MISSISSAUGA, ON, July 25, 2012 /PRNewswire/ - Nuvo Research Inc. (TSX: NRI), a
specialty pharmaceutical company dedicated to building a portfolio of
products for the topical treatment of pain, today announced that the
United States Patent Office has granted the reinstatement of Patent #
6,465,709 related to Synera® Patch (Synera Patent). The Synera Patent expiry date is July 7, 2020.
Nuvo has listed the Synera Patent in the U.S. Food and Drug
Administration's (FDA) Orange Book. The Orange Book listing requires
an Abbreviated New Drug Application (ANDA) applicant seeking FDA
approval for a generic version of Synera prior to expiration of the
patent to notify Nuvo of its ANDA filing before it can obtain FDA
"We are very pleased that we have received additional patent protection
for Synera Patch in the U.S.," said Tina Loucaides, Nuvo's
Vice-President and General Counsel. "The listing of this patent in the
FDA Orange Book provides us with significantly more years of protection
and will allow us to better explore expanded indications for this
unique topical local anesthetic patch."
Synera (lidocaine 70 mg/tetracaine 70 mg) Patch is a combination amide
and ester local anesthetic topical patch indicated for use on intact
skin to provide local dermal analgesia for superficial venous access
and superficial dermatological procedures such as excision,
electrodessication and shave biopsy of skin lesions.
About Nuvo Research Inc.
Nuvo Research is a publicly traded, 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 product portfolio includes Pennsaid®, Pliaglis® and Synera®. Pennsaid, a topical nonsteroidal anti-inflammatory drug (NSAID), is
used to treat the signs and symptoms of osteoarthritis of the knee(s).
Pennsaid is sold in the United States by Mallinckrodt Inc., the
Pharmaceuticals business of Covidien, in Canada by Paladin Labs Inc.
and in several European countries. Pliaglis is a topical local
anesthetic cream which provides topical local analgesia for superficial
dermatological procedures. The Company has licensed worldwide
marketing rights to Pliaglis to Galderma Pharma S.A., a global company
dedicated to 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. The Company is also developing the
compound WF10, for the treatment of immune related diseases.
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 Company's Annual Report, as
well as in Nuvo's Annual Information Form for the year ended December
31, 2011. Nuvo disclaims any intention or obligation to update or
revise any forward-looking statements, whether as 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.
SOURCE Nuvo Research Inc.