Actavis has signed an $40 million-plus option to acquire the biopharma company Rhythm’s wholly owned subsidiary, Rhythm Health, and its Phase IIb-ready drug candidate relamorelin (RM-131), a peptide ghrelin agonist, designed to treat diabetic gastroparesis and other GI functional disorders, the companies said today.
Rhythm has completed a successful Phase II trial of relamorelin for diabetic gastroparesis, as well as a second successful Phase II trial for chronic constipation. Rhythm said it expects to initiate a Phase IIb clinical trial of relamorelin for diabetic gastroparesis by early 2015.
“If successful in development, relamorelin could provide a significant addition to our GI family, which currently includes Linzess, Delzicol/Asacol, Carafate, Canasa, Pylera and Rectiv, and for which we are currently developing eluxadoline, the product opportunity acquired earlier this year with our acquisition of Furiex Pharmaceuticals,” David Nicholson, Actavis’ svp, global brands research and development, said in a statement.
Actavis said in April it will acquire Furiex for up to $1.46 billion, in a deal that grew the buyer’s portfolio of gastrointestinal drugs.
In today’s deal, Actavis agreed to pay Rhythm $40 million upfront, and an undisclosed amount if it exercises its option to acquire Rhythm Health and the worldwide rights to relamorelin following completion of the Phase IIb study.
Relamorelin has completed a Phase II trial in diabetic gastroparesis and a Phase IIa study in chronic constipation, while an additional Phase II trial is under way in lower GI functional disorders. The FDA has granted Fast Track review status to relamorelin for the treatment of diabetic gastroparesis.
Actavis and Rhythm also agreed to establish a joint development committee to oversee the development of relamorelin, with Rhythm managing all aspects of the development program during the option period.
Not included in the deal is Rhythm’s other subsidiary, Rhythm Metabolic, which is developing the MC4R peptide agonist RM-493 for the treatment of obesity, including obesity caused by genetic deficiencies in the MC4 pathway such as Prader Willi Syndrome.