Rolapitant is potentially a best-in-class supportive care product for CINV / PONV. Characteristics include:
Long-acting (5 day activity as opposed to 1 or 2 days for other treatments)
Acquisition of Rolapitant
In October 2009, OPKO acquired Rolapitant, a potent and selective competitive antagonist of the NK-1 receptor, in addition to other neurokinin-1 (NK-1) assets from Schering Plough Corporation.
In December 2010, OPKO exclusively out-licensed the development, manufacture, and commercialization of Rolapitant to biopharmaceutical company TESARO, Inc.
Rolapitant has successfully completed Phase II clinical testing for prevention of chemotherapy-induced nausea and vomiting (CINV) and post-operative-induced nausea and vomiting (PONV).
In April 2012, Rolapitant entered Phase 3 of clinical testing. It underwent three global studies, one of which involved approximately 2,400 patients.
Complete results are anticipated in the second half of 2013.
License Agreement with TESARO
Under terms of the license with TESARO, OPKO is eligible to receive up-front and milestone payments of up to $121 million.
OPKO is also entitled to double-digit tiered royalties on sales of the licensed product, a share of future profits from product commercialization in Japan, and an option to market the product in Latin America.
OPKO has also acquired an equity position in TESARO.
U.S. market opportunity of approximately $1.25 billion
6.6 million annual CINV patient treatments in 2011
NCCN and ASCO guideline recommendations could lead to 70% penetration by the NK-1 class
Merck-EMEND® is currently the only NK-1 receptor antagonist on the market
Strong IP portfolio with U.S. exclusivity expected through 2028