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History & Milestones


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timeline


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1997
  • Listed on the Toronto Stock Exchange under the name Dimethaid Research Inc., symbol DMX; upon completion an initial public offering which raised proceeds of more than $30 million.
2000
  • Opened manufacturing plant in Varennes, Quebec, with the primary mandate to manufacture Pennsaid® and future transdermal products.

  • Received Canadian license for manufacturing, packaging and testing pharmaceutical solutions.

  • Received successful U.K. manufacturing, packaging and testing report for the Varennes plant covering distribution of Pennsaid® in European Union markets.

  • Received final marketing approval for Pennsaid® in the U.K., the first market where Pennsaid® was approved for marketing.

2001
2002
  • Entered into a distribution agreement with Italchimici SpA for the exclusive distribution of Pennsaid® in Italy and Malta.

  • Completed the acquisition of the remaining 80% of Oxo Chemie AG (“Oxo”) from its founder, Dr Friedrich-Wilhelm Kühne. Oxo (later renamed Dimethaid AG) is a Swiss-based company that developed and commercialized proprietary therapeutic products for treating immune dysfunction.
2003
  • Received final marketing approval and launched Pennsaid® in Italy.

  • Received final Health Canada approval for Pennsaid®.

  • Launched Pennsaid® in Canada using an internal sales force.

  • Received marketing approvals for Pennsaid ® in Greece and Portugal.

2004
  • Entered into an agreement with Jaba Recordati S.A. for the exclusive distribution of Pennsaid® in Portugal, Madeira and the Azores.

  • Entered into a co-promotion agreement with Solvay Pharma Inc. covering the sales and marketing of Pennsaid® in Canada.

  • Entered into a distribution agreement with Vianex S.A. for the exclusive distribution of Pennsaid in Greece.

  • New Board of Directors elected at the Annual General Meeting.

  • New senior management appointed with Dr. Henrich Guntermann named CEO, Daniel H. Chicoine as Chairman of the Board and John C. London as Corporate Secretary.

  • Released news of the FDA's non-approvable letter and management's plan to complete the clinical trails necessary to resubmit a Pennsaid® NDA by mid 2006.
2005 (page 1 of 2)
  • Entered into a distribution agreement with Healthcare Logistics Limited for the distribution of Pennsaid® in the UK.

  • Developed Pennsaid® Plus, a follow on product to Pennsaid®. This formulation is designed to provide users with the efficacy of existing Pennsaid® with less frequent dosing and increased ease of application.

  • Sold Dimethaid Health Care Ltd., a subsidiary of Dimethaid Research Inc. which included the license to market Pennsaid® in Canada to Paladin Labs Inc.

  • Commenced a Phase II clinical trial of WF10 in combination with Xeloda® in the treatment of pancreatic cancer at the University of Heidelberg and the National Center for Tumor Diseases.
2005 (page 2 of 2)
  • Formed a Scientific Advisory Board to advise on pipeline development.

  • Changed the name of the company to Nuvo Research Inc.

  • Formed a panel of FDA experts to guide the NDA resubmission for Pennsaid®.

  • Reported positive results from the Phase III efficacy/safety trial for Pennsaid®, which met all primary endpoints. The trial confirmed the effectiveness of Pennsaid® in the relief of the signs and symptoms of osteoarthritis of the knee.

  • Acquired fqubed, Inc. a San Diego, California based research and development company with proprietary high-throughput screening technology for identifying promising transdermal formulations.
2006
  • Entered into an agreement with Paladin Labs Inc., expanding their relationship with respect to the sale and marketing of Pennsaid® in Canada.

  • Reported positive results of the Phase III, long-term, open-label safety trial ("Study 112E") for Pennsaid® confirming the safety profile of Pennsaid®.

  • Completed an equity financing for gross proceeds of $15 million.

  • Licensed Canadian Pennsaid® Plus rights to a subsidiary of Paladin Labs Inc.

  • Received an Approvable letter from the U.S. Food and Drug Administration (FDA) for Pennsaid®.
2007
  • Determined path to approval for Pennsaid® following discussions with the FDA and commenced the required studies.

  • Completed a bought deal equity financing for gross proceeds of $20 million.

  • Successfully launched Pennsaid® in Greece through the Company's partner Vianex S.A.

2008
  • Signed Oxoferin distribution and license agreement with a regional pharmaceutical company for Russia and some of the former Soviet republics

  • Nuvo purchases the right to commercialize topical pain product from Paladin Labs Inc. & Paladin invests $1.0 million in Nuvo by way of a private placement for common shares and warrants

  • 5 millionith script written for Pennsaid®

  • Nuvo receives from Paladin's wholly owned subsidiary, Squire Pharmaceuticals payment of $2.5 million in lieu of future payments relating to Canadian sales of Pennsaid®

  • Squire invests $2 million in Nuvo through a two-year convertible debenture

  • Amended existing Pennsaid® Plus license between Nuvo & Squire to grant Squire the right to market, distribute and sell Pennsaid® Plus in South Africa and if certain conditions are met, Central and South America
2009
  • FDA accepts Nuvo's resubmission of its Pennsaid approval application as a complete response to the FDA's December 28, 2006 Approvable Letter - FDA sets PDUFA date of August 5, 2009

  • Nuvo's INSIGHT platform wins a bronze medal in the Science and Medical category for the 2009 Edison Best New Products Award

  • Nuvo signs a License and Development Agreement and receives an up-front signing payment of US$10 million - with Covidien granting them exclusive U.S. sales and marketing rights for Pennsaid and Pennsaid Plus

  • FDA approves the New Drug Application for Pennsaid allowing for the sale and marketing of the product in the U.S.

  • Entered into an exclusive license agreement with Ranbaxy Laboratories Limited for the supply and distribution of Oxoferin in Malaysia, Cambodia, Philippines, Vietnam and Singapore