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Mallinckrodt completes acquisition of three commercial-stage hemostasis drugs from The Medicines Company

Press releases may be edited for formatting or style | February 01, 2016
CHESTERFIELD, United Kingdom, Feb. 1, 2016 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading specialty biopharmaceutical company, today announced it closed the acquisition of the global portfolio of three commercial-stage topical hemostasis drugs from The Medicines Company. The portfolio includes RECOTHROM® Thrombin topical (Recombinant), PreveLeak™ Surgical Sealant, and RAPLIXA™ (Fibrin Sealant (Human)).

Under Mallinckrodt's acquire to invest operating model, the company will invest in market development of RECOTHROM, PreveLeak and RAPLIXA, all innovative, highly durable hemostasis products that increase surgeons' choices. The addition of these global hemostasis assets to the company's Specialty Brands segment will expand Mallinckrodt's growing hospital portfolio, including INOmax® (nitric oxide) for inhalation and THERAKOS® immunotherapy systems, and specifically augments its current OFIRMEV® (acetaminophen) injection surgical pain management offering. Products that help control bleeding are essential to surgical practice, and the market is estimated at $750 million annually in the U.S. and at least $1 billion globally.

"Acquiring and promoting leading hemostasis brand RECOTHROM alongside OFIRMEV broadens Mallinckrodt's impact in the surgical suite for patients and physicians, and creates a strong framework to broadly commercialize innovative, highly durable agents PreveLeak and RAPLIXA, which carry intellectual property protection to 2028 and 2031, respectively," said Mark Trudeau, President and Chief Executive Officer of Mallinckrodt.

Ron Lloyd, Senior Vice President and President, Hospital Therapies, said, "As we continue to further diversify our portfolio, we're excited about the volume growth opportunity these products offer, which can expand access to patients in the hospital setting for years to come."

RECOTHROM is widely used in the U.S., and is the first and only recombinant topical thrombin approved for use in adult and pediatric patients. PreveLeak provides an ideal balance of strength and flexibility, and is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage. RAPLIXA is the first biologically active powdered hemostat which contains both thrombin and fibrinogen. The RAPLIXASpray™ device allows for greater versatility in administering RAPLIXA.

Each of the acquired products is approved for use in the U.S. and certain European countries, with long-range market exclusivity through intellectual property protection – RECOTHROM to 2026, PreveLeak to 2028 and RAPLIXA to 2031. Only RECOTHROM is currently marketed in the U.S.

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