WESTON, Mass. ? March 27, 2013 ? Today Biogen Idec (NASDAQ: BIIB) announced that the U.S. Food and Drug Administration (FDA) has approved TECFIDERA? (dimethyl fumarate), a new first-line oral treatment for people with relapsing forms of multiple sclerosis (MS). Biogen Idec will make this oral capsule available to people living with MS in the United States in the coming days.
TECFIDERA has been clinically proven to significantly reduce important measures of disease activity, including relapses and development of brain lesions, as well as to slow disability progression over time, while demonstrating a favorable safety and tolerability profile.
?With the FDA approval of TECFIDERA, we will offer the MS community a treatment with strong efficacy and a favorable safety profile in the convenience of a pill ? a combination we believe will have a significant positive impact on the way people live with this chronic disease,? said George A. Scangos, Ph.D., chief executive officer of Biogen Idec. ?Biogen Idec is committed to delivering innovative treatments and setting new standards for the next generation of medicines. We believe TECFIDERA will raise expectations for what people living with MS can achieve with their therapy.?
The FDA approval of TECFIDERA is based on data from a robust clinical development program that included DEFINE and CONFIRM, two global Phase 3 studies that enrolled more than 2,600 patients. In the ongoing extension study, ENDORSE, some patients receiving TECFIDERA have been followed for more than four years.
In DEFINE, TECFIDERA, administered twice daily, significantly reduced the proportion of patients who relapsed by 49 percent (p<0.0001), the annualized relapse rate (ARR) by 53 percent (p<0.0001), and 12-week confirmed disability progression, as measured by the Expanded Disability Status Scale (EDSS), by 38 percent (p=0.0050) compared to placebo at two years. In CONFIRM, twice-daily TECFIDERA significantly reduced ARR by 44 percent (p<0.0001) and the proportion of patients who relapsed by 34 percent (p=0.0020) compared to placebo at two years. While not statistically significant, TECFIDERA showed a 21 percent reduction in 12-week confirmed disability progression in CONFIRM. Both studies also showed that TECFIDERA significantly reduced lesions in the brain compared to placebo, as measured by magnetic resonance imaging (MRI). ?In clinical trials, patients treated with dimethyl fumarate had less disease activity when compared to patients on placebo ? whether they were in the early stages of MS or had more established disease,? said Robert Fox, M.D., medical director of the Mellen Center for Multiple Sclerosis at Cleveland Clinic, lead investigator of the CONFIRM study, and a paid advisor for Biogen Idec for projects not related to TECFIDERA clinical development. ?With the efficacy, safety and tolerability measures seen in CONFIRM, this drug provides physicians with an important additional treatment option for their patients across the MS spectrum.? The most common side effects associated with TECFIDERA are flushing and gastrointestinal (GI) events (i.e., diarrhea, nausea and abdominal pain). In clinical studies, flushing symptoms usually began soon after initiating treatment, were mostly mild to moderate, and usually improved or resolved over time. The incidence of GI events was higher early in the course of treatment (primarily in the first month) and decreased over time. Overall, clinical trial discontinuations due to flushing and GI events were low. TECFIDERA may decrease lymphocyte counts in some patients. In clinical studies, mean lymphocyte counts decreased during the first year of treatment and then remained stable. The incidence of infections and serious infections was similar in TECFIDERA-treated patients and those on placebo. There were no opportunistic infections in TECFIDERA-treated patients. In patients with low lymphocyte counts, there was no increased incidence in serious infections. Patients taking TECFIDERA should have a complete blood count (CBC) before starting treatment to measure lymphocyte counts. A follow up CBC is recommended annually and at the discretion of the treating physician. ?We are pleased to see a new, needed treatment option available to people living with MS,? said Dr. Timothy Coetzee, chief research officer at the National MS Society. ?With the collaborative focus on MS research around the world, it is an exceptionally encouraging time for those who have been diagnosed with relapsing forms of MS.? TECFIDERA marks the fourth therapy Biogen Idec offers worldwide to people living with MS. Additional TECFIDERA Updates On March 22, 2013 the Committee for Medicinal Products for Human Use (CHMP) in the European Union (EU) issued a positive opinion recommending a marketing authorization be granted for TECFIDERA as a first-line oral treatment for adults with relapsing-remitting multiple sclerosis (RRMS). The CHMP's recommendation has now been referred to the European Commission (EC), which grants marketing authorization for medicines in the European Union. On March 19, 2013, the United States Patent and Trademark Office issued a patent covering the dosing regimen of daily administration of 480 mg of TECFIDERA. This patent will expire in 2028. The European Patent Office recently determined that Biogen Idec?s application for a patent covering the dosing regimen of daily administration of 480 mg of TECFIDERA is allowable. Once granted, the EU patent would also expire in 2028. TECFIDERA is also currently under review by regulatory authorities in Australia, Canada and Switzerland. For more information on TECFIDERA, prescribing information and financial assistance programs go to TECFIDERA.com or biogenidec.com. For members of the media interested in more information and additional resources, please visit biogenidec.com/us_media_corner. About TECFIDERA? TECFIDERA delayed-release capsules are indicated for the treatment of patients with relapsing forms of MS. TECFIDERA has been proven to reduce MS relapses, progression of disability and MS brain lesions. The efficacy and safety of TECFIDERA has been studied in a large, global clinical program with more than 3,600 MS patients, which includes an ongoing long-term extension study. It is believed that TECFIDERA provides a new approach to treating MS by activating the Nrf2 pathway, although its exact mechanism of action is unknown. This pathway provides a way for cells in the body to defend themselves against inflammation and oxidative stress caused by conditions like MS. The starting dose for TECFIDERA is 120 mg twice a day orally. After seven days, the recommended dose increases to 240 mg twice a day orally. The most common adverse reactions for TECFIDERA were flushing, mostly mild to moderate in nature, and GI events (i.e., diarrhea, nausea, abdominal pain). These events are most common at the start of therapy and usually decrease over time. TECFIDERA may decrease lymphocyte counts. Before starting treatment with TECFIDERA, a recent CBC (i.e., within six months) should be available. A CBC is recommended annually and as clinically indicated. TECFIDERA has not been studied in patients with pre-existing low lymphocyte counts and caution should be exercised when treating these patients. TECFIDERA has a Pregnancy Category C. Before starting treatment with TECFIDERA, women should talk to their doctor if they are pregnant or planning to become pregnant. For complete TECFIDERA prescribing information, please visit TECFIDERA.com. Biogen Idec Patient Support As part of its ongoing commitment to the MS community, Biogen Idec provides a variety of support services for patients and caregivers through MS ActiveSource?. These world-class services are thoughtfully crafted around the informational, emotional, financial and logistical needs that come with living with MS. MS ActiveSource is available via phone (Monday-Friday 8:30 a.m. - 8 p.m. ET) at 1-800-456-2255 or via web at MSActiveSource.com. About Multiple Sclerosis Multiple sclerosis (MS) is a chronic, often disabling disease that attacks the central nervous system (CNS), which is made up of the brain, spinal cord and optic nerves. Symptoms may be mild or severe, ranging from numbness in the limbs to paralysis or loss of vision. The progression, severity and specific symptoms of MS are unpredictable and vary from one person to another. MS affects more than 2.1 million people worldwide.[i] Best current estimates indicate that there are at least 400,000 people with MS in the United States.[ii] RRMS is the most common form of the disease, accounting for 85 percent of cases, and is characterized by clearly defined acute attacks with full recovery or with residual deficit upon recovery.[iii] About Biogen Idec Through cutting-edge science and medicine, Biogen Idec discovers, develops and delivers to patients worldwide innovative therapies for the treatment of neurodegenerative diseases, hemophilia and autoimmune 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 $5 billion in annual revenues. For product labeling, press releases and additional information about the company, please visit biogenidec.com. Safe Harbor This press release contains forward-looking statements, including statements about the development, commercialization and therapeutic impact of TECFIDERA. These forward-looking statements may be accompanied by such words as ?anticipate,? ?believe,? ?could,? ?estimate,? ?expect,? ?forecast,? ?intend,? ?may,? ?plan,? ?potential,? ?project,? ?target,? ?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 uncertainty of success in commercialization of TECFIDERA, which may be impacted by, among other things, the medical community?s acceptance of TECFIDERA, the effectiveness of our sales force and marketing efforts, product competition in the MS market, including the possibility of future competition from generic versions of TECFIDERA, problems with our manufacturing processes and our reliance on third parties to manufacture and supply TECFIDERA, the occurrence of adverse safety events, changes in the availability of reimbursement for our products, adverse market and economic conditions, failure to comply with government regulation, our ability to obtain regulatory approvals in jurisdictions outside of the U.S., our ability to protect our intellectual property rights and have sufficient rights to market our products together with the cost of doing so, product liability claims 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 U.S. Securities and Exchange Commission (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.