-- Report is aimed at helping practitioners and the industry prepare for the future by supporting the evolving needs of patients --
-- North American medical aesthetic market expected to grow more than 10 percent annually through 2026* --
-- Built on robust research and analysis of global social listening data, global aesthetics practitioners, academic studies and Allergan Aesthetics proprietary global research into thousands of consumer attitudes 1 --
Allergan Aesthetics, an AbbVie company, and a global leader in medical aesthetics treatments, today announces the U.S. publication of 'The Future of Aesthetics' global trends report, developed to understand what is shaping the aesthetics industry of tomorrow.
Consumer interest in medical aesthetics continues to rise, and the growth rate of the North American medical aesthetics market is expected to accelerate to more than 10 percent annually through 2026.The number and type of non-surgical aesthetic procedures conducted worldwide grew by nearly two million between 2017 and 2020. 2,3,4,5 This growth is expected to continue, with 23 million dermal fillers and 14.6 million body procedures predicted by 2025. 6 In parallel, physicians globally saw an increased volume of younger patients, more patients from a diverse range of ethnic backgrounds, and more male patients than ever before. 1
"Aesthetics is a dynamic industry, which must continually adapt and evolve with changing habits and shifting cultural norms. Our trends report – The Future of Aesthetics report – builds on insights uncovered in the 2019 Allergan 360 Aesthetics Report™ on evolving beauty perceptions and diverse priorities around the world 7 ," commented Carrie Strom , President, Global Allergan Aesthetics. " We recognize the fast-moving nature of aesthetics and are committed to furthering research and innovation in our field. Our research on the evolution of consumer preferences aims to support practitioners to better meet future patient needs. Thank you to our partners who participated in this important study."
Exploring the underlying themes and trends for modern aesthetics The research identified key themes driving the future of aesthetics including: Aesthetic Fluency , De-stigmatizing Treatments and a desire to move Back to Nature . 1 Resulting from these are 10 major trends, which will likely drive medical aesthetics practice in the coming years. 1
By acknowledging changes in the industry, clinicians may be able to educate and communicate with patients more effectively.
Renowned board-certified dermatologist, Elizabeth Hale says: "Recently, I have witnessed the evolution of the 'aesthetic patient' to one that is much more diverse, knowledgeable and vocal about their needs. 'The Future of Aesthetics' report provides research-driven and anecdotal observations to help health care providers prepare for the continued growth of the aesthetics industry and prepare for modern-day patients."
Brought to you by some of the world's leading practitioners The Future of Aesthetics report, commissioned by Allergan Aesthetics and independently developed by Wunderman Thompson Intelligence, is informed by extensive research and analysis across consumer and business media, social listening data, and market research from around the globe that was validated through one-on-one interviews with 15 leading aesthetics practitioners † . The Future of Aesthetics report provides a unique view of what tomorrow holds for the aesthetics industry.
To access The Future of Aesthetics report and for more information, please contact your local Allergan Aesthetics representative or visit news.allerganaesthetics.com/future-of-aesthetics to register your interest in receiving the report.
About Allergan Aesthetics At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit allerganaesthetics.com.
About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across our Allergan Aesthetics portfolio.
About Wunderman Thompson Intelligence Wunderman Thompson Intelligence is Wunderman Thompson's futurism, research and innovation unit. It charts emerging and future global trends, consumer change, and innovation patterns—translating these into insight for brands. It offers a suite of consultancy services, including bespoke research, presentations, co-branded reports and workshops. It is also active in innovation, partnering with brands to activate future trends within their framework and execute new products and concepts. The division is led by Emma Chiu and Marie Stafford , Global Directors of Wunderman Thompson Intelligence.
† Chytra Anand , Cosmetic Dermatologist, India ; Jonquille Chantrey , Aesthetic Surgeon, United Kingdom , Ligia Colucci , Dermatologist, Brazil ; Dmitry Durdyklychev , Dermatologist, Russia ; Tijion Esho , Cosmetic Doctor, United Kingdom ; Nobutaka Furuyama , Plastic and Cosmetic Surgeon, Japan ; Lana Kashlan , Consultant Dermatologist, US/UAE; Steven Liew , Specialist Plastic Surgeon, Australia ; José R. Montes , MD and Oculopalstic Surgeon, Puerto Rico / USA ; Roni Munk , Medical and Cosmetic Dermatologist, Canada ; Kyung-Ho Park , MD and Dermatologist, South Korea ; Chantal Sciuto , Dermatologist, Italy ; Rashmi Shetty , Dermatologist, India ; Danru Wang , Professor of Cosmetic Surgery, China ; Gong Wei , Editor-in-Chief of Medical Aesthetics Observer, China
* Medical Insight, May 2022 North American MedSpa Market Opportunities Market Study
1 Allergan Aesthetics. The Future of Aesthetics global trends report. March 2022 ALL-AGNA-220005
2 ISAPS international survey 2017. Available at ISAPS_2017_International_Study_Cosmetic_Procedures_NEW.pdf . Accessed March 2022.
3 ISAPS international survey 2018. Available at: ISAPS-Global Survey Results 2018.indd . Accessed March 2022.
4 ISAPS International survey 2019. Available at: Global Survey_2019_Stand_2020.indd (isaps.org) . Accessed March 2022.
5 ISAPS international survey 2020. Available at: ISAPS-Global-Survey_2020.pdf . Accessed March 2022.
6 Medical Insight. The Global Aesthetic Market Study: XIX. November 2021
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Sirona Biochem Corp . (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) (" Sirona ") is pleased to announce it has entered into a global exclusive licensing agreement with Allergan Aesthetics, an AbbVie company (NYSE: ABBV), pursuant to which Allergan Aesthetics will develop and commercialize topical skin care treatments based on active ingredients derived from certain of Sirona's patents for TFC-1067 and related family of compounds.
"We are very pleased to have finalized terms with a global leader in medical aesthetics and the innovator behind SkinMedica™, a leader in the science of skin rejuvenation," said Dr. Howard Verrico, CEO of Sirona Biochem. "Our most recent clinical trial of TFC-1067 was a collaborative effort with Allergan Aesthetics to demonstrate the clinical potential in topical skin care treatments. This further validates our platform technology as viable for additional commercial products which we are actively pursuing. We would like to thank Dr. Linda Pullan of Pullan Consulting who assisted with our current success."
"Allergan Aesthetics' global presence in the aesthetic space and goal to further enhance aesthetic medicine combined with Sirona's disruptive technology made this all possible," reports Dr. Linda Pullan, of Pullan Consulting.
Under the license agreement, Sirona will a receive an upfront payment and further payments on achievement of milestones and royalties on product sales and has also agreed to financial terms as a supplier of its compounds.
About Sirona Biochem Corp. Sirona Biochem 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 current pipeline includes further cosmetic related products for cell preservation and repair, keloid therapy, scar therapy, anti-aging, anti-wrinkle, and cellulite treatment. In the pharmaceutical space, Sirona Biochem is working on a therapeutic for diabetic animals and new anti-viral therapies for humans. An extensive list of viable options for future programs applicable to the platform technology is maintained by Sirona's chemistry team in France to ensure continued growth of the company.
Sirona's compounds are licensed to leading companies around the world in return for licensing fees, milestone fees and ongoing royalty payments. Sirona's scientific development unit, TFChem in France, is recipient of multiple 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: Jonathan Williams Managing Director Momentum PR Phone: 1.450.332.6939 Email: jwilliams@momentumpr.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.
Sirona Biochem cautions you that statements included in this press release that are not a description of historical facts may be forward-looking statements. Forward-looking statements are only predictions based upon current expectations and involve known and unknown risks and uncertainties. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of release of the relevant information, unless explicitly stated otherwise. Actual results, performance or achievement could differ materially from those expressed in, or implied by, Sirona Biochem's forward-looking statements due to the risks and uncertainties inherent in Sirona Biochem's business including, without limitation, statements about: uncertainty and risks relating to the progress and timing of development and commercialization of products licensed to Allergan Aesthetics, the progress and timing of its clinical trials; difficulties or delays in development, testing, obtaining regulatory approval, producing and marketing its products; unexpected adverse side effects or inadequate therapeutic efficacy of its or licensed products that could delay or prevent product development or commercialization; the scope and validity of patent protection for its or licensed products; competition from other pharmaceutical or biotechnology companies; and its ability to obtain additional financing to support its operations. Sirona Biochem does not assume any obligation to update any forward-looking statements except as required by law.
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CAMBRIDGE, Mass. & NORTH CHICAGO, Ill.–(BUSINESS WIRE)–The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of a marketing authorization for ZINBRYTA™ (daclizumab) intended for the treatment of relapsing forms of multiple sclerosis (RMS), Biogen (NASDAQ: BIIB) and AbbVie (NYSE: ABBV) announced today. ZINBRYTA is a once-monthly, self-administered, subcutaneous investigational treatment for RMS. ZINBRYTA is also currently under regulatory review in the United States, Switzerland, Canada and Australia. “For people with relapsing forms of MS (RMS) and active disease, ZINBRYTA has the potential to offer robust efficacy, a manageable safety profile through patient monitoring, and once-monthly subcutaneous dosing,” said Alfred Sandrock, M.D., Ph.D., executive vice president and chief medical officer at Biogen. “ZINBRYTA may offer another option for people with multiple sclerosis (MS) with its targeted mechanism of action (MOA) which did not cause broad and prolonged immune cell depletion.” The CHMP positive opinion is now referred to the European Commission (EC), which grants marketing authorizations for centrally authorized medicines in the European Union. A decision from the EC is expected within the coming months. “Together with Biogen, AbbVie is committed to meeting the needs of patients with MS, and the positive opinion issued by the CHMP is a critical step that moves us closer to bringing ZINBRYTA to patients in Europe,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. According to the CHMP opinion, the benefits of ZINBRYTA are its ability to reduce the annualized relapse rate (ARR), as well as the risk of 24-week confirmed disability progression. The opinion is based on results from two clinical trials, DECIDE and SELECT, in which ZINBRYTA 150 mg, administered subcutaneously every four weeks improved results on key measures of MS disease activity in patients with RMS compared to AVONEX 30 mcg intramuscular injection administered weekly and placebo, respectively. In the DECIDE study, the overall incidence of adverse events was similar in the ZINBRYTA and AVONEX groups. In patients treated with ZINBRYTA compared to AVONEX, there was an increased incidence of serious infections (4% versus 2%), serious cutaneous reactions (2% versus <1%), elevations of liver transaminases greater than five times the upper limit of normal (6% versus 3%), gastrointestinal disorders (31% versus 24%), and depression (8% versus 6%). About ZINBRYTA™ (daclizumab) ZINBRYTA (daclizumab) is an investigational compound being developed for the treatment of relapsing forms of MS. ZINBRYTA is a new form of a humanized monoclonal antibody that selectively binds to the high-affinity interleukin-2 (IL-2) receptor subunit (CD25) that is expressed at high levels on T-cells that become activated in people with MS. ZINBRYTA modulates IL-2 signaling without general immune cell depletion. Biogen and AbbVie are jointly developing ZINBRYTA. About Biogen Through cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological, autoimmune and rare diseases. Founded in 1978, Biogen is one of the world’s oldest independent biotechnology companies and patients worldwide benefit from its leading multiple sclerosis and innovative hemophilia therapies. For more information, please visit www.biogen.com. Follow us on Twitter. Biogen Safe Harbor This press release contains forward-looking statements, including statements about the anticipated timing of the EC’s decision on the marketing authorization for ZINBRYTA, and potential impact of ZINBRYTA, if approved. These statements may be identified by words such as “believe,” “expect,” “may,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. You should not place undue reliance on these statements. Drug development and commercialization involve a high degree of risk. Factors which could cause actual results to differ materially from our current expectations include the risk that the EC may fail to approve or may delay approval of ZINBRYTA or may not follow the recommendation of the CHMP, uncertainty of success in commercialization of ZINBRYTA For more detailed information on the risks and uncertainties associated with our drug development and commercialization activities and risks relating to our collaborations with third parties, please review the Risk Factors section of our most recent annual or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. About AbbVie AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world’s most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page. Forward-Looking Statements Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words “believe,” “expect,” “anticipate,” “project” and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie’s operations is set forth in Item 1A, “Risk Factors,” in AbbVie’s 2014 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
The biosimilar alliance between Merck (NYSE:MRK) and Samsung Bioepis appears to have paid off, as the companies have won South Korean approval for their copy of Amgen’s (NASDAQ:AMGN) blockbuster drug Enbrel. According to Fierce Biotech:
Korea’s Ministry of Food and Drug Safety signed off on the injection, to be marketed as Brenzys, to treat rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and psoriasis in adults. The biosimilar, developed as SB4, proved itself equivalent to Amgen’s cash cow in a 596-patient study disclosed this year, reducing symptoms of rheumatoid arthritis on pace with its reference product, according to Merck and Samsung. Brenzys’ approval marks the first marketing victory for the two companies, a milestone Merck hopes will be a harbinger of future success in biosimilars. The approval could also have major implications for Samsung Bioepis, long rumored to be considering a U.S. IPO. Details of the company’s Wall Street plans have been tricking out for months, and The Wall Street Journal reported in August that Samsung is planning a $1 billion debut offering for its biologics division, valuing the company at about $7 billion. Samsung Bioepis, a joint venture with Biogen ($BIIB) that is 85% owned by the South Korean company, joined forces with Merck in 2013 in a wide-ranging deal designed to crack the growing market for off-patent biological treatments. Beyond Enbrel, the pair are working on copies of the similar Humira from AbbVie ($ABBV) and Remicade from Johnson & Johnson ($JNJ). The companies are also developing biosimilars of Sanofi’s ($SNY) blockbuster insulin Lantus and Roche’s ($RHHBY) cancer treatment Herceptin.
Click here to read the full article on Fierce Biotech.
What are the top biotech companies? The following five stocks have market capitalizations worth billions of dollars and operate in countries all around the globe.
Plus, these big-name biotech players have pipelines stuffed with potentially disruptive products — and enough revenue to recover should some of those products fail.
This means that investors can experience the excitement of biotech investing while minimizing risk. Although returns are never guaranteed, company size can insulate investors from volatility.
If you’re cautiously interested in biotech stocks, starting with the top companies by market cap could be a good strategy. This list of the largest NASDAQ biotech stocks and NYSE biotech stocks was compiled using Investing.com’s stock screener, and all numbers were current as of June 21, 2022.
This biopharmaceutical company is one of the most well-known organizations in the industry. AbbVie’s operations are spread throughout 75 countries and its products are sold in over 170 nations.
The Chicago-based company aims to treat a range of diseases in five key areas. Its treatment areas include: virology, whixch includes hepatitis C and HIV; neurodegenerative diseases, such as schizophrenia, Alzheimer’s disease, Parkinson’s disease and multiple sclerosis; immunology, including spondyloarthropathies, hidradenitis suppurativa and uveitis; oncology, which is the treatment of cancer; and general medicine, including women’s health.
In mid-2021, AbbVie announced the submission of a supplemental new drug application to the US Food and Drug Administration (FDA) for atogepant. The company recently completed a successful Phase 3 progress study on the use of atogepant in the treatment of chronic migraines. It is already approved by the FDA to treat adults with episodic migraines and is marketed as QULIPTAin the US.
Amgen has heavily invested in gene-based research. The biotech company is firmly established as a leader in using advanced human genetics to develop and manufacture therapeutics targeting diseases with unmet medical needs.
Amgen’s Q1 2022 revenue increased by 6 percent over Q1 2021 to reach US$6.2 billion, and it's on track to reach its 2022 total revenue guidance of US$25.4 billion to US$26.5 billion. "We achieved strong, volume-driven growth in the quarter, while launching two very promising first-in-class medicines," CEO Robert A. Bradway said. "We are also advancing a robust pipeline with data for several mid-to-late stage candidates expected during the year."
For three decades, global biopharmaceutical company Gilead Sciences has developed breakthrough medicines to prevent and treat serious diseases such as HIV, viral hepatitis and cancer. One of its recent successes is Yescarta, a CAR-T cell therapy for blood cancer and the first such therapy for certain types of non-Hodgkin's lymphoma.
Gilead’s Q1 2022 product sales increased 3 percent over Q1 2021 to total US$6.5 billion, primarily driven by higher demand for its HIV therapy Biktarvy, cell therapy products and second-line cancer treatment Trodelvy. The company’s 2022 total product sales guidance stands at US$23.8 billion to US$24.3 billion.
Biotech leader Regeneron Pharmaceuticals develops and commercializes medicines targeting cancer, pain and a wide variety of diseases, including inflammatory, cardiovascular, metabolic, hematologic and rare diseases.
The FDA has approved nine of the treatments in the company’s portfolio, which also includes a number of product candidates in development. The company’s Regeneron Genetics Center is investigating approaches to speeding up the discovery and development of medicines for serious illnesses. In late May 2022, Regeneron acquired immune-oncology company Checkmate Pharmaceuticals, whose lead investigational candidate, vidutolimod, has demonstrated clinical responses as a monotherapy in patients with PD-1 refractory melanoma.
Vertex Pharmaceuticals is a global biotech firm focused on developing and commercializing therapies for treating cystic fibrosis. It has a number of approved treatments for cystic fibrosis, and a pipeline of genetic and cell therapies for diseases such as sickle cell disease, beta thalassemia, Duchenne muscular dystrophy and type 1 diabetes.
Vertex and its partner CRISPR Therapeutics (NASDAQ:CRSP) are in Phase 3 clinical studies for drug candidate CTX001 as a one-time treatment for severe sickle cell disease and transfusion-dependent beta thalassemia.
This is an updated version of an article originally 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.
Komo Plant Based Foods Inc. (CSE:YUM)(OTCQB:KOMOF)(FRA:9HB) ("Komo") is pleased to announce it is increasing retail distribution for all of it's 9 products across Canada with Loblaw Companies Ltd. 4 SKUs will be listed nationally in 8 Loblaws warehouses and the remaining 5 SKUs will be distributed to Loblaw's banner stores direct from our distributor partners to retail locations across western Canada
Loblaw Companies is Canada's largest Canadian food retailer with over 2,400 stores across the country including corporate and franchise supermarkets operating under 22 regional and market segment banners including Loblaws.
Komo's original flagship line of products, including the 2 serving Lasagna, the 2 serving Shepherd's Pie, the Chickenless Pot Pie, and the 2 serving newly launched Komo product, "Mac & Greens", are being sent to 8 Loblaws' warehouses located across Canada for distribution in Loblaw's banners.
Komo's "Meal Helpers" line, which includes the BBQ Mushroom Lentil Taco Filling and Komo's Walnut Mushroom Bolognese, as well as the family size SKUs of the Mac & Greens, Shepherd's Pie and Lasagna will be distributed directly to Loblaw banner stores by Komo's distributors. Banner stores anticipated to be carrying Komo products include Loblaws, Superstores including Great Canadian Superstore (Atlantic Provinces), No Frills, YIGs, City Markets, Extra Foods, Fortino's and Provigo (Quebec). Products are expected to be on store shelves beginning the first week of November 2022.
"Achieving distribution for all of our healthy vegan frozen products to Loblaw's customers across Canada including our latest innovation "Mac & Greens" demonstrates the market demand for our quality products," says Komo CEO William White. " All of our products are 100% plant-based, made with wholesome ingredients, free from preservatives, artificial colours and flavours and frozen for freshness."
Komo Plant Based Foods Inc. is a premium plant-based food company that develops, manufactures and sells a variety of plant-based frozen meals that are always hearty, satisfying, and made with wholesome ingredients. At Komo, our mission is to help make plant-based meals a staple on every dinner table by sharing our love for feel-good food that connects the people to the planet. We believe plant-based eating is the future and - Change can start with a single biteTM. Our experienced plant-based innovation and development team recreates vegan versions of traditionally cheesy and meaty classics, with 100% plants. Komo's products are sold direct-to-consumer through our eCommerce website and a distribution network of online and brick and mortar grocery, convenience and natural retailer channels. Our operating subsidiary Komo Comfort Foods launched in 2021 with our flagship products: plant-based Lasagna, Shepherd's Pie and Chickenless Pot Pie and Komo Plant-Based Meal HelpersTM - versatile meal starters to allow the creation of many dishes at home. Komo's newest product is Mac & Greens. All of our products are 100% plant-based, made with wholesome ingredients, free from preservatives, and frozen for freshness. Freezing products is a natural and effective way of keeping food products for longer without having to use any preservatives. Komo's meals have a 18 months frozen shelf life.
Learn more at: www.komocomfortfoods.com and follow on Instagram: @komocomfortfoods
For further information, please contact:
William White, President & CEO, Komo Plant Based Foods Inc. will@komoeats.com +1(236) 8000-YUM / (236) 800-0986
The Canadian Securities Exchange has not reviewed, approved or disapproved the contents of this news release.
Cautionary Statement Regarding Forward-Looking Statements
Certain statements contained in this press release constitute forward-looking information. These statements relate to future events or Komo's future performance. The use of any of the words "could", "expect", "believe", "will", "projected", "estimated" and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Komo's current belief or assumptions as to the outcome and timing of such future events. Actual future results may differ materially. In particular, Komo's product development plans, its ability to launch its products on food delivery apps, its ability to retain key personnel, its revenues, and its expectation as to the acceptance of its products by retailer stores and consumers constitute forward-looking information. Actual results and developments may differ materially from those contemplated by forward-looking information. Readers are cautioned not to place undue reliance on forward-looking information. The statements made in this press release are made as of the date hereof. Komo disclaims any intention or obligation to publicly update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as may be expressly required by applicable securities laws.
SOURCE: Komo Plant Based Foods Inc.
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Powerful, Effective, Targeted Topical Treatment Formulated to Prevent and Address Visible Signs of Body Skin Aging
Today, Allergan Aesthetics, an ABBVie company (NYSE: ABBV), announces the launch of SkinMedica ® Firm & Tone Lotion for Body, the first product from the professional-grade skincare line formulated to prevent and address visible signs of body skin aging for a toned look. 1 It is clinically proven to diminish the look of crepey skin, address uneven skin texture, improve the appearance of body skin firmness and tone, and improve the look of sagging skin. 1
"The skin on the body represents 95% of our skin. It's unique and different from the skin on our face and neck 1 . As our body skin ages, it has specific needs and requires a targeted approach," said Carrie Strom , President, Global Allergan Aesthetics and Senior Vice President, AbbVie. "Environmental factors, such as sun exposure and pollutants, and intrinsic factors, including changes in fat distribution and muscle tone, take a toll on the body. 2 SkinMedica ® Firm & Tone Lotion for Body is a luxurious formula rooted in science that delivers transformative results."
With more than two decades of excellence in innovation, SkinMedica ® continues to rely on research to formulate the most advanced and innovative professional-grade skincare products. Following the launch of the brand's Neck Correct Cream for Neck and Décolleté in April 2021 , Allergan Aesthetics continues to expand its footprint with SkinMedica ® science for every body with this dermatologist-tested product that can be used alone or following a body contouring procedure.
SkinMedica ® Firm & Tone Lotion for Body contains carefully curated ingredients including Green Microalgae and Shitake Mushroom Extracts, Lemon Balm Extract, Coffea Arabica Seed Oil, Caffeine, Hydrolyzed Rice Protein, Japanese Parsley, Paradisi (Grapefruit Peel) Oil, and Ginger Root Extract.
The hydrating formula features a scientifically proven technology that targets five pathways related to fat and laxity in the skin and supports the extracellular matrix, firmness and crepiness: 1
"Body skin aging begins as early as age 25. The skin on your body becomes thinner with age, which can further accelerate the visible signs of aging 3-4 ," says Dr. Mona Gohara , Dermatologist and Associate Clinical Professor, Yale School of Medicine . "Start prioritizing your body now – the product shows significant results such as skin appearing visibly tighter, smoother and more toned. In addition to adding SkinMedica ® Firm & Tone lotion to my patients' overall body care regimen as a standalone, patients can also use the product following body contouring procedures."
In a head-to-head clinical study 1 where the products were used twice a day, investigators assessed the following improvements at weeks 4, 8, and 12:
Firm & Tone Lotion showed significant visible improvements vs. a leading professional-grade topical body for body skin crepiness, texture, skin tone evenness, and smoothness. 1
With continued results over 12 weeks.
*Week 4, (p ≤ 0.031). †Week 8, (p ≤ 0.022). ‡Week 12, (p ≤ 0.022)
SkinMedica ® Firm & Tone Lotion for Body ( $165 USD MSRP) is available for purchase at SkinMedica.com , and through a network of licensed physicians and medically supervised spas. For use, dispense the lotion into hands, and massage into the skin until the product is fully absorbed. Apply to desired area twice daily or as needed. Do not apply to broken or irritated skin. SkinMedica ® Firm & Tone Lotion for body may be used alone or following a body contouring procedure. For more information follow @SkinMedica on Instagram or click here .
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.AllerganAesthetics.com .
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .
The SkinMedica ® product described here is intended to meet the FDA's definition of a cosmetic product, an article applied to the human body to cleanse, beautify, promote attractiveness, and alter appearances. This SkinMedica ® product is not intended to be a drug product that diagnoses, treats, cures or prevents any disease or condition. This product has not been approved by the FDA and the statements on these pages have not been evaluated by the FDA.
For more information, please talk to your provider or visit SkinMedica.com . To report an adverse reaction, please call Allergan at 1-800-433-8871.
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Bristol Myers Squibb (NYSE: BMY) today announced that the company will take part in a fireside chat at Citi's 17 th Annual BioPharma Conference on Thursday, September 8, 2022 in Boston, Massachusetts. Company executives will answer questions about the company at 8:50 a.m. ET.
Investors and the general public are invited to listen to a live webcast of the session at http://investor.bms.com . An archived edition of the session will be available later that day.
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn , Twitter , YouTube , Facebook , and Instagram .
View source version on businesswire.com: https://www.businesswire.com/news/home/20220831005061/en/
Bristol Myers Squibb Media: media@bms.com Investor Relations: investor.relations@bms.com
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LUMAKRAS Met Primary Endpoint of Progression-Free Survival, Demonstrating Superiority Over Standard of Care Docetaxel Chemotherapy, in KRAS G12C-Mutated Non-Small Cell Lung Cancer
Detailed Data to be Presented at an Upcoming Medical Congress
Amgen (NASDAQ: AMGN) today announced that the global Phase 3 CodeBreaK 200 trial evaluating once daily oral LUMAKRAS ® (sotorasib) met its primary endpoint of progression-free survival (PFS), demonstrating statistical significance and superiority over standard of care chemotherapy, intravenous docetaxel. The first randomized clinical trial for a KRAS G12C inhibitor assessed the efficacy and safety of LUMAKRAS in 345 previously treated patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC) who had received at minimum, prior platinum-based doublet chemotherapy and checkpoint inhibitor therapy.
"Further analyses of the data are ongoing, and we look forward to sharing detailed data at an upcoming medical meeting," said David M. Reese , M.D., executive vice president of Research and Development at Amgen. "We are grateful to all of the investigators and patients who participated in this first randomized, controlled clinical trial of a KRAS G12C inhibitor."
About LUMAKRAS ® /LUMYKRAS ® (sotorasib) Amgen took on one of the toughest challenges of the last 40 years in cancer research by developing LUMAKRAS/LUMYKRAS, a KRAS G12C inhibitor. 1 LUMAKRAS/LUMYKRAS has demonstrated a positive benefit-risk profile with rapid, deep, and durable anticancer activity in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation with a once daily oral formulation. 2
Amgen is progressing the largest and broadest global KRAS G12C inhibitor development program with unparalleled speed and exploring more than 10 sotorasib combination regimens, including triplets, with clinical trial sites spanning five continents. To date, over 6,500 patients around the world have received LUMAKRAS/LUMYKRAS through the clinical development program, expanded access and commercial use.
In total, LUMAKRAS/LUMYKRAS is approved in over 44 markets around the world, including the United States , the European Union, Japan , United Arab Emirates , South Korea , Hong Kong , Switzerland , Taiwan and Qatar , and in Australia , Brazil , Canada , Great Britain , Israel and Singapore under the U.S. FDA's Project Orbis. Amgen has submitted MAAs in Argentina , Colombia , Kuwait , Malaysia , Mexico , Saudi Arabia , Thailand and Turkey.
LUMAKRAS/LUMYKRAS is also being studied in multiple other solid tumors. 3
About Non-Small Cell Lung Cancer and the KRAS G12C Mutation Lung cancer is the leading cause of cancer-related deaths worldwide, and it accounts for more deaths worldwide than colon cancer, breast cancer and prostate cancer combined. 4 Overall survival rates for NSCLC are improving but remain poor for patients with advanced disease, and 5-year survival is only 8% for those with metastatic disease. 5
KRAS G12C is the most common KRAS mutation in NSCLC. 6 About 13% of patients with NSCLC harbor the KRAS G12C mutation. 7 Unmet medical need remains high and treatment options are limited for NSCLC patients with the KRAS G12C mutation whose first-line treatment has failed to work or has stopped working. The outcomes with other approved therapies are suboptimal, with a median progression-free survival of approximately four months following second-line treatment of KRAS G12C-mutated NSCLC. 8
About CodeBreaK The CodeBreaK clinical development program for Amgen's drug sotorasib is designed to study patients with an advanced solid tumor with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers.
CodeBreaK 100, the Phase 1 and 2, first-in-human, open-label multicenter study, enrolled patients with KRAS G12C-mutant solid tumors. 9 Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumor type and stage of disease. The primary endpoint for the Phase 2 study was centrally assessed objective response rate. The Phase 2 trial in NSCLC enrolled 126 patients, 124 of whom had centrally evaluable lesions by RECIST at baseline. 2 The Phase 2 trial in colorectal cancer (CRC) is fully enrolled and results have been published. 10
CodeBreaK 200, the global Phase 3 randomized active-controlled study comparing sotorasib to docetaxel in KRAS G12C-mutated NSCLC completed enrollment of 345 patients. Eligible patients had previously treated, locally advanced and unresectable or metastatic KRAS G12C-mutated NSCLC. The primary endpoint is progression-free survival and key secondary endpoints include overall survival, objective response rate, and patient-reported outcomes. 11
Amgen also has several Phase 1b studies investigating sotorasib monotherapy and sotorasib combination therapy across various advanced solid tumors (CodeBreaK 101) open for enrollment. 12 A Phase 2 randomized study will evaluate sotorasib in patients with stage IV KRAS G12C-mutated NSCLC in need of first-line treatment (CodeBreaK 201). 13
For information, please visit www.hcp.codebreaktrials.com .
LUMAKRAS ® (sotorasib) U.S. Indication LUMAKRAS is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.
This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
LUMAKRAS ® (sotorasib) Important U.S. Safety Information
Interstitial Lung Disease (ILD)/Pneumonitis
Please see LUMAKRAS full Prescribing Information .
About Amgen Oncology At Amgen Oncology, our mission to serve patients drives all that we do. That's why we're relentlessly focused on accelerating the delivery of medicines that have the potential to empower all angles of care and transform lives of people with cancer.
For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company's history, moving with great speed to advance those innovations for the patients who need them.
For more information, follow us on www.twitter.com/amgenoncology .
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 2021, Amgen was named one of the 25 World's Best Workplaces™ by Fortune and Great Place to Work™ and one of the 100 most sustainable companies in the world by Barron's .
For more information, visit www.amgen.com and follow us on www.twitter.com/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., Kyowa-Kirin Co., Ltd., or any collaboration to manufacture therapeutic antibodies against COVID-19), the performance of Otezla ® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), the Five Prime Therapeutics, Inc. acquisition, or the Teneobio, Inc. acquisition or the recently announced proposed acquisition of ChemoCentryx, Inc., 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 such as the ongoing COVID-19 pandemic on our business, 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. A breakdown, cyberattack or information security breach 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 Megan Fox , 805-447-1423 (media) Jessica Akopyan , 805-440-5721 (media) Arvind Sood , 805-447-1060 (investors)
LUMAKRAS and LUMYKRAS are trademarks of Amgen Inc.
1 Canon J, et al. Nature . 2019;575: 217–223. 2 Skoulidis F, et al. N Engl J Med . 2021;384:2371-2381. 3 Hong DS, et al. N Engl J Med . 2020;383:1207-1217. 4 Sung H, et al. CA Cancer J Clin . 2021; 71:209-249. 5 American Cancer Society. Lung Cancer Survival Rates. 2021. Available at: https://www.cancer.org/cancer/lung-cancer/detection-diagnosis-staging/survival-rates.html . Accessed on June 24, 2022. 6 Arbour KC, et al. Clin Cancer Res . 2018; 24:334-340. 7 Nassar AF, et al. N Engl J. Med . 2021;384:185-187. 8 Spira Al, et al. Lung Cancer . 2021;159 :1-9. 9 ClinicalTrials.gov. CodeBreaK 100. Available at: https://clinicaltrials.gov/ct2/show/NCT03600883 . Accessed on April 14, 2022. 10 Fakih MG, et al. Lancet Oncol. 2022;23:115-124. 11 ClinicalTrials.gov . CodebreaK 200. Available at: https://clinicaltrials.gov/ct2/show/NCT04303780 . Accessed on April 14, 2022. 12 ClinicalTrials.gov . CodeBreaK 101. Available at: https://clinicaltrials.gov/ct2/show/NCT04185883 . Accessed on April 14, 2022. 13 ClinicalTrials.gov . CodeBreaK 201. Available at: https://clinicaltrials.gov/ct2/show/NCT04933695 . Accessed on April 14, 2022.
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New Positive Data From Phase 3 SPROUT Trial, Studying Otezla (apremilast) in Children Ages 6-17 With Moderate to Severe Plaque Psoriasis
Positive Results From the Phase 3 DISCREET Study, Investigating Clinical Efficacy and Safety of Otezla in Patients With Moderate to Severe Genital Psoriasis
New Rocatinlimab Phase 2 Analyses Highlight Emerging Clinical Profile in Moderate to Severe Atopic Dermatitis
Amgen (NASDAQ:AMGN) today announced that clinical and real-world data from across its inflammation portfolio, including both established treatments and pipeline assets, will be presented at the 31 st European Academy of Dermatology and Venereology (EADV), taking place in Milan, Italy Sept. 7-10, 2022 .
Presentations will cover a range of clinical data for Otezla ® (apremilast), including positive, 16-week results from the Phase 3 SPROUT study in children ages 6-17 with moderate to severe plaque psoriasis. Successful 16-week results from the Phase 3 DISCREET study, assessing the efficacy and safety of Otezla ® (apremilast), in patients with moderate to severe genital psoriasis will also be presented. Furthermore, there will be data presented on the role of Otezla in patients with plaque psoriasis featuring special area skin involvement or persistent itch, incorporating data and analyses from the EMBRACE and ADVANCE studies.
Other research highlights being presented from Amgen's portfolio include a late-breaking post-hoc analysis from the rocatinlimab (AMG 451/KHK4083) Phase 2b study with a focus on patients with moderate to severe head and neck atopic dermatitis and a biomarker analysis of blood and tissue samples in subjects treated with rocatinlimab. Finally, a new analysis of the multinational UPLIFT survey on the impact of psoriasis involvement in special locations on quality of life will be presented.
"The research that will be presented at EADV reinforces the strength of Amgen's inflammation portfolio and our continued support for patients living with autoimmune skin diseases like plaque psoriasis and moderate to severe atopic dermatitis. We remain committed to delivering novel therapies which address pressing treatment gaps that continue to exist for patients," said David M. Reese , M.D., executive vice president of Research and Development at Amgen.
Key Abstracts and Presentation Times:
Abstracts can be found on the EADV website .
About SPROUT SPROUT (PPS0-003) a phase 3, multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of Otezla ® (apremilast) in pediatric patients from 6 through 17 years of age with moderate to severe plaque psoriasis (defined as BSA involvement of ≥ 10, PASI score of ≥ 12, sPGA score of ≥ 3). A total of 245 patients were randomized 2:1 to receive Otezla 20 mg (patients 20kg to 50 kg) twice daily or Otezla 30 mg (patients ≥ 50 kg) twice daily or placebo for the first 16 weeks. All patients then received Otezla during an open-label extension phase through week 52.
The primary endpoint was the percentage of patients with sPGA response [defined as a sPGA score of clear (0) or almost clear (1) with greater than or equal to 2-point reduction from baseline] at week 16.
About DISCREET DISCREET (PSOR-025) is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study evaluating the efficacy and safety of Otezla ® (apremilast), in patients with moderate to severe genital psoriasis (defined as modified sPGA-G score ≥ 3). Patients also had moderate to severe plaque psoriasis (sPGA score ≥ 3) with BSA involvement ≥ 1% in a non-genital area and had an inadequate response or intolerance to topical therapy for psoriasis affecting the genital area. The study randomized 289 patients 1:1 to receive Otezla 30 mg twice daily or placebo for the first 16 weeks. Following the 16-week placebo-controlled, double-blind phase of the trial, patients continued or switched to Otezla during the extension phase of the study and were treated through week 32.
The primary endpoint was the proportion of patients who achieve modified sPGA-G response at week 16 (defined as modified sPGA-G score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline at Week 16).
About ADVANCE ADVANCE ( NCT03721172 ) is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study evaluating the efficacy and safety of Otezla ® (apremilast), in patients with mild to moderate plaque psoriasis (defined as BSA involvement of 2% to 15%, Psoriasis Area and Severity Index (PASI) score of 2 to 15, sPGA score of 2 to 3). In this study, 595 patients were randomized 1:1 to receive Otezla (n=297) 30 mg twice daily or placebo (n=298) for the first 16 weeks. All patients then received Otezla during an open-label extension phase through week 32.
The primary endpoint was the percentage of patients with sPGA response [defined as a sPGA score of clear (0) or almost clear (1) with a >2 point reduction from baseline] at week 16.
About EMBRACE EMBRACE ( NCT03774875 ) is a phase 4, multicenter, randomized, placebo-controlled, double-blind study evaluating the efficacy and safety of Otezla ® (apremilast), over 52 Weeks in patients with plaque psoriasis not controlled by topicals. A total of 277 patients, who had psoriasis in one or more 1 special areas, a Psoriasis Area and Severity Index (PASI) score between 3 and 10 and Dermatology Life Quality Index (DLQI) score above 10, were randomized (2:1) to receive Otezla or placebo from Weeks 0 to 16, after which all patients continued with Otezla or were switched from placebo to Otezla until Week 52.
The primary endpoint was DLQI response (4-point reduction or more) at Week 16. Secondary endpoints included DLQI score, Itch Numeric Rating Scale, skin discomfort/pain visual analog scale, affected body surface area, and Patient Benefit Index response (score 1 or more). Safety analyses included all patients treated with Otezla at any time.
About the UPLIFT Survey In 2020, Amgen conducted the global Understanding Psoriatic Disease Leveraging Insights for Treatment (UPLIFT) survey exploring the evolution of attitudes and behaviors of 3,806 people living with psoriasis and psoriatic arthritis, 473 dermatologists and 450 rheumatologists in eight countries in North America , Europe and Asia . The survey was conducted in 2020 and was overseen by an academic steering committee of thought leaders in dermatology and rheumatology. The survey builds upon findings from the 2012 Multinational Assessment of Psoriasis and Psoriatic Arthritis (MAPP) survey, a first-of-its-kind study conducted by Celgene that looked in-depth at the effect of psoriasis and psoriatic arthritis on people living with these conditions.
About APPRECIATE APPRECIATE ( NCT02740218 ) is a multinational, observational, retrospective, cross-sectional study in patients treated for psoriasis with Otezla, conducted across seven countries ( Austria , Germany , Ireland , Spain , Sweden , Switzerland , and UK) from May 2016 to October 2019 . The aim of this post-hoc analysis was to explore the agreement of patients and physicians on specific body locations affected by psoriasis (genital, non-genital inverse, palmoplantar, scalp) by comparing data collected by from both adult patients and their dermatologists.
About REALIZE REALIZE ( NCT03757013 ) is a longitudinal multicenter observational study assessing adult patients from French clinical practice with moderate to severe chronic plaque psoriasis, that had been prescribed Otezla according to the French label up to four weeks previously. Data were collected at 0, 6 and 12 months of follow-up, including patient and disease characteristics, patient benefit index questionnaire (PBI; range 0 [no patient-relevant benefit] to 4 [maximum patient-relevant benefit]), nine-item Treatment Satisfaction Questionnaire for Medication (TSQM-9; range 0-100), Dermatology Life quality Index (DLQI; range 0 to 30) and adverse events (AEs).
About Psoriasis Psoriasis is a serious, chronic inflammatory disease that causes raised, red, scaly patches to appear on the skin, typically affecting the outside of the elbows, knees or scalp, though it can appear on any location. 1 Approximately 125 million people worldwide have psoriasis, including around 14 million people in Europe and more than 8 million people in the United States . 2,3 About 80% of those patients have plaque psoriasis. 4
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 700,000 patients worldwide. 5
Otezla ® (apremilast) U.S. 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
Please click here for the full Prescribing Information for Otezla.
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 (AMG 451/KHK4083) Rocatinlimab (AMG 451/KHK4083) is an investigational, potential first-in-class anti-OX40 monoclonal antibody that inhibits and reduces the number of OX40+ pathogenic T cells responsible for orchestrating the atopic dermatitis inflammatory response.
Amgen and Kyowa Kirin Collaboration On June 1, 2021 , Amgen and Kyowa Kirin entered into an agreement to jointly develop and commercialize AMG 451/KHK4083. Under the terms of the agreement, Amgen will lead the development, manufacturing, and commercialization for AMG 451/KHK4083 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 . The initial AMG 451/KHK4083 antibody was discovered in collaboration between Kyowa Kirin US Research and La Jolla Institute for Immunology.
About TEZSPIRE ® (tezepelumab-ekko) TEZSPIRE is a first-in-class human monoclonal antibody that works on the primary source of inflammation: the airway epithelium, which is the first point of contact for viruses, allergens, pollutants and other environmental insults. Specifically, TEZSPIRE targets and blocks TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and initiates an overreactive immune response to allergic, eosinophilic and other types of airway inflammation associated with severe asthma. 6,7 TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles. 6,7
Expression of TSLP is increased in the airways of patients with asthma and has been correlated with disease severity. 6,8 Blocking TSLP may prevent the release of pro-inflammatory cytokines by immune cells, resulting in the prevention of asthma exacerbations and improved asthma control. 6,8 By working at the top of the cascade, TEZSPIRE helps stop inflammation at the source and has the potential to treat a broad population of severe asthma patients. 6,8
TEZSPIRE is also in development for other potential indications including chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria and eosinophilic esophagitis (EoE). In October 2021 , tezepelumab was granted Orphan Drug Designation by the FDA for the treatment of EoE.
TEZSPIRE ® (tezepelumab-ekko) U.S. Indication TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.
TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus.
TEZSPIRE ® (tezepelumab-ekko) Important Safety Information CONTRAINDICATIONS Known hypersensitivity to tezepelumab-ekko or excipients.
WARNINGS AND PRECAUTIONS Hypersensitivity Reactions Hypersensitivity reactions (e.g., rash and allergic conjunctivitis) can occur following administration of TEZSPIRE. These reactions can occur within hours of administration, but in some instances have a delayed onset (i.e., days). In the event of a hypersensitivity reaction, initiate appropriate treatment as clinically indicated and then consider the benefits and risks for the individual patient to determine whether to continue or discontinue treatment with TEZSPIRE.
Acute Asthma Symptoms or Deteriorating Disease TEZSPIRE should not be used to treat acute asthma symptoms, acute exacerbations, acute bronchospasm, or status asthmaticus.
Abrupt Reduction of Corticosteroid Dosage Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with TEZSPIRE. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.
Parasitic (Helminth) Infection It is unknown if TEZSPIRE will influence a patient's response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with TEZSPIRE. If patients become infected while receiving TEZSPIRE and do not respond to anti-helminth treatment, discontinue TEZSPIRE until infection resolves.
Live Attenuated Vaccines The concomitant use of TEZSPIRE and live attenuated vaccines has not been evaluated. The use of live attenuated vaccines should be avoided in patients receiving TEZSPIRE.
ADVERSE REACTIONS The most common adverse reactions (incidence ≥3%) are pharyngitis, arthralgia, and back pain.
USE IN SPECIFIC POPULATIONS There are no available data on TEZSPIRE use in pregnant women to evaluate for any drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Placental transfer of monoclonal antibodies such as Tezepelumab-ekko is greater during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy.
Please see the TEZSPIRE full Prescribing Information .
You may report side effects related to AstraZeneca products by clicking here .
About ABP 654 ABP 654 is being developed as a biosimilar candidate to STELARA® (ustekinumab), an approved human interleukin-12 and interleukin-23 antagonist indicated for the treatment of moderate to severe plaque psoriasis in adults and pediatric patients (6 years or older) who are candidates for phototherapy or systemic therapy, active psoriatic arthritis in adults and pediatric patients (6 years or older), as well as for adult patients with moderately to severely active Crohn's disease and moderately to severely active ulcerative colitis. ABP 654 has the same pharmaceutical form, dosage strength, route of administration and dosing regimen as United States -licensed and European Union (EU)-approved ustekinumab.
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 2021, Amgen was named one of the 25 World's Best Workplaces™ by Fortune and Great Place to Work™ and one of the 100 most sustainable companies in the world by Barron's.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen .
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., Kyowa Kirin Co., Ltd., or any collaboration to manufacture therapeutic antibodies against COVID-19), the performance of Otezla ® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), the Five Prime Therapeutics, Inc. acquisition, the Teneobio, Inc. acquisition, or the recently announced proposed acquisition of ChemoCentryx, Inc., 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 such as the ongoing COVID-19 pandemic on our business, 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. A breakdown, cyberattack or information security breach 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 Michael Strapazon , 805-313-5553 (Media) Jessica Akopyan , 805-447-0974 (Media) Arvind Sood , 805-447-1060 (Investors)
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