Vimirogant

October 27, 2016 By Alex Keown , BioSpace.com Breaking News Staff DUBLIN – Allergan continues to build up its pipeline through a string of acquisitions. This time the company struck a $200 million deal to snag Motus Therapeutics, Inc. in an effort to shore up its gastrointestinal therapies. Allergan struck after Motus’ drug candidate relamorelin (RM-131) , a ghrelin agonist, after the drug passed a Phase IIb efficacy trial for diabetic gastroparesis with flying colors. Trial results indicate patients taking the treatment for 12 weeks saw a 75 percent reduction of vomiting and abdominal pain in the targeted population of diabetic patients. Motus is a wholly-owned subsidiary of Rhythm Holding Company, LLC . The U.S. Food and Drug Administration granted Fast Track review status to relamorelin for the treatment of diabetic gastroparesis. The drug is injectable, which is a benefit to patients as many of them cannot successfully ingest drugs due to the amount of vomiting they endure. David Nicholson , Allergan’s executive vice president of Global Research and Development, said the company intends to push relamorelin into a pivotal Phase III trial based off the successful Phase IIb and an earlier Phase IIa trials. There has not been a drug approved for gastroparesis by the FDA since 1983. “Patients with diabetic gastroparesis suffer greatly and have very limited treatment options,” Michael Camilleri , a gastroenterologist at Mayo Clinic who was a clinical trial adviser, said in a statement. “The findings in this trial support initiating Phase III clinical trials to confirm these Phase IIb results with relamorelin for the treatment of moderate to severe diabetic gastroparesis. Under terms of the deal, Allergan will pay the exercise price of $200 million at closing to Rhythm Holding, Motus’ parent company. Rhythm Holding will be eligible for a contingent payment upon first commercial sale of relamorelin. Allergan previously made $47 million in payments related to the option-to-acquire Motus and the relamorelin Phase IIb clinical trial. Completion of Allergan’s acquisition of Motus Therapeutics is expected to occur by the end of 2016 subject to customary closing conditions. Bill Meury , Allergan’s chief commercial officer, told Enpoints relamorelin has the potential to be “a flagship for us in gastroenterology in what could be a multibillion dollar drug market.” According to the data, relamorelin was safe and well-tolerated in the phase IIb study. There was some evidence of dose-related adverse events related to worsening of glycemic control in some patients. In the wake of Allergan’s merger with Pfizer falling apart earlier this year, the Irish company has been aggressive in its M&A activities. So far the company has struck a $60 million upfront deal to acquire gene therapy company Retrosense Therapeutics . In August, the company bagged the Bay Area’s ForSight Vision5 to gain that company’s glaucoma product. In April, Allergan acquired Boston-based Topokine Therapeutics and its lead product, XAF5, a first-in-class topical agent to treat steatoblepharon, better known as bags under the eyes. One day after the Pfizer deal fell through, Allergan entered into an agreement with Heptares Therapeutics for exclusive global rights to a portfolio of novel subtype-selective muscarinic receptor agonists for the treatment of several neurological disorders, including Alzheimer’s disease. Allergan also Allergan struck a $639 million deal to acquire Vitae Pharmaceuticals and its experimental oral psoriasis treatment, VTP-43742 and other dermatological products. Brent Saunders , Allergan’s chief executive officer, said the deals the company has focused on since the Pfizer deal fell apart, are for products that Allergan believes it can grow and develop into strong revenue generators.

October 3, 2016 By Mark Terry , BioSpace.com Breaking News Staff UK-based AstraZeneca announced today that its biologics research-and-development unit, MedImmune , inked a licensing deal with Dublin-based Allergan for MEDI2070. MEDI2070 is an IL-23 monoclonal antibody that is presently in a Phase IIb trial for moderate-to-severe Crohn’s disease. It is also expected to start a Phase II trial for ulcerative colitis. AstraZeneca has been developing MEDI2070 since March 2012, when it signed a collaboration agreement with Amgen , based in Thousand Oaks, California. As a result, AstraZeneca will pay Amgen a third of all payments and royalties it receives from Allergan. Amgen is also eligible for a single-digit inventor royalty. As part of the deal, Allergan is paying AstraZeneca an upfront fee of $250 million. Various milestone payments could hit up to $1.27 billion, and any approved therapeutics will include tiered royalties. “This agreement demonstrates our sharp focus on three main therapy areas while creating value from the increased R&D productivity and innovative science in our pipeline through collaborations,” Bahija Jallal , MedImmune’s executive vice president, said in a statement. “Allergan has significant experience in gastrointestinal and inflammatory diseases and is the right partner to progress the development and commercialization of MEDI2070.” AstraZeneca has three primary therapeutic areas, Respiratory, Cardiovascular & Metabolic Diseases, and Oncology. MedImmune will continue an ongoing Phase IIa trial of the drug in Crohn’s disease to completion, then transition the Phase IIb trial to Allergan. “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,” said David Nicholson , Allergan’s chief research & development officer, in a statement. “The MEDI2070 program also reinforces Allergan’s commitment to bringing forward important innovations in the treatment of inflammation and autoimmune disorders where significant unmet need exists across many of our therapeutic areas.” The drug is consistent with Allergan’s strong presence in gastroenterology. It already is marketing drugs for Irritable Bowel Syndrome-C (IBS-C), Chronic Idiopathic Constipation (CIC), Irritable Bowel Syndrome-D (IBS-D) and Ulcerative Colitis. The company recently acquired Vitae Pharmaceuticals , which simultaneously picked up VTP-43742, an orally active retinoic acid receptor-related orphan receptor gamma inhibitor to treat psoriasis and other autoimmune disorders. Allergan paid $639 million for the Pennsylvania-based company. “Vitae has pioneered the discovery and development of highly differentiated first-in-class compounds in atopic dermatitis, psoriasis and autoimmune diseases, areas of medicine where innovation is needed for patients,” Brent Saunders, Allergan’s president and chief executive officer, said in a statement. Allergan has definitely been in a buying mood since its merger deal with Pfizer fell apart. In early September, it acquired gene therapy company Retrosense Therapeutics with $60 million up front. In August, Allergan bought the Bay Area’s ForSight Vision5 , and in April, it acquired Boston-based Topokine Therapeutics . Only a day after the Pfizer deal fell apart, Allergan acquired global rights to Heptares Therapeutics ’ portfolio of novel subtype-selective muscarinic receptor agonists to treat a variety of neurological disorders, including Alzheimer’s disease. The deal with AstraZeneca is expected to close before the end of the year.