Biogen Idec Inc. (NASDAQ:BIIB) is in the news again; on July 4, 2013 the company presented new data in support of clinical and safety profile for ELOCTATE, its candidate for hemophilia A that it is developing in partnership with Swedish Orphan Biovitrum AB. Earlier, in May this year, the FDA had accepted the company’s Biologics License Application (BLA) for the marketing approval of ELOCTATE. Biogen now has product candidates for both hemophilia A and B. Given its long list of major marketed drugs, I am bullish on the stock as of now.
Hemophilia A treatment angle
Hemophilia A is a rare, inherited blood disorder in which the ability of the patient’s blood to clot is severely reduced. It is caused by a congenital deficiency or absence of Factor VIII, which is required for blood clotting. Patients with hemophilia A need to be given Factor VIII injections for restoring the process of coagulation in order to prevent frequent bleeds, which among other things may lead to life-threatening hemorrhages.
About ELOCTATE for Hemophilia A
ELOCTATE, a recombinant Factor VIII Fc fusion protein, belongs to a new class of long-lasting clotting factor therapies that Biogen Idec Inc. (NASDAQ:BIIB) is developing with its proprietary monomeric Fc fusion technology, which delays the destruction of the factor and cycles it back into the bloodstream.
New data presented this month at the XXIV International Society on Thrombosis and Haemostasis (ISTH) Congress in Amsterdam, showcases ELOCTATE’s potential of reducing the number of injections required by hemophilia A patients and efficacy in controlling bleeding and treating episodes of acute bleeding.
About ALPROLIX for Hemophilia B
A day earlier, the company had presented new data for ALPROLIX that supported its safety, efficacy and pharmacokinetic profile. ALPROLIX, also being developed in collaboration with Swedish Orphan Biovitrum, is a recombinant factor IX Fc (rFIXFc) fusion protein, Biogen’s candidate for treatment of hemophilia B. As per the new data released by the company, one injection of ALPROLIX helped control more than 90% of bleeds. Earlier Phase III results had shown that ALPROLIX could effectively control and prevent bleeding and perioperative management.
In a pharmacokinetic analysis it was found that ALPROLIX had more than double the longevity of Pfizer Inc. (NYSE:PFE)’s BeneFIX, a recombinant factor IX (or Christmas factor) also used to treat Hemophilia B. Global sales of BeneFIX have grown at the rate of nearly 12% and reached $775 million in 2012.
Both ALPROLIX and ELOCTATE came to Biogen Idec Inc. (NASDAQ:BIIB) with the acquisition of Syntonix Pharmaceuticals in January 2007.
About Biogen Idec
Established in 1978, Biogen Idec is among the world’s oldest independent biotechnology companies. The company focuses on neurodegenerative and autoimmune disorders and hemophilia. Its portfolio of ten approved drugs include four for treatment of various forms of multiple sclerosis, including TECFIDERA (dimethyl fumarate), which was successfully launched this year in the U.S. Analysts expect 2013 sales of TECFIDERA to be around $422 million in 2013.
Biogen Idec Inc. (NASDAQ:BIIB)’s annual revenues for 2012 were $5.52 billion, an increase of over 8% from prior year. The company reports its second quarter 2013 financial figures on July 25, 2013. Analysts expect the company to report Q2 2013 EPS at $1.91 against $1.82 reported for the same quarter prior year. For the full year the street expectation is $7.90 per share against the $6.54 per share reported for FY 2012.