BioMarin and La Jolla sign agreement to develop and commercialise Riquent

BioMarin Pharmaceutical and La Jolla Pharmaceutical Company have entered into an agreement to jointly develop and market Riquent, La Jolla's investigational drug for lupus nephritis worldwide, excluding Asia Pacific.

BioMarin will pay US$15m upfront to La Jolla, which could receive up to US$289m in cash through milestones and equity purchases by BioMarin as part of the deal, the companies said.

Both companies will jointly commercialise Riquent, which is currently in Phase 3 trials, as a treatment for lupus, in the US. BioMarin will take responsibility for all other commercialisation activities in Europe and other territories outside of Asia.

Results from the Phase 3 studies of Riquent are expected in this year's first quarter and by June 2009. Lupus is a potentially fatal, chronic auto-immune disease in which the body creates antibodies that attack its own connective tissues.

Following a successful Phase 3 trial, both companies will share equally in all losses and profits.

Jean-Jacques Bienaime, chief executive of BioMarin said: "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."

Bienaime added: "If the Phase 3 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."

The agreement provides near-term funding towards the completion of the Phase 3 trial and also facilitates La Jolla's plans to build a US commercial infrastructure going forward, the companies said.

La Jolla will maintain primary manufacturing responsibility, and work collaboratively with BioMarin to maximise supply chain and process efficiencies.