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Biotech / Medical : Indications -- Psoriasis/Chronic Inflammation -- Ignore unavailable to you. Want to Upgrade?

To: Icebrg who wrote (446)	9/30/2003 8:14:04 AM
From: Icebrg	Read Replies (2) \| Respond to of 631

Roche and Protein Design Labs Restructure Commercial Alliance on Zenapax(R) Tuesday September 30, 8:02 am ET PDL Obtains Exclusive Worldwide Rights in Non-Transplant Indications Webcast to Discuss Agreement Scheduled for 8:30 a.m. Eastern Time [Doesn't this look a little bit desperate on the part of PDLI? Trying to squeeze a couple of extra dollars out of Zenapax.] FREMONT, Calif. and NUTLEY, N.J., Sept. 30 /PRNewswire-FirstCall/ -- Protein Design Labs, Inc. (PDL) (Nasdaq: PDLI - News) and Roche today announced that PDL has obtained exclusive worldwide rights to market, develop manufacture and sell Zenapax® (daclizumab) in all disease indications other than organ transplantation. Roche will continue to market Zenapax in transplantation indications until 2007. An earlier transfer of rights in transplantation to PDL could occur at Roche's election. The PDL-Roche collaboration dates to 1989 when Roche acquired the rights to commercialize Zenapax worldwide. PDL began receiving royalties on sales of Zenapax following its commercial launch in 1997. In October 1999, under a revised agreement PDL assumed worldwide responsibility for the clinical development of daclizumab for the potential treatment of autoimmune diseases. Roche retained exclusive worldwide rights to Zenapax for non-autoimmune diseases as well as commercialization rights worldwide, and continued to market Zenapax for the prevention of kidney transplant rejection. Under the new agreement, PDL will immediately assume worldwide responsibility for the development and, if successful, sales and marketing of daclizumab in all indications other than transplantation. PDL also will have rights to manufacture the product. PDL currently is conducting a randomized, placebo-controlled Phase II clinical trial of Zenapax in patients with moderate-to-severe ulcerative colitis. A Phase II trial of daclizumab in severe asthma is fully enrolled, and PDL currently expects to report results of that study in the first quarter of 2004. About the New Agreement PDL will pay a total of $80 million for return of all exclusive rights in indications other than transplantation and a reversion right, exercisable in 2006 but effective in 2007, to repurchase all rights in remaining transplant indications, unless earlier elected by Roche. Transfer of Zenapax in the transplantation indications to PDL will result in an additional exercise fee payable to Roche. The exercise fee will be based on the average annual gross sales of Zenapax during the period January 1, 2004 through the calendar quarter prior to the date of exercise, and currently is estimated to be approximately $21 million, assuming sales remain at or near expected 2003 levels. If PDL does not receive transplantation rights, PDL would pay modest royalties to Roche on any sales in all diseases other than transplantation, and would continue to receive royalties on sales of Zenapax sold by Roche in transplantation. "Zenapax has been, and will continue to be, an important medicine for the transplantation community, a community Roche has been committed to serving for many years," said William M. Burns, Head of Roche's Global Pharmaceutical Division. "While Zenapax remains an important part of Roche's transplantation portfolio, we are excited about the fact that Zenapax could benefit a broader patient population. In addition, we are proud to help enable our long time partner to achieve one of its key corporate goals with this new arrangement." Mark McDade, Chief Executive Officer, PDL, said, "As the first antibody we humanized, we are deeply committed to the broadest possible development of Zenapax in important diseases outside of transplantation. This agreement creates a means to continue Roche's commitment to the transplant community, at the same time providing a clearer path for PDL to expand uses of daclizumab in underserved medical markets, such as ulcerative colitis and multiple sclerosis. We are indebted to Roche's significant efforts during the past five years aimed at establishing Zenapax as a key element in renal transplantation. "PDL may now fully exploit the opportunity in inflammatory bowel disease, a core therapeutic focus for us, and retain the full financial benefits of that opportunity with little or no obligation to Roche in the future," Mr. McDade added. "We gain additional flexibility to explore significant partnerships in larger disease indications and are positioned to generate PDL product revenues by 2007, given the option to begin marketing Zenapax directly via a PDL sales and marketing effort. We are very excited at the opportunities for Zenapax as a PDL marketed product."