Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.BioMarin Pharmaceutical and La Jolla Pharmaceutical Company have entered into an agreement to develop and commercialize Riquent, La Jolla's investigational drug for lupus nephritis, in the US, Europe and all other territories of the world, excluding the Asia-Pacific region.
Subscribe to our email newsletter
Under the terms of the agreement, BioMarin will receive a co-exclusive license to develop and commercialize Riquent and La Jolla could receive up to $289 million in cash through milestones and equity purchases by BioMarin. Specific payments include: $15 million upfront, up to approximately $92.5 million related to clinical milestones, $55 million for regulatory milestones, and up to approximately $126 million for achieving specified annual net sales milestones beginning at $250 million in sales.
Following a successful Phase III trial, the parties will share equally in all losses and profits. In the US, BioMarin and La Jolla will jointly commercialize Riquent. In Europe and other territories outside of Asia, BioMarin will be responsible for all commercialization activities.
The collaboration also provides La Jolla an ability to participate equally in sales and marketing responsibilities in the US to facilitate building its commercial infrastructure. La Jolla will maintain primary manufacturing responsibility, and work collaboratively with BioMarin to maximize supply chain and process efficiencies. Upon signing, BioMarin will pay La Jolla a total upfront payment of $15 million, $7.5 million in cash and $7.5 million for the purchase of 3.39 million preferred shares at a price per share of $2.21.
Riquent is being evaluated in the international Phase III Aspen trial designed to demonstrate that Riquent treatment delays the time to renal flare and reduces proteinuria in patients with lupus renal disease.
At each of the two interim efficacy analyses (the first expected in the first quarter of 2009 and the second expected in mid-2009) or when the Aspen study comes to a successful completion, BioMarin may exercise its option to fully participate and share all losses and profits on a 50:50 basis. Prior to BioMarin’s decision to participate fully, La Jolla will fund 100% of all costs. La Jolla expects consideration from the deal to significantly cover the remaining costs of the Phase III Aspen study.
The final efficacy analysis is expected to occur in the second half of 2009. Assuming a positive outcome of the Aspen Phase III trial, a new drug application is expected to be submitted in the first half of 2010. If approved, Riquent would reportedly be the first new drug approved specifically for lupus in more than 45 years.