Adding a fifth product to its portfolio of approved and investigational multiple sclerosis therapies, Biogen Idec Inc. agreed to collaborate on CDP323, an oral alpha-4 integrin inhibitor discovered by UCB.

Cambridge, Mass.-based Biogen will pay UCB a $30 million up-front fee, plus development and sales milestones that could exceed $170 million for development and commercialization of CDP323 in MS and other indications. Biogen will help pay for clinical development of the drug, which is expected to begin Phase II testing next year, and the companies will share commercialization costs and profits.

"Biogen will take the lead on commercialization in the U.S. and Canada, and UCB will have a co-promotion option" in those territories, said Biogen's spokesman, Jose Juves.

Conversely, UCB will lead marketing efforts in Europe and Japan, where Biogen will hold an option to co-promote.

A small-molecule prodrug antagonist of alpha-4 integrin, CDP323 has been tested in three Phase I trials in healthy volunteers. Data from those trials was reported last week at the 2006 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Madrid, Spain.

That early clinical data, combined with the fact that CDP323 is orally administered, "makes it very attractive," Juves said.

A chronic disease caused by damage to the myelin surrounding nerve fibers in the central nervous system, it affects about 400,000 people in North America and more than 1 million worldwide and manifests in a range of symptoms, from loss of balance to paralysis.

Biogen markets two approved MS therapies. Avonex, a once-weekly interferon beta-1a injection, pulled in revenues of $429 million for the second quarter. Tysabri (natalizumab), an alpha-4 antagonist administered by infusion, was voluntarily pulled from the market by Biogen and partner, Dublin, Ireland-based Elan Corp. plc, last year after being linked to a fatal brain infection, but gained a second approval in June in a limited capacity. (See BioWorld Today, June 6, 2006.)

"We're committed to this therapeutic area," Juves told BioWorld Today, adding that Biogen is "hoping to offer MS patients a portfolio of potential therapies."

In its development pipeline for MS, the firm has Rituxan (rituximab), a B-cell targeted therapy that is in Phase II. That product, partnered with South San Francisco-based Genentech Inc., is marketed for rheumatoid arthritis and non-Hodgkin's lymphoma.

Also in Phase II is daclizumab, an antibody designed to bind to the IL-2 receptor on activated T cells. Daclizumab was one of three products Biogen licensed from Protein Design Labs Inc., of Fremont, Calif., in an August 2005 deal potentially worth up to $800 million. (See BioWorld Today, Aug. 4, 2005.)

Earlier this year, Biogen agreed to acquire Fumapharm AG, of Lucerne, Switzerland, to consolidate rights to BG-12, an oral fumarate derivative that demonstrated positive results in a Phase II trial in patients with relapsing-remitting MS.

"We expect to initiate Phase III with that product in the first half of '07," Juves said.

For Biogen, which has been aggressive in product licensing and acquisitions in the last few months, the "intent is to continue to strike a balance between our internal organic pipeline and external opportunities," Juves said.

In addition to its efforts in MS, the company bolstered its oncology pipeline in May when it decided to buy San Diego-based Conforma Therapeutics Corp. That agreement, which included a $150 million payment at closing, plus up to $100 million in development milestones, brought in Phase I-stage heat-shock protein 90 (hsp90) inhibitors aimed at solid tumors. (See BioWorld Today, May 4, 2006.)

And last month, the company licensed U.S. and European rights to Aviptadil, a pulmonary arterial hypertension product, from Basel, Switzerland-based mondoBiotech AG. Biogen agreed to pay mondoBiotech $7.5 million up front, up to $30 million in milestones, as well as royalties and a potential $5 million equity investment upon an initial public offering by mondoBiotech. (See BioWorld Today, June 1, 2006, and Sept. 15, 2006.)

Shares of Biogen (NASDAQ:BIIB) gained 64 cents Tuesday to close at $44.88.

Brussels, Belgium-based UCB announced separately that it had signed an expanded agreement with Palo Alto, Calif.-based Jazz Pharmaceuticals Inc. to obtain commercialization rights to Xyrem (sodium oxybate) for fibromyalgia syndrome upon approval in that indication. The product previously was approved in excessive daytime sleepiness and cataplexy in narcolepsy patients, and is marketed in Europe by UCB.

Specific terms were not disclosed, but UCB made an up-front payment to Jazz and agreed to milestone payments based on development and sales results. The new agreement also doubles the number of countries in which UCB has commercialization rights from 27 to 54, and UCB will pay royalties on Xyrem sales from all those territories.

Jazz, which markets Xyrem in the U.S., began a Phase III program last month to evaluate the product against placebo in patients who meet the American College of Rheumatology diagnostic criteria for fibromyalgia.