NUVO PHARMACEUTICALS INC 
By
Mississauga, Ontario, Canada - January 29, 2013 - Nuvo Research Inc. (Nuvo) (TSX:NRI) announced today that it has entered into a settlement agreement with Apotex Inc. and Apotex Corp. (together Apotex) respecting patent infringement litigation brought by Nuvo and Nuvo's U.S. licensing partner, Mallinckrodt Inc. (Mallinckrodt), in response to Apotex's filing of an abbreviated new drug application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of PENNSAID (diclofenac sodium topical solution) 1.5% w/w (PENNSAID).
Under the terms of the settlement agreement, Nuvo and Mallinckrodt granted a license to Apotex that permits Apotex, upon approval of its ANDA by the FDA, to launch its generic version of PENNSAID on a date that is the earlier of 45 days after Mallinckrodt or Nuvo makes a first commercial shipment of PENNSAID (diclofenac sodium topical solution) 2% w/w (PENNSAID 2%) in the United States and April
1, 2014, or earlier under certain circumstances.
PENNSAID 2% is pending approval by the FDA and is expected to be the follow-on product to original PENNSAID. PENNSAID 2% is designed to be dosed twice per day with a metered dose pump bottle. In 2012, Mallinckrodt submitted a New Drug Application (NDA) for PENNSAID 2% with the FDA. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of March 4, 2013 for action on the submission.
About PENNSAID
PENNSAID is a non-steroidal anti-inflammatory drug (NSAID) used for treating the signs and symptoms of osteoarthritis of the knee(s).
PENNSAID is the only FDA-approved topical NSAID for the treatment of knee osteoarthritis which demonstrated statistically significant differences in all three primary efficacy endpoints: pain and physical function (WOMAC®), patient overall health assessment (POHA), and patient global assessment of knee osteoarthritis.
PENNSAID is a registered trademark of Nuvo Research Inc.
WOMAC is a registered trademark of Nicholas Bellamy.
WOMAC® is a proprietary health status questionnaire. For further information visit the WOMAC®
website at www.WOMAC.com.
About PENNSAID 2%
PENNSAID 2%, which is not yet approved by the FDA, is a topical non-steroidal anti-inflammatory drug
(NSAID) containing 2% diclofenac sodium compared to 1.5% for original PENNSAID. It is more viscous than original PENNSAID, is supplied in a metered dose pump bottle and was studied in clinical
trials using twice daily dosing compared to four times a day for original PENNSAID.
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 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(s). Pennsaid is sold in the United States by Mallinckrodt Inc., the Pharmaceuticals business of Covidien, in Canada by Paladin Labs Inc. and in several European countries. Pliaglis is a topical local anesthetic cream which provides 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 which will be launching Pliaglis in the U.S. and E.U. in the first half of 2013. 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 anesthesia 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. The Company is also developing the compound WF10, for the treatment of immune related diseases.
Email : ir@nuvoresearch.com
Website : www.nuvoresearch.com
INDICATION
PENNSAID® is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s).IMPORTANT RISK INFORMATION ABOUT PENNSAID®
Cardiovascular Risk • Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. • PENNSAID is contraindicated in the perioperative setting of coronary artery bypass graft (CABG) surgery. Gastrointestinal Risk • NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.
PENNSAID is also contraindicated in patients:
