicles.
1. Global X Genomics & Biotechnology ETF (NASDAQ:GNOM)
AUM: US$100.17 million
The Global X Genomics & Biotechnology ETF tracks genomic science stocks, such as companies focused on gene editing, genomic sequencing, genetic medicine and therapy, computational genomics and biotechnology. This fund was first introduced to the market in April 2019 and invests at least 75 percent of its assets in mid- and small-cap companies.
There are 42 holdings in this biotech fund. Its top holdings include Natera (NASDAQ:NTRA), weighing in at 6.79 percent; CRISPR Therapeutics (NASDAQ:CRSP) with a weight of 6.22 percent; and Ultragenyx Pharmaceutical (NASDAQ:RARE) at a 4.71 percent weightage.
2. ProShares Ultra NASDAQ Biotechnology (NASDAQ:BIB)
AUM: US$96.8 million
The ProShares Ultra NASDAQ Biotechnology ETF was launched in April 2010 and is leveraged to the broad-based NASDAQ Biotechnology Index, which currently tracks 220 holdings. ETFdb.com says the fund is ideal “for investors with a bullish short-term outlook for biotechnology or pharmaceutical companies.”
The top biotech stocks in this ETF are Regeneron Pharmaceuticals (NASDAQ:REGN) at a 5.98 percent weight; Vertex Pharmaceuticals (NASDAQ:VRTX) at a 5.86 percent weight; and Amgen (NASDAQ:AMGN) at a 5.12 percent weight.
3. Tema Cardiovascular and Metabolic ETF (NASDAQ:HRTS)
AUM: US$49.86 million
Launched in November 2023, the Tema Cardiovascular and Metabolic ETF tracks biotech stocks with a focus on diabetes, obesity and cardiovascular diseases. More than three-quarters of its holdings are based in the US.
There are 45 holdings in this biotechnology fund, with about a 50/50 split between small- to mid-cap stocks and large-cap companies. Its top holdings include Eli Lilly (NYSDE:LLY) at a weight of 5.02 percent; Vertex Pharmaceuticals at 4.91 percent; and Viking Therapeutics (NASDAQ:VXTK), weighing in at 3.29 percent.
4. Principal Healthcare Innovators ETF (NASDAQ:BTEC)
AUM: US$48.6 million
The Principal Healthcare Innovators ETF tracks US-listed healthcare stocks with a focus on companies that are researching and developing innovative medicines and therapies. This fund was first introduced to the market in August 2016 and invests at least 88 percent of its assets in mid- and small-cap companies.
There are 219 holdings in this biotechnology fund. Its top holdings are Karuna Therapeutics (NASDAQ:KRTX) at 2.81 percent; Sarepta Therapeutics (NASDAQ:SRPT) at a 2.54 percent weightage; and Exact Sciences (NASDAQ:EXAS) at 2.45 percent.
5. Range Cancer Therapeutics ETF (NASDAQ:CNCR)
AUM: US$21.88 million
Launched in October 2013, the Range Cancer Therapeutics ETF provides exposure to biotech companies focused on a wide range of cancer therapeutic modalities. Its broad basket of holdings includes companies across nearly the entire lifecycle of cancer drug development and distribution.
There are 82 holdings in this biotechnology fund, with about 77 percent being small- to mid-cap stocks. Its top holdings include MacroGenics (NASDAQ:MGNX) at a weight of 3.85 percent; Janux Therapeutics (NASDAQ:JANX) at a weight of 3.57 percent; and Mersana Therapeutics (NASDAQ:MRSN) at 3.38 percent.
This is an updated version of an article originally published by the Investing News Network in 2015.
Don’t forget to follow us @INN_LifeScience for real-time news updates!
Securities Disclosure: I, Melissa Pistilli, hold no direct investment interest in any company mentioned in this article.
AMGEN PRESENTS NEW RESEARCH ON OTEZLA® AT AAD 2024
SPROUT 52-Week Data Demonstrate Durable Response and Consistent Safety Profile of Oral Otezla in Children with Moderate to Severe Plaque Psoriasis
Late-Breaking Phase 3 Study of Otezla in Palmoplantar Pustulosis Achieves Primary and Secondary Endpoints at 16 Weeks
Amgen (NASDAQ:AMGN) today announced new, 52-week results from the Phase 3 SPROUT study examining the use of Otezla ® (apremilast) in children and adolescents aged 6 to 17 years with moderate to severe plaque psoriasis. These data, along with findings from a Phase 3 late-breaking study on Otezla in palmoplantar pustulosis, will be presented at the 2024 American Academy of Dermatology (AAD) Annual Meeting, March 8-12 in San Diego.
"These data reflect Amgen's commitment to exploring new ways to treat inflammatory skin disease," said Ponda Motsepe-Ditshego, vice president, Global Medical, at Amgen. "A decade after the launch of Otezla, we continue to study how this oral therapy can help improve care and reduce disease burden in underserved patient populations."
SPROUT Phase 3 Study
Results from SPROUT, a multicenter, randomized, placebo-controlled, double-blind study, demonstrated the efficacy and safety of Otezla in pediatric patients aged 6 to 17 years with moderate to severe plaque psoriasis inadequately controlled by or intolerant to topical therapy. Continued Otezla use resulted in sustained improvements in psoriasis severity and skin involvement in patients for up to one year. The safety profile was consistent with previous Otezla studies. These findings add to the published 16-week results . 1
"For the first time, we have a full year of data on a potential oral treatment for children and adolescents with moderate to severe plaque psoriasis, who currently lack any approved oral treatment options," said Loretta Fiorillo , M.D., FRCPC, clinical professor of pediatrics, University of Alberta . "At 52 weeks, more than half of patients achieved clear or almost clear skin. Otezla showed increased efficacy beyond that seen at the week 16 primary endpoint, with a durable maintenance of response – an important finding for families living with this chronic inflammatory disease."
All patients in the study received Otezla for a 36-week extended active treatment period following the 16-week randomized placebo-controlled treatment period, providing up to 52 weeks of data. There were 186 patients who completed the 36-week extension: 125 who continued to receive Otezla, and 61 patients switched from placebo to Otezla.
Study findings include: 2
- 56.3% of patients who received Otezla through week 52 achieved static Physician Global Assessment (sPGA) response (score of ≥3), an investigator assessment of overall disease severity of plaque psoriasis, the study's primary endpoint.
- 52.5% of patients who switched from placebo to Otezla achieved sPGA response at week 52.
- 71.4% of patients who received Otezla through week 52 achieved Psoriasis Area and Severity Index (PASI)-75, an investigator assessment of disease severity and skin involvement, a secondary endpoint.
- 75.4% of patients who switched from placebo to Otezla achieved PASI-75 at week 52.
- Treatment-emergent adverse events (AEs) were consistent with the known safety profile of Otezla in adults. The most common AEs (>10%) throughout the study were nausea, diarrhea, abdominal pain, vomiting and headache.
Findings will be presented as an e-poster with an oral presentation on Saturday, March 9 at 4:50 p.m. PST .
Phase 3 Late-Breaking Palmoplantar Pustulosis Findings
Amgen also will present late-breaking findings from a Phase 3 study evaluating the efficacy and safety of Otezla in patients with moderate to severe palmoplantar pustulosis in Japan following inadequate response to topical therapy. Palmoplantar pustulosis is a chronic inflammatory condition characterized by pustules on the palms and soles. The condition can be difficult to treat, with limited available treatment options. 3,4
"Palmoplantar pustulosis can severely impact daily functioning due to its painful effects on the hands and feet, necessitating new therapeutic options for this impactful inflammatory skin condition," said Melinda Gooderham , M.D., FRCPC, dermatologist and clinical investigator at SKiN Centre for Dermatology and assistant professor, Queen's University, Ontario, Canada . "The study presented at AAD highlighted significant improvement in disease severity, symptoms such as itch, pain, discomfort, and patient-reported quality of life among those treated with Otezla compared to placebo."
The randomized, placebo-controlled, double-blind study included 176 patients who received Otezla (n=88) or placebo (n=88) for 16 weeks. All primary and secondary endpoints were met.
Study findings include: 5
- 67.8% of patients who received Otezla achieved the primary endpoint of PPPASI 50 (>50% improvement in the Palmoplantar Pustulosis Area and Severity Index); this was a significantly greater response as compared to placebo (35.3%; P
- Statistically significant improvements in all secondary endpoints were observed with Otezla relative to placebo, including changes from baseline to week 16 in PPPASI, PPSI (Palmoplantar Pustulosis Severity Index), Patient Visual Analogue Scale of palmoplantar pruritus and pain/discomfort and DLQI (Dermatology Life Quality Index).
- Treatment-emergent AEs were consistent with the known safety profile of Otezla. The most common AEs (>10%) throughout the study were diarrhea, soft feces, headache and nausea.
Findings will be presented as a late-breaking oral presentation on Saturday, March 9 at 9:20 a.m. PST .
Additional Amgen data to be presented at AAD include:
Otezla Abstracts
- Long-term Impact of Apremilast on Cardiometabolic Parameters and the Relationship of Cardiometabolic Changes with Psoriasis Efficacy
Abstract #50668, E-Poster and Oral Presentation of Poster on Saturday, March 9 at 3:55 p.m. PST - Beyond Race-Ethnicity: Fitzpatrick Skin Type Analysis Highlights Unmet Needs and Differing Treatment Patterns in Psoriasis Among the Conventional Systemics Cohort of British Association of Dermatologists Biologic and Immunomodulators Register (BADBIR)
Abstract #51067, E-Poster and Oral Presentation of Poster on Saturday, March 9 at 4:15 p.m. PST - Apremilast Improves Clinical Outcomes and Pain in Patients with Oligoarticular Psoriatic Arthritis
Abstract #51246, E-Poster - Efficacy of Apremilast in Adults with Mild-to-Moderate Plaque Psoriasis with Scalp Involvement: Pooled Data from PROMINENT, ADVANCE, and EMBRACE Trials
Abstract #51480, E-Poster - Proportion of the US Psoriasis Population Impacted by Common Warnings for Moderate-to-Severe Plaque Psoriasis Treatment
Abstract #52846, E-Poster
Rocatinlimab (AMG 451/KHK4083) Abstract
- Rocatinlimab Significantly Improves Clinical Responses in Patients with Moderate-to-Severe Atopic Dermatitis by Week 2 in a Randomized Double-Blind Placebo-Controlled Phase 2b Study
Abstract #50233, E-Poster
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. 6 Approximately 125 million people worldwide have psoriasis, including around 14 million people in Europe and more than 8 million people in the United States . 7,8 About 80% of those patients have plaque psoriasis. 9
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 920,000 patients worldwide. 10
Otezla ® (apremilast) U.S. INDICATIONS
INDICATIONS
Otezla ® (apremilast) is indicated for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.
Otezla is indicated for the treatment of adult patients with active psoriatic arthritis.
Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet's Disease.
Otezla ® (apremilast) U.S. 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 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 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 patients treated with Otezla compared to 1% (3/382) of patients treated with placebo
- 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 patients with mild to moderate plaque psoriasis was consistent with the safety profile previously 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 Otezla ® Full Prescribing Information.
About Atopic Dermatitis
Atopic dermatitis is a chronic inflammatory disease that causes excessively dry, itchy skin that can be painful. Repeated scratching can cause the skin to thicken, harden or become vulnerable to infection. Atopic dermatitis is the most common form of eczema – affecting 1-3% of adults worldwide – and the prevalence is increasing. The disease typically manifests in childhood followed by other allergy symptoms.
About rocatinlimab
Rocatinlimab (AMG 451/KHK4083), an investigational product, is a potential first-in-class anti-OX40 monoclonal antibody that is being studied for its ability to inhibit and reduce the number of OX40+ pathogenic T cells responsible for driving systemic and local AD inflammatory responses.
It has been reported that effector T cells expressing OX40 are present in the lesions of patients with atopic dermatitis and are critical in the disease pathophysiology. The initial antibody was discovered in collaboration between Kyowa Kirin US Research and La Jolla Institute for Immunology.
Amgen and Kyowa Kirin Collaboration
On June 1, 2021 , Kyowa Kirin and Amgen entered into an agreement to jointly develop and commercialize rocatinlimab. Under the terms of the agreement, Amgen will lead the development, manufacturing, and commercialization for KHK4083/AMG 451 for all markets globally, except Japan , where Kyowa Kirin will retain all rights. If approved, the companies will co-promote the asset in the United States and Kyowa Kirin has opt-in rights to co-promote in certain other markets including Europe and Asia.
About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average and is also part of the Nasdaq-100 index. In 2023, Amgen was named one of "America's Greatest Workplaces" by Newsweek, one of "America's Climate Leaders" by USA Today and one of the "World's Best Companies" by TIME.
For more information, visit Amgen.com and follow us on X (formerly known as Twitter), 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, 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.
The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Further, any scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses.
CONTACT: Amgen, Thousand Oaks
Kate Meyer , 872-867-0754 (media)
Jessica Akopyan , 805-440-5721 (media)
Justin Claeys , 805-313-9775 (investors)
References
1 Fiorillo L, Becker E, de Lucas R, Belloni-Fortina A, Armesto S, Maes P, Oberoi R, Paris M, Zhang W, Zhang Z, & Arkin L. Efficacy and safety results of apremilast in pediatric patients with moderate to severe plaque psoriasis: 16-week results from SPROUT, a phase 3, randomized, controlled study. SKIN, 2023;7(2):s109; https://doi.org/10.25251/skin.7.supp.109.
2 Fiorillo L, et al. Efficacy and Safety of Apremilast in Pediatric Patients With Moderate to Severe Plaque Psoriasis: 52-Week Results From the SPROUT Randomized Controlled Trial. AAD Annual Meeting, March 2024 .
3 Brunasso AMG and Massone C. Recent advances in palmoplantar pustulosis. Faculty Reviews 2021 10:(62) https://doi.org/10.12703/r/10-62 .
4 Chung J, Callis Duffin K, Takeshita J, Shin DB, Krueger GG, Robertson AD, et al. Palmoplantar psoriasis is associated with greater impairment of health-related quality of life compared with moderate to severe plaque psoriasis. J Am Acad Dermatol . 2014 Oct; 71(4):623-32. doi: 10.1016/j.jaad.2014.04.063.
5 Terui T, et all. Efficacy and Safety of Apremilast for the Treatment of Japanese Patients With Palmoplantar Pustulosis (PPP): 16-Week Results From a Phase 3, Randomized, Placebo-Controlled Study. AAD Annual Meeting, March 2024 .
6 National Psoriasis Foundation. About Psoriasis. Available at: https://www.psoriasis.org/about-psoriasis. Accessed January 30, 2024 .
7 National Psoriasis Foundation. Statistics. Available at: https://www.psoriasis.org/content/statistics . Accessed January 30, 2024 .
8 Ortonne JP, Prinz JC. Alefacept: a novel and selective biologic agent for the treatment of chronic plaque psoriasis. Eur J Dermatol. 2004;14(1):41–45.
9 National Psoriasis Foundation. Plaque Psoriasis. Available at: https://www.psoriasis.org/about-psoriasis/types/plaque . Accessed January 30, 2024 .
10 Amgen Data on File. November 2023 .
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SOURCE Amgen
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5 Biggest Biotechnology ETFs in 2024
Investing in the biotech industry can be a long road to gains given the sector’s volatility.
Even with a good understanding of the system, no one can predict which treatment, device or therapy will give the biggest return, making biotech exchange-traded funds (ETFs) a more secure option than individual biotech stocks.
An ETF is a relatively safe investment route that can minimize losses while offering exposure to multiple companies instead of focusing on the gains and losses of a single biotech stock. With that in mind, here’s a brief look at the five top biotechnology ETFs by total assets. Data was sourced from ETFdb.com on March 1, 2024, and all data was current as of that time.
1. SPDR S&P Biotech ETF (ARCA:XBI)
Total assets: US$8.153 billion
Established on February 6, 2006, the SPDR S&P Biotech ETF is a largely balanced fund in terms of weight that focuses mostly on biotech companies with some pharmaceutical companies. As noted by ETF.com, it focuses on small- and micro-cap companies, which makes the weight of each holding smaller than the holdings of other ETFs in this sector.
The SPDR S&P Biotech ETF has 122 companies in its portfolio, with the top three being: Viking Therapeutics (NASDAQ:VKTX) which has a 4.5 percent weighting; Iovance Biotherapeutics (NASDAQ:IOVA) weighted at 2.5 percent; and Cytokinetics (NASDAQ:CYTK) with a 2.22 percent weight.
2. iShares NASDAQ Biotechnology ETF (NASDAQ:IBB)
Total assets: US$7.78 billion
The iShares NASDAQ Biotechnology ETF was launched on February 5, 2001, and tracks 220 holdings. This iShares ETF is a diversified fund in that it provides exposure to biotechnology, pharmaceutical and life science tools and services. Its overarching investment goal is to track NASDAQ-listed companies focused on these areas.
Its top three holdings are: Vertex Pharmaceuticals (NASDAQ:VRTX), weighted at 8.82 percent; Regeneron Pharmaceuticals (NASDAQ:REGN) with a 8.72 percent weight; and Amgen (NASDAQ:AMGN) at a weight of 7.55 percent.
3. ARK Genomic Revolution Multi-Sector ETF (ARCA:ARKG)
Total assets: US$1.915 billion
The ARK Genomic Revolution Multi-Sector ETF came into existence on October 31, 2014, and tracks 43 holdings. This ETF follows companies that develop products such as CRISPR technology, bioinformatics, molecular diagnostics and stem cells.
This top biotechnology ETF's three most significant company holdings are: CRISPR Therapeutics (NASDAQ:CRSP), weighted at 8.21 percent; Recursion Pharmaceuticals (NASDAQ:RXRX) at a weight of 6.45 percent; and Twist Bioscience (NASDAQ:TWST) at 5.97 percent.
4. Direxion Daily S&P Biotech Bull 3x Shares ETF (ARCA:LABU)
Total assets: US$1.36 billion
Founded on May 28, 2015, the Direxion Daily S&P Biotech Bull 3x Shares ETF does not mirror an index. Instead, its goal is to obtain daily investment results of at least 300 percent of the S&P Biotechnology Select Industry Index.
Like some of the other ETFs on this list, companies in the Direxion Daily S&P Biotech Bull 3x Shares ETF have an equally weighted average. Its top holdings include: Viking Therapeutics (NASDAQ:VKTX), which has a 3.13 percent weight; Iovance Biotherapeutics with a weight of 1.95 percent; and Cytokinetics at a weight of 1.87 percent.
5. First Trust NYSE Arca Biotechnology Index (ARCA:FBT)
Total assets: US$1.189 billion
The First Trust NYSE Arca Biotechnology ETF entered the market on June 23, 2006, and aims to track the NYSE Arca Biotechnology Index as closely as it can. Companies in this fund are generally involved in areas such as recombinant DNA technology, molecular biology, genetic engineering and genomics.
The fund has only 31 holdings; this means they are largely equally weighted. The top three holdings of the fund are the following large-cap companies: Natera (NASDAQ:NTRA) at a 4.78 percent weighting; Bruker Corporation (NASDAQ:BRKR) representing a 4.09 percent weight, and Halozyme Therapeutics (NASDAQ:HALO), coming in at a 3.89 percent weight.
This is an updated version of an article first published by the Investing News Network in 2016.
Don’t forget to follow us @INN_LifeScience for real-time news updates!
Securities Disclosure: I, Melissa Pistilli, hold no direct investment interest in any company mentioned in this article.
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