ALS Therapy Development Institute Announces Research Agreement with Biogen Idec and UCB to Investigate the Role of CD40L in ALS

CAMBRIDGE, Mass., Dec. 19, 2011 /PRNewswire-USNewswire/ -- The ALS Therapy Development Institute (ALS TDI) today announced a research agreement with Biogen Idec (NASDAQ: BIIB) and UCB Pharma SA (EN Brussels: UCB) to investigate the use of an anti-CD40L antibody as a potential therapy for Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's or Motor Neuron Disease. Financial terms of the agreement were not disclosed.

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Under the terms of a collaboration between Biogen Idec and UCB, UCB is currently developing an anti-CD40L monovalent pegylated Fab' antibody fragment (CDP7657) in a Phase 1 clinical trial of patients with systemic lupus erythematosus, or SLE.

From research so far conducted, ALS TDI believes that targeting CD40L is a potential therapeutic approach for ALS. ALS TDI has studied a commercially available research reagent that targets CD40L in a preclinical disease model of ALS (known as SOD1). The results, which were published in Nature Genetics in 2010*, showed that the antiCD40L research reagent slowed paralysis and improved survival in the pre-clinical SOD1 model.

Under the terms of this agreement, ALS TDI will test a murine surrogate of CDP7657 in the SOD1 model. On conclusion of the study, Biogen Idec and UCB will have the option to license global rights to develop and commercialize compounds targeting the CD40L pathway in ALS.                                                                                             

"This relationship validates the approach taken by ALS TDI to bridge the gap between basic science and drug development for ALS.  There is great hope that this project will be a successful one and lead to additional therapeutic options for people living with ALS today," said Steve Perrin, Ph.D., CEO & Chief Scientific Officer of ALS TDI.

"ALS is a devastating and deadly disease, and Biogen Idec and UCB are both committed to finding therapies for severe neurological diseases with high unmet medical need. We are excited about this project and look forward to working with ALS-TDI in this investigation," said Douglas Kerr, M.D., Ph.D., Director of Medical Research at Biogen Idec.

"By combining ALS TDI's innovative approach to bridging the translational research gap with our companies' strengths in developing and commercializing novel therapies, we hope to advance this promising compound for ALS patients," added Neil Weir, Senior Vice President Discovery Research, at UCB.

Executive staff from ALS TDI will hold a webcast on January 5, 2012 at 1:00 p.m. (EDT) to discuss the collaboration further.  For more information on the webcast, visit www.als.net.

About ALS Therapy Development Institute

The mission of the ALS Therapy Development Institute (ALS TDI) is to develop effective therapeutics that slow or stop amyotrophic lateral sclerosis (ALS, Lou Gehrig's disease), as soon as possible. Focused on meeting this urgent unmet medical need, ALS TDI executes a robust target discovery program, while simultaneously operating the world's largest efforts to preclinically validate potential therapeutics; including a pipeline of dozens of small molecules, protein biologics, gene therapies and cell-based constructs. The world's first nonprofit biotech, ALS TDI has developed an industrial-scale platform that allows for the development and testing of dozens of potential therapeutics each year. Built by and for patients, the Institute is the world's only nonprofit biotechnology company with more than 30 professional scientists. In addition, the Cambridge, Massachusetts based research Institute collaborates with leaders in both academia and industry to accelerate ALS therapeutic development. For more information, please visit us online at www.als.net.

Forward looking statement Biogen Idec

This press release contains forward-looking statements, including statements about the development of potential therapies for ALS. 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. Drug development and commercialization involve a high degree of risk. Factors which could cause actual results to differ materially from current expectations include the risk that adverse safety events may occur, regulatory authorities may require additional information or may fail to approve any potential new therapy, product reimbursement may be limited or unavailable, problems with manufacturing processes may arise, intellectual property rights may not be adequately protected, and the other risks and uncertainties that are described in the Risk Factors section of Biogen Idec Inc.'s most recent annual or quarterly report and in other reports Biogen Idec Inc. has filed with the SEC. These statements are based on current beliefs and expectations and speak only as of the date of this press release. No obligation to publicly update any forward-looking statements is undertaken.

Forward looking statement UCB

This press release contains forward-looking statements based on current plans, estimates and beliefs of management. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, political, regulatory or clinical results and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions which could cause actual results to differ materially from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, product liability claims, challenges to patent protection for products or product candidates, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws and hiring and retention of its employees. UCB is providing this information as of the date of this press release and expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report a change in its expectations.

There is no guarantee that new product candidates in the pipeline will progress to product approval or that new indications for existing products will be developed and approved. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences between the partners. Also, UCB or others could discover safety, side effects or manufacturing problems with its products after they are marketed.

Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement

* Lincecum, J. M. et al. From transcriptome analysis to therapeutic anti-CD40L treatment in the SOD1 model of amyotrophic lateral sclerosis. Nat. Genet. 42, 392–399 (2010).

Media Contacts:  Robert A. Goldstein, ALS TDI, [email protected], 617-441-7295

SOURCE ALS Therapy Development Institute