Biogen Idec to Provide Business Update at Investor Meeting
TYSABRI(R) Surpasses $1 Billion in 2009 Sales as Patients on Therapy Increase 30% Pipeline Continues to Advance, Including Fampridine EU Filing
SAN FRANCISCO, Jan 12, 2010 (BUSINESS WIRE) -- In a presentation to investors today at the 28th Annual J.P. Morgan Healthcare Conference in San Francisco, Biogen Idec (NASDAQ: BIIB) Chief Executive Officer James C. Mullen will outline the company's plan to continue to drive shareholder value. Mr. Mullen speaks at 4:30 p.m. PST today, and his remarks will be available via webcast on the Investor Relations section of www.biogenidec.com. A corresponding slide presentation will also be available on the website.
Mr. Mullen will reiterate that the company's business strategy is centered on the following areas to maximize shareholder value:
Accelerating the growth of TYSABRI(R) (natalizumab);
Extending AVONEX(R) (Interferon beta-1a) and RITUXAN(R) (rituximab) through lifecycle management;
Advancing the company's broad and deep pipeline of more than 20 programs in Phase 2 and beyond; and
Maintaining disciplined use of cash through a combination of strategic investments and returning cash to shareholders.
"Biogen Idec has a strong platform of products, pipeline and financial position to drive shareholder value and deliver on our mission of offering first-in class or best-in-class products in specialty markets to patients with high unmet medical needs," said Mr. Mullen. "We will continue to focus on accelerating the growth of TYSABRI, Biogen Idec's third blockbuster product; actively pursuing lifecycle management initiatives with AVONEX and RITUXAN; advancing our pipeline and maintaining a disciplined use of cash."
Accelerating TYSABRI Growth
In 2009, TYSABRI achieved "blockbuster" status with more than $1 billion in sales as the number of patients on therapy grew by 30% over the prior year. Based upon data available to the company through the TOUCH(R) prescribing program and other third-party sources as of the end of December 2009, the company estimates that approximately 48,800 patients were on commercial and clinical TYSABRI therapy worldwide. This includes approximately 24,500 on therapy commercially in the U.S.; approximately 23,700 on therapy commercially in the rest of the world; and approximately 600 clinical trial patients.
Advancing the Pipeline
Mr. Mullen will review some recent pipeline advancements as well as the approximately 14 milestones expected in 2010, including for its leading multiple sclerosis (MS) portfolio and its hemophilia programs. Highlights include:
Biogen Idec announced today the submission of a marketing authorization application to the European Medicines Agency for Fampridine Prolonged Release (Fampridine-PR) tablets, a novel oral therapy for the improvement of walking ability in adult patients with MS. The company also has filed a New Drug Submission to Health Canada.
In the first half of 2010, Biogen Idec and its partner Biovitrum expect to initiate a registrational trial for their long-acting, fully-recombinant Factor IX Fc fusion protein (rFIXFc) in hemophilia B patients.
Also in the first half of 2010, the company expects to begin a Phase 1 study of anti-LINGO-1, which has shown promise in repairing the myelin sheath, the protective coating around nerve fibers that is damaged by MS.
TYSABRI is approved in more than 45 countries. In the U.S., it is approved for relapsing forms of MS and in the European Union for relapsing-remitting MS. According to data from the Phase III AFFIRM trial published in the New England Journal of Medicine, after two years, TYSABRI treatment led to a 68 percent relative reduction (p<0.001) in the annualized relapse rate, when compared with placebo, and reduced the relative risk of disability progression by 42-54 percent (p<0.001).
TYSABRI is redefining success in the treatment of MS. In post-hoc analyses of the Phase III AFFIRM trial and as published in The Lancet Neurology, 37 percent of TYSABRI-treated patients remained free of their MS activity, based on MRI and clinical measures, compared to seven percent of placebo-treated patients. In addition, data has been presented showing that treatment with TYSABRI significantly increased the probability of sustained improvement in disability in patients with a baseline expanded disability status scale (EDSS) score = 2.0 by 69 percent relative to placebo.
TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain. The risk of PML increases with increasing duration of use. 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 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 Pharmaceuticals, Inc. For more information about TYSABRI, please visit http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.tysabri.com&esheet=6138842&lan=en_US&anchor=www.tysabri.com&index=8&md5=24ee455200bc2cc5a95094405142b78c, http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.biogenidec.com&esheet=6138842&lan=en_US&anchor=www.biogenidec.com&index=9&md5=6e68fbe3328266f0a5a16b7e7b626cc4 or http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.elan.com&esheet=6138842&lan=en_US&anchor=www.elan.com&index=10&md5=9809b98e41fba43aa75b23ed8b613303, or call 1-800-456-2255.
About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.biogenidec.com&esheet=6138842&lan=en_US&anchor=www.biogenidec.com&index=11&md5=7595811bb58ef67feebed274a5e80827.
This press release contains forward-looking statements about the anticipated development and timing of programs in our clinical pipeline, our growth strategies for our marketed products and our strategy for maximizing shareholder value. These statements are based on our current beliefs and expectations and involve risks and uncertainties that could cause actual results to differ materially from those which we expect. Important factors which could cause actual results to differ from our expectations and which could negatively impact our financial position and results of operations include our dependence on our three principal products, AVONEX(R), RITUXAN(R) and TYSABRI(R), the importance of market acceptance and successful sales growth of TYSABRI, uncertainty of success in commercializing other products, the occurrence of adverse safety events with our products, competitive pressures, changes in the availability of reimbursement for our products, 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, problems with our manufacturing processes and our reliance on third parties, charges related to our manufacturing facilities, fluctuations in our effective tax rate, our ability to attract and retain qualified personnel, the risks of doing business internationally, board representation by activist shareholders, our ability to protect our intellectual property rights and the cost of doing so, product liability claims, fluctuations in our operating results, credit and financial market conditions, 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 quarterly and annual reports filed with the SEC. Forward-looking statements, like all statements in this press release, speak only as of the date of this press release (unless another date is indicated). Unless required by law, we do not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise.
SOURCE: Biogen Idec
Biogen Idec Media Contact:Amy Reilly, 617-914-6524Associate Director, Public AffairsorBiogen Idec Investor Relations Contact:Eric Hoffman, 617-679-2812Director, Investor Relations
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