Biogen Idec will gain control over the commercialization of the multiple sclerosis therapy oral fumarate BG-12 through the acquisition of the privately held pharmaceutical company Fumapharm.

Biogen Idec announced a definitive agreement to acquire Switzerland-based Fumapharm, its development partner on BG-12, May 31 after releasing positive Phase II study results in relapsing remitting MS patients.

The deal gives Biogen Idec control over a late-stage pipeline candidate in one of its core therapeutic areas. The company already markets Avonex (interferon beta-1a) for the treatment of MS and expects to reintroduce the MS therapy Tysabri (natalizumab) onto the market later this year.

Speaking about BG-12 during a Bear Stearns Biotech conference in Boston May 31, Biogen CFO Peter Kellogg said, "We wanted to have complete control over how that was developed and how that was positioned in the marketplace in a complementary manner."

BG-12 is dosed orally, which would give the biologic a significant point of differentiation over Tysabri and Avonex, which are both dosed intravenously.

Biogen Idec is currently in discussions with regulatory authorities over the Phase III trial design of BG-12 in MS patients. The company told "The Pink Sheet" DAILY that it intends to begin enrolling patients in early 2007.

The completed Phase II study enrolled 257 patients who were randomized to receive placebo or BG-12 120 mg, 360 mg or 720 mg per day for six months. Patients in the 720 mg treatment arm experienced a 69% reduction in the mean number of gadolinium-enhancing lesions versus placebo and had a 48% reduction in newly enlarging T2-hyperintense lesions, the company reported.

The Phase III design will likely move forward with the higher dose, Kellogg said. BG-12 is also being studied in psoriasis patients, and met a primary endpoint of efficacy and safety in treatment of moderate to severe psoriasis in a Phase III study.

Biogen Idec does not currently have plans to file BG-12 for psoriasis but said it is working to develop a plan for psoriasis and other indications.

Biogen Idec and Fumapharm first entered into a collaboration for BG-12 in October 2003. In Germany, Fumapharm markets Fumaderm (fumaric acid esters) for the treatment of psoriasis.

The acquisition is in line with Biogen Idec's initiative to bolster the company's pipeline through external collaborations following the withdrawal of Tysabri from the market last year (¹ Also see "Biogen Idec Business Development Plan Includes Small Molecules For Oncology" - Pink Sheet, 27 October, 2005.).

"We had to make certain strategic choices about what we were going to do at the company," Kellogg explained. "All of that created about $200 mil.-$300 mil. in annual savings in our [profit and loss] that we have committed to external growth."

The addition of Fumapharm follows Biogen Idec's acquisition of Conforma Therapeutics, announced May 3, which gave the firm two Phase I oncology compounds (² Also see "Biogen Idec Seeks Oncology Pipeline Boost Through Acquisition" - Pink Sheet, 3 May, 2006.).

- Jessica Merrill

Biogen Idec Will Move MS Therapy Into Phase III After Fumapharm Buy

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