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Expertise and a Proven Track Record: Ingredients for the Amgen-Provention Collaboration

Amgen carefully evaluates internal programs to determine the best way to advance them. Occasionally, a program will come along that Amgen will seek to develop in collaboration. AMG 714, an IL-15 inhibitor, is one such program.  Amgen sought a strong partner with expertise in celiac disease to conduct the next phase of studies. After evaluating options, Amgen chose a company run by Dr. Francisco Leon and Ashleigh Palmer, both former AMG 714 collaborators, to take the program to the next major clinical inflection point.

A New Direction for AMG 714

AMG 714 is an anti-IL-15 monoclonal antibody that, following rheumatoid arthritis and psoriasis studies, Amgen had previously deprioritized. However there was a scientist outside of Amgen who hadn’t forgotten about anti-IL-15. Dr. Francisco Leon, a leading expert in the development of therapeutics for celiac disease, had been following this antibody and a growing body of scientific literature suggesting IL-15’s central role in refractory celiac disease and non-responsive celiac disease. Dr. Leon believed AMG 714 was a ready tool to test the hypothesis that blocking IL-15 could benefit celiac patients.  Dr. Leon’s conviction led him to team up with Ashleigh Palmer to form Celimmune in 2014.  Amgen licensed AMG 714 to Celimmune with an option to re-acquire rights upon completion of two proof-of-concept studies. In 2017 Amgen re-acquired program rights.

Continuing a Successful Collaboration on AMG 714

Following Amgen’s acquisition of Celimmune, Ashleigh Palmer and Dr. Francisco Leon cofounded a new startup, Provention Bio, focused on the prevention and interception of immune-mediated diseases. They rapidly built Provention to complete this mission, assembling a strong team to advance carefully selected and sourced clinical programs to reduce the high morbidity, mortality, patient suffering and escalating costs of debilitating autoimmune and inflammatory diseases. The Amgen team sought to again leverage Palmer’s and Leon’s expertise in celiac disease. After several months of discussions, Amgen chose to collaborate with the Provention team on AMG 714 using a carefully tailored deal structure that preserved Amgen’s ability to commercialize AMG 714 after the next phase of studies have been run.   On Nov 5, 2018, Amgen and Provention Bio announced a licensing and co-development agreement for AMG 714 to be studied for the treatment of gluten-free diet non-responsive celiac disease (NRCD).  As stated in the announcement, Provention agreed to conduct and fund a Phase 2b trial in NRCD and lead the next phase of development and regulatory activities for the program.

At the Time of the Announcement, Amgen and Provention Bio’s Leaders Expressed Excitement for the Collaboration

"Celiac disease impacts millions of people around the world and remains the only common autoimmune disease with no approved therapeutic treatment," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We are pleased to collaborate with Provention, given their expertise and familiarity with AMG 714, in advancing a potential new treatment option for patients living with this life-interrupting illness."

"Our AMG 714 co-development collaboration with Amgen is a significant milestone in the growth and advancement of Provention. AMG 714 has the potential to be the first FDA-approved treatment for celiac disease and aligns with Provention's mission to prevent and intercept immune-mediated disease," said Ashleigh Palmer, co-founder and chief executive officer of Provention.

"Data presented at Digestive Disease Week 2018 from two Phase 2a clinical trials of AMG 714 demonstrated the drug's potential in celiac disease and refractory celiac disease type II (RCD-II), an in situ gastrointestinal T cell lymphoma, and confirmed that IL-15 plays a central role in non-responsive celiac disease and RCD-II," said Francisco Leon, M.D., Ph.D., co-founder and chief scientific officer of Provention. "We are delighted to be collaborating with Amgen to advance AMG 714 by way of the planned Phase 2b NRCD study."

Forward-Looking Statements

This article 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 article 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. 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.

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.