THOUSAND OAKS, Calif. and OLDWICK, N.J., Nov. 5, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Provention Bio, Inc. (NASDAQ:PRVB), a clinical-stage biopharmaceutical company focused on immune-mediated diseases, today announced a licensing and co-development agreement for AMG 714, identified by Provention as PRV-015. AMG 714 is a novel anti-IL-15 monoclonal antibody being developed for the treatment of gluten-free diet non-responsive celiac disease (NRCD). Development efforts at Provention will be led by researchers with previous experience developing AMG 714.
Under the terms of the agreement, Provention will conduct and fund a Phase 2b trial in NRCD and lead the next phase of development and regulatory activities for the program. Amgen will make a $20 million investment coincident with Provention's next financing event, subject to certain terms and conditions. Amgen is also responsible for the manufacturing of AMG 714. Upon completion of the Phase 2b trial, Provention will be eligible to receive a $150 million milestone payment, as well as additional regulatory milestone payments and royalties if Amgen continues AMG 714 development.
"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."
About AMG 714 AMG 714 (PRV-015) is a human immunoglobulin monoclonal antibody that binds to IL-15. AMG 714 was initially developed by Amgen in rheumatoid arthritis and later investigated for possible use in celiac disease. In 2015, Amgen outlicensed AMG 714 to Celimmune LLC, a clinical development-stage immunotherapy company founded by Ashleigh Palmer and Francisco Leon, M.D., Ph.D. Celimmune conducted two separate AMG 714 Phase 2a clinical trials in celiac disease and refractory celiac disease type II, after which Amgen acquired Celimmune in 2017. Data from both clinical trials were presented at Digestive Disease Week 2018.
About Celiac Disease Celiac disease is a chronic hereditary systemic autoimmune and inflammatory disease triggered by gluten consumption that results in damage to the lining of the small intestine, causing gastrointestinal dysfunction and debilitating symptoms. Nutritional malabsorption can lead to a failure to thrive in children, and anemia and osteopenia in children and adults. Over the course of a lifetime, untreated or poorly managed celiac disease is often associated with deteriorating general health, multiple serious intestinal and extra-intestinal medical complications, and increased morbidity and mortality. It is estimated that currently one percent of Western and .5 percent of Asian populations suffer from celiac disease and diagnosed prevalence is expected to increase with improved diagnostic tools and clinical awareness. There are no approved medications for celiac disease.
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.
About Provention Bio, Inc. Provention Bio, Inc. is a clinical-stage biopharmaceutical company leveraging a transformational drug development strategy that is focused on the prevention or interception of immune-mediated disease. Provention's diverse portfolio was assembled with product candidates that have undergone clinical testing but may have been underdeveloped or deprioritized assets at other companies. Provention's mission is to in-license, transform and develop clinical-stage, or nearly clinical-stage, therapeutic candidates targeting the high morbidity, mortality and escalating costs of autoimmune and inflammatory diseases including: type 1 diabetes (T1D), Crohn's disease, ulcerative colitis, lupus, and certain life-threating viral diseases.
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Provention Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on Provention's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA approvals or clearances and noncompliance with FDA regulations; uncertainties of patent protection and litigation; limited research and development efforts and dependence upon third parties; substantial competition; our need for additional financing and the factors listed under "Risk Factors" in our quarterly report on Form 10-Q for the quarter ended June 30, 2018 and any subsequent filings with the Securities and Exchange Commission (SEC). As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Provention does not undertake an obligation to up-date or revise any forward-looking statement. The information set forth herein speaks only as of the date hereof.