Rhythm, Actavis Partner On Relamorelin For GI Disorders

Actavis and Rhythm have struck a deal wherein Actavis will co-develop relamorelin (RM-131) for gastrointestinal (GI) disorders and have the option to buy Rhythm’s subsidiary, Rhythm Health, which is developing relamorelin. The two companies announced the move in a press release, stating that further movement is dependent on a Phase 2b trial, expected to begin in 2015.

David Nicholson, Senior VP of Global Brands Research and Development at Actavis, said, “This venture allows Actavis, in partnership with Rhythm, to advance the development of this molecule in a manner that minimizes risk in early stage development, yet ensures our ability to acquire global rights to the product upon initiation of Phase 3 trials."

Keith Gottesdiener, MD, CEO of Rhythm, said that patients have not had a new therapy for gastroparesis for 30 years. He said that the agreement leverages Actavis’ experience and marketing network for GI conditions. Activis currently markets Linzess, Delzicol/Asacol, Carafate, Canasa, Pylera, and Rectiv.

Rhythm and Actavis Agreement

Under the terms of the agreement between Rhythm and Actavis, the two will co-develop relamorelin, starting by establishing a joint development committee. Rhythm will manage development through the end of the Phase 2b trial. Actavis will provide a $40 million upfront payment to Rhythm for relamorin activities. Additionally, Actavis has acquired an exclusive option to acquire Rhythm Health including worldwide rights to relamorelin. Actavis may exercise its option following Phase 2b study completion. Financial terms for the option to acquire were not disclosed. The deal only concerns Rhythm Health and not Rhythm’s other subsidiary, Rhythm Metabolic.

Relamorelin

Relamorelin is a peptide ghrelin agonist, which shows promise in treating gastroparesis and other GI disorders. Rhythm has already completed two Phase 2 trials of relamorelin in diabetic gastroparesis and chronic constipation. Relamorelin is derived from the natural ghrelin sequence and is optimized to stimulate gastrointestinal (GI) motility. The Food and Drug Administration (FDA) has granted Fast Track status to relamorelin in the treatment of diabetic gastroparesis.

About Rhythm

Rhythm develops peptide therapeutics for gastrointestinal diseases and obesity, including obesity caused by genetic deficiencies in the MC4 pathway. The company is developing an MC4R peptide agonist, RM-493, for obesity, including obesity caused by genetic deficiencies in the MC4 pathway. MPM Capital, New Enterprise Associates, Third Rock Ventures, Ipsen, and Pfizer Ventures invest in Rhythm, which is headquartered in Boston, Massachusetts.