Nuvo Research Inc (MRVFF)

[AC416]

was that the final shake before the news tomorrow.....massive drop...not sure what to say

[AC416]

to my knowledge the pdufa date is tomorrow....at the latest i can see them do a pr after market close...which would make it gap up on thursday....in my opinion the approval is there..just has to made official....go to their website and look at the presentation they had in april 09....either i am too optimistic or its clear that they are very confident in get the approval...covidien deal solidifies it more as well...since last time, they didnt have this....

in anyacse, pennsaid solid not in canada, italy and greece...market share is huge especially if private drug plans are wlling to pay for it...i cant imagine where this will be approval...it can go anywhere...only competition is novartis volatren emulgel....other than that, no real competition....

we shall wait and see....good luck

[rzdzr]

Hi AC,
seen you on another board (you are an assistant on) of which I have averaged down and hold a strong position.
I've just entered a position with nuvo on a close friends recommendation. I have done some research and strongly believe in what this company is attempting to accomplish. I hear that there is some news coming out tomorrow. Can you confirm this? If this news is correct and they DO get the Pensaid approval this will explode...IMO.
I am in the health care industry and encounter a number of people on a daily basis who presently enjoy the benefits of pensaid. If this goes to the US...omg! (IMO)
happy trading

[AC416]

thats my expectation....i could be right, i can be wrong....based on market value of the product...it can....

[HopeUnderstand]

You really think it can hit $2 upon approval??

[AC416]

great volume, less than 3 weeks before the fda decides.....

[AC416]

it can easily run into 10 dollars but i cant see that happen this year...if it does then my apologies in advance....

pennsaid works well, works quick....but has stiff competition....celebrex by pfizer is its main competition, that has 3-4 yrs left on it patent....disadvantage with celebrez is it can upset the stomach and lead to ulcers...main airithirity population is the eldery which are already at risk of ulcer and arithiritis....pennsaid avoid both these issues....so as a product it has a huge market....

other competition to pennsaid is voltaren emulgel...exact same product, but in a gel for, but it is less potent...hence pennsaid plus is being made as a gel....volatren emulgel is over the counter and could be bought with out a prescription and is relative cheap...in canada, volatren costs 10 includes taxes for a tube, similar qty for pennsaid run 30 dollars and requires a prescription....

so as great as pennsaid is has some competition...i have no clue what powers coviden has in distribution...in any case, the product is very good, it works, so potential is there...i expect atleast 2 dollars at approval, and once distribution through out the us starts, then who know...it also depends if the drug is covered by issurance and is going to be back up by goverment plans...in canada, the province i am in, its covered by private plans, but not by the goverment plan, which covers seniors (main population of pennsaid users, or candidate users).....so depending on approval for payment, this can go anywhere....10 dollar maybe a stretch, 2-5 very possible....

we shall find out in less than 6 weeks, what will happen....

[Stockboy 2]

To AC416
I appreciate your reply. I'm in my mid 70's having held 8,000 shares for a few years. I was hoping for 12 to $15.00 to pay off line of credit and car loan. (Nuvo was once $12.00 based on unmaterialized expectation of approval.) The pie in the sky $100,000,000 company had me thinking maybe I should sell in quantities hoping for a share split. I was impressed by all research and FDA submission costs being paid by the distributor leaving Nuvo with only production costs. WF10 and toe nail fungus developments are in the possible future. Obviously I know nothing about share values. Maybe I should sell the works at $2.50.

[AC416]

tough to say, but i can see this trading atleast at the 2 dollar range based on approval....everything is will be over once the approval is done, paid phase 3 clinical trials and development of pennsaid plus, distribution....all they have to do is manufacture the product which they are doing so now anyways.....very widely used...so really its only a scale up procedure....investment required 0.....this can only fly with approval...how high no one know...but on approval, i am guess atleast 2-2.5 range....

[Stockboy 2]

If FDA does approve on August 5, can anybody suggest a share price
upon approval and by the end of 2009?
Stockboy

[AC416]

Nuvo Research and Covidien sign U.S. license and development agreement for Pennsaid(R) and Pennsaid Plus(R)
Tue Jun 16, 7:00 AM
Email Story IM Story Printable View
MISSISSAUGA, ON, June 16 /CNW/ - Nuvo Research Inc. (TSX: NRI.TO) 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 it has entered into a license and development agreement with Mallinckrodt Inc., a subsidiary of Covidien (NYSE: COV), a leading global provider of healthcare products, granting it exclusive rights to market and sell Pennsaid(R), and its follow-on product, Pennsaid Plus(R), in the United States.

Pennsaid and Pennsaid Plus are Nuvo's topical non-steroidal anti-inflammatory drug ("NSAID") candidates. Nuvo has been advised by the U.S. Food and Drug Administration ("FDA") that it expects to respond to Nuvo's resubmitted new drug application for Pennsaid by August 5, 2009.

Under the terms of the license and development agreement, Nuvo will receive an up-front, non-refundable payment of US$10 million. In addition, Nuvo is eligible to receive a US$15 million milestone payment on Pennsaid's approval by the FDA, which will increase to US$20 million if certain labeling criteria are agreed to by the FDA. Nuvo will receive royalties on net U.S. sales of Pennsaid and Pennsaid Plus at rates that are consistent with industry standards for products at similar stages of development. Nuvo will be eligible to receive additional escalating sales milestone payments for the products totaling up to US$100 million.

Covidien will assume responsibility for all future development activities and expenses for Pennsaid Plus, including two Phase 3 clinical trials that Covidien expects to commence in 2010. Covidien has a right to negotiate with Nuvo on an exclusive basis for a period of 90 days to expand the licensed territory to include additional unlicensed countries worldwide. Nuvo will manufacture and supply Pennsaid and Pennsaid Plus to Covidien from its existing manufacturing facility in Varennes, Québec.

Covidien is a leading global healthcare products company with revenues of nearly US$10 billion in 2008, and more than 41,000 employees in 59 countries worldwide. Its products are sold in more than 140 countries. A market study commissioned by Nuvo estimates that the market for topical NSAIDs will grow to US$2 billion annually within five years.

"Covidien is an ideal partner with the infrastructure, market reach, resources and commitment to maximize the commercial potential of Pennsaid and Pennsaid Plus," said Dan Chicoine, Chairman of Nuvo. "It is aggressively adding resources to maximize the value of the Pennsaid/Pennsaid Plus franchise and pursue its strategy of becoming a global presence in the treatment of pain."


About Pennsaid and Pennsaid Plus

[AC416]

slowly rising....partnership talks, and approval pending...where is this going to go after approval deadline....lets wait and see

[JOHNNYBOO]

8 million in volume today finishing at .26 with 2 mill on the bid...
we could see a nice steady climb to a $1.00 before the approval even happens...very nice play here...lots of institutional buying...follow the smart money I say...and GL

[AC416]

2 months till possible approval date, this thing can fly on approval....product is available, its being prescribed, response is good in canada, italy and greece....if the U.S gets on board, i cant imagine what can happen....

in dollar in no time...its not an expensive product, but demand for an arithiritis product is huge...

[514]

looks really good..even with the speculation ou can make money on this one.

good luck

[AC416]

some nice movement upon anticipation

[AC416]

its a pretty good product, works really well, lets hope it finally gets the approval it deserves

[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.

[AC416]

NRI back moving with FDA submission....Aug 2009 response date, nice steady climb until then.....

[AC416]

NRI on the move again, look for a possible jump, due to updated filing in the first Q of 09

[AC416]

Nuvo Research subsidiary signs collaboration agreement with Fortune Global 500 company
Tuesday November 25, 7:00 am ET


MISSISSAUGA, ON, Nov. 25 /CNW/ - Nuvo Research Inc. (TSX: NRI - News), a Canadian drug development company focused on the research and development of drug products delivered to and through the skin, today announced that fqubed, Inc., its San Diego-based research and development subsidiary, has signed a research and development collaboration agreement with a Fortune Global 500 company that develops and markets skin care products. Financial details of the agreement were not disclosed.
ADVERTISEMENT


"The fqubed technologies have valuable applications beyond our primary focus on pharmaceutical products delivered to and through the skin," said Dan Chicoine, Nuvo's Chairman. "Collaboration agreements such as this allow us to leverage the power of our transdermal screening and high throughput formulation development platforms in complementary areas, and to improve our research capabilities so that we can more effectively develop our own topical drug pipeline."

Under the collaboration, fqubed will expand the scope of its TEMPEST(TM) high throughput experimentation (HTE) platform to evaluate potential formulations for its partner's product portfolio. TEMPEST(TM) is currently used to screen the impact that formulation variations have on the penetration of a drug molecule through skin. TEMPEST(TM) offers testing throughput significantly higher than conventional equipment thereby increasing the likelihood of new discoveries.

"Collaborations with leading third parties validate fqubed's HTE technology leadership position," added John M. Newsam, fqubed's President and Managing Director. "They also allow us to broaden and strengthen our proprietary HTE platforms with input from groups that have extensive and complementary experience with skin-applied products."

Nuvo acquired fqubed in 2005 to increase its ability to develop novel drug products for delivery to or through the skin. The Nuvo subsidiary has discovered molecular penetration enhancer (MPE(TM)) systems suitable for enhancing drug delivery and is advancing a portfolio of prospective new topical pain products.

About Nuvo Research Inc.

Nuvo is focused on the research and development of drug products delivered to and through the skin using its topical and transdermal drug delivery technologies. Nuvo's lead product is Pennsaid(R), a topical non-steroidal anti-inflammatory (NSAID) used for the treatment of osteoarthritis. Nuvo intends to leverage its skin-penetrating technologies to create a portfolio of topical and transdermal products targeting a variety of indications.

[AC416]

Nuvo Research presents positive Phase III study results for Pennsaid at leading rheumatology conference
Monday October 27, 5:00 pm ET


MISSISSAUGA, ON, Oct. 27 /CNW/ - Nuvo Research Inc. (TSX: NRI - News), 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 showing that Pennsaid, Nuvo's topical diclofenac solution, is an effective treatment option for the symptoms of osteoarthritis of the knee, with an improved safety profile compared to oral diclofenac, were detailed in a poster presentation at the 2008 American College of Rheumatology Scientific Meeting in San Francisco.
ADVERTISEMENT


The lead author of the presentation was Dr. Lee Simon, Associate Clinical Professor of Medicine, Harvard Medical School. This was the first presentation to a medical and scientific audience of the Phase III clinical study results, which were originally announced by the Company upon study completion in January 2006.

"Presenting at a prestigious event such as the American College of Rheumatology Scientific Meeting provides Nuvo with a forum to share our compelling Pennsaid clinical data with medical and scientific leaders," said Dr. Brad Galer, Vice President and General Manager of Nuvo's Pain Group. "As we move closer to Pennsaid's approval by the U.S. FDA, it is important that the professional rheumatology community be aware of what we believe is the strongest clinical efficacy and safety evidence of any topical NSAID formulation for the treatment of osteoarthritis. We believe that this data supports the conclusion that Pennsaid, once approved, will be the best-in-class product available in the U.S."

"These results confirm and extend previous studies and show that this novel topical diclofenac solution is efficacious for the relief of symptoms in patients with symptomatic knee osteoarthritis," said Dr. Marc C. Hochberg, Head, Division of Rheumatology & Clinical Immunology at the University of Maryland School of Medicine. "Furthermore, it had similar efficacy to orally administered diclofenac with fewer gastrointestinal, hepatic and renal adverse events. Topical NSAIDs should be considered in the management of patients with symptomatic osteoarthritis involving joints accessible to these agents."

Nuvo's Phase III trial, Study 112, 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(R) 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(R)) plus oral placebo, 4) topical placebo plus oral diclofenac and 5) Pennsaid(R) plus oral diclofenac.

Pennsaid(R) (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(R) (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(R) (arm 1) and oral diclofenac (arm 4) for all three 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(R) if combined with an oral NSAID. This combination showed no increased incidence of the usual side effects, just the expected additive profiles of Pennsaid(R) alone plus oral diclofenac alone.

Further data published today in the poster presentation showed that dry skin was the most common adverse event with Pennsaid use. Fewer digestive system adverse events and laboratory abnormalities (hemoglobin, AST, ALT, creatinine) were observed with Pennsaid than oral diclofenac.

[AC416]

FDA application due in the new year, would it be for Penssaid, or Plenssaid Plus, the new improved formulation, with less doising applications per day.

[AC416]

Voltaren emulgel is now available in the canadian market, and proves to be some competition for NRI.....

[AC416]

Novartis already has approved a diclofenac gel, which is over the counter. I have a feeling that NRI may have the final ok from the FDA, lets wait and see, its been a long time in the making.

[AC416]

NRI looking forward for a submission by the end of this year, any one still around following...

[BioSpecialist]

Another great Day


http://finance.yahoo.com/q?s=nri.to

[BioSpecialist]

Nuvo Research -- Good Volume today up 15%

Marktkap: 37,4 million C$
Cash : 19 million C$

http://finance.yahoo.com/q?s=nri.to&x=0&y=0


Presentation....must read
http://www.nuvoresearch.com/documents/2007%20-%20Investor%20Presentation.pdf

[BioSpecialist]

Insider Activity

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

[BioSpecialist]

"Pennsaid on track to be best in class FDA approved topical NSAID for osteo-arthritis"

Nuvo Research (NRI.TO)


Marketcap: 35 Million C$
Cash: 19,1 Million C$
Price: 0,12 C$


Please read
http://www.nuvoresearch.com/documents/2007%20-%20Investor%20Presentation.pdf


Nuvo announces first quarter 2008 financial results
Thursday May 1, 7:00 am ET
http://biz.yahoo.com/cnw/080501/nuvo_q1_2008_results.html?.v=1
Key Corporate Developments:

- Pennsaid product sales more than tripled to $1.7 million;
- Successful launch continued in Greece with Pennsaid capturing over
30% of its market during the first quarter, placing it first in
its class by revenue;
- The Company continued to make substantial progress regarding the
studies to be provided to the FDA to address the conditions raised
in the Approvable Letter for Pennsaid, a topical non-steroidal
anti-inflammatory drug (NSAID) used to treat the pain and
stiffness associated with knee osteoarthritis (OA); and,
- The Company believes it will be in a position to file a complete
resubmission of its Pennsaid application to the FDA in early 2009
and be eligible to receive final marketing approval six months
later.

"We are extremely optimistic about Nuvo's future. We have a post-Phase III
product that is unlicensed for the large and growing U.S. OA market and we
remain confident that we will be in a position to file a complete resubmission
of our application for Pennsaid approval in early 2009," said Henrich
Guntermann, President and Chief Executive Officer, "In addition, our high
throughput screening and MMPE technology is creating a promising pipeline of
transdermal drug candidates."



Fighting arthritis with exercise and Pennsaid
Provided by: Sun Media

'Why are you using Celebrex, an oral nonsteroidal anti-inflammatory drug (NSAID) to treat arthritis of your knee when a safer medication, Pennsaid, is available? And a new report from Boston will also help to ease your pain."

This is the advice I recently gave my tennis partner.

Several years ago in my book, The Healthy Barmaid, I told the story of a patient whose arthritic fingers were improved by playing the piano. For years, I've been convinced that many people would not require hip and knee replacements if they used their legs more.
Ad


But a report from Boston claims that once arthritis sets in, walking isn't the entire answer. Dr. Ronenn Roubenoff, a rheumatologist at Tuft's University, says it also depends on the type of exercise.

He claims that few people realize the enormous pressures to which the joints are subjected. Amazingly, for every pound we weigh, a single step creates three pounds of pressure across the knees and hips.

VICIOUS CYCLE

This can be a problem therefore when the doctor says, "You've got to walk more." Rather than helping the pain, the knee hurts more and patients stop walking. This creates a vicious cycle. Inactivity leads to further weight gain, and more pressure on the knees causes more pain. It's a lose-lose situation.

Dr. Roubenoff says specific exercise is needed to strengthen the muscles which act like the shock absorbers of a car. We know we feel every bump in the road if our car's shock absorbers wear out. And this is what happens to joints if muscles are weak.

Fortunately Dr. Roubenoff's program needs no expensive equipment nor the worry of Draconian exercise. Leg muscles are strengthened by simply sitting in a chair and repeatedly getting up and down.

Another exercise involves placing increasing weights on the extended leg while sitting in a chair and moving the knee up and down. Dr. Roubenoff's patients were asked to do this twice a week.

By the end of 16 weeks, his patients had increased muscle strength by 71%. Now many could walk up and down stairs, sleep better and pain was decreased by 43%.

However, to achieve this end, Dr. Roubenoff insisted it's mandatory to push muscles beyond their current limits. This is what eventually makes the muscles more powerful. And if patients have the motivation to do so, they do not have to blindly accept the diagnosis of chronic arthritic pain.

A recent Harvard study, however, reported that rheumatoid specialists only recommended exercise in 50% of cases of rheumatoid arthritis. And a study in Canada showed that family doctors prescribed exercise to only one-third of patients with arthritis of the knee.

Today, many patients are taking Celebrex, Vioxx and other oral NSAIDs to treat arthritis of the knee. But these drugs can cause serious complications such as gastro-intestinal bleeding. It's estimated that 1,900 patients die in Canada every year due to these drugs.

This is a high price to pay for pain relief --and I have no desire to lose a tennis partner. That's why I told my friend not to take this chance and to use muscle-strengthening exercises and the new locally applied Pennsaid.

Pennsaid is a non-steroidal anti-inflammatory solution initially applied to the surface of the knee four times a day. Since it's locally applied, the likelihood of serious side-effects is decreased markedly. Equally important, studies show that it is as effective in controlling symptoms of osteoarthritis as the oral NSAIDs.

The most common side-effect of Pennsaid is a skin rash. But this problem pales in comparison to losing your life or possibly developing kidney and liver problems with the oral NSAIDs.

Doctors and patients have been waiting a long time for a safer product to treat osteo-arthritis. Pennsaid, a prescription drug, fills that need and is a godsend for arthritic patients.