--One of the Industry’s Top Multiple Sclerosis Portfolios and Neurology Pipelines Demonstrates Commitment to Advancing Treatment Standards--
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Biogen Idec (NASDAQ: BIIB) today announced that 38 company-sponsored platform and poster presentations will be presented during the American Academy of Neurology’s (AAN) 62nd Annual Meeting in Toronto, April 10 – 17, 2010. The AAN Annual Meeting is the world’s largest gathering of neurologists. These presentations include data on five compounds that are marketed or currently in development by Biogen Idec and its partners for the treatment of multiple sclerosis (MS), including two approved therapies for MS, TYSABRI® (natalizumab) and AVONEX® (interferon beta-1a), and three promising compounds in the late stages of development: BG-12 (dimethyl fumarate), PEGylated interferon beta-1a and daclizumab.
“I don’t think any other company is doing more for patients with multiple sclerosis,” said Alfred Sandrock, M.D., Ph.D., Senior Vice President of Neurology Research and Development at Biogen Idec. “Our leading marketed products, AVONEX and TYSABRI, along with our robust pipeline, offer hope for patients who are faced with potentially serious outcomes caused by this unpredictable disease.”
Biogen Idec continues to expand one of the industry's top MS portfolios
Biogen Idec’s comprehensive MS portfolio includes marketed MS therapies that are setting new standards for measuring success. The Biogen Idec pipeline has the potential to redefine future success for MS treatment with the hope of additional convenient and effective therapies.
“Over the last several years we have continued to expand and redefine the measure of success for managing MS,” said Dr. Sandrock. “Our ability to bring effective treatments to market has provided substantial benefit to many patients, and our innovative pipeline of MS product candidates is a testament to our commitment to the MS community.”
In addition to the marketed products, TYSABRI and AVONEX, Biogen Idec currently has three compounds in late-stage clinical trials for the treatment of MS. BG-12 is an investigational oral MS therapy currently being evaluated in two fully-enrolled Phase III clinical trials. PEGylated interferon beta-1a, currently in a Phase III clinical trial, is a subcutaneous therapy that is being evaluated for its ability to extend the time that interferon beta-1a remains in the system and has the potential to offer fewer injections for patients. Biogen Idec is also currently recruiting patients for a registrational trial for daclizumab, which is administered as a monthly subcutaneous injection and may offer a distinct immunomodulatory mechanism of action, potentially providing a new approach to treating MS.
The following represents select data highlights during the Congress from the company’s portfolio of marketed products.
There are 15 company-sponsored TYSABRI posters and presentations during the Congress. Key data include a post-hoc analysis of Phase III data showing that TYSABRI was associated with sustained visual improvement as measured by low-contrast letter acuity tests (Low-Contrast Letter Acuity Detects Visual Function Improvement in Phase 3 Relapsing MS Trials of Natalizumab – P05.060). Another poster will present data from a post-hoc analysis of Phase III data showing that sustained improvement in physical function, as measured by the Expanded Disability Status Scale (EDSS), was associated with improved quality of life for patients with relapsing MS taking TYSABRI (Improvement in EDSS Corresponds with Improvement in Quality of Life in Patients with Multiple Sclerosis – P02.169).
Two presentations will feature studies related to the JC virus (JCV). One study found that patients who developed progressive multifocal leukoencephalopathy (PML) had evidence of prior infection with JCV, as measured by the presence of anti-JCV antibodies. Additional analyses are needed to determine whether the presence or absence of anti-JCV antibodies may be useful in stratifying patients for PML risk (Evaluation of the Incidence of anti-JCV Antibodies in a Cohort of Natalizumab-Treated MS Patients – S31.003). Data from a second study suggests that treatment with TYSABRI does not have a substantial effect on the presence of JCV DNA in MS patients (Effects of Natalizumab Treatment on the Presence of JC Virus DNA in Blood or Urine in Multiple Sclerosis Patients – S31.002).
Eight Biogen Idec-sponsored posters present long-term safety and efficacy of AVONEX among different patient populations. Poster highlights include data that, for the first time, evaluate the efficacy and safety of AVONEX in patients who are more than 50 years old (Efficacy and Safety of Weekly Intramuscular Interferon Beta-1a in Patients More than 50 Years of Age – P06.131). Another important poster will present findings from the AVONEX Pregnancy Exposure Registry, showing that the rate of serious birth defects was not increased with exposure to AVONEX (Pregnancy Outcomes from the AVONEX® (interferon beta-1a) Pregnancy Exposure Registry – P04.186).
Biogen Idec’s neurology leadership continues to be evident through data from its broad pipeline, including MS candidates BG-12, PEGylated interferon beta-1a and daclizumab, as well as a Parkinson’s disease (PD) candidate, vipadenant.
“Our strong presence at AAN showcases our continued progress and innovative research programs that have allowed Biogen Idec to develop one of the deepest and most extensive neurology pipelines in the industry,” said Frederick E. Munschauer III, M.D., Vice President of U.S. Medical Affairs at Biogen Idec. “Our comprehensive understanding of the potential of targeting multiple pathways in MS has enabled us to explore novel ways to help patients, both now and in the future. We are committed to meeting unmet needs in neurology by expanding our leading MS franchise and developing therapies for other neurological diseases, such as Parkinson's disease, which hasn’t had a breakthrough treatment in nearly 40 years.”
BG-12 (dimethyl fumarate)
There are seven Biogen Idec-sponsored BG-12 posters and presentations at the Congress. BG-12 is an investigational oral therapy with a potentially distinct mechanism of action. Data highlights include a presentation that looks at the use of magnetization transfer ratio (MTR) imaging, which is currently being performed in Phase III BG-12 MS trials, to provide valuable data regarding demyelination and remyelination in MS (Magnetization Transfer Ratio Imaging is Feasible in Large Multicenter MS Trials – S10.005). Another key study found that the pharmacokinetic profile of BG-12 was not altered by co-administration with intramuscular interferon beta-1a or glatiramer acetate and no safety signals were raised in healthy patients (Pharmacokinetics of Oral BG-12 Alone Compared with BG-12 and Interferon β-1a or Glatiramer Acetate Administered Together, Studied in Healthy Volunteers – P04.207). This study helps provide a rationale for future combination studies.
PEGylated Interferon beta-1a
There are two Biogen Idec-sponsored PEGylated interferon beta-1a posters being presented during the Congress. PEGylation protects interferon beta-1a from being degraded. PEGylated interferon beta-1a is being evaluated for its ability to last longer in a patient’s system, potentially leading to an MS treatment that would require fewer injections. One poster will focus on safety results from the completed Phase I clinical trial (Immunogenicity of PEGylated Interferon Beta-1a: Data from Preclinical and Phase 1 Clinical Studies – P06.141). A second poster will include data on dosing and administration from the same trial (Pharmacological Changes Induced by Administration of PEGylated IFNβ-1a in Healthy Volunteers – P05.040). These data support the continued evaluation of the compound in the current Phase III ADVANCE clinical study, which is currently enrolling patients.
Two company-sponsored daclizumab posters are being presented at the Congress. The first looks at changes in magnitude of the subset of the natural killer cells (CD56bright cells) that help regulate the immune system during treatment with daclizumab (Prediction and Characterization of CD56bright NK Cell Expansion During Daclizumab Treatment for Multiple Sclerosis – P04.214). The second focuses on daclizumab’s effect on the balance of regulatory and activated T-cell (immune cell) numbers in people with MS (Changes in Circulating Tregs Parallel Reductions in Activated T Cells During Daclizumab Treatment of MS – P04.193). Daclizumab is currently in late-stage clinical trials for the treatment of relapsing-remitting MS, one of the most common forms of MS.
Biogen Idec’s neurology portfolio also includes Phase II PD candidate vipadenant (BIIB014). Two company-sponsored vipadenant posters are being presented at the Congress. The first poster shows significantly increased ON time (amount of time for which symptoms are controlled) in optimally treated patients with motor fluctuations (Efficacy of the Adenosine A2A Receptor Antagonist BIIB014 in Parkinson's Disease (PD) Patients with Motor Fluctuations – PD4.004). The second poster examines the safety and tolerability of vipadenant and showed that it was generally well tolerated (Safety and Tolerability Profile of the Adenosine A2A Receptor Antagonist BIIB014 as an Adjunct Treatment in Parkinson’s Disease (PD) Patients with Motor Fluctuations – PD4.005). The data demonstrated in these studies justify further clinical development in patients with moderate-to-late stage PD.
The Congress will also feature four presentations on prolonged-release fampridine, a formulation developed to improve walking ability in people with MS.
Biogen Idec licensed the right to market prolonged-release fampridine tablets outside of the United States from Acorda Therapeutics, Inc. Currently, it is marketed by Acorda under the trade name AMPYRA™ (dalfampridine) Extended Release Tablets in the United States. Data presented at the Congress include two platform presentations: Characteristics of Walking Speed Improvement Observed in Three Well Controlled Studies of Dalfampridine Extended Release Tablets 10mg Bid in Patients with Multiple Sclerosis – S01.003, a presentation that will further characterize the primary endpoint of Timed Walk Response (TWR) in patients with MS, and Interim Analysis of Open-Label Extension Studies of Dalfampridine Extended Release Tablets in Patients with Multiple Sclerosis – S01.008, an interim assessment of efficacy and safety of dalfampridine extended-release tablets in ongoing, open-label extension studies.
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.
Data from the Phase III AFFIRM trial highlights TYSABRI’s powerful efficacy. According to that data, which was 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). 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.
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.
AVONEX is one of the most prescribed treatments for relapsing forms of MS worldwide, with 140,000 patients on therapy. It is used worldwide as a treatment for relapsing forms of MS to slow the progression of physical disability and reduce relapses. AVONEX is also approved for patients who have their first clinical MS attack and have a brain MRI scan consistent with MS.
The most common side effects associated with AVONEX multiple sclerosis treatment are flu-like symptoms, including myalgia, fever, fatigue, headache, chills, nausea, vomiting, pain and asthenia.
AVONEX should be used with caution in patients with depression or other mood disorders and in patients with seizure disorders. AVONEX should not be used by pregnant women. Patients with cardiac disease should be closely monitored. Patients should also be monitored for signs of hepatic injury. Routine periodic blood chemistry and hematology tests are recommended during treatment with AVONEX. Rare cases of anaphylaxis have been reported. Please see complete prescribing information available at www.AVONEX.com.
About PEGylated Interferon beta-1a
PEGylated interferon beta-1a is under investigation for the treatment of RMS and is currently enrolling a Phase III clinical trial. PEGylation, administered via subcutaneous injection, protects the interferon beta-1a molecule from being degraded, extending the amount of time the drug remains in a patient's system.
BG-12 (BG00012, dimethyl fumarate) is an investigational oral therapy in Phase III clinical development for the treatment of relapsing-remitting multiple sclerosis (RRMS), the most common form of MS, and in Phase II clinical development for rheumatoid arthritis (RA). BG-12 received Fast Track designation in MS from the US Food and Drug Administration (FDA), which may expedite U.S. regulatory review. Biogen Idec retains full worldwide commercial rights to BG-12.
The Phase IIb study of BG-12, which was published in The Lancet, showed that BG-12 reduced the number of new gadolinium enhancing (Gd+) lesions by 69 percent in patients with RRMS when compared to treatment with placebo (p<0.0001). The presence of Gd+ lesions is thought to indicate continuing inflammatory activity within the central nervous system. Results from this study stimulated further evaluation of BG-12’s potential for neuroprotection. BG-12 is the first compound in trials for the treatment of MS that has been shown to activate the Nrf2 pathway.
Daclizumab is a humanized monoclonal antibody that binds to the CD25 alpha subunit of the high affinity IL-2 receptor. CD25 is expressed at low levels on resting T-cells (immune cells) and at high levels on T-cells that can become activated in response to autoimmune conditions such as MS. Daclizumab is believed to work by selectively binding to and inhibiting this receptor on activated T-cells without causing general T-cell depletion. Daclizumab is an investigational agent in clinical development for the treatment of MS under a collaboration between Facet and Biogen Idec. Daclizumab is anticipated to enter a Phase III global active comparator clinical trial DECIDE, to assess the ability of monthly daclizumab to reduce relapses in patients with relapsing-remitting multiple sclerosis compared to once weekly interferon beta-1a in the second quarter of 2010.
About Vipadenant (BIIB014):
Vipadenant (BIIB014) is a new, small molecule, adenosine A2A receptor antagonist in Phase II clinical development for Parkinson’s disease (PD). It is believed that an A2A receptor antagonist may possess advantages over current PD therapies by compensating for the loss of dopamine signaling without the side effects of current dopaminergic treatments. Vipadenant is being developed under a collaboration agreement with Vernalis.
About Prolonged Release Fampridine
Prolonged release fampridine is an orally-administered formulation of 4-aminopyridine (Fampridine) that has been developed to improve walking in adult patients with multiple sclerosis (MS). Studies have shown that fampridine can increase conduction velocity along damaged nerves, which may result in improved nerve function. This prolonged release formulation is approved in the United States (where it is known as AMPYRA™), and Biogen Idec is planning to commercialize the product outside of the United States under a licensing agreement with Acorda Therapeutics.
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 worldwide 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 www.biogenidec.com.
This press release contains forward-looking statements about our marketed products and our products in development. Drug development and commercialization involves a high degree of risk, and all of our products are subject to a number of risks and uncertainties. Important risk factors include the risk that we may be unable to adequately address concerns or questions raised by FDA or other regulatory authorities, the occurrence of adverse safety events with our products, that concerns may arise from additional data, that we may not be able to get the drugs in development approved and that the incidence and/or risk of any safety issues with respect to our products may be higher than observed in clinical trials. The company may also encounter other unexpected hurdles. Additional risks and uncertainties are described in the Risk Factors section of our reports on Form 10-K and Form 10-Q and in other reports we file with the SEC. These forward-looking statements speak only as of the date of this press release, and we do not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise.