CINV & PONV
Rolapitant
Rolapitant is potentially a best-in-class supportive care product for CINV / PONV. Characteristics include:
- Single dose
- Rapid onset
- 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.
Clinical Development
- 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.
Market Opportunity
- 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