Biogen Inc. hasn't decided whether it will terminate an agreement with Celltech Group plc to develop a Crohn's disease drug following news Tuesday that the product missed its endpoint in a Phase III trial.
The product in question is a humanized anti-TNF-alpha antibody called CDP 571. Biogen, of Cambridge, Mass., in April entered an agreement with Celltech, of Slough, UK, to develop and market CDP 571. (See BioWorld Today, April 25, 2002.)
But according to Amy McKnight, Biogen's associate director of corporate communications, the structure of the deal gives Biogen the option to review the Phase III data and drop the project if it sees fit.
"We're going to be reviewing the collaboration to figure out what the next steps will be," McKnight told BioWorld Today. "We did not meet our primary endpoints, but there may be something in the secondary endpoints that are of value."
She deferred all questions related to this 400-patient trial, as well as a second 270-patient trial, which also had poor results, to Celltech.
While Celltech could not be reached for comment, the company released a prepared statement saying it plans to seek guidance from U.S. and European regulatory authorities "with regard to the database likely to be required for CDP 571 marketing approval for acute treatment of active Crohn's disease, and for its ongoing clinical management on an as-needed basis."
Mark Schoenebaum, a biotechnology analyst with CIBC World Markets Corp. in New York, told BioWorld Today that he fully expects Biogen to terminate this deal.
Nevertheless, he said the failed collaboration shouldn't have a major impact on Biogen. "We estimated the Crohn's market around $150 million and Remicade [Centocor Inc.] is already in that market, so in our model we had only assumed peak sales in a best-case scenario of about $100 million [worldwide]," Schoenebaum said. "So this is likely to have a minor impact on our model, but it does increase Biogen's dependency on Amevive for future earnings growth."
Biogen is waiting for FDA approval of Amevive (alefacept), for moderate to severe chronic plaque psoriasis. In June, the FDA asked the company to submit additional "clarification and information" on data related to the product. One analyst said Amevive is expected to reach worldwide peak sales of $350 million to $500 million. (See BioWorld Today, June 17, 2002.)
When Biogen and Celltech entered the agreement to develop CDP 571, officials at Celltech referred to the deal as a "50-50 profit share." Biogen did not pay up-front fees, but was scheduled to pay milestones described by Celltech as being "very small."
Schoenebaum estimates that Biogen has spent about $10 million on the project.
At the time of the signing, the Phase III trials were under way.
The principal 400-patient study assessed the safety and efficacy of CDP 571 in achieving acute clinical responses and in maintaining responses over 28 weeks, Celltech said.
The 28-week combined primary endpoint (Crohn's disease activity index reduction > 100 points and/or remission) was not reached when analyzed on an intent-to-treat basis, but did achieve statistical significance on per-protocol data analysis. Celltech said CDP 571 showed an excellent safety profile.
In the 35-week study of 270 patients, Celltech assessed the ability of CDP 571 to enable safe withdrawal of steroids from the patients while maintaining disease remission. The company said CDP 571 enabled 55 percent of the patients to discontinue steroid use at the end of the treatment period, but there was no significant difference when compared with the placebo group, which showed an unusually high response rate. CDP 571 was well tolerated in that study.
Meanwhile, at Celltech on Tuesday, the company said it entered an agreement with Pharmacia Corp., of Peapack, N.J., to gain access to Dipentum, a treatment for ulcerative colitis, an inflammatory bowel disorder.
Celltech sought the deal in order to build its gastroenterology sales force before launching CDP 571 and another Crohn's candidate, CDP 870.
The agreement gives Celltech exclusive sales, marketing and distribution rights for Dipentum in the U.S. and it provides Celltech with the option to acquire all rights to the product in the U.S. and the rest of the world, excluding Europe, in January 2005.
Celltech made an initial $6 million payment and will make additional payments of up to $12 million should it exercise its options.
Biogen's stock (NASDAQ:BGEN) closed Tuesday at $36.19, up 24 cents. Celltech's stock (NYSE:CLL) closed at $12.48, down $1.36, or 9.8 percent.