BioLineRx has announced that an Issue Notification has been received from the United States Patent and Trademark Office (USPTO) granting 1,787 days of Patent Term Adjustment for the patent claiming the composition of BCM (BL-1040), a novel medical device for prevention of cardiac remodeling following an acute myocardial infarction.
Accordingly, the term of this patent will now extend through at least the end of April 2029, which is almost three years longer than previously reported by the Company.
Additional patents claiming the BL-1040 composition and its use for the treatment of ventricular remodeling and congestive heart failure due to acute myocardial infarction are granted or pending in Europe, Japan, Canada, Korea, Mexico, Israel, India, China and Australia.
In June 2009, BioLineRx out-licensed BL-1040 to Ikaria, Inc. for continuation of development and commercialization of BL-1040, which was previously named IK-5001 by Ikaria and now is known as Bioabsorbable Cardiac Matrix (BCM).
In December 2011, Ikaria commenced the PRESERVATION I clinical trial, a CE Mark registration trial for BL-1040.
Dr. Kinneret Savitsky, CEO of BioLineRx, stated, "We are pleased with the extension of the patent covering BL-1040's composition by the USPTO. There is now a significantly longer period of exclusivity to this unique device for preventing irreversible cardiac remodeling in patients following an acute myocardial infarction, which is known to occur in many cases of myocardial infarction. Currently, approximately 1.5 million cases of myocardial infarction occur annually in the U.S. alone. BL-1040 has demonstrated efficacy at preventing cardiac remodeling following an acute myocardial infarction in pre-clinical studies, giving new hope to patients around the world. In addition, we are pleased with the intensive efforts being made by Ikaria, who are carrying out the CE Mark Registration Trial."