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 Biogen Buys Another Promising MS Drug (BG-12)

BG-12Just days after jointly announcing promising results in Phase II MS trials of an oral compound known as BG-12, Biogen Idec has bought the therapy's creator, Fumapharm of Switzerland.

BG-12, in a double-blind, placebo controlled trial with over 250 patients, demonstrated a 69% reduction in active lesions versus placebo between months 3 and 6 after starting the therapy. There was a 48% decrease in new T2 lesions (T2 lesions are plaques that are generally considered to be a marker of overall disease activity in the past year). A 32% reduction...

story continues, please click "read more"

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...in relapse rate was seen, though the trial was not set up to accurately measure this factor.

The trial results were released on May 30th, and the acquisition announcement followed just 1 day later. Fumapharm also brings a Psoriasis treatment called Fumaderm, currently available only in Germany.

Biogen is clearly setting aside Multiple Sclerosis as an arena that it aims to dominate, with Avonex recently "celebrating" its 10th anniversary, Tysabri (shared with Elan) about to be reintroduced, Rituxan (rituximab, intravenous) in Phase II/III trials, Daclizumab (intravenous) in Phase II, and now BG-12 (oral) about to enter Phase III.

Though the results from the BG-12 trial are not astounding (and do not measure the all important disability progression, especially critical given that there is only loose correlation between lesions/relapses and disability), one must take comfort that Biogen would likely not buy a company and product that it did not feel added a compelling value to its already formidable multiple sclerosis lineup. The fact that BG-12 is an oral therapy could certainly be the critical factor here, but we would likewise think that Biogen by now has the expertise to know an effective therapy when it sees one.

"This acquisition supports our goal of developing innovative therapeutic options for people living with MS," said James C. Mullen, Biogen Idec's President and Chief Executive Officer. "We look forward to continuing the development of BG-12, a promising oral compound in MS

Press Release and further links follow...

Fumapharm Acquisition Press Release

Press Release Source: Biogen Idec

Biogen Idec to Acquire Fumapharm AG
Wednesday May 31, 7:00 am ET
Consolidates Ownership of Oral Compound BG-12 Being Studied for Multiple Sclerosis

CAMBRIDGE, Mass. and LUCERNE, Switzerland--(BUSINESS WIRE)--May 31, 2006--Biogen Idec (NASDAQ: BIIB - News) and Fumapharm AG, a privately held pharmaceutical company, today announced that they have signed a definitive agreement for the acquisition of Fumapharm by Biogen Idec.

Fumapharm AG, founded in Switzerland in 1983, develops therapeutics derived from fumaric acid esters for patients with high unmet medical need. The company has two products: FUMADERM®, a commercial product available in Germany for the treatment of psoriasis, and BG-12, a clinical-stage product that has been jointly developed with Biogen Idec. BG-12, an oral fumarate, is being studied for the treatment of multiple sclerosis (MS) and psoriasis.

"This acquisition supports our goal of developing innovative therapeutic options for people living with MS," said James C. Mullen, Biogen Idec's President and Chief Executive Officer. "We look forward to continuing the development of BG-12, a promising oral compound in MS, as well as expanding our European operations by working with Fumapharm's existing partners to provide FUMADERM to psoriasis patients in Germany."

On May 30, 2006, Biogen Idec and Fumapharm announced positive results from a Phase II study designed to evaluate the efficacy and safety of BG-12 in patients with relapsing-remitting MS. The study achieved its primary endpoint, demonstrating that treatment with BG-12 led to a statistically significant reduction in the total number of gadolinium-enhancing brain lesions as measured by MRI with six months of treatment versus placebo.

"Biogen Idec is perfectly positioned to continue the development of BG-12 because of its global commercial and regulatory experience and unsurpassed expertise in MS. We are proud of the work that Fumapharm has accomplished in the last 20 years and are confident that Biogen Idec will continue our legacy of helping patients," said Dr. Hans Peter Strebel, Chairman and CEO of Fumapharm.

The transaction, which has been approved by the boards of directors of both companies and is subject to customary closing conditions, is expected to close within the next two months. Upon completion, Biogen Idec will acquire all of the issued and outstanding shares of the capital stock of Fumapharm and will take over manufacture and sale of FUMADERM for the treatment of psoriasis in Germany through Fumapharm's existing network. Financial terms of the transaction were not disclosed.

About BG-12

In October 2003, Biogen Idec licensed certain exclusive worldwide rights to develop and market BG-12, oral fumarate derivative with an immunomodulatory mechanism of action, from Fumapharm. Biogen Idec and Fumapharm are evaluating BG-12 in a range of diseases, including MS and psoriasis. In April 2005, the companies announced that the primary endpoint was met in a Phase III study designed to evaluate the efficacy and safety of BG-12 in the treatment of moderate to severe psoriasis.

In the Phase II MS study, the most commonly reported adverse events were flushing, gastrointestinal disorders, headache, and nasopharyngitis. Liver enzyme elevations were reported in 2% to 8% of the active treatment groups, compared to 5% in the placebo group. Infection rates were balanced.

About Fumapharm AG and FUMADERM

Fumapharm is a privately held pharmaceutical company headquartered in Lucerne, Switzerland. For more information, please visit http://www.fumapharm.ch.

FUMADERM, an oral product containing fumaric acid esters, was approved in Germany in 1994 where it is the leading prescription for oral systemic treatment of severe psoriasis. Fumedica GmbH distributes FUMADERM in Germany.

About Biogen Idec

Biogen Idec creates new standards of care in oncology, neurology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.

Biogen Idec Safe Harbor

This press release contains forward-looking statements regarding the acquisition of Fumapharm, the development of BG-12, and the availability of FUMADERM. These statements are based on the companies' current beliefs and expectations. Drug development involves a high degree of risk. Factors which could cause actual results to differ materially from the companies' current expectations include the risk that unexpected concerns may arise from additional data or analysis; that regulatory authorities may require additional information, further studies, or may fail to approve the drug; the impact of competitive products on the company's products, a change in market acceptance of FUMADERM; and that the company may encounter other unexpected hurdles. For more detailed information on the risks and uncertainties associated with Biogen Idec's drug development and other activities, see the section entitled "Risk Factors" in Biogen Idec's annual report on form 10-K for the fiscal year ended December 31, 2005 that was filed with the Securities and Exchange Commission, as well as the other periodic and current reports of Biogen Idec filed with the Securities and Exchange Commission. Biogen Idec assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact:

Biogen Idec Media Contact:
Jose Juves, Director, Public Affairs
617-914-6524
or
Katja Buller, Director, Public Affairs
41 41 392 1792
or
Biogen Idec Investment Community Contact:
Elizabeth Woo, Vice President, Investor Relations
617-679-2812

Source: Biogen Idec

BG-12 Trial Results Press Release

Press Release Source: Biogen Idec

Oral Compound BG-12 Achieves Primary Endpoint in Phase II Study of Relapsing-Remitting Multiple Sclerosis
Tuesday May 30, 10:00 am ET
Treatment with BG-12 Led to Statistically Significant Reductions in MRI measures

LAUSANNE, Switzerland--(BUSINESS WIRE)--May 30, 2006--Biogen Idec (NASDAQ: BIIB - News) and Fumapharm AG announced positive results from a Phase II study designed to evaluate the efficacy and safety of BG-12, an oral fumarate, in patients with relapsing-remitting multiple sclerosis (MS). The study achieved its primary endpoint, demonstrating that treatment with BG-12 led to a statistically significant reduction in the total number of gadolinium-enhancing brain lesions as measured by MRI with six months of treatment versus placebo. These data were presented today at the annual meeting of the European Neurological Society in Lausanne, Switzerland.

"We are encouraged that these Phase II data demonstrate that BG-12 may be a promising oral therapy to treat MS. As part of our ongoing commitment to MS patients, we are working with regulatory authorities to determine the next steps in the development of this program," said Burt Adelman, MD, executive vice president, Development, Biogen Idec.

This Phase II multi-center, double-blind, placebo-controlled, dose-ranging study enrolled 257 patients at sites in 10 countries in Europe. Patients were randomized to receive placebo or BG-12 at 120 mg, 360 mg, or 720 mg per day for six months. The patient group treated with 720 mg of BG-12 per day had a 69% reduction in the mean number of gadolinium-enhancing lesions versus placebo as measured monthly from weeks 12 to 24 of the study. The 720 mg dose group also had a 48% reduction in newly enlarging T2-hyperintense lesions. BG-12 therapy was also associated with a trend towards reduction in relapse rate. The patient group treated with 720 mg of BG-12 per day had a 32% reduction in relapse rate compared to placebo, however, the study was not designed to achieve statistical significance for this endpoint.

The results of the 120 mg and 360 mg BG-12-treated groups were not statistically significant versus placebo. Patients were followed for an additional six months as part of a dose-blinded safety extension study.

The most common adverse events were flushing, gastrointestinal disorders, headache, and nasopharyngitis. The incidence of liver enzyme elevation greater than or equal to three times the upper limit of normal at any time during the placebo controlled phase of the study was between 2% and 8% in the three active treatment groups, compared with 5% in the placebo group. Improvement in liver enzyme levels was seen after discontinuation of BG-12. Infection rates were found to be balanced between the BG-12-and placebo-treated groups and no opportunistic infections occurred.

About Biogen Idec

Biogen Idec creates new standards of care in oncology, neurology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare. For press releases and additional information about the company, please visit http://www.biogenidec.com.

About Fumapharm AG

Fumapharm has licensed exclusive worldwide rights to develop and market BG-12 to Biogen Idec. Fumapharm is a privately held pharmaceutical company headquartered in Lucerne, Switzerland. For more information, please visit http://www.fumapharm.ch.

Safe Harbor/Forward-Looking Statements

This press release contains forward-looking statements regarding the development of BG-12 for multiple sclerosis. These statements are based on our current beliefs and expectations. They are subject to the risks inherent in drug development, including the risks that the effects of the product in larger clinical trials may not be as expected or that there may be safety issues or other problems or delays that arise during clinical trials, unexpected technical or manufacturing hurdles, or intellectual property disputes. There is no certainty that the risk/benefit profile of the product will be acceptable to the Company or to regulatory authorities for a particular indication. Drug development involves a high degree of risk. Only a small number of research and development programs result in the commercialization of a product.

Success in early stage clinical trials does not ensure that later stage or larger scale clinical trials will be successful. For more detailed information on the risks and uncertainties associated with these forward looking statements and Biogen Idec's other activities see the periodic and other reports that Biogen Idec has filed with the SEC. Biogen Idec does not undertake any obligation to publicly update any forward-looking statements.

Contact:

Media:
Biogen Idec
Amy Brockelman, 617-914-6524
or
Investor:
Biogen Idec
Elizabeth Woo, 617-679-2812

Source: Biogen Idec




 
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Biogen Buys Another Promising MS Drug (BG-12)


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