Replies to post #62336 on Biotech Values

[Bio_pete]

Nuvo Research - I think Pennsaid could do well in the market. Alpharma has exceeded expectations with the Flector patch and I'd rather use Nuvo's formulation then a patch.

[BioSpecialist]

re Nuvo Research -- A big opportunity ???

Insider Activity
http://canadianinsider.ca/coReport/allTransactions.php?ticker=nri

iling Date Transaction Date Insider Name Ownership Type Securities Nature of transaction # or value acquired or disposed of Unit Price
Mar 06/08 Mar 04/08 GALER, BRADLEY STUART Direct Ownership Common Shares 30 - Acquisition under a purchase/ownership plan 136,145 $0.097
Mar 06/08 Mar 04/08 GALER, BRADLEY STUART Direct Ownership Common Shares 10 - Acquisition in the public market 111,270 $0.106
Mar 06/08 Mar 04/08 Dobranowski, Anthony Edward Direct Ownership Common Shares 10 - Acquisition in the public market 100,000 $0.100
Feb 29/08 Feb 26/08 GALER, BRADLEY STUART Direct Ownership Common Shares 10 - Acquisition in the public market 400,000 $0.106
Feb 29/08 Feb 26/08 GALER, BRADLEY STUART Direct Ownership Common Shares 10 - Acquisition in the public market 290,000 $0.107
Jan 10/08 Dec 31/07 GALER, BRADLEY STUART Direct Ownership Common Shares 97 - Other 682,592 $0.135
Dec 19/07 Dec 18/07 Dobranowski, Anthony Edward Direct Ownership Common Shares 10 - Disposition in the public market -40,000 $0.090
Dec 19/07 Dec 17/07 Dobranowski, Anthony Edward Direct Ownership Common Shares 10 - Disposition in the public market -10,000 $0.090
Dec 19/07 Dec 17/07 Dobranowski, Anthony Edward Indirect Ownership Common Shares 10 - Acquisition in the public market 50,000 $0.090

[BioSpecialist]

Nuvo Research -- Insider Activity

http://canadianinsider.ca/coReport/allTransactions.php?ticker=nri

[Preciouslife1]

Vioxx's Heart Risk Lingered Long After Use Ended
By Steven Reinberg
Mon Oct 13, 7:04 PM ET

http://news.yahoo.com/s/hsn/vioxxsheartrisklingeredlongafteruseended

MONDAY, Oct. 13 (HealthDay News) -- When the pain killer Vioxx was pulled from the market in 2004 -- over concerns that it increased the risk of heart attack, stroke and death -- many assumed that stopping the drug would end the risk.

But a new study finds that "the risk was increased close to twofold, and the risk persisted for approximately a year," said co-author Dr. Robert Bresalier, a professor of medicine at the M.D. Anderson Cancer Center in Houston.

"The good news is that, after a year, the risk seemed to go back down toward normal," he said.
However, the study's researchers and other experts also believe that long-term use of most non-aspirin painkilling drugs in this class -- called non-steroidal anti-inflammatory drugs (NSAIDs) -- also boost users' risks of heart attack, stroke and death to some degree.

NSAIDs include cox-2 inhibitor drugs such as the now-banned Vioxx and Bextra, as well as the remaining cox-2 on the market, Celebrex. Those drugs target the cyclooxygenase 2 (cox-2) enzyme involved in inflammation.

NSAIDs also include less targeted anti-inflammatory medications such as ibuprofen (Advil, Motrin) and naproxen (Aleve)
The report was published online in the Oct. 14 issue of The Lancet.
For the study, Bresalier's group followed people who had participated in the international APPROVe trial, which compared Vioxx to placebo over 3 years in an attempt to see whether the drug could cut the recurrence of cancerous colon polyps.
The trial was stopped early in 2004 because of the increased risk for heart attacks and stroke.

The researchers in the new study were able to contact 84 percent of the almost 2,600 people who had participated in the trial.
They found that a year after discontinuing Vioxx, ex-users still had a 79 percent increased risk of heart attack, stroke or death compared with those who had received placebo.

This finding was consistent with the increased risk observed during the trial, where the odds for cardiovascular trouble was more than double for those taking Vioxx.
For individual patients, the risk of heart attack or stroke was doubled during the year after stopping the drug. The increased risk of dying was 31 percent compared with those who had taken placebo, the researchers noted.


Bresalier's group did find that Vioxx was able to reduce the recurrence of colon polyps, but this benefit has to be weighed against the increase in cardiovascular risk, they said.
Bresalier suspects that long-term use of all non-aspirin NSAIDs can raise the odds of cardiovascular trouble to some extent.

"Similar data has been evident for some of the other cox-2 inhibitors," he noted. "In fact, it seems to be a class effect for most if not all NSAIDs. There is a dose-dependent risk with Celebrex as well, whose magnitude was not that much different from Vioxx," he said.
Bresalier believes that certain patients should not take high doses of these drugs over a long period. "If you have a history of cardiovascular disease, speak to your doctor to understand the relative risks and benefits. If you're somebody who really needs to take these drugs because of chronic pain or severe arthritis, be aware of the issues. But you shouldn't be afraid to take these drugs if you need them," he said.

For people who take these drugs only intermittently -- for short-term pain relief, for example -- the risk is very small, Bresalier said. "It doesn't mean if you take one or two pills you're going to get a heart attack. For the vast majority of people taking these drugs, these are very good and safe drugs," he said.

Dr. Eric J. Topol, director of the Scripps Translational Science Institute and Chief Academic Officer of Scripps Health in La Jolla, Calif., was not surprised that the risk for heart attack and stroke continued even after Vioxx was stopped.
"What this does is help further demonstrate not only the risk of Vioxx, but the temporal duration," Topol said. "Now, we have compelling data that the risk extends a year after stopping the drug," he said.

Topol, who was one of the first to sound the alarm about Vioxx, is not sure that this is a class effect of all cox-2 inhibitors, however.

"There was always a signal that it [the risk] was worse for Vioxx that other cox-2 inhibitors. Whether or not other drugs like Celebrex shared that isn't known. That has not been demonstrated in studies of Celebrex. But you have to be suspicious, particularly since high doses of Celebrex have heart attack and stroke risk. But there's never been a study to show that it's a long-lasting liability," he said.

[BioSpecialist]

re best in class topical NSAID for osteo-arthritis

Pennsaid(R) Phase 3 study results to be published in leading international PAIN journal
4/23/2009 7:00 AM - Canada NewsWire

MISSISSAUGA, ON, Apr 23, 2009 (Canada NewsWire via COMTEX News Network) --

Nuvo Research Inc. (TSX: NRI), a Canadian drug development company focused on the research and development of drug products delivered to and through the skin using its topical and transdermal drug delivery technologies, today announced that study results demonstrating that the Company's lead product, Pennsaid, a topical non-steroidal anti-inflammatory drug (NSAID), is an efficacious treatment for the symptoms of osteoarthritis of the knee will be published in the June 2009 edition of PAIN.

PAIN is the world's leading publication on pain research and treatments and the official journal of the International Association for the Study of Pain (IASP(R)). The IASP, founded in 1973, is the leading professional forum for science, practice, and education in the field of pain and has more than 6,500 members in 118 countries who are professionals involved in the research, diagnosis and treatment of pain.

The scientific article details Nuvo's previously announced study results, which demonstrated that Pennsaid is efficacious for the relief of symptoms in patients with knee osteoarthritis. In addition, the study demonstrated that Pennsaid is as effective as oral diclofenac at relieving knee osteoarthritis symptoms but with less NSAID-related systemic toxicity. The article, titled, "Efficacy and safety of topical diclofenac containing dimethyl sulfoxide (DMSO) compared with those of topical placebo, DMSO vehicle and oral diclofenac for knee osteoarthritis", was written by Dr. Lee Simon as lead author, and Dr. Lisa Grierson, Zahid Naseer, Dr. Arthur A.M. Bookman, M.D., and Dr. J. Zev Shainhouse as co-authors. It is currently available on the PAIN website.

"The publication of this article in the premier international pain journal further confirms Pennsaid's unique and compelling efficacy and safety profile among all other topical NSAIDs," said Dr. Brad Galer, Vice President and General Manager of Nuvo's Pain Group. "This published data provides further support to our conclusion that Pennsaid, when approved by the U.S. Food and Drug Administration (FDA), will be the best-in-class product available in the United States."

Nuvo resubmitted its application for Pennsaid approval to the FDA in February 2009. The FDA has indicated that it intends to advise Nuvo of its decision regarding the approval of Pennsaid by August 5, 2009 (the "PDUFA Date") under the Prescription Drug User Fee Act.

The subject of the PAIN article is Nuvo's Phase 3 trial, Study 112, which enrolled 775 patients in the U.S. and Canada with symptoms of primary osteoarthritis of the knee. Patients in this five-arm, double-blind, 12-week trial applied a topical solution and took an oral pill. The five arms were: 1) Pennsaid plus oral placebo, 2) topical placebo containing a small amount of DMSO for blinding purposes (DMSO facilitates delivery of diclofenac to the knee) plus oral placebo, 3) topical vehicle-control (containing the same concentration of DMSO as in Pennsaid) plus oral placebo, 4) topical placebo plus oral diclofenac and 5) Pennsaid plus oral diclofenac.

Pennsaid (arm 1) was superior to placebo (arm 2) with statistically significant improvement in all three primary clinical endpoints required by the FDA: pain relief (p=0.019), improvement in physical function (p=0.046) and improved patient overall health assessment (POHA) (p(less than)0.0001).

Additional results from the trial show that Pennsaid (arm 1) was superior to vehicle control (arm 3) (pain, p=0.009; physical function, p=0.026; POHA, p=0.016). There was no difference between vehicle control (arm 3) and placebo (arm 2) indicating that DMSO alone is ineffective against the symptoms of knee osteoarthritis (p greater than 0.05). There was no difference between Pennsaid (arm 1) and oral diclofenac (arm 4) for all three efficacy endpoints (p greater than 0.05). Arm 5 was included in the trial at the FDA's request to review the side effect profile of Pennsaid if combined with an oral NSAID. This combination showed no increased incidence of the usual systemic side effects, just the expected additive profiles of Pennsaid alone plus oral diclofenac alone.

Dry skin was the most common adverse event with Pennsaid use. Fewer digestive system adverse events and laboratory abnormalities (decreased hemoglobin and increased AST, ALT and creatinine) were observed with Pennsaid as compared to oral diclofenac.