Mississauga, Ontario, Canada – September 7, 2010 - Nuvo Research Inc. (TSX: NRI), a specialty pharmaceutical company focused on the research and development of drug products that are delivered into and through the skin using its topical and transdermal drug delivery technologies, today provided an update on its Pennsaid franchise, its ongoing Phase 2 study of WF10 for the treatment of allergic rhinitis, and its plans to strengthen its pipeline by in-licensing or acquisition.
“Following on the ongoing successful launch of Pennsaid in the U.S., we are continuing to work to further strengthen Nuvo through additional product development and potential product in-licensing agreements or acquisitions,” said Dan Chicoine, Co-CEO of Nuvo Research. “Fundamentally, we are stronger than at any time in our corporate history and we are extremely excited about Nuvo’s future. With more than $32 million in cash as of the end of the last quarter, we are on solid financial ground. We have commercialized our first product, which is generating revenue in a growing U.S. market. We have an expert, proven scientific and medical team, a promising pipeline, and the opportunity to add additional products to our portfolio to enhance Nuvo’s value. We remain focused on building a strong, diversified specialty pharmaceutical company and are confident we have the experience, personnel and resources to accomplish this goal.”
Pennsaid
Nuvo’s U.S. licensee, Mallinckrodt Inc., a Covidien (NYSE: COV) company, began selling Pennsaid in the U.S. in late April, 2010. Weekly prescriptions and sales of Pennsaid have continued to increase week over week as physicians and patients learn about the benefits of Pennsaid from Covidien’s sales force. Covidien continues to work with private and public medical insurers to maximize reimbursement of the cost of prescriptions to Pennsaid patients. Nuvo is optimistic that these positive trends will continue.
Covidien plans to supplement its direct sales calls to physicians by highlighting Pennsaid at targeted upcoming medical society meetings. In November, two posters and several lectures related to Pennsaid are scheduled to be presented at the American College of Rheumatology annual meeting, and one poster is scheduled to be highlighted at the National Pain Week Meeting in Las Vegas September 8-11. National Pain Week is the national pain conference for frontline clinicians. Pennsaid will also be highlighted at six additional medical meetings in 2010.
“While it is still relatively early in the launch, the results so far have been very encouraging,” added Chicoine. “The continuing growth of Pennsaid sales strengthens our conviction that there is a robust market for an effective and safe topical NSAID such as Pennsaid.”
Nuvo receives royalties and is eligible to receive sales based milestone payments from Covidien based upon net U.S. sales of Pennsaid. Nuvo records deferred royalty revenue from Pennsaid as product is shipped to Covidien’s U.S. distributors. These royalties are payable to Nuvo after the end of each of Covidien’s financial quarters. The deferred royalty revenue is recorded as actual revenue when, according to third party prescription data, Pennsaid is sold to patients.
Pennsaid Gel
Pennsaid’s follow-on product, Pennsaid Gel is progressing well in its clinical development program. Pennsaid Gel is intended to enhance the long-term value of the Pennsaid franchise due to its superior dosing, convenience, and anticipated patent protection. Covidien, which has assumed operational and financial responsibility for Pennsaid Gel development, began enrolling patients in its Pennsaid Gel Phase 2 clinical study in July of this year. Enrollment is on schedule and it is anticipated that the study will be completed in the first half of 2011. The Phase 3 clinical program is projected to commence in 2011 following completion of the Phase 2 study.
WF 10 update – Phase 2 Study in Allergic Rhinitis
Nuvo’s immune modulating drug candidate WF10 is making solid progress in its Phase 2 European clinical trial that is being co-funded by the Development Bank of Saxony in Germany. The randomized, double-blind, placebo-controlled, single-centre trial is assessing the efficacy and safety of WF10 infusions for the treatment of patients with severe allergic rhinitis. The treatment phase and monitoring of the last patient has been completed and Nuvo expects that initial top-line study results will be available in late 2010.
Listing of Nuvo shares in the United States
U.S. stock exchanges typically have minimum share price listing requirements that are greater than Nuvo’s current share price. At Nuvo’s Special and Annual General Meeting in April, 2010, Nuvo shareholders authorized the consolidation of Nuvo’s issued and outstanding common shares in connection with an application to list its shares on a U.S. stock exchange. The consolidation would result in fewer shares outstanding, with each share having a greater value. The timing for a potential share consolidation and the subsequent U.S. listing, have not yet been determined and will depend on a number of internal and external factors including macro economic and capital market conditions.
Pipeline Expansion
Nuvo is actively seeking to expand its pipeline by acquiring or in-licensing mid to later-stage assets to provide a more balanced portfolio of products under development, and a new series of inflection points for prospective and current investors. The Company’s focal point for new product candidates is primarily in the therapeutic area of pain, which is the core area of expertise for Nuvo’s scientific and medical senior management.
To date, Management has evaluated multiple product candidates and remains committed to finding the right asset or assets at the right cost for the benefit of the Company and its shareholders.
Conference Call Notice
Nuvo Research will host a conference call and webcast September 8, 2010 at 10:00 a.m. ET to discuss this development. To access the conference call by telephone, dial 647-427-7450 or 1-888-231-8191. A live audio webcast will also be available through the Company’s website at www.nuvoresearch.com. A replay of the webcast will be available by telephone through September 15, 2010. To access the telephone replay, dial 416-849-0833 or 1-800-642-1687 and enter reservation number 99086112 followed by the number sign.
About Nuvo Research Inc.
Nuvo is primarily focused on the research and development of drug products delivered into and through the skin using its topical and transdermal drug delivery technologies, and on the development of its immune modulating drug candidate WF10. Nuvo’s lead product is Pennsaid, a topical non-steroidal anti-inflammatory drug (NSAID), which is sold in Canada, the United States and several European countries. Pennsaid was approved for marketing in the U.S. by the United States Food and Drug Administration on November 4, 2009 and is being sold throughout the United States by Nuvo’s licensing partner, Mallinckrodt Inc., a Covidien (NYSE: COV) company. Nuvo intends to create a portfolio of products through internal research and development and by in-licensing and acquisition. Nuvo is a publicly traded, Canadian pharmaceutical company headquartered in Mississauga, Ontario. Nuvo’s Pain Group is located in West Chester, Pennsylvania. Its manufacturing facilities are located in Varennes, Québec and Wanzleben, Germany, and its research and development centers are located in San Diego, California and Leipzig, Germany. For more information, please visit www.nuvoresearch.com
For more information about Nuvo, please contact: Media and Investor Relations Adam Peeler The Equicom Group Inc. Tel: (416) 815-0700 x225 email: apeeler@equicomgroup.com
Forward-Looking Statements 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 annual report, as well as in Nuvo’s Annual Information Form for the year ended December 31, 2009. Nuvo disclaims any intention or obligation to update or revise any forward-looking statements whether 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
