Genentech Inc. has the marketing bases covered - Xoma Ltd. on first, itself standing on second and now Serono SA manning third - for its psoriasis product, Raptiva. Now all it has to do is touch home plate by getting approval.
Genentech, of South San Francisco, signed an agreement giving Serono, of Geneva, exclusive rights to market Raptiva in areas outside the U.S., Japan and certain other Asian countries. Genentech and Xoma, of Berkeley, Calif., will handle U.S. sales, and Genentech retains rights to Japan and the certain Asian countries. But with Serono signed on, the world is now effectively wrapped in a Raptiva marketing blanket.
"It's exciting in that we feel we have a lot of momentum with this product," Colleen Sweeney, manager of corporate communications at Genentech, told BioWorld Today. "We are excited because it's a partner for the European [area] and other international areas that Serono has proven success in."
Genentech is still deciding if it will partner the areas it still has rights to or market the product in them itself. Sweeney said Genentech "hasn't made a decision either way."
Specific financial terms were not disclosed for the Serono deal, but Christine Cramer, director of public relations at Serono Inc. in Rockland, Mass., said Serono would provide "an undisclosed up-front payment and make additional payments on the completion of certain filing and approval milestones." Genentech and Xoma also would receive royalties on sales made by Serono.
Raptiva (efalizumab, formerly Xanelim) is a humanized monoclonal antibody and a targeted T-cell modulator designed to inhibit inflammatory processes associated with psoriasis. It is being developed through a partnership between Xoma and Genentech and is in Phase III studies for moderate to severe plaque psoriasis. The companies had planned to file a biologics license application late last year, but the FDA requested a pharmacokinetic study to confirm that the materials used for testing and manufacturing were the same. That study didn't produce positive results, but the hope is that other studies, including an additional efficacy study, will help support Raptiva's approval. (See BioWorld Today, Aug. 5, 2002.)
Cramer said data from the U.S. efficacy trial should be available late this quarter and should be submitted in the fourth quarter as part of the BLA. Serono, for it's part, will handle regulatory filings in the European Union and expects to file in the first quarter of 2003, Cramer said. Serono would file in the other countries it is responsible for after that.
Raptiva's marketing trio could be further entwined. The product is in Phase II trials for moderate to severe rheumatoid arthritis. The companies might collaborate on that as well as further indications for Raptiva, Sweeney said.
Psoriasis, an affliction in serious need of therapies, seems on the cusp of getting some. Besides Raptiva, Biogen Inc., of Cambridge, Mass., is awaiting approval of Amevive for psoriasis as the company submits additional "clarification and information" on data related to the product. Amgen Inc., of Thousand Oaks, Calif. - following its merger with Immunex Corp. - is aiming for approval of Enbrel for psoriasis, and Centocor Inc., of Malvern, Pa., is developing Remicade for psoriasis. It's a big market that could get crowded in the future.
But that's the future.
"We think it's early to talk about market share, but we do know that psoriasis really needs a therapy and we do believe there are opportunities there," Cramer told BioWorld Today.
Sweeney, pointing out that psoriasis affects about 4.5 million people in the U.S. and more than 5.5 million in Europe, said it is hard to predict what an approved Raptiva could do in that landscape. But she agreed the need is there for an effective product.
"We're just looking forward to finishing the additional things that we need to do, file and then wait for approval," Sweeney said.