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Actavis signs option to acquire Rhythm Subsidiary and its GI Development Product, Relamorelin
Friday, October 24, 2014
Actavis plc, a leading global specialty pharmaceutical company, and Rhythm, a biopharmaceutical company, today announced that Actavis has been granted an exclusive option to acquire Rhythm''s wholly owned subsidiary, Rhythm Health, Inc., which is developing relamorelin (RM-131), a peptide ghrelin agonist, for the treatment of diabetic gastroparesis and other GI functional disorders.
Rhythm has completed a successful Phase 2 trial of relamorelin for the treatment of diabetic gastroparesis and a second successful Phase 2 trial for chronic constipation. Rhythm expects to initiate a Phase 2b clinical trial for the treatment of diabetic gastroparesis by early 2015.
Under the terms of the agreement, Actavis will provide a $40 million upfront payment to Rhythm, and will have the option to acquire Rhythm Health, Inc. and the worldwide rights to relamorelin for an undisclosed amount following the completion of the Phase 2b study. Actavis and Rhythm will establish a joint development committee to oversee the development of relamorelin, with Rhythm managing all aspects of the development program during the option period.
The transaction is limited to the acquisition of Rhythm Health, Inc. and does not include Rhythm''s other subsidiary, Rhythm Metabolic, Inc., 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.
"The option to acquire Rhythm Health, Inc. and its relamorelin development candidate demonstrates our commitment to identify unique opportunities and, through innovative business initiatives, expand our potential product franchises in core therapeutic categories," said David Nicholson, Senior Vice President, Global Brands Research and Development, Actavis. "Relamorelin has the potential to be a significant new advance in the treatment of gastroparesis and other GI functional disorders where there is an urgent need for better therapies, particularly drugs like relamorelin that have a prokinetic mechanism of action. 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. 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."
"This is a very positive partnership for both companies, and also potentially for patients with diabetic gastroparesis who have not had a new therapy for gastroparesis approved in the U.S. for more than 30 years," said Keith Gottesdiener, MD, CEO of Rhythm. "This agreement leverages Actavis'' commitment and capabilities for gastroenterology drug development and commercialization, and so we are very pleased to work together on the upcoming Phase 2b study for relamorelin."
Source : http://www.actavis.com
