MISSISSAUGA, ON, Feb. 23, 2012 /CNW/ - Nuvo Research Inc. (TSX: NRI), a specialty pharmaceutical company dedicated to building a portfolio of products for the topical treatment of pain and the development of its immune modulating drug candidate WF10, today provided an update on the status of its Pennsaid franchise.
Pennsaid Opportunity Due to Voltaren Gel U.S. Product Shortage
Endo Pharmaceuticals Holdings Inc. (Endo) and Novartis Consumer Health (Novartis) recently announced that the Novartis manufacturing facility at which Voltaren Gel is manufactured, has been closed due to manufacturing issues unrelated to Voltaren Gel. Votaren Gel is the main competitive product to Pennsaid in the U.S. Endo, which licenses Voltaren Gel from Novartis for the U.S. market, has indicated there may be shortages of Voltaren Gel as Novartis transfers manufacturing to another facility. This unexpected development may be contributing to a recent increase in Pennsaid U.S. prescriptions and may provide Mallinckrodt Inc., a Covidien company (NYSE: COV), Nuvo's U.S. licensing partner, with an opportunity to further increase U.S. Pennsaid sales.
Pennsaid U.S. Reimbursement Status
Covidien has advised Nuvo that since the beginning of 2012, new contracts with a number of large, well known insurance providers have taken effect that will enhance Medicare Part D and commercial insurance coverage for an additional 11 million U.S. Pennsaid patients. Covidien is continuing its efforts to increase the number of insurance plans under contract for Pennsaid.
Pennsaid Greek Sales Update
Nuvo has recently received additional orders for Pennsaid from our Greek distributor. In 2010 and 2011, Greece represented the second largest market for Pennsaid unit sales, although in 2011, our Greek sales declined after the Greek government, as part of its austerity measures, discontinued reimbursement for all topical NSAIDs, the class of prescription drugs that includes Pennsaid. Our Greek distributor has repositioned Pennsaid as an over-the-counter product available without a doctor's prescription. We believe that recent increased orders for Pennsaid in Greece may suggest that this initiative is gaining traction.
Pennsaid 2% Regulatory Status
Covidien has advised Nuvo that in the second quarter of 2012, it will be filing a supplementary New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) for Pennsaid 2%, the follow-on product to Pennsaid. Covidien has advised that it believes this filing will make Pennsaid 2% eligible for FDA approval in the fourth quarter of 2012 or the first quarter of 2013. Nuvo believes that Pennsaid 2% offers significant improvements over currently available topical non-steroidal anti-inflammatory drugs (NSAIDs) for the treatment of the signs and symptoms of knee osteoarthritis in the U.S. due to (1) its more convenient dosing regimen - Pennsaid 2% is twice per day dosing as compared to current Pennsaid and its main competitive product, Voltaren Gel, which are four times per day dosing and (2) it is easier to apply - Pennsaid 2% is more viscous than Pennsaid and dispensed via a simple to use metered dose pump. Nuvo has a U.S. patent application pending for Pennsaid 2%.
"The start to 2012 has brought renewed momentum to our Pennsaid franchise," stated Bradley Galer, M.D. President of Nuvo's Pain Group. "In addition, we are excited about our recent launch of Synera® into the U.S. market and the anticipated Pliaglis'® U.S. and European approvals and launches by our partner Galderma Pharma S.A. later this year."
About Nuvo Research Inc.
Nuvo Research is a publicly traded, Canadian specialty pharmaceutical company, headquartered in Mississauga, Ontario. The Company is building a portfolio of products for the treatment of pain through internal research and development and by in-licensing and acquisition. The Company's Pain Group, located in West Chester, Pennsylvania, is focused on the development and commercialization of topically delivered pain products. The Company's product portfolio includes Pennsaid, Pliaglis and Synera. Pennsaid, a topical non-steroidal anti-inflammatory drug (NSAID), is used to treat the signs and symptoms of osteoarthritis of the knee. Pennsaid is sold in the United States by Mallinckrodt Inc., a Covidien company (NYSE: COV), in Canada by Paladin Labs Inc. (TSX:PLB) and in several European countries. Pliaglis is a topical local anesthetic cream, which is U.S. Food and Drug Administration (FDA) approved to provide topical local analgesia for superficial dermatological procedures. The Company has licensed worldwide marketing rights to Pliaglis to Galderma Pharma S.A., a global specialty pharmaceutical company specialized in dermatology. Synera is a topical patch that combines lidocaine, tetracaine and heat, approved in the United States to provide local dermal analgesia for superficial venous access and superficial dermatological procedures and in Europe, for surface anaesthesia of normal intact skin. Nuvo currently markets Synera in the United States and its licensing partner, EuroCept International B.V., has initiated a pan-European launch of Synera (under the name Rapydan) in several European countries. Through its subsidiary, Nuvo Research GmbH, based in Leipzig, Germany, the Company is also developing the compound WF10, for the treatment of immune related diseases.
This document contains forward-looking statements. Some forward-looking statements may be identified by words like "expects", "anticipates", "plans", "intends", "indicates" or similar expressions. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Nuvo considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but caution that these assumptions regarding future events, many of which are beyond the control of the Company, may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations, are discussed in the annual report, as well as in Nuvo's Annual Information Form for the year ended December 31, 2010. Nuvo disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information or future events, except as required by law. For additional information on risks and uncertainties relating to these forward looking statements, investors should consult the Company's ongoing quarterly filings, annual report and Annual Information Form and other filings found on SEDAR at www.sedar.com.
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