MISSISSAUGA, ON, June 24, 2015 /CNW/ - Nuvo Research Inc. (TSX:NRI), a specialty pharmaceutical company with a diverse portfolio of topical and immunology products, today provided an update on its international licensing initiatives for Pennsaid 2%.
Regulatory Approval to Conduct Phase 3 Trial
The Company has received approval from the German Federal Institute for Drugs and Medical Devices (BfArM) to conduct a placebo controlled Phase 3 trial of Pennsaid 2% for the treatment of acute ankle sprains. The 124 patient trial will be conducted in Germany commencing early July of this year. Topline results are expected to be available in Q4 2015 or Q1 2016. The trial is intended to support regulatory applications for marketing approval of Pennsaid 2% in the E.U., Canada and certain other international territories.
PricewaterhouseCoopers retained to Support Out-licensing
The Company has retained PricewaterhouseCoopers Corporate Finance Inc. (PwC) to assist it in securing international license agreements for Pennsaid 2%. PwC will assist Nuvo in identifying, contacting and qualifying potential licensees for available territories using its international offices and contacts. An information sheet outlining the licensing opportunity has been posted to the Company's website at www.nuvoresearch.com.
Pennsaid 2% was approved by the U.S. Food and Drug Administration (FDA) on January 16, 2014. In October 2014, the Company sold the U.S. rights to Pennsaid 2% to Horizon Pharma plc (Horizon) for US$45 million. The Company has licensed Pennsaid 2% marketing rights to Paladin Labs Inc. for Canada, to NovaMedica LLC for Russia and some of the Community of Independent States and to Vianex S.A. for Greece. Pennsaid 2% is available for out-licensing in all other territories.
U.S. Market Update
Under the terms of an exclusive manufacturing agreement, the Company earns revenue from U.S. product sales of Pennsaid 2% to Horizon. Since its launch by Horizon on January 1, 2015, U.S. prescriptions for Pennsaid 2% have increased more than fivefold compared to the number of prescriptions being generated by Nuvo's previous U.S. licensee.
"Horizon's successful launch of Pennsaid 2% in the U.S. supports our belief that Pennsaid 2% is one of the most effective and patient-friendly topical NSAIDs available anywhere in the world and has the potential to become a major global brand," said Dan Chicoine, Nuvo's Chairman and Co-CEO. "PwC's understanding of the international pharmaceutical business and its vast network of international connections will help us secure profitable commercial terms from the most qualified licensees."
Any inquiries and requests for information related to the international licensing of Pennsaid 2% should be addressed to Nitin Kaushal at (416) 687-8269 or [email protected] or Shilpa Joshi at (416) 869-2482 or [email protected].
About Pennsaid 2%
Pennsaid 2% is a topical product containing 2% diclofenac sodium compared to 1.5% for original Pennsaid. It is approved in the U.S. for pain of osteoarthritis (OA) of the knee(s). It is more viscous than Pennsaid, is supplied in a metered dose pump bottle and has been approved in the U.S. for twice daily dosing compared to four times a day for Pennsaid. Pennsaid 2% is protected by 7 U.S. patents that are listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations database or Orange Book. Pennsaid 2% has not yet received regulatory approval outside of the U.S. Patents protecting Pennsaid 2% have been issued or are pending in multiple major international territories.
About PwC Canada
PwC Canada helps organizations and individuals create the value they're looking for. More than 5,800 partners and staff in offices across the country are committed to delivering quality in assurance, tax, consulting and deals services. PwC Canada is a member of the PwC network of firms with more than 195,000 people in 157 countries. Find out more by visiting www.pwc.com/ca.
© 2015 PricewaterhouseCoopers LLP, an Ontario limited liability partnership. All rights reserved.
PwC refers to the Canadian member firm, and may sometimes refer to the PwC network. Each member firm is a separate legal entity. Please see www.pwc.com/structure for further details.
About Nuvo Research Inc.
Nuvo (TSX:NRI) is a specialty pharmaceutical company with a diverse portfolio of products and technologies. The Company operates two distinct business units: the Topical Products and Technology (TPT) Group and the Immunology Group. The TPT Group currently has four commercial products, a pipeline of topical and transdermal products focusing on pain and dermatology and multiple drug delivery platforms that support the development of patented formulations that can deliver actives into or through the skin. The Immunology Group has two commercial products and an immune system modulation platform that supports the development of drug products that modulate chronic inflammation processes resulting in a therapeutic benefit. For additional company information visit www.nuvoresearch.com.
Certain statements in this press release constitute forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include, but are not limited to statements concerning the Company's future objectives, strategies to achieve those objectives, as well as statements with respect to management's beliefs, plans, estimates, and intentions, and similar statements concerning anticipated future events, results, circumstances, performance or expectations that are not historical facts. Forward-looking statements generally can be identified by the use of forward-looking terminology such as "outlook", "objective", "may", "will", "expect", "intend", "estimate", "anticipate", "believe", "should", "plans" or "continue", or similar expressions suggesting future outcomes or events. Such forward-looking statements reflect management's current beliefs and are based on information currently available to management. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those contemplated by such statements. Factors that could cause such differences include general business and economic uncertainties and adverse market conditions as well as other risk factors included in the Company's Annual Information Form dated February 19, 2015 under the heading "Risks Factors" and as described from time to time in the reports and disclosure documents filed by the Company with Canadian securities regulatory agencies and commissions. This list is not exhaustive of the factors that may impact the Company's forward-looking statements. These and other factors should be considered carefully and readers should not place undue reliance on the Company's forward-looking statements. As a result of the foregoing and other factors, no assurance can be given as to any such future results, levels of activity or achievements and neither the Company nor any other person assumes responsibility for the accuracy and completeness of these forward-looking statements. The factors underlying current expectations are dynamic and subject to change. Although the forward-looking information contained in this press release is based upon what management believes are reasonable assumptions, there can be no assurance that actual results will be consistent with these forward-looking statements. All forward-looking statements in this press release are qualified by these cautionary statements. The forward-looking statements contained herein are made as of the date of this press release and except as required by applicable law, the Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
SOURCE Nuvo Research Inc.
For further information: Investor Relations, Email: [email protected]