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Amgen Canada Receives Approval of Marketing Authorization Transfer of OTEZLA® for the Treatment of Moderate to Severe Plaque Psoriasis and Psoriatic Arthritis

Addition of OTEZLA Strengthens Amgen’s Long-Standing Expertise in Inflammation

MISSISSAUGA, ON (February 12, 2020) – 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
As a leader in innovation, Amgen Canada understands the value of science. With main operations located in Mississauga, Ont.’s vibrant biomedical cluster, and its research facility in Burnaby, B.C., Amgen Canada has been an important contributor to advancements in science and innovation in Canada since 1991. The company contributes to the development of new therapies and new uses for existing medicines in partnership with many of Canada’s leading health-care, academic, research, government and patient organizations. To learn more about Amgen Canada, visit www.amgen.ca.

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 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 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 its 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 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. Amgen develops 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 Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with its products, including its devices, after they are on the market.

Amgen's results may be affected by its 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 its products and global economic conditions. In addition, sales of Amgen's 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, Amgen's research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Amgen's business may be impacted by government investigations, litigation and product liability claims. In addition, Amgen's business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. While Amgen routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors, or Amgen may fail to prevail in present and future intellectual property litigation. Amgen performs a substantial amount of its commercial manufacturing activities at a few key manufacturing facilities, including in Puerto Rico, and also depends on third parties for a portion of its manufacturing activities, and limits on supply may constrain sales of certain of its current products and product candidate development. 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, Amgen competes with other companies with respect to many of its marketed products as well as for the discovery and development of new products. 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. Amgen's business performance could affect or limit the ability of the Amgen Board of Directors to declare a dividend or its ability to pay a dividend or repurchase its common stock. Amgen may not be able to access the capital and credit markets on terms that are favorable to it, or at all.

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CONTACT: 
Natasha Bond
Amgen Canada
Ph: 905-285-3007
natashab@amgen.com



i OZTEZLA ® Product Monograph. Amgen Canada Inc. (February 2020).

ii  htttps://www.psoriasisconnect.com/learn-about-psoriasis/what-is-psoriasis

iii https://dermatology.ca/public-patients/skin/psoriasis/

iv https://www.psoriasis.org/content/statistics

v https://www.psoriasis.org/about-psoriasis/types/plaque

vi https://www.psoriasisconnect.com/learn-about-psoriasis/what-is-psoriatic-arthritis