MISSISSAUGA, ON, June 24, 2015 /PRNewswire/ – 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@example.com or Shilpa Joshi at (416) 869-2482 or firstname.lastname@example.org.