Reports Progress on New Framework for Growth
SAN FRANCISCO--(BUSINESS WIRE)--In a presentation to investors today at the 29th Annual J. P. Morgan Healthcare Conference, Biogen Idec (NASDAQ: BIIB) Chief Executive Officer George Scangos, Ph.D., will outline the company’s progress on its Framework for Growth and detail anticipated milestones in 2011 and beyond. Dr. Scangos speaks at 3:30 p.m. (PST) today. A webcast of his remarks and a corresponding slide presentation will be available on the Investors section of www.biogenidec.com.
“Biogen Idec’s business fundamentals are strong – and we are building on those strengths to transform the company in 2011 and beyond,” said Dr. Scangos. “Since announcing our Framework for Growth in November, we’ve hired two high-caliber leaders to head R&D and Corporate Development, marking the completion of an excellent management team. We’ve filed with U.S. and European regulators seeking approval to update the TYSABRI label with information about JCV antibody status, an important step in our efforts to help patients assess their individual risk benefit profile. We’ve acquired three early-stage neurodegenerative programs, advancing our neurology pipeline in diseases like Parkinson’s, Alzheimer’s and ALS, or Lou Gehrig’s disease. And with data readouts on two late-stage multiple sclerosis programs and the initiation of a Phase 3 trial in ALS planned for 2011, there are exciting opportunities on the horizon at Biogen Idec.”
Progress on Framework for Growth
A transformation of Biogen Idec is underway as the company reports progress on its new Framework for Growth, including:
- Securing top talent to lead Research and Development (R&D) with the appointment of Douglas E. Williams, Ph.D., who brings more than 20 years of scientific and senior leadership experience at biotechnology companies, most recently as Chief Executive Officer of Zymogenetics and previously head of research at Immunex Corp., where he played a significant role in the discovery and development of Enbrel.
- Reorganizing business development, venture development, corporate strategy and program management into one cohesive group and naming Steven H. Holtzman, Chair and former CEO of Infinity Pharmaceuticals, to the newly created position of Executive Vice President of Corporate Development.
- Filing with the U.S. Food and Drug Administration and the European Medicines Agency for approval to update TYSABRI® (natalizumab) labeling to include anti-JC virus antibody status as an additional factor to help stratify the risk of progressive multifocal leukoencephalopathy (PML) in TYSABRI patients.
- Continuing to expand TYSABRI utilization in the U.S. and abroad. Based upon data available to the company through the TOUCH® prescribing program and other third-party sources as of the end of December 2010, Biogen Idec estimates that approximately 56,600 multiple sclerosis (MS) patients were on commercial and clinical TYSABRI therapy worldwide, an increase of 1,700 patients in the fourth quarter and 8,200 patients in 2010. This includes approximately 27,600 on therapy commercially in the U.S.; approximately 28,400 on therapy commercially in the rest of the world; and approximately 600 clinical trial patients.
- Acquiring three promising early-stage programs from Neurimmune targeting neurodegenerative diseases, including Parkinson’s, Alzheimer’s and amyotrophic lateral sclerosis (ALS), which complements the exclusive license signed earlier in 2010 with Knopp Neurosciences for late-stage ALS drug candidate dexpramipexole.
- Initiating a global registrational trial for the company’s long-lasting recombinant Factor VIII Fc fusion protein (rFVIIIFc) in previously treated hemophilia A patients.
Key Anticipated Pipeline Advancements in 2011
Biogen Idec continues to work towards its goal of launching five new products by 2015. Among the anticipated key pipeline events of 2011, are:
- Dexpramipexole, for the treatment of ALS, is expected to advance into Phase 3 trials.
- BG-12, Biogen Idec’s late-stage oral MS drug candidate, is expected to have readouts of both its DEFINE and CONFIRM Phase 3 trials.
- Daclizumab, a drug candidate for relapsing MS, is also expected to have a readout of its Phase 2b SELECT registration trial.
About TYSABRI
TYSABRI is approved in more than 45 countries. In the U.S., it is approved for relapsing forms of multiple sclerosis (MS) and in the European Union for relapsing-remitting MS. TYSABRI has advanced the treatment of MS patients with its established and powerful efficacy. It has been proven to reduce flare-ups and slow physical disability progression. Data from the Phase III AFFIRM trial, which was published in the New England Journal of Medicine, showed that after two years, TYSABRI treatment led to a 67 percent relative reduction (0.22 vs. 0.67, p<0.001) in the annualized relapse rate when compared with placebo and reduced the relative risk of physical disability progression by 42 percent (17% vs. 29%, p<0.001). At the end of a separate two-year study, more than six out of 10 patients on TYSABRI had no flare-ups at all. In the same study, more than 8 out of 10 TYSABRI patients had no physical disability progression.
TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. The risk of PML increases with longer treatment duration and in patients treated with an immunosuppressant prior to receiving TYSABRI. Data beyond three years are limited. Other serious adverse events that have occurred in TYSABRI-treated patients include hypersensitivity reactions (e.g., anaphylaxis) and infections, including opportunistic and other atypical infections. Clinically significant liver injury has also been reported in patients treated with TYSABRI in the post-marketing setting. Common adverse events reported in TYSABRI-treated MS patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain, and rash.
TYSABRI is co-marketed by Biogen Idec Inc. and Elan Corporation, plc. For more information about TYSABRI, please visit www.tysabri.com, www.biogenidec.com or www.elan.com, or call 1-800-456-2255.
About Biogen Idec
Biogen Idec uses cutting-edge science to discover, develop, manufacture and market biological products for the treatment of serious diseases with a focus on neurological disorders. Founded in 1978, Biogen Idec is the world’s oldest independent biotechnology company. Patients worldwide benefit from its leading multiple sclerosis therapies, and the company generates more than $4 billion in annual revenues. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.
Safe Harbor
This press release includes forward-looking statements, including statements about the anticipated development and timing of programs in our clinical pipeline, regulatory actions and new commercial launches. These forward-looking statements may be accompanied by such words as “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “will” and other words and terms of similar meaning. You should not place undue reliance on these statements.
These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including our dependence on our three principal products, AVONEX®, RITUXAN® and TYSABRI, the importance of TYSABRI’s sales growth, product competition, uncertainty of success in commercializing other products, the occurrence of adverse safety events with our products, changes in the availability of reimbursement for our products, market and economic conditions, our dependence on collaborations over which we may not always have full control, failure to execute our growth initiatives, failure to comply with government regulation and possible adverse impact of changes in such regulation, charges and other costs relating to our properties, problems with our manufacturing processes and our reliance on third parties, fluctuations in our effective tax rate, our ability to attract and retain qualified personnel, the risks of doing business internationally, our ability to protect our intellectual property rights and the cost of doing so, representation of activist shareholders on our board of directors, product liability claims, fluctuations in our operating results, the market, interest and credit risks associated with our portfolio of marketable securities, our level of indebtedness, environmental risks, aspects of our corporate governance and collaborations and the other risks and uncertainties that are described in the Risk Factors section of our most recent annual or quarterly report and in other reports we have filed with the SEC.
These statements are based on our current beliefs and expectations and speak only as of the date of this press release. We do not undertake any obligation to publicly update any forward-looking statements.
