1 As an approval by FDA is nearing. Nuvo Research Inc. NRI.TO Pliaglis (sNDA) FDA decision on 04/16/2012 Pliaglis as topical local anesthetic cream
2.Nuvo Research Inc. announced receipt from Mallinckrodt Inc., a Covidien company (Covidien), of PENNSAID Viscous Solution (topical diclofenac sodium viscous solution) 2% w/w, previously referred to as PENNSAID Gel.
Nuvo Research Provides Pennsaid® Update * 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 /PRNewswire/ - 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 U.S. 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.