BioMarin Pharmaceutical Inc. and La Jolla Pharmaceutical Company have entered into an agreement to develop and commercialize Riquent(R), La Jolla’s investigational drug for lupus nephritis, in the United States, Europe and all other territories of the world, excluding the Asia Pacific region. Following a successful Phase 3 trial, the parties will share equally in all losses and profits. In the United States, BioMarin and La Jolla will jointly commercialize Riquent. In Europe and other territories outside of Asia, BioMarin will be responsible for all commercialization activities. Jean-Jacques Bienaime, Chief Executive Officer of BioMarin commented, “We are very pleased to become La Jolla Pharmaceutical’s partner for Riquent. The development history of Riquent has been long and challenging, but we feel the current study addresses the shortcomings of prior studies and provides the best possible opportunity to demonstrate that Riquent reduces the frequency of renal flares in lupus nephritis patients. The ASPEN Phase 3 study is the largest clinical study ever conducted in lupus nephritis and there is increasing evidence that Riquent targets one of the most important underlying causes of kidney disease in lupus patients, antibodies to double stranded DNA. Mr. Bienaime continued, “This product opportunity also represents an exceptionally good strategic fit for BioMarin. Lupus nephritis is a serious and potentially fatal orphan disease treated by specialists, primarily nephrologists and rheumatologists, and there are no products specifically approved to treat lupus renal disease. Importantly, if the ASPEN study is successful, Riquent provides BioMarin the opportunity to launch a product in the 2010 and 2011 timeframe in regions where we can leverage existing commercial operations.” “BioMarin is a proven leader in successfully bringing value-added therapies to patients suffering from orphan diseases and we are very pleased to have BioMarin as a partner to develop and commercialize Riquent in the U.S., Europe, the Middle East and Latin America,” said Deirdre Y. Gillespie, M.D., President and CEO of La Jolla Pharmaceutical Company. “This is an outstanding partnership for us as it not only provides significant near term funding towards the completion of the ASPEN trial but also facilitates La Jolla’s plans to build a U.S. commercial infrastructure going forward. 2009 is a pivotal year for La Jolla and we are pleased to start the year with this positive announcement. We look forward to the first interim analysis of the ASPEN trial data which is expected to occur later in this quarter,” continued Dr. Gillespie.
