Aachen, Germany, and Cambridge, MA, USA, January 8, 2016 – Grünenthal today announced the joint global drug development program with Akashi Therapeutics, Inc., for HT-100, an orally available small molecule drug candidate designed to reduce fibrosis and inflammation and to promote healthy muscle fiber regeneration in Duchenne Muscular Dystrophy (DMD) patients. The drug has orphan designation in both the U.S. and the EU, and fast track designation in the U.S. Grünenthal will be responsible for commercialization in Europe and Latin America, while Akashi Therapeutics Inc. will retain rights for the U.S. and all other markets. This partnership is a key milestone in Grünenthal’s strategy to broaden its portfolio in niche indications by building on its track record of bringing innovative pain therapies to patients.
Grünenthal joins forces with Akashi Therapeutics Inc., a company founded by leading patient organizations, to combine skills and capabilities in a unique way for the benefit of patients with DMD. The alliance could in the future be expanded in the effort to the search for improvements for the treatment of boys and young men affected by DMD. HT-100 is currently in clinical phase 1b/2a at five hospitals across the U.S.
“We are very excited about this unique collaboration with Akashi. At Grünenthal, we are highly committed to innovation and have been focusing on bringing innovative therapies to patients with high medical need. We are very motivated to use all our strength for the development of HT-100 together with our partners from Akashi and the patient groups supporting them”, said Dr. Klaus-Dieter Langner, Chief Scientific Officer of Grünenthal.
In 2014, Grünenthal announced its strategy to broaden its focus from pain and inflammation to niche indications with high unmet medical need. On average, the company invests 25% of its revenues back into R&D and is a global leader in the area of prescription opioid analgesics. “As a mid-cap pharmaceutical company, we will be in a position to give the development program of HT-100 high priority in order to hopefully improve the devastating situation of DMD patients”, concludes Klaus-Dieter Langner.
“Grünenthal brings to our collaboration outstanding scientific and intellectual capital, significant financial resources and a powerful commitment to positively impact the treatment of DMD,” said Marc Blaustein, CEO, Akashi Therapeutics Inc., a company that to date has been entirely funded by DMD patient foundations. “Akashi was founded to bring safe and effective treatments to DMD patients, and we look forward to working with our new partners to accelerate achievement of this goal.”
Under the terms of the agreement, Grünenthal will make upfront and milestone payments to Akashi. In addition, the company will assume all post-Phase 2 global development costs through commercialization of an approved product. Akashi will receive royalties on net sales. In total, Grünenthal plans to commit more than $100 million to the partnership and will receive royalties on U.S. net sales in exchange for funding development of Akashi’s U.S. commercial infrastructure.
HT-100 (delayed-release halofuginone) is an orally available, small molecule drug candidate designed to reduce fibrosis and inflammation and promote healthy muscle fiber regeneration in DMD patients. HT-100 has been granted orphan designation for DMD in both the U.S. and E.U., and fast track designation in the U.S. A phase 1b/2a clinical program is currently underway at five hospitals in the U.S. For more information, please contact Akashi Therapeutics Inc. (www.akashirx.com)