Monday, July 27, 2015
Actavis’ Viberzi (eluxadoline) has been approved by the FDA as a twice-daily, oral treatment for adults suffering from irritable bowel syndrome with diarrhea (IBS-D). Viberzi (eluxadoline) has mixed opioid receptor activity, it is a mu receptor agonist, a delta receptor antagonist and a kappa receptor agonist.
Rhythm, a biopharmaceutical company, and Actavis, a global pharmaceutical company, have initiated a phase IIb clinical trial assessing the efficacy and safety of relamorelin (RM-131), Rhythm’s ghrelin agonist, for the treatment of gastroparesis in patients with type 1 and type 2 diabetes. Ghrelin is a peptide hormone produced in the stomach that stimulates gastrointestinal (GI) motility. Actavis has an exclusive option to acquire Rhythm’s wholly owned subsidiary, Rhythm Pharmaceuticals, upon the completion of the phase IIb study.
Aptalis Pharmaceutical Technologies has announced that its divestiture from Actavis to TPG, a Texas-based global private investment firm, has been completed. The company also announced its new name is Adare Pharmaceuticals, and John Fraher, who was president of Aptalis Pharmaceutical Technologies, has been named CEO. He is joined by key executives from his current management team.
Actavis, headquartered in Dublin, Ireland, will adopt a new corporate name—Allergan—following the anticipated successful completion of the acquisition of Allergan. The company said that it intends to use the Allergan name as its corporate name and for its global branded pharmaceutical portfolio, and will retain the Actavis name for select geographic regions and product portfolios. The change in corporate name would be subject to approval by Actavis’ shareholders at its annual general meeting later this year.
Actavis, headquartered in Dublin, and TPG, a global private investment firm, have entered into definitive agreements under which Actavis will divest to TPG the business currently known as Aptalis Pharmaceutical Technologies (Pharmatech)—a pharmaceutical outsourcing and R&D business operating in the U.S., Canada and Europe (where the transaction is, in certain jurisdictions, still subject to local regulations, discussions and clearances). No other Aptalis businesses or products are included in the transaction. Financial terms have not been disclosed.
Actavis, a global specialty pharmaceutical company, will acquire Auden Mckenzie, a company focused on the development, licensing and marketing of niche generic medicines and proprietary brands in the U.K., for approximately $461.8 million in cash, plus a two-year royalty on a percentage of gross profits of one of Auden Mckenzie’s products.
Grünenthal, an independent, family-owned, international, research-based pharmaceutical company headquartered in Aachen, Germany, has terminated a license agreement with Actavis for the development and commercialization of cebranopadol, a novel analgesic for the treatment of chronic pain.
The FDA has accepted for filing Actavis‘ supplemental New Drug Application (sNDA) for Saphris (asenapine) for the acute treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients 10 to 17 years of age. Actavis’ sNDA for Saphris has been granted priority review status by the FDA.