`Oral Compound BG-12 Being Studied for Multiple Sclerosis
`
`BIOWIRE2K
`
`May 31, 2006 07:00 AM Eastern Daylight Time
`
`CAMBRIDGE, Mass. and LUCERNE, Switzerland--(BUSINESS WIRE)--May 31, 2006--
`Biogen Idec (NASDAQ: BIIB) 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(R), 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.
`
`MYLAN PHARMS. INC. EXHIBIT 1058 PAGE 1
`
`MYLAN PHARMS. INC. EXHIBIT 1058 PAGE 1
`
`
`
`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.
`
`Contacts
`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
`
`MYLAN PHARMS. INC. EXHIBIT 1058 PAGE 2
`
`MYLAN PHARMS. INC. EXHIBIT 1058 PAGE 2
`
`