Nuvo Research Provides Pennsaid® Update
April 12, 2012
- Pennsaid U.S. prescriptions increase 98% quarter-over-quarter
- New American College of Rheumatology Osteoarthritis Treatment Guidelines include recommendations for use of topical NSAIDS
MISSISSAUGA, ON, April 12, 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 U.S. developments relating to Pennsaid, its topical non-steroidal anti-inflammatory drug (NSAID) used to treat the signs and symptoms of osteoarthritis (OA) of the knee.
Pennsaid is sold in the U.S. by Nuvo's U. S. licensee, Mallinckrodt Inc., a Covidien company. According to IMS Health, during the first quarter of 2012, U.S. prescriptions of Pennsaid continued to grow quarter-over-quarter to 93,000. This represents a significant increase of 98% over the number of prescriptions in the fourth quarter of 2011 and an increase of 174% from the comparative period in 2011.
In January 2012, Endo Pharmaceuticals Holdings Inc. (Endo) indicated that there would be temporary shortages in the U.S. of its licensed product, Voltaren Gel, the main competitor product to Pennsaid, as a result of manufacturing issues unrelated to Voltaren Gel at a facility owned by Novartis Consumer Health that was supplying Voltaren Gel for the U.S. market. Such product shortages likely have contributed to recent substantial increases in Pennsaid U.S. prescriptions. Endo has indicated that it does not expect to return to full commercial supply of Voltaren Gel until the end of the second quarter of 2012. Nuvo cannot be certain to what extent future Pennsaid prescriptions will be affected once Voltaren Gel supply shortages end.
IMS Health data for the most recently reported week (ending March 30, 2012) indicated that:
|i)||Pennsaid surpassed Voltaren Gel in the number of U.S. prescriptions filled.|
|ii)||Each Pennsaid prescription was filled with an average of 1.31 months' supply (for a patient with OA of one knee) as compared to each Voltaren Gel prescription being filled with an average of 0.41 months' supply (for a patient with OA of one knee). Pennsaid prescriptions for this week represented more than 4 times the number of patient days of treatment as compared to Voltaren Gel.|
|iii)||Pennsaid U.S. gross sales are now running at an annualized rate of approximately US$124 million.|
The American College of Rheumatology (ACR) Subcommittee on OA Guidelines has approved and issued updates to Clinical Practice Guidelines for the treatment of OA, based on evidence and expert consensus-based recommendations; www.rheumatology.org/practice/clinical/guidelines/PDFs/ACR_OA_Guidelines_FINAL.pdf#toolbar=1. With the addition of these newly published ACR OA Guidelines to the already published European and Canadian OA Treatment Guidelines, topical NSAIDS are now recommended as first-line OA treatment worldwide, for at least subpopulations of OA patients. In the U.S., the only topical NSAIDs approved for marketing by the U.S. Food and Drug Administration (FDA) for OA are Pennsaid (marketed by Covidien) and Voltaren Gel (marketed by Endo). Only Pennsaid has the FDA-approved broad indication to treat the signs and symptoms of OA of the knee.
These new OA Guidelines, published in the April issue of Arthritis Care & Research, conditionally recommend that healthcare providers consider topical NSAIDs as one option for the pharmacologic management of knee OA. The ACR guidelines strongly recommend the use of oral or topical NSAIDs or intra articular corticosteroid injections in patients with an unsatisfactory clinical response to acetaminophen. They also state oral NSAIDs should not be prescribed in patients with contraindications to these medications and that patients and doctors should be aware of their warnings and precautions. The ACR Guidelines "strongly recommends the use of topical rather than oral NSAIDs" in those patients aged 75 years or older.
"We are very excited and proud that the American College of Rheumatology has included topical NSAIDs in their newly published Guidelines as a recommended treatment for many patients with knee OA," stated Bradley Galer, M.D., President of Nuvo's Pain Group. "We believe that Pennsaid has the strongest clinical efficacy and safety data in the entire topical NSAID class, making it the best choice for American doctors prescribing a topical NSAID for OA of the knee."
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 Consolidated Financial Statements, Management's Discussion & Analysis, as well as in Nuvo's Annual Information Form for the year ended December 31, 2011. 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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