Today, Amgen Canada Inc. (“Amgen Canada”) announced Health Canada’s approval of the Marketing Authorization transfer of OTEZLA® (apremilast) from Celgene Corporation to Amgen Canada.
| MISSISSAUGA, ON, Feb. 12, 2020 /CNW/ - Today, Amgen Canada Inc. (“Amgen Canada”) announced Health Canada’s approval of the Marketing Authorization transfer of OTEZLA® (apremilast) from Celgene Corporation to Amgen Canada. This transfer is in line with Amgen Inc.'s previously announced acquisition of the worldwide rights to OTEZLA completed in November 2019. OTEZLA is approved in Canada for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, and (alone or in combination with methotrexate) for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response, intolerance, or contraindication to a prior disease-modifying anti-rheumatic drug (DMARD).i “We are pleased that Health Canada has granted approval for Amgen to market OTEZLA in Canada and we are proud to offer this treatment option to those who need it most, including those living with debilitating, inflammatory conditions,” says Brian Heath, vice president and general manager at Amgen Canada. “OTEZLA represents a unique opportunity to build on our long-standing commitment in psoriasis and inflammation and enhances our ability to support both patients and their physicians.” The acquisition of OTZELA complements Amgen Canada’s existing portfolio of innovative biologics and biosimilar products and is a strong strategic fit with Amgen Canada’s long-standing expertise in moderate-to-severe plaque psoriasis and active psoriatic arthritis. OTEZLA is approved in more than 50 markets outside Canada including the U.S., the European Union and Japan. About Psoriasis Psoriasis is a lifelong condition of the immune system. The exact cause is unknown; however, researchers think that family history, environment, and the immune system can all play a role in psoriasis.ii Psoriasis affects and estimated 1 million Canadiansiii and 125 million people worldwide.iv Plaque psoriasis is the most common form of the condition and it affects approximately 80 - 90 per cent of patients.v The severity of psoriasis is based on how it affects an individual and how much of their body is covered. Approximately 1 in 5 people with psoriasis have moderate to severe plaque psoriasis.ii Other types of psoriasis can affect different areas of the body and appear in a variety of forms. Psoriatic arthritis includes a combination of skin and joint symptoms. Up to 30 per cent of people with psoriasis may actually have or develop psoriatic arthritis.vi About OTEZLA® (apremilast)I OTEZLA belongs to a class of drugs called phosphodiesterase 4 (PDE4) inhibitors. It contains the active ingredient apremilast which works by reducing the activity of PDE4. This results in less inflammation in the skin and joints.OTEZLA is available in Canada in 10 mg, 20 mg and 30 mg tablets. Important Safety Informationi OTEZLA (apremilast) is contraindicated in:
OTEZLA is not approved for use in combination with any other medicines taken by mouth used to treat psoriasis, biological therapies (such as TNF antagonists and anti-IL-12/23 p40 antibodies) or with phototherapy (light therapy using UV light). OTEZLA tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take OTEZLA. In the Phase 3 psoriasis studies, the most common adverse reactions (≥ 5%) were diarrhea, nausea, upper respiratory tract infection, tension headache, and headache. In the Phase 3 psoriatic arthritis studies, diarrhea, nausea, and headache were the most commonly reported (≥ 5%) adverse drug reactions. More information on Adverse Reactions may be found in the OTEZLA Product Monograph. About Amgen Canada Amgen Forward-Looking Statements No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. 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 Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints Amgen has selected. 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Further, some raw materials, medical devices and component parts for Amgen’s products are supplied by sole third-party suppliers. Certain of Amgen’s distributors, customers and payers have substantial purchasing leverage in their dealings with Amgen. The discovery of significant problems with a product similar to one of Amgen’s products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on its business and results of operations. Amgen’s efforts to acquire other companies or products and to integrate the operations of companies Amgen has acquired may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of Amgen’s systems and Amgen’s data. Amgen’s stock price may be volatile and may be affected by a number of events. 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SOURCE Amgen Canada |