Ironwood Pharmaceuticals and Depomed inked a collaboration, research, and license agreement giving Ironwood rights to use Depomed’s AcuForm™ gastric retentive drug delivery technology in combination with one of its early-stage development programs. Under terms of the deal, Depomed will provide initial formulation support, but Ironwood will be responsible for all product development and commercialization activities. The firm will also pay Depomed an up-front license fee, plus development and regulatory milestones and sales royalties.
“We believe the AcuForm technology is highly complementary to our internal effort to create differentiated medicines and provides Ironwood with the opportunity to continue to build a portfolio of development candidates through both internal and external R&D,” states Jim O’Mara, Ironwood vp for corporate development.
Specialty pharmaceuticals firm Depomed is working both in house and through partnerships to develop enhanced formulations of well-characterized oral drugs through the application of its AcuForm technology. The polymer-based drug delivery platform is designed to optimize targeted, extended release of pharmaceuticals specifically to the upper gastrointestinal (GI) tract. AcuForm is based on polymers that allow the tablet to be retained in the stomach for approximately eight to nine hours. During this time the active ingredient is steadily delivered to the upper GI tract at the desired rate, and without the potentially irritating burst of drug that can occur with other formulations, DepoMed claims.
Two AcuForm-formulated drugs have gained marketing approval. The type 2 diabetes drug, Glumetza (extended release metformin hydrochloride tablets), was first approved by FDA in 2006, and is marketed by Santarus in the U.S. Glumetza has in addition been approved in Canada, where it is marketed by Biovail. Depomed is currently seeking commercialization partners for European territories.
In January this year FDA cleared Depomed’s AcuForm gapapentin drug, Gralise™, as a once-daily treatment for post-herpetic neuralgia. The drug is licensed to Abbott in the U.S., Canada, and Mexico, and its approval in the U.S. triggered a $48 million milestone payment from Abbott.
The firm’s current clinical pipeline is headed by Serada™, an extended-release AcuForm formulation of gabapentin, which is in Phase III development as a potential treatment for menopausal hot flashes. Phase II studies with an extended release formulation of omeprazole have also been carried out. This candidate, DM-3458, is in development for treating nocturnal acid breakthrough associated with gastroesophageal reflux disease (GERD). Depomed’s third clinical-stage candidate, DM-1992, is a gastric retention formulation of levodopa/carbidopa, which has undergone Phase I evaluation in Parkinson disease patients.
In March Boehringer Ingelheim paid Depomed an initial $12.5 million for a worldwide license to the AcuForm technology for use in the development of certain fixed-dose combination products, including extended release metformin and proprietary Boehringer Ingelheim compounds, in development for type 2 diabetes. The firm also negotiated a right of reference to the Glumetza NDA and associated data for use in potential regulatory submission processes.