Update: Legacy Schering’s Rolapitant Program, Now At Tesaro. . .

A fine commenter wrote us back on November 10, and I failed to highlight it. Here is that fine comment — updating my old story, below:

. . . .I wasn’t sure where to post this but figured this post was closest to the mark. On Friday’s edition of Mad Money Cramer went on at length about Tesaro Biotech and how their anti-nausea cancer drug, Rolapitant, looked to be very promising. What would be of interest in this story to you and your readers would be that Rolapitant was acquired through several licensing deals that began with the Merck-Schering merger. This is a Legacy Schering drug Merck needed to sell since it has a drug in this space already. Various sub-licensing deals landed it at Tesaro where it now appears to be more safe and effective than the Legacy Merck drug it was thrown over for. Tesaro is also entering a licensing deal with Merck for another product on Phase I at present. . . .

November 10, 2012 2:27 PM


[July 2012]

You may recall that the Hart-Scott authorities at FTC/DoJ Antitrust required New Merck to divest the cancer candidate research and development program around Rolapitant, because there was concern of decreased competition (one of the two soon-to-be internal cancer candidate programs would be moth-balled, and thus price levels increased) — as a result of the bust-up of legacy Schering-Plough (and swallowing, in large part, by New Merck).

Well, back around bust-up time (late October/early November of 2009), Opko Health acquired — for a palty $2 million upfront payment — what was then the legacy Schering-Plough Rolapitant program. Then, in December 2010, Tesaro in-licensed the rights from Opko. Now, as of June 27, 2012, Tesaro has gone public — although about 68 percent of the shares remain in insiders’ hands. Morgan Stanley and Citi were lead underwritiers on the six million share offering — at an IPO price of $13.50.

Here is the rub — that Rolapitant program may now one day directly compete with Merck’s offerings in the solid tumor space — including Temodar.

From the Tesaro IPO prospectus then:

. . . .We in-licensed the exclusive worldwide rights to rolapitant from OPKO Health, Inc., or OPKO, in December 2010. OPKO had acquired certain NK-1 receptor related assets in 2010, including rolapitant, from Schering-Plough Corporation, or Schering-Plough, as part of a United States Federal Trade Commission requirement to divest certain assets in connection with Schering-Plough’s combination with Merck. Prior to its divestiture of rolapitant, Schering Plough evaluated rolapitant in over 1,000 subjects, including studies for the prevention of post-operative nausea and vomiting, or PONV, and chronic cough, and completed a Phase 2 clinical trial in patients at high risk for CINV. . . .

We currently do not have any products that have gained regulatory approval. The success of our business is dependent upon our ability to develop and commercialize rolapitant, niraparib and TSR-011, which are currently our only product candidates. We are particularly dependent on the future success of rolapitant, because it is our only late-stage product candidate, and it is just beginning a Phase 3 clinical program. Our other product candidates are at an earlier stage of development. While niraparib has undergone a Phase 1 clinical trial in cancer patients as a monotherapy and is currently under evaluation by Merck for use in combination with temozolomide for the treatment of solid tumors, we have not yet established a development plan, and TSR-011 is still in preclinical development. . . .

Success in preclinical testing and early clinical studies does not ensure that later clinical trials will generate adequate data to demonstrate the efficacy and safety of an investigational drug. A number of companies in the pharmaceutical and biotechnology industries, including those with greater resources and experience, have suffered significant setbacks in clinical trials, even after seeing promising results in earlier clinical trials. Despite the results reported in earlier clinical trials for rolapitant and niraparib and in preclinical studies for TSR-011, we do not know whether the clinical trials we may conduct will demonstrate adequate efficacy and safety to result in regulatory approval to market in any particular jurisdiction or jurisdictions any of our product candidates. If later-stage clinical trials do not produce favorable results, our ability to achieve regulatory approval for any of our product candidates may be adversely impacted. . . .

Well — we shall see whether the Rolapitant candidate ever sees a US market launch. . .


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