Amgen (AMGN) And AbbVie Agree To Settlement Allowing Commercialization Of AMGEVITA™

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Amgen And AbbVie Agree To Settlement Allowing Commercialization Of AMGEVITA™

Amgen to Begin Launching Biosimilar Adalimumab in Europe in 2018

Amgen (AMGN) today announced that it has reached a global settlement with AbbVie to resolve all pending litigation regarding AMGEVITA™/AMJEVITA™, a biosimilar to AbbVie’s Humira® (adalimumab). Under terms of the agreement, AbbVie will grant patent licenses for the use and sale of AMGEVITA/AMJEVITA worldwide, on a country-by-country basis, and the companies have agreed to dismiss all pending litigation. Amgen expects to launch AMGEVITA in Europe on Oct. 16, 2018, and AMJEVITA in the United States on Jan. 31, 2023.

“We look forward to leveraging our existing biologics capabilities to bring high-quality biosimilars to patients worldwide. AMGEVITA will be one of our first biosimilar launches, and this agreement will allow us to secure a strong foothold in the $4 billion European adalimumab market,” said Scott Foraker, vice president and general manager of Biosimilars at Amgen. “Building on our strong inflammatory disease presence in the United States, we are excited to develop our inflammation capabilities in Europe, extending our reach and helping more patients gain access to this important class of therapies.”

Specific financial terms of the agreement were not disclosed.

About Amgen Biosimilars

Amgen Biosimilars is committed to building upon Amgen’s experience in the development and manufacturing of innovative human therapeutics to expand Amgen’s reach to patients with serious illnesses. Biosimilars will help to maintain Amgen’s commitment to connect patients with vital medicines, and Amgen is well positioned to leverage its more than 35 years of experience in biotechnology to create high quality biosimilars and reliably supply them to patients worldwide.

For more information, visit www.amgenbiosimilars.com and follow us on www.twitter.com/amgenbiosim.

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.

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 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 our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and 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.

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