Opko Health Inc (OPK)

[tomsylver]

opko health, Rolapitant, tesaro

TESARO Baird's 2014 Health Care Conference ( http://ir.tesarobio.com/events.cfm )

http://opkodd.files.wordpress.com/2014/09/tesarobaird2014.png&h=101
http://opkodd.files.wordpress.com/2014/09/audio.gif&h=22  Listen to webcast ( http://wsw.com/webcast/baird39/tsro )

September 3, 2014 - September 4, 2014
The New York Palace - New York, NY

(Paraphrase)
Chris (Baird) (Q&A) Portion> Question:
Time frame on NDA for Rolapitant? Can you give us a time frame, any day now?

Tesaro Lonnie Moulder (CEO & Co Founder)> Answer:
Mary Lynne (President & Co-Founder) is here (Baird's 2014 Health Care Conference), she is not overseeing the writing of an NDA now, so that's a good sign Chris.

Chris (Baird) (Q&A) Portion> Question:
So we should assume the NDA is Imminent?

Tesaro Lonnie Moulder (CEO & Co Founder)> Answer:
Yes Imminent.

Chris (Baird) (Q&A) Portion> Response:
Excellent, I guess we not go any further than that.

Rolapitant FDA Timeline:
PDUFA V
Tesaro Lonnie Moulder (CEO & Co Founder):
Clarify the timing under PDUFA V. It's a Ten month review from the time of the acceptance of the file. It Sixty days to the acceptance of the file, so it's actually Twelve months from the time you submit. We (Tesaro) will be launch ready in 3rd Quarter of September of next year. September is launch ready for next year.


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