The Medicines Company announced today that it has entered into an agreement to acquire Incline Therapeutics, Inc., a company focused on the development of IONSYS® (fentanyl iontophoretic transdermal system), a compact, disposable, needleless Patient-Controlled Analgesia (PCA) system in development for the short-term management of acute postoperative pain in the hospital setting.
The Medicines Company announced in a separate news release that it has entered into a global collaboration and option agreement with Bristol-Myers Squibb relating to Recothrom®, a recombinant thrombin approved by the U.S. Food and Drug Administration (FDA) for use as a topical hemostat to control non-arterial bleeding during surgical procedures.
“With two simultaneous transactions, selected and engineered as major elements in an established acute and intensive care hospital strategy, we believe The Medicines Company is in position to be the leading biopharmaceutical industry player in perioperative care,” said Clive Meanwell, MD, PhD, Chairman and Chief Executive Officer of The Medicines Company.
IONSYS was originally developed and evaluated in an extensive clinical program, including seven Phase 3 clinical trials, which formed the basis of FDA and European Medicines Agency (EMA) marketing clearances in 2006 for the short-term management of acute post-operative pain in the hospital setting. In 2008, IONSYS was launched in Europe, achieving strong hospital formulary acceptance. However, due to device stability issues, IONSYS was voluntarily recalled in Europe and was not launched in the US. Incline acquired IONSYS from ALZA Corporation in 2010.
Glenn Sblendorio, President and Chief Financial Officer, said, “We have been very impressed with the work that the Incline team has done to address prior challenges and to prepare the product for near-term resubmission for marketing in the US and Europe. We expect that if we obtain IONSYS approval, we could launch IONSYS in early 2014 in the US and soon thereafter in Europe.”
Alan Levy, Incline’s Chief Executive Officer, stated, “The Medicines Company has a proven track record of success in developing and commercializing acute and intensive care products, as highlighted by the considerable success of Angiomax. We have great confidence in their ability to optimize the therapeutic and commercial potential of IONSYS.”
The Medicines Company has agreed to pay Incline $185 million in an upfront payment with additional payments if certain regulatory and commercial milestones are met.