The Medicines Company has agreed to purchase Incline Therapeutics, a hospital-focused specialty pharmaceutical company, for an upfront payment of $185m.
Incline’s commercial products include a compact, disposable, needleless patient-controlled IONSYS (fentanyl iontophoretic transdermal system), designed for the short-term management of acute postoperative pain in adult patients requiring opioid analgesia during hospitalisation.
IONSYS, which was demonstrated in seven Phase III clinical trials, formed the basis of FDA and European Medicines Agency (EMA) marketing clearances in 2006.
Acquired from ALZA, IONSYS was launched in Europe in 2008 and achieved strong hospital formulary acceptance.
The device, however, was voluntarily recalled in Europe due to stability issues and was not launched in the US.
The Medicines Company president and chief financial officer Glenn Sblendorio said to address prior challenges, Incline has prepared the product for near-term resubmission to make it available 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," Sblendorio said.
Incline Therapeutics chief executive officer Alan Levy said; "We have great confidence in their ability to optimise the therapeutic and commercial potential of IONSYS."
The Medicines Company said it will also provide Incline with additional payments, if certain regulatory and commercial milestones are met.