By Brady Huggett
Biogen Inc. and Elan Corp. are gearing up for Phase III trials this year based on positive Phase II results for their partnered product, Antegren, in multiple sclerosis and Crohn's disease.
The companies joined over Antegren, discovered by Elan Corp., of Dublin, Ireland, in August, when the product already was in late Phase II. The deal gave Biogen Inc., of Cambridge, Mass., exclusive worldwide development, manufacturing and commercialization rights to Antegren, with Elan receiving milestone payments. (See BioWorld Today, Aug. 18, 2000.)
"This is a product of our labs," said Max Gershenoff, spokesman for Elan. "We didn't acquire this and we didn't take on a company six months ago. This was organically grown, so to speak."
The MS Phase II trial was a double-blind placebo study involving 213 patients at 26 sites in the United States, Canada and the United Kingdom. The patients received monthly doses of Antegren or placebo over a six-month period.
"The endpoint was reduction of new gadolinium-enhancing lesions, and we achieved that endpoint," said Kathryn Bloom, director of communications at Biogen.
The Crohn's disease Phase II was also a double-blind study with placebo control, but conducted across 38 sites in eight European countries and involving 240 patients with moderate to severe Crohn's disease. Patients received doses of Antegren or placebo at week zero and again at week four. The endpoints included induction of remission as measured by the Crohn's Disease Activity Index.
Other than endpoints, both companies were tight-lipped concerning specifics of the results, planning instead to present the data for both indications at meetings in the spring.
"That's what we are hoping, but it's early," Gershenoff said.
Antegren is an alpha-4 integrin inhibitor therapeutic designed to block cell adhesion to blood vessel walls and the subsequent migration of white blood cells to tissues. Bloom explained it further:
"It binds to the 4 molecule and also binds to the alpha-4-beta-7, which are cell-surface receptors," she said. "Blocking these receptors with Antegren prevents the cells from contributing to the inflammation by stopping their migration and subsequent activation."
The next step is Phase III, and both companies spoke of a continued joint effort.
"We are in the process of planning the Phase III together," Bloom said. "We have to discuss it with the appropriate regulatory folks in the United States and Europe, but we anticipate that we can start the Phase III before the end of 2001."
"We will be pursuing both indications concurrently," Gershenoff said. "We are not prepared to discuss the structure of Phase III trials, but we will be working closely with Biogen."
Gershenoff said the intention was to investigate Antegren as a monotherapy for MS, but also in combination with Biogen's Avonex, the most prescribed treatment for MS worldwide. Either way, the move to Phase III will mark progress toward Elan's own endpoint.
"Elan has been moving steadily toward its future as a fully integrated specialty pharmaceutical company," Gershenoff said. "This is an important step toward that goal."
Elan's stock (NYSE:ELN) moved up $2.562, or about 5 percent, Tuesday to close at $51.25. Biogen's stock (NASDAQ:BGEN) received a bigger boost, moving up $5.078, or about 8 percent, closing at $66.765.