Nuvo Research announces launch of Synera® in the U.S.
MISSISSAUGA, ON, Feb. 2, 2012 /CNW/ - Nuvo Research Inc. (TSX: NRI), a
specialty pharmaceutical company dedicated to building a portfolio of
products for the topical treatment of pain and the development of its
immune modulating drug candidate WF10, today announced the U. S. launch
of Synera® (70 mg lidocaine/ 70 mg tetracaine/ heated topical patch).
Synera is approved by the U.S. Food and Drug Administration (FDA) 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.
Nuvo will be directly marketing Synera to interventional pain doctors
with a dedicated 21 person contract sales force. Nuvo believes that
there is a significant opportunity for Synera to be used prior to
subcutaneous injections for painful needle procedures such as knee
drains, epidurals and a variety of nerve blocks. This new sales force
will initially target a highly concentrated number of doctors and
clinics that perform these painful procedures as a regular part of
their practice. Each year, approximately 3,600 U.S. physicians perform
50% of these 23 million interventional needle procedures.
"The launch of Synera is an important milestone for Nuvo as we
transition from a purely drug development company into a fully
integrated specialty pain company with a dedicated, focused pain
specialty sales force," said Dr. Bradley Galer, MD, President of Nuvo's
Pain Group. "We believe that Synera has great potential and now
represents our second source of revenue, in addition to Pennsaid®.
Also, by the end of 2012, we expect E.U. and U.S. approval and the
launch of our third commercial product, Pliaglis®, by our worldwide
marketing partner, Galderma Pharma S.A."
In the U.S., Nuvo will also be marketing Synera to large national
accounts, such as dialysis and infusion centers. Nuvo's U.S. marketing
strategy includes out-licensing Synera for the hospital and pediatric
markets. Nuvo is in discussion with potential licensees that have the
existing infrastructure to sell Synera in those markets.
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 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 non-steroidal anti-inflammatory drug
(NSAID), is used to treat the signs and symptoms of osteoarthritis of
the knee. 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 U.S. Food and Drug Administration
(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 specialized in 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.