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Re: EastCoastCdn post# 55

Thursday, 11/05/2009 9:38:21 PM

Thursday, November 05, 2009 9:38:21 PM

Post# of 84
Apparently they cut it short on the link.

Here is the full article:

"
TORONTO (Dow Jones)--It's taken the better part of a decade, but Nuvo Research Inc. (NRI.T) has finally landed U.S. approval of its topical pain medicine, Pennsaid.

Earlier Thursday, the Canadian biotech - formerly known as Dimethaid - said the U.S. Food and Drug Administration approved Pennsaid for the treatment of "the signs and symptoms of osteoarthritis of the knee." The approval triggers a $15 million milestone payment from marketing partner Covidien PLC (COV), and Nuvo will receive royalties on sales "consistent with industry standards," estimated at about 20%.

In a release, Nuvo Chairman Dan Chicoine said he is "thrilled" with the result, and that the product's launch will support development of its pipeline products. The main product it has in development is a follow-on to Pennsaid, Pennsaid Plus, a gel formulation that could be more efficacious using less medication.

In Toronto Thursday, Nuvo is up 6 Canadian cents to 41 Canadian cents on 29.7 million shares. It traded as high as 54 Canadian cents earlier in the session.

Nuvo's road to U.S. approval was long and difficult and dilutive for the company, which has a whopping 391 million shares outstanding, plus a host of unexercised options and warrants. Approval was denied twice by the FDA -- in 2002 and 2006 -- and the agency was originally to have ruled a third time in August but needed more time to analyze all the data.

In a report, Dundee Securities analyst David Martin said he believes the substantial safety data Nuvo collected since 2006, coupled with no changes in "direction" at the FDA's pain division, gave Pennsaid better odds of approval this time.

He said a peak sales estimate for Pennsaid of $100 million is reasonable based on the current market size for drugs in this class and potentially stronger efficacy and improved patient convenience compared to its key competitor, Voltaren gel.

Company Web Site: http://www.nuvoresearch.com

-By Andy Georgiades, Dow Jones Newswires; 416-306-2031; andy.georgiades@dowjones.com "
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