Nuvo Research Inc. - Home
Ok. This thread was on that other site we are so kindly putting behind us; anyways, I have not seen anyone post about it here. Nuvo Research (NRI.TO, NRIFF.PK) has an upcoming FDA approval/rejection date of August 5, 2009. The drug of interest is Pennsaid.
Nuvo Research Inc. is a publicly traded, Canadian pharmaceutical company headquartered in Mississauga, Ontario with manufacturing facilities located in Varennes, Quebec and Wanzleben, Germany, and a research and development facility in San Diego, California.
Nuvo is focused on developing targeted therapeutic products designed to produce minimal side effects. The Company develops drugs based on two technology platforms: transdermal drug delivery and immune system regulation.
Nuvo markets two products Pennsaid®, a topical non-steroidal anti-inflammatory drug (NSAID) used for the treatment of osteoarthritis and Oxoferin™, a topical wound healing agent.
Nuvo's primary focus is obtaining approval to market, and ultimately commercialize Pennsaid® in the U.S. market. Nuvo intends to leverage its transdermal drug delivery capabilities to create a portfolio of transdermal products targeting a variety of indications.
Pennsaid®Pennsaid®, the Corporation's lead product, is used to treat the pain and stiffness associated with knee osteoarthritis (OA). The drug combines a transdermal carrier (containing dimethyl sulfoxide, popularly known as DMSO) with diclofenac sodium, a leading NSAID, and delivers the active drug through the skin directly to the pain site. While, conventional oral NSAIDs have some serious systemic side effects such as gastrointestinal bleeding and cardiovascular problems, Nuvo's clinical trials suggest that some of these systemic side effects occur less frequently with topically applied Pennsaid®.
The American College of Rheumatology (ACR) estimates that over 70 million Americans are affected by arthritis and musculoskeletal disorders and may have a substantial impact on an individuals quality of life and use of health-care resources. According to The Arthritis Society, arthritis and disorders of the musculoskeletal system are a leading cause of work-related disability.
The ACR offers the following description:
"OA is the most common form of arthritis in the United States. Patients with OA have pain (that typically worsens with weight bearing and activity and improves with rest), as well as morning stiffness and gelling of the involved joint after periods of inactivity. On physical examination, they often have tenderness on palpation, bony enlargement, crepitus of motion, and/or limitation of joint motion. Unlike the case with rheumatoid arthritis (RA) and other systemic inflammatory arthritides, inflammation and joint effusion, if present, is usually mild and localized to one or two affected joints."
The ACR estimates that nearly 21 million Americans are living with OA and many are experiencing limitation in motion as a result. While the disease can affect any age group, it is more common among those over 45, and the incidence is expected to rise as the population ages. In fact, 70% of people over the age of 70 have X-ray evidence of the disease. However, only half ever develop symptoms. Women are affected more often than men, especially with OA of the fingers and the knees.
A number of existing pharmaceutical products treat the pain associated with OA. The goal, according to the ACR, is to "include control of pain and improvement in function and health-related quality of life, with avoidance, if possible, of toxic effects of therapy." The U.S. osteoarthritis market is estimated to have annual sales of approximately US$4 billion. Of the many products on the market, most fall into one of the following categories:
* over-the-counter oral medications that are accessible without a doctor's prescription, such as acetaminophen and low-dose NSAIDs (Advil®, Motrin®, Aleve®);
* oral, full-dose, NSAIDs which are available only by prescription;
* oral COX-2 selective NSAIDs which are available only by prescription; and
oral narcotics, such as opioid analgesics which are available only by prescription.
Unlike these oral medications, Pennsaid® is a topical NSAID solution available only by prescription.
New License Agreement with Covidien in the United States
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 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®, and its follow-on product,
Pennsaid Plus®, 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
Pennsaid, Nuvo’s lead product, combines a transdermal carrier (containing
dimethyl sulfoxide, popularly known as “DMSO”) with diclofenac sodium, a
leading non-steroidal anti-inflammatory drug (“NSAID”), and delivers the active
drug through the skin directly to the site of pain. Pennsaid Plus is the follow-on
product candidate to Pennsaid. Pennsaid Plus will feature a twice-daily dosing
regime as a gel formulation.
Recent SP Action
I bought in @ 0.25 a while back (NRIFF.PK), and since then, we have been up to 0.40 two times and back again (I wish I could have been at my computer to take advantage of this, but I did not see this coming the second time). Anyways, the opportunity has once again presented itself to get in at a decent SP before the pending FDA approval/rejection run-up. I think this is a BUY right now, but you may be able to squeeze a few more pennies out if you set your limits a little lower. I am holding at least to a couple of days prior to the FDA decision, and then I will most likely let my free shares ride it out. Note that this is a resubmission to the FDA 2006 approvable letter. This stock had a run-up to the 0.50-0.70 range prior to that FDA decision, and I fully expect it to happen again here, especially considering the recent licensing/development agreements. I believe this has a great chance for approval and Nuvo has given the FDA everything they had asked for in the past approvable letter. The Pennsaid phase III results are promising:
Mississauga, Ontario, Canada – April 23, 2009 - 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®). 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 vehiclecontrol
(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<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>0.05). There was no difference between Pennsaid (arm 1) and
oral diclofenac (arm 4) for all three efficacy endpoints (p>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.
Osteoarthritis is an ever-increasing ailment with the aging population, so this product has a significant market if approved in the US. Again, you may be able to squeeze out a couple of cents, but this is a buy regardless even at current prices, so do not wait too long. It is not often you are given the chance to enter three times (two pull-backs). Good luck.