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Celimmune: License to Drive Innovation

Amgen Licenses Antibody to Celiac Dream Team

As part of its disciplined approach to funding innovation, Amgen carefully evaluates each internal program to determine which ones will receive much-coveted development funding. Occasionally, a program will come along that does not make Amgen’s resource allocation cut in their intended indication but shows great promise in other areas. This presents a dilemma. Does Amgen provide more funding to explore this new promising area?  Or, does Amgen put this asset in the hands of a committed outside party? In one recent deal, Amgen found some middle ground. When a particular molecule showed promise outside its intended area, an external team committed to moving it forward was located, while Amgen holds an option to take it back at a later stage. This is how startup company Celimmune came to develop AMG 714.

A New Direction for AMG 714

AMG 714 is an anti-IL-15 monoclonal antibody that, following a series of rheumatoid arthritis and psoriasis studies, Amgen deprioritized. But 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.

Praise in Partnership

Intrigued, Amgen struck an agreement with Celimmune, where Dr. Leon serves as CEO and chief medical officer. Amgen has licensed AMG 714 to Celimmune, which has rights to develop, manufacture and commercialize AMG 714 on a worldwide basis excluding Japan. In connection with the license, Celimmune granted Amgen an exclusive option to acquire Celimmune, and thus to reacquire AMG 714, upon completion of certain clinical studies in patients with celiac disease. “We do not hesitate in going on record to speak to the ‘best-in-industry’ licensing and post-transactional alliance management support we have been so privileged to experience to date with Amgen,” said Ashleigh Palmer, Executive Chairman, Celimmune weeks after the deal’s completion.

“Dr. Leon’s conviction was so strong and his credentials so compelling, we couldn’t help but take notice,” said Jeremy Grunstein, an executive director from Amgen’s Business Development team. “Celimmune provided not only an avenue to test this important hypothesis, but also a mechanism for Amgen to reprioritize the program in its pipeline. It’s the kind of deal structure we’d like to replicate.”

Celiac disease is a chronic hereditary systemic autoimmune and inflammatory disease triggered by gluten consumption, which can cause gastrointestinal dysfunction and debilitating symptoms including nutritional malabsorption. Celimmune plans to initiate Phase 2 studies of AMG 714 for the treatment of diet non-responsive celiac disease and type II refractory celiac disease (RCD-II), an in situ small bowel T-cell lymphoma.

Dr. Leon stated, "Celiac disease is the only common autoimmune disease without any approved medication. Published literature demonstrates that a gluten-free diet is not a solution for the majority of patients. As such, Celimmune is delighted to have an opportunity to license an experimental therapeutic that will test one of the main hypotheses in the pathophysiology of celiac disease, namely that IL-15 plays a central role in RCD-II and non-responsive celiac disease.”

Ashleigh Palmer, Celimmune’s Executive Chairman, concurred, “AMG 714 could be the first drug to market for a celiac indication and there’s room for growth. In addition to celiac, AMG 714 could have longer-term expansion and life cycle management opportunities within adjacent gastrointestinal autoimmune diseases."

With this deal, Amgen is still making a bet on external innovation, but with science that originated from within Amgen.

“This deal is win-win-win. If Celimmune is successful, both parties will be rewarded and most importantly, patients will be one step closer to the first medicine available for celiac disease,” said Grunstein.


Forward-Looking Statements

This release contains forward-looking statements that are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. 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 (SEC) reports filed by Amgen, including Amgen's most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen's most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of April 28, 2015 and expressly disclaims any duty to update information contained in this release.

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