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Biopharmaceuticals Oncology

 News Release - January 9, 2017

Amgen and Immatics Enter Strategic Collaboration to Develop Novel Bispecific Cancer Immunotherapies

THOUSAND OAKS, Calif. and TUEBINGEN, Germany, Jan. 9, 2017 -- (Healthcare Sales & Marketing Network) -- Amgen (AMGN) and Immatics Biotechnologies GmbH, a leading company in the field of cancer immunotherapy, today announced a research collaboration and exclusive license agreement to develop next-generation, T-cell engaging bispecific immunotherapies targeting multiple cancers.

The collaboration will combine Immatics' world-leading XPRESIDENT® target discovery and T-cell receptor (TCR) capabilities with Amgen's validated Bispecific T-cell Engager (BiTE®) technology with the aim of creating novel oncology drugs. Amgen will be responsible for the clinical development, manufacturing and commercialization worldwide.

Under the terms of the agreement, Immatics will receive an upfront fee of $30 million and is eligible to receive over $500 million in development, regulatory and commercial milestone payments for each program and tiered royalties up to a double-digit percentage of net sales.

"We are very pleased to be entering this strategic collaboration with Amgen, which is contributing its bispecific T-cell engagers expertise, as together we look to develop novel immunotherapies that will deliver a step change in the treatment of several cancers. This collaboration also demonstrates Amgen's confidence in Immatics' world-leading immune-oncology target and TCR discovery capabilities," said Carsten Reinhardt, M.D., Ph.D., managing director and chief medical officer at Immatics.

"The intersection of immunology and oncology represents a promising and rapidly developing approach that can have a significant impact for patients with cancer," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We look forward to collaborating with Immatics to translate their unique target and TCR discovery capabilities combined with Amgen's validated BiTE® technology into novel therapies."

About T-cell Engaging Bispecific Cancer Immunotherapies

T-cell engaging bispecifics leverage the body's immune system by redirecting the T-cell response towards cancer cells expressing specific tumor antigens. Immatics' TCR-bispecifics and Amgen's BiTE® antibody constructs each possess two or more binding domains. One such binding domain specific to an intracellular antigen discovered by XPRESIDENT® presented on the surface of a cancer cell; another such binding domain is designed to recognize a T-cell activator, such as CD3. This approach allows every T-cell to become activated and able to attack the tumor, independent of the T-cells' intrinsic specificity. This bispecific approach is designed to improve the immunotherapies' ability to eradicate malignant cells while avoiding damage to healthy tissues.

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.

About Immatics

Immatics is a clinical stage biopharmaceutical company spearheading the development of advanced immunotherapies that are active against multiple cancer indications. Based in Tübingen, Germany and Houston, Texas, the company has recognized that novel, better and safer targets are the key to developing future cancer immunotherapies. Immatics has revolutionized the identification and qualification of novel, proprietary and tumor-specific peptide antigens (TUMAPs) by developing its world-leading TCR and target discovery platform XPRESIDENT®. TUMAPs significantly expand the target space for immune-oncology as they are not limited to surface proteins, which are the targets of classical antibodies or CAR-T therapies. Immatics believes that by using its TUMAP expertise it can unlock the significant potential of immune oncology drugs, such as adoptive cellular therapies, biologicals and vaccines to improve the treatment of a wide range of cancers.

Immatics' pipeline includes several TCR-bispecifics and T-cell therapy programs such as ACTolog® and ACTengine® developed in collaboration with MD Anderson Cancer Center, Houston, USA. By using its world leading target and TCR discovery expertise, Immatics aims to deliver safer, best-in-class immunotherapies to cancer patients with high medical needs in multiple indications.

For regular updates about Immatics, visit http://www.immatics.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 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 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 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 or others could identify safety, side effects or manufacturing problems with its products after they are on the market. 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. If Amgen fails to meet the compliance obligations in the corporate integrity agreement between it and the U.S. government, Amgen could become subject to significant sanctions. Further, 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 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. 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. 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. Amgen may not be able to access the capital and credit markets on terms that are favorable to it, or at all. Amgen is increasingly dependent on information technology systems, infrastructure and data security. 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.

The scientific information discussed in this news release related to Amgen's 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.


Source: Amgen

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