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Nuvo Pharmaceuticals Inc (MRV) RSS Feed

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      Special Alert►   Pennsaid 2% with March 4th, 2013 PDUFA Date 
                                                      (A Best in Class topical medication for osteoarthritis)
 

                             

Nuvo Research Inc. (TSX:NRI / OTC:NRIFF)


 
A Specialty pharmaceutical company
 
• U.S. based Pain Group
 
• Germany based Immunology Group


 
Growing revenue with 3 approved pain products:


•  Pennsaid®: topical NSAID for osteoarthritis, partnered with Covidien for  U.S., targeting $8B oral NSAID market
 
 
•   Pliaglis®: analgesic peelable cream, targeting global cosmetic and  dermatology markets, partnered with Galderma, worldwide launch commencing Q2 2013

 
• Synera®: analgesic patch for needle stick pain, targeting U.S. dialysis and  infusion centers


 
Potential game changing immunology platform with positive Phase 2  results in allergic rhinitis



Expanding pipeline, royalty stream, and direct product sales



Nuvo will hit profitability this year with 2 new product launches in 2Q 2013 



Nuvo Annual Revenue already hits $30 Million



Nasdaq Listing planned for 2013



 



 
PropThink: Nuvo Research Gaining visibility; New Patent for Pennsaid 2% is Positive
 
Nuvo Research Inc. (TSX:NRI/OTC:NRIFF) announced that it obtained an additional U.S. patent for Pennsaid 2%, an improved follow-on formulation of its currently marketed

Pennsaid product. Pennsaid contains the anti-inflammatory drug diclofenac, which is applied on the skin for pain conditions such as osteoarthritis of the knee. Pennsaid is

currently marketed by Covidien's (NYSE:COV) pharmaceutical division Mallinkrodt, and Pennsaid 2% is undergoing FDA review for approval. The new version is a higher

strength version of the product, and is formulated to increase the penetration of diclofenac through the skin to the site of pain. Importantly, the new formulation, if

approved, will have patent protection out to 2028, and could become an important product for Covidien's pharmaceutical division, which is expected to be spun out to

COV shareholders as a pure-play company in mid-2013. In July, Nuvo and Covidien announced that the FDA had accepted their New Drug Application (NDA) for

Pennsaid 2% with a PDUFA (FDA action) date of March 4, 2013. Covidien stated that once Pennsaid 2% is approved, it expects to have the new patent listed in the

FDA's Orange Book.



NRI shares remain on the radar screen, but could gain visibility on its portfolio of products for the topical treatment of pain. In addition to Covidien, the company is

partnered with leading dermatology company Galderma, which is gearing up for approval and launch of Pliaglis. Pliaglis is Nuvo's topical anesthetic cream that will be

marketed by Galderma for the reduction of pain associated with dermatological procedures. Several European countries have already notified Galderma that Pliaglis has

been approved, and Galderma has responded to a Complete Response Letter (CRL) in the U.S. for potential FDA approval. Nuvo is also re-launching its Synera product,

a topical anesthetic patch approved in the U.S. to provide pain relief for superficial dermatological procedures, and the company may seek to partner the drug in major

markets. With only a $36 million market cap, shares of Nuvo Research have substantial room to run as U.S. investors become more familiar with the company.




Corporate Profile

Nuvo Research Inc. is a publicly traded (TSX:NRI/OTC:NRIFF), Canadian specialty pharmaceutical company, headquartered in Mississauga, Ontario. The Company is building a

portfolio of products for the treatment of pain through internal research and development and by in-licensing and acquisition.



The Company's Pain Group, located in West Chester, Pennsylvania, is focused on the development and commercialization of topically delivered pain products. The

Company's product portfolio includes Pennsaid®, Pliaglis® and Synera®.


Pennsaid, a topical NSAID, is used to treat the signs and symptoms of OA of the knee(s). Pennsaid is sold in the United States by Mallinckrodt Inc., a Covidien company

(NYSE: COV), in Canada by Paladin Labs Inc. (TSX:PLB) and in several European countries.


Pliaglis is a topical local anesthetic cream, which is FDA-approved to provide topical local analgesia for superficial dermatological procedures. The Company has

licensed worldwide marketing rights to Pliaglis to Galderma Pharma S.A., a global specialty pharmaceutical company focused on dermatology.


Synera is a topical patch that combines lidocaine, tetracaine and heat, approved in the United States to provide local dermal analgesia for superficial venous access and

superficial dermatological procedures and in Europe, for surface anaesthesia of normal intact skin. Nuvo currently markets Synera in the United States and its licensing

partner, EuroCept International B.V., has initiated a pan-European launch of Synera (under the name Rapydan) in several European countries.



Through its subsidiary, Nuvo Research GmbH, based in Leipzig, Germany, the Company is also developing the compound WF10, for the treatment of immune related

diseases



 

Nuvo Research Inc. Website:  http://www.nuvoresearch.com/



Market Cap : $ 36 M     Cash: $ 12 M



Nuvo Research Inc. Announces 2012 Third Quarter Results



Investors Overview

 

Nuvo is focused on increasing shareholder value by:

  • Committing to disciplined spending
  • Building a leader in the topical pain space
  • Focusing on growing revenues organically and through acquisition
  • Optimizing the value of the pain and immunology pipelines


 

Pennsaid Partners - North America

 

Canada - Paladin Labs Inc.
 
 
United States - Covidien plc
 
 

Pennsaid Partners - Europe

 

Greece - Vianex S.A.
 
 
Italy - Italchimici
 
 
United Kingdom - Movianto UK
 
 

Pennsaid 2% Partners - Worldwide

 

Canada, Central & South America, South Africa & Israel - Paladin Labs Inc.
 
 
United States - Covidien plc
 
 

Pliaglis Partner

 

Worldwide - Galderma Pharma S.A.
 
 

Synera Partners

 

European Union and China - Eurocept International B.V.
 
 
Canada - Paladin Labs Inc.
 



 


Executive Management

 

Daniel N. Chicoine, CA Chairman & Co-Chief Executive Officer
 
John C. London, LLB, LLM President & Co-Chief Executive Officer
 
Dr. Bradley S. Galer, MD President, Pain Group
 
Dr. Henrich R.K. Guntermann, MD, MSc President, Europe & Immunology Group
 
Stephen L. Lemieux, BA, MMPA, CA Vice President & Chief Financial Officer
 
Tina K. Loucaides, MSc, LLB Vice President, Secretary & General Counsel



Board of Directors

 

Daniel N. Chicoine, CA Chairman & Co-Chief Executive Officer
 
David A. Copeland, CA Chair of the Audit Committee, Lead Director
 
Anthony E. Dobranowski, BA, MBA  Director
 
Dr. Henrich R.K. Guntermann, MD, MSc President, Europe & Immunology Group

John C. London, LLB, LLM  President & Co-Chief Executive Officer
 
Jacques Messier, DVM, MBA Chair of the Compensation & Corporate Governance Committee
 
Theodore H. Stanley, MD Director
 
Klaus von Lindeiner, Dr en droit (University of Geneva) Director





Corporate Structure

Nuvo Research Inc. was incorporated on August 22, 1983 under the laws of the Province of Ontario as Clark Pharmaceutical Laboratories Ltd. On November 14, 1990, the articles were amended to change the name of the Company from Clark Pharmaceutical Laboratories Ltd. to Dimethaid Research Inc. On September 30, 2005, the articles were further amended to change the name of the Company from Dimethaid Research Inc. to Nuvo Research Inc. On January 1, 2007, the Company completed a short-form amalgamation with Akorn Pharmaceuticals Canada Limited, Excelpharm Inc., Femina Inc., Dimethaid Management Inc. and Dimethaid Manufacturing Inc., certain of its subsidiaries. The amalgamated entity continues as Nuvo Research Inc.

Nuvo Research Inc. has two Canadian locations. Its registered office and principal place of business is its head office located in Mississauga, Ontario. It also operates a manufacturing facility in Varennes, Quebec where it manufactures Pennsaid®.

Nuvo Research AG, Nuvo Manufacturing GmbH and Nuvo Research GmbH
Nuvo's Immune system regulation business is conducted through Nuvo Research AG (NRAG) and NRAG's two wholly owned German subsidiaries. In December 2011, Nuvo increased its ownership in NRAG from 60% to 100% by acquiring the minority interest held by Dr. Kühne.

Nuvo Manufacturing GmbH produces OXO-K993 from its manufacturing facility in Wanzleben and Leipzig based Nuvo Research GmbH (NRG) conducts and coordinates research and development activities related to WF10 in collaboration with the Fraunhofer Institute for Cell Therapy and Immunology in Leipzig. NRG has received funding commitments for certain of its research and development projects from the Development Bank of Saxony.

 

ZARS Pharma, Inc.
On May 12, 2011, Nuvo acquired all of the outstanding securities of ZARS Pharma, Inc. (ZARS), through the merger of its wholly owned subsidiary, Nuvo Research Delaware Inc. (Newco) with and into ZARS, with ZARS as the surviving corporation.  ZARS is a specialty pharmaceutical company focused on the development and commercialization of topically administered drugs, primarily for the treatment of pain, using its proprietary drug delivery technologies.

 

ZARS (UK) Limited
ZARS (UK) Limited is incorporated in the United Kingdom and holds the Pliaglis Marketing Authorization Application that was submitted in the European Union. ZARS (UK) Limited is a wholly owned subsidiary of ZARS.

 

Nuvo Research US, Inc.
Nuvo Research US, Inc. consists primarily of the West Chester, Pennsylvania based Pain Group operations and  management team.  Nuvo Research US, Inc. also included the San Diego research facility which wound down operations in early 2011.  The Company has maintained the majority of its capabilities and technology by relocating key equipment from the research facility to other Nuvo facilities.

 

Nuvo Research America, Inc. 
In July 2011, Nuvo Research America, Inc. (Nuvo America) was incorporated in the State of Delaware as a wholly owned subsidiary of Nuvo Research Inc.  In December 2011, Nuvo completed transactions that transferred ownership of wholly owned subsidiaries, Nuvo US and ZARS to Nuvo America in exchange for additional shares of Nuvo America.

 

Dimethaid (UK) Limited
Dimethaid (UK) Limited is a British company, incorporated in 1999, that holds the marketing authorization for Pennsaid® in the United Kingdom.

 

Dimethaid Immunology Inc.
In June 1993, Dimethaid Immunology was incorporated as a wholly owned subsidiary of the Company. It was responsible for the Canadian marketing and distribution of WF10, an aqueous solution of Oxo-K993 containing stabilized chlorite ions, as well as related products developed by Oxo Chemie. Oxo Chemie  (now Nuvo Research AG) was purchased by the Company in May 2002. Dimethaid Immunology Inc. currently has limited activity since WF10 and related products are not currently approved for sale in Canada.






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