PROLOR Biotech Wins Notice of Allowance for New US Patent Covering Long-Acting Coagulation Factors VII and IX

PROLOR Biotech, Inc.

today announced that it received a notice of allowance from the U.S. Patent and Trademark Office for a new patent application covering the company's proprietary long-acting CTP-enhanced coagulation factors for the treatment of hemophilia:  Factor VIIa-CTP, Factor Vll-CTP and Factor IX-CTP.  The allowed claims cover both product composition and treatment methods. "This new patent allowance is important for PROLOR, as we move forward with plans to initiate a Phase II clinical study of our long-acting Factor VIIa-CTP in early 2014," said Shai Novik, President of PROLOR.  "Our intellectual property strategy is designed to provide multiple layers of protection for our product portfolio, and we believe that this new patent will provide additional reinforcement to our existing patent estate for our hemophilia drug candidates." PROLOR previously presented preclinical data on its long-acting versions of factor Vlla and factor IX.  In hemophilic mice, Factor VIIa-CTP demonstrated superior performance on multiple parameters and resulted in greater survival of the subjects compared to commercially available factor VIIa.  Factor VIIa-CTP also demonstrated the potential for subcutaneous administration in addition to administration using standard IV dosing.  Factor IX-CTP demonstrated significantly longer duration of clotting activity in hemophilic mice, and bleeding episodes were significantly shorter and less intense compared with commercially available factor IX.  None of the animals treated with Factor IX-CTP had any spontaneous re-occurring bleeding events, as compared with a 50% incidence of re-bleeding events for the group treated with commercially available factor IX. The new patent is expected to issue in the next few months.