THOUSAND OAKS, Calif., Sept. 20, 2021 /PRNewswire/ -- Amgen today announced that the U.S. District Court for the District of New Jersey has upheld patents that protect Amgen's psoriasis therapy Otezla® (apremilast) in a patent infringement lawsuit against Sandoz Inc. ("Sandoz") and Zydus Pharmaceuticals (USA), Inc. ("Zydus"). The asserted patents claim apremilast as a composition of matter ("COM"), methods of treating psoriasis with apremilast, and crystalline forms of apremilast. The court found infringement and upheld the validity of four patents ? three against each defendant -- but ruled against Amgen on claims in U.S. Patent No. 10,092,541 covering methods of treating psoriasis with apremilast according to a specific dosing schedule. Today's decision will prevent Sandoz and Zydus from making, using, selling, offering to sell, or importing each of their generic versions of Otezla until expiration of the COM patent, U.S. Patent No. 7,427,638, in Feb. 2028.
The decision comes after the New Jersey court held a bench trial in June 2021. Prior to trial, Sandoz acknowledged that its generic version of Otezla infringes eight claims in U.S. Patent Nos. 7,427,638, 7,893,101, 8,455,536, and 10,092,541, and Zydus acknowledged that its generic version of Otezla infringes eight claims in U.S. Patent Nos. 7,427,638, 8,093,283, 8,455,536, and 10,092,541, leaving only the issues of whether Zydus's generic version of Otezla infringes U.S. Patent No. 7,893,101 and the validity of the asserted patent claims to be addressed by the court.
Amgen believes in the value of intellectual property and will continue to vigorously defend its intellectual property rights.
In the U.S., Otezla is approved for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy, adult patients with active psoriatic arthritis and adult patients with oral ulcers associated with Behçet's Disease.
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.
Otezla® (apremilast) U.S. INDICATIONS
Otezla® (apremilast) is indicated for the treatment of adult patients with moderate to severe 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
Warnings and Precautions
Use in Specific Populations
Please click here for Otezla® Full Prescribing Information.
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 biologics manufacturing 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 the world's largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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), or the Five Prime Therapeutics, Inc. acquisition, 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, outcomes, progress, or effects relating to studies of Otezla as a potential treatment for COVID-19, 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.
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