Opko Health Inc (OPK)

[tomsylver]

Guggenheim Starts Tesaro (TSRO) at Buy

On October 2, 2014

Guggenheim initiated coverage on Tesaro (NASDAQ: TSRO) with a Buy rating and a price target of $46.00 ( http://www.streetinsider.com/New+Coverage/Guggenheim+Starts+Tesaro+(TSRO)+at+Buy/9879136.html )

CINV
Rolapitant

Rolapitant is potentially a best-in-class supportive care product for Chemotherapy-induced nausea and vomiting (CINV). 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 completed Phase 3 clinical development for CINV. Two phase 3 trials of rolapitant that together enrolled a total of 1,070 patients receiving highly emetogenic chemotherapy (HEC) and met the primary endpoint of a higher rate of complete response in the delayed phase. The results indicated that protection from CINV was maintained over the full five day at-risk period in both trials. One additional phase 3 trial of rolapitant that enrolled 1,369 patients receiving moderately emetogenic chemotherapy (MEC) successfully achieved the primary endpoint of higher rate of complete response in the delayed phase. a New Drug Application (NDA) is on track for mid-2014.

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® (Aprepitant) is currently the only NK-1 receptor antagonist on the market Strong IP portfolio with U.S. exclusivity expected through 2028