Good FDA News for Nuvo Research (TSX:NRI) and Sunesis (Nasdaq: SNSS) Print E-mail
By Staff and Wire Reports   
Thursday, 05 November 2009 03:00

Covidien (NYSE:COV) and Nuvo Research Inc. (TSX:NRI), a Canadian drug development company, are announcing that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application for Pennsaid® Topical Solution (diclofenac sodium topical solution).


Pennsaid Topical Solution is a non-steroidal anti-inflammatory drug (NSAID) used for the treatment of the signs and symptoms of osteoarthritis of the knee. Nuvo develops drug products delivered to and through the skin using its topical and transdermal drug delivery technologies.

“FDA approval of Pennsaid is the most significant milestone in Nuvo’s history,” said Dan Chicoine, Chairman of Nuvo Research. “We are thrilled that we have been able to successfully navigate a very challenging regulatory pathway for this product and look forward to the upcoming launch of Pennsaid in the U.S. by Covidien. This will support the development of our product pipeline as we progress toward becoming the global leader in the research and development of drug products delivered to or through the skin.”

“Building on more than a century of pain treatment experience, Covidien is focused on expanding the limits of pain therapy by combining proven drugs with innovative delivery systems,” said Timothy R. Wright, President, Pharmaceuticals, Covidien. “We are pleased to be collaborating with Nuvo Research on this opportunity to expand our branded pharmaceutical portfolio by selling and marketing Pennsaid throughout the United States.”

Covidien is the largest supplier of controlled pain medications in the United States based on number of prescriptions.

In June, the companies announced that Mallinckrodt Inc., a Covidien company, had entered into a license and development agreement with Nuvo that encompasses Pennsaid Topical Solution and its follow-on topical diclofenac formulation, Pennsaid® Plus Gel, which is currently under development.

As a result of the FDA approval of Pennsaid Topical Solution, Nuvo will receive a $15 million milestone payment from Covidien. Going forward, Nuvo will receive royalties on net U.S. sales of Pennsaid at rates that are consistent with industry standards. Nuvo will also be eligible to receive additional escalating sales milestone payments for Pennsaid and Pennsaid Plus totaling up to $100 million.

Elswhere, Sunesis Pharmaceuticals (Nasdaq: SNSS) today announced that the U.S. Food and Drug Administration has granted voreloxin orphan drug designation for the treatment of acute myeloid leukemia (AML). Sunesis is currently conducting two Phase 2 clinical trials of voreloxin in AML: a single-agent study, known as REVEAL-1, of voreloxin in newly diagnosed elderly AML patients unlikely to benefit from standard induction chemotherapy and a study evaluating voreloxin in combination with cytarabine in relapsed/refractory AML.

"This designation recognizes the acute need for more options in treating this poor-prognosis disease," stated Steven B. Ketchum, Ph.D., Senior Vice President of Research and Development at Sunesis. "We believe voreloxin has the potential to impact the standard of care for AML and we continue to be encouraged by our progress. We are finalizing a registration strategy for voreloxin in AML and anticipate launching a pivotal trial in 2010."

Orphan drug designation is granted by the FDA Office of Orphan Drug Products to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. The designation provides eligibility for a seven-year period of market exclusivity in the United States after product approval and an exemption from user fees.

Vinny Cassano, a contributor to BioMedReports, who authors VFC's Stockhouse blog and is Long NRIFF has this to say about the news:

Investors were disappointed with the price action of the NRIFF stock (just under fifty cents) at Thursday's open before dipping down to the low forty cent range, but that action is in line with the recent price action of stocks that have just received FDA approvals.

In my opinion, in this market investors and traders are more impatient than ever and are willing to take advantage of anticipatory, short term spikes before an approval decision (in order to bank some quick profits) before then changing course and going long after the drop that occurs at the point of "sell the news."

It's a manipulative game, in my opinion - BioDelivery Sciences International, Inc.(NASDAQ:BDSI) got beat down, for instance, on Wednesday after starting to run early in the day - but it's also a game that can also benefit the small investor just as much as it benefits the big boys.

It's a lot less gut-wrenching to buy a stock for a decent price when you know the approval is in place rather than having to be all-in at decision time when you're sweating the decision.

In the case of NRIFF, at this point patience is needed. The drug will not be launched until the first half of 2010, so if you can get in for a decent price now and have the patience to hang one - I think that at least a double could be in order by launch time. I'm not expecting too much more than that for now, but the risk of this investment just dropped significantly; with an approved product and a strong partner, NRIFF is a pretty safe bet to rise.

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