FDA extends review of Pennsaid® diclofenac sodium topical solution
August 4, 2009
ST. LOUIS and MISSISSAUGA, ON, Aug. 4 /CNW/ - Covidien (NYSE:COV), a leading global provider of healthcare products, and Nuvo Research Inc. (TSX:NRI), a Canadian drug development company, today announced that the U.S. Food and Drug Administration (FDA) has set a new action date under the Prescription Drug User Fee Act (PDUFA) for Pennsaid (diclofenac sodium) topical solution 1.5% w/w of November 4, 2009. During the review process, Nuvo provided the FDA with supplemental information, which the Agency determined to be a major amendment to the Pennsaid New Drug Application. As a result, the FDA has extended its action date by three months to provide time for a full review of the submission. "We believe we have submitted a high-quality application for Pennsaid and will continue to work closely with the FDA throughout the remaining review process," stated Dan Chicoine, Chairman of Nuvo Research. "Covidien is committed to the future success of Pennsaid topical solution and we are continuing with our preparations to launch the product anticipating FDA approval," said Timothy R. Wright, President, Pharmaceutical Products and Imaging Solutions, Covidien. Nuvo develops drug products delivered to and through the skin using its topical and transdermal drug delivery technologies. Covidien is the largest supplier of controlled pain medications in the United States based on number of prescriptions. In June, the companies announced that Covidien's Mallinckrodt Inc. subsidiary had entered into a license and development agreement with Nuvo that encompasses Pennsaid Topical Solution and another topical formulation of diclofenac now under development. Under the agreement, Nuvo is responsible for regulatory submissions, owns and maintains the intellectual property, and will be responsible for manufacturing. Covidien is responsible for all commercialization activities, including marketing, selling and medical education. About Covidien Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in four segments: Medical Devices, Imaging Solutions, Pharmaceutical Products and Medical Supplies. With 2008 revenue of nearly $10 billion, Covidien has more than 41,000 employees worldwide in 59 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business. About Nuvo Research Inc. Nuvo is focused on the research and development of drug products delivered to and through the skin using its topical and transdermal drug delivery technologies. Nuvo's lead product is Pennsaid, a topical non-steroidal anti-inflammatory drug (NSAID). Nuvo intends to leverage its skin-penetrating technologies to create a portfolio of topical and transdermal products targeting a variety of indications. Nuvo is a publicly traded, Canadian pharmaceutical company headquartered in Mississauga, Ontario, with manufacturing facilities in Varennes, Québec and Wanzleben, Germany and a research and development Center in San Diego, California. For more information, please visit www.nuvoresearch.com. Pennsaid® is a trademark of Nuvo Research, Inc. Forward-Looking Statements Any statements contained in this communication that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on our management's current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or Company actions to differ materially from what is expressed or implied by these statements. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, our ability to effectively introduce and market new products or keep pace with advances in technology, the reimbursement practices of a small number of large public and private insurers, cost-containment efforts of customers, purchasing groups, third-party payers and governmental organizations, intellectual property rights disputes, complex and costly regulation, including healthcare fraud and abuse regulations, manufacturing or supply chain problems or disruptions, rising commodity costs, recalls or safety alerts and negative publicity relating to Covidien or its products, product liability losses and other litigation liability, including legacy Tyco-related litigation, divestitures of some of our businesses or product lines, our ability to execute strategic acquisitions of, investments in or alliances with other companies and businesses, competition, risks associated with doing business outside of the United States, foreign currency exchange rates, issues related to our existing material weakness in accounting for income taxes or potential environmental liabilities. These and other factors are identified and described in more detail in our filings with the SEC. We disclaim any obligation to update these forward-looking statements other than as required by law.
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For further information: Contacts - Covidien: Stephen Littlejohn, Vice President, Communications, Pharmaceutical Products and Imaging Solutions, (314) 654-6595, firstname.lastname@example.org; Coleman Lannum, CFA, Vice President, Investor Relations, (508) 452-4343, email@example.com; Bruce Farmer, Vice President, Public Relations, 508-452-4372, firstname.lastname@example.org; Brian Nameth, Director, Investor Relations, (508) 452-4363, email@example.com; Contact - Nuvo Research Inc.: Adam Peeler, The Equicom Group Inc., Tel: (416) 815-0700 x225, email: firstname.lastname@example.org