Nuvo Research Reports FDA Approval Of Third-party Generic Of Pennsaid 1.5%

(RTTNews) - Nuvo Research Inc. (NRI.TO), a specialty pharmaceutical company with a diverse portfolio of topical and immunology products, announced Thursday that a third party has received U.S. Food and Drug Administration or FDA approval to market and sell a topical diclofenac sodium 1.5% solution in the United States. The product is a generic version of Nuvo's Pennsaid (diclofenac sodium topical solution) 1.5% w/w (Pennsaid 1.5%).

Mallinckrodt Inc. (MNK) is Nuvo's U.S. commercial licensee for the sale of both Pennsaid 1.5% and its follow-on product Pennsaid (diclofenac sodium topical solution) 2% w/w (PENNSAID 2%). Pennsaid 2% was approved by the FDA on January 16, 2014 and was launched by Mallinckrodt in February 2014.

Pennsaid 2% is the first twice per day dosed topical non-steroidal anti-inflammatory drug or NSAID available in the U.S. for the treatment of the pain of osteoarthritis of the knee. It is protected by 5 U.S. patents that are listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations database or "Orange Book".

Mallinckrodt has informed Nuvo that its strategy is to convert Pennsaid 1.5% patients and prescribers to Pennsaid 2%. Since the launch of Pennsaid 2%, U.S. prescriptions for Pennsaid 1.5% have declined and been offset by increased Pennsaid 2% prescriptions.

The most recent IMS data for the week ended May 16, 2014, indicated that the number of Pennsaid 2% prescriptions exceeded the number of Pennsaid 1.5% prescriptions. Nuvo receives a 20% of net sales royalty on Mallinckrodt's U.S. sales of both Pennsaid 1.5% and Pennsaid 2%.