DUBLIN, Ireland - Elan Corp. plc teamed up with Biogen Inc. to accelerate development of its first potential blockbuster, Antegren, which currently is in Phase IIb studies for multiple sclerosis and Crohn's disease.
Financial terms were not disclosed. The deal includes "up-front and milestone payments that recognize the value each party brings to the collaboration," the companies said. Each has taken a 50 percent interest in the alliance.
Dublin-based Elan decided to partner out the compound because otherwise "the time to market would be elongated," chief scientific and medical officer Ivan Lieberburg told BioWorld International. Biogen, of Cambridge, Mass., is the ideal ally, he said, because of its expertise in MS - its interferon beta-1a treatment Avonex notched up sales of US$364.6 million in the first half of the year - "and they know how to manufacture proteins."
The agreement covers development, manufacture and full commercialization of Antegren, which potentially could be administered in combination with Avonex. "There is every reason to suggest that it is synergistic, or at least additive if not synergistic," Lieberburg said.
Antegren is a humanized monoclonal antibody that disrupts white cell trafficking across blood vessel walls by blocking the binding between the integrin VLA-4 (also called alpha 4 beta 1) on circulating lymphocytes or monocytes and vascular cell adhesion molecule-1 (VCAM-1) on the surface of capillary cells. Overexpression of VCAM-1 can increase white cell migration into a range of tissues and contribute to the development of a range of inflammatory conditions, including MS, inflammatory bowel disease and rheumatoid arthritis. Elan obtained the compound through its purchase in 1996 of Athena Neurosciences Inc.
"This is a product we think has a broad utility," Lieberburg said. In addition to its two lead indications, Elan so far has conducted a small Phase II trial for ulcerative colitis. Studies of the drug in other disease settings have not progressed beyond animal experiments. Antegren also has potential application in tissue transplantation.
Lieberburg said he expects the MS and Crohn's disease Phase II studies to finish in the first and second quarter, respectively, next year, paving the way for pivotal Phase III trials that will measure real clinical endpoints. The Phase II MS study demonstrated a "dramatic reduction in new inflammatory lesions" within two weeks, said Lieberburg. However, Antegren is not regarded as being suitable for acute treatment of MS flares. The company has yet to report efficacy data for Antegren in Crohn's disease.
Antegren could become Elan's biggest-selling drug, Lieberburg said, although its Alzheimer's vaccine program, which is at an earlier stage of development, has an even bigger potential upside. Investors responded positively to news of the deal Thursday, pushing up Elan's shares by US$5.875, or 10.9 percent, to close at US$59.875, while Biogen's stock edged up 25 cents to US$70.50.