|Biogen and Sobi Announce European Medicines Agency Validates ELOCTA™; BioLineRx Reports Results from Previous Phase 1/2 Trial for BCM (BL-1040)|
|By William Kent|
|Friday, 31 October 2014 19:06|
Biogen Idec (NASDAQ: BIIB) and Swedish Orphan Biovitrum AB (publ) (Sobi) (STO: SOBI) announced the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) of ELOCTA™ (rFVIIIFc), a recombinant factor VIII Fc fusion protein product candidate for the treatment of hemophilia A. The validation of the MAA initiates the EMA’s review process.
ELOCTA is the European trade name for rFVIIIFc, which is also known as ELOCTATE™ [Antihemophilic Factor (Recombinant), Fc Fusion Protein] in the U.S., Canada, and Australia, where it is approved for the treatment of hemophilia A. ELOCTATE is the first recombinant clotting factor VIII therapy with prolonged circulation to provide protection from bleeding episodes with the potential for an extended interval between prophylactic injections.
“The validation of ELOCTA’s application by the EMA is an important step toward bringing this innovative treatment to people with hemophilia A in Europe,” said Douglas E. Williams, Ph.D., executive vice president of Research and Development at Biogen Idec. “ELOCTA has the potential to protect against bleeding episodes while helping to address the challenge of frequent injections.”
The regulatory application included results from the pivotal, Phase 3 clinical study, A-LONG that examined the efficacy, safety and pharmacokinetics of rFVIIIFc in males 12 years of age and older with severe hemophilia A and from the Phase 3 clinical study, Kids A-LONG that evaluated the efficacy and safety of rFVIIIFc in children with hemophilia A under 12 years of age.
Biogen Idec and Sobi are collaborators in the development and commercialization of ELOCTATE/ELOCTA for hemophilia A. Sobi has an opt-in right to take over final development and commercialization of ELOCTA for the Sobi territories (Europe, North Africa, Russia and most Middle Eastern markets). Biogen Idec leads development for ELOCTATE/ELOCTA, has manufacturing rights, and has commercialization rights in North America and all other regions in the world excluding the Sobi territories.
“Sobi and Biogen Idec are committed to addressing significant medical needs in the global hemophilia community,” said Birgitte Volck, M.D., Ph.D., senior vice president development and chief medical officer of Sobi. “We’re working collaboratively to deliver innovative medicines that have the potential to change the way hemophilia A is treated.”
BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced publication of the results of a previous Phase 1/2 (pilot) study for IK-5001 (BL-1040), currently named Bioabsorbable Cardiac Matrix (BCM), a novel resorbable polymer solution for the prevention of cardiac remodeling following an acute myocardial infarction (AMI). This first-in-man pilot study, which was completed in 2010, demonstrates that intracoronary deployment of BCM is feasible and well tolerated.
The study, which was now published in the journal Circulation: Cardiovascular Interventions, was conducted by BioLineRx, and was performed at selected sites in Germany and in Belgium. Twenty seven AMI patients were enrolled and treated with BCM within seven days after the infarction. Clinical safety assessment, including coronary angiography, holter monitoring and blood tests, shows that BCM deployment was well tolerated following the coronary injection, and patient evaluation at six months after treatment confirmed the sustained safety profile of the product. In addition, echocardiography six months after treatment showed preservation of left ventricular functional indices in study participants, implying that BCM has potential to help in preventing cardiac remodeling of the left ventricle. This data is limited due to the uncontrolled nature of the study, but is encouraging in its resemblance to results observed in former pre-clinical studies.
BCM, which was out-licensed to Bellerophon in 2009 for further development and commercialization, is in the midst of the PRESERVATION I study, a CE Mark registration trial at over 80 sites worldwide, 16 of which are in the U.S. To date, over 280 patients have been enrolled in the study, which is designed to enroll a total of approximately 300 patients. Enrollment is expected to be completed by the end of this year, with study completion anticipated in mid-2015.
"We are pleased that the results of this Phase 1/2 trial have been published in a highly respected peer journal, since these results were the basis for initiation of the multicenter, randomized and controlled PRESERVATION I CE Mark registration trial to confirm the safety and efficacy of this new approach in high-risk AMI patients," said Dr. Kinneret Savitsky, BioLineRx's CEO. "1.5 million cases of myocardial infarction occur annually in the U.S. alone, many of which result in irreversible pathological cardiac remodeling. Pre-clinical studies show that BL-1040 is efficacious at preventing cardiac remodeling following an acute myocardial infarction. The pre-clinical studies, along with certain encouraging trend data in the Phase 1/2 study, raise the hope that we will be able to help preserve cardiac function for millions of potential patients around the world. We are eagerly awaiting completion of the PRESERVATION I trial being carried out by our partner Bellerophon, which is expected in mid-2015.”
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