Shares of Biogen Idec Inc. (NASDAQ: BIIB) touched a new life-time high of $83.99 on Tuesday. The company said it received positive opinion for Avonex Pen against multiple sclerosis from the European Medicines Agency’s Committee for Medicinal Products for Human Use.
The Weston, Massachusetts-based biotechnology company said the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of Avonex Pen for patients with relapsing multiple sclerosis and patients with a single demyelinating event. The company also announced an authorisation for Avonex Pen from Health Canada.
This positive CHMP opinion and authorisation in Canada is a testament to our commitment to not only develop new treatments for the multiple sclerosis community, but our continued drive to further improve patients’ experience with our existing industry-leading therapies, said Douglas Williams, executive vice president, research and development at Biogen Idec.
Avonex Pen is designed to be the first single-use, once-a-week, fully integrated intramuscular autoinjector available for use with Avonex treatment in patients with relapsing multiple sclerosis, integrating the currently approved Avonex Prefilled Syringe and utilizing a 25 gauge 16 mm (5/8 inch) needle specifically created for Avonex Pen.
The Committee's recommendation provides the basis for a European Commission licensing decision, which is expected within 75 days from the opinion.
The application in the European Union includes data from a Phase 3b open-label, multicenter study, which evaluated the safety and efficacy of Avonex Pen. The study included patients with multiple sclerosis using Avonex Prefilled Syringe for at least 12 weeks prior to enrollment. Efficacy of Avonex Pen was assessed through objective and subjective assessments of key aspects of patients’ use of Avonex Pen.
Separately, Genentech, a member of the Roche Group, and Biogen Idec announced that the U.S. Food and Drug Administration (FDA) approved Rituxan (rituximab), in combination with corticosteroids, as a new medicine for adults with Wegener’s Granulomatosis (WG) and Microscopic Polyangiitis (MPA).
WG and MPA are two severe forms of vasculitis called anti-neutrophil cytoplasm antibodies (ANCA)-Associated Vasculitis (AAV), a rare autoimmune disease that largely affects the small blood vessels of the kidneys, lungs, sinuses, and a variety of other organs. Both WG and MPA are considered orphan diseases with an estimated prevalence in the United States of about three cases per 100,000 people.
The approval is based on a National Institutes of Health-sponsored study known as RAVE (Rituxan in ANCA-Associated Vasculitis). The study showed that Rituxan was not inferior to the current standard of care, cyclophosphamide (CYC) in inducing disease remission at six months in adults with WG and MPA.
Meanwhile, Biogen is set to release its first quarter results on April 21. Street analysts are expected Biogen to earn $1.41 a share on revenue of $1.18 billion, compared to previous year's earnings of $1.08 a share and revenue of $1.11 billion.
Biogen Idec stock gapped open sharply higher April 19 at $82.88 compared to previous day's close of $82.61. The stock touched a new all-time high of $83.99 on Tuesday.
The stock closed Tusday's regular trading up 1.67 percent at $83.99 on the NASDAQ Stock Market with a volume of 1.95 million shares. In the after-hours, the stock further rose 0.20 percent to $84.16. The stock traded between $45.96 and $83.99 during the past 52 weeks.