October 03, 2016
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Allergan acquires global rights to AstraZeneca's IBD drug candidate

AstraZeneca’s global biologics research and development arm, MedImmune, has licensed Allergan with exclusive worldwide development and commercialization rights to an investigational drug candidate for inflammatory bowel disease, according to a press release from AstraZeneca.

MEDI2070 (MedImmune) is an interleukin (IL)-23 monoclonal antibody being investigated for Crohn’s disease and ulcerative colitis.

“Targeting IL-23 alone may allow for a broader therapeutic window compared to IL12/23 targeting therapies and may translate into better efficacy,” according to a press release from Allergan.

A phase 2b clinical trial in moderate-to-severe Crohn’s disease is ongoing, and a phase 2 clinical trial in ulcerative colitis is ready to be initiated. MedImmune will complete an ongoing phase 2a study in Crohn’s disease and will transition the phase 2b trial to Allergan at an agreed upon transition date.

“This agreement demonstrates our sharp focus on three main therapy areas,” — respiratory, cardiovascular and metabolic diseases, and oncology — “while creating value from the increased R&D productivity and innovative science in our pipeline through collaborations,” Bahija Jallal, executive vice president of MedImmune, said in the press release. “Allergan has significant experience in gastrointestinal and inflammatory diseases and is the right partner to progress the development and commercialization of MEDI2070.”

Allergan will pay $250 million up front to AstraZeneca, and up to $1.27 billion in potential milestone payments, as well as tiered royalty payments on potential sales.

MedImmune has led the drug’s clinical development under a collaboration agreement made between AstraZeneca and Amgen in March 2012. Under this new agreement, AstraZeneca will pay Amgen one-third of all payments and royalties received from Allergan, and Amgen will also receive a single-digit percentage inventor royalty, according to the press release.

“MEDI2070 represents an exciting addition to our Open Science pipeline, adding an important new program currently being studied in Crohn’s disease, with potential across a number of inflammatory and autoimmune disorders,” David Nicholson, chief R&D officer at Allergan, said in the press release.

The transaction is expected to close in the fourth quarter of the year. The addition of MEDI2070 will expand Allergan’s GI portfolio, which includes therapies for irritable bowel syndrome, chronic idiopathic constipation and ulcerative colitis, according to Allergan’s press release.

Bruce E. Sands, MD

Bruce E. Sands

“Although much progress has been made in the last 15 years in treating immune-mediated diseases such as Crohn’s disease and ulcerative colitis, there continues to be a large need to provide safe and effective therapies for those patients who fail to have a durable response to existing agents,” Bruce E. Sands, MD, chief of the Dr. Henry D. Janowitz Division of Gastroenterology at the Mount Sinai Health System, Dr. Burrill B. Crohn Professor of Medicine at the Icahn School of Medicine at Mount Sinai, and investigator of the phase 2a and phase 2b studies of MEDI2070, said in Allergan’s press release. “Evidence suggests that interleukin-23 is a key cytokine in the immune processes that drive inflammatory bowel diseases. Based upon early clinical trial data, MEDI2070 may be an effective treatment for patients with Crohn’s disease.”

Disclosures: Jallal is employed by MedImmune. Nicholson is employed by Allergan. Sands reports being a consultant and receiving research grants from MedImmune.