FDA SETS PDUFA DATE OF APRIL 16, 2012
MISSISSAUGA, ON, Feb. 21, 2012 /PRNewswire/ - 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 an update to
Pliaglis regulatory approval in the U.S. and the E.U.
U.S. Regulatory Status
The U.S. Food and Drug Administration (FDA) has accepted the
supplemental New Drug Application (sNDA) for Pliaglis for review. The
sNDA was submitted by Galderma Laboratories, LP, the U.S. subsidiary of
Galderma Pharma S.A. (Galderma). Nuvo has licensed worldwide marketing
rights for Pliaglis to Galderma, a global pharmaceutical company
specialized in dermatology. The FDA has set a PDUFA (Prescription Drug
User Fee Act) date of April 16, 2012 for action on the submission.
Pliaglis is an FDA-approved topical local anesthetic cream which uses
the Company's proprietary phase-changing topical technology. It
provides local analgesia for superficial dermatological procedures,
such as dermal filler injection, pulsed dye laser therapy, facial laser
resurfacing and laser-assisted tattoo removal. Pliaglis was initially
approved by the FDA in June 2006, but was voluntarily removed from the
U.S. market by Galderma in 2008, due to manufacturing issues at
Galderma's third-party contract manufacturer. Galderma subsequently
transferred Pliaglis manufacturing to Galderma and has resolved the
manufacturing issues. Galderma and Nuvo believe that the sNDA
addresses the manufacturing site change and the resolution of the
manufacturing issues. Galderma plans to launch the marketing and sale
of Pliaglis in the U.S. in the second half of 2012.
E.U. Regulatory Status
In July 2011, a Marketing Authorization Application (MAA) for Pliaglis
was submitted to 17 E.U. countries using the decentralized submission
procedure and is under active review. The MAA requests marketing
approval for producing local dermal anaesthesia on intact skin in
adults prior to superficial dermatological procedures. Nuvo expects to
receive a response in the first half of 2012 and Galderma plans to
launch in a number of E.U. countries in the second half of 2012.
Pursuant to Nuvo's license agreement with Galderma, Nuvo is entitled to
receive milestone payments totaling US$6.0 million from Galderma once
Pliaglis is launched in the first three E.U. countries.
"We are extremely excited and optimistic about the anticipated approval
and launch of Pliaglis in the U.S. and E.U.," said Dr. Bradley Galer,
President, Pain Group. "The milestone and royalty revenues from
Pliaglis, together with our growing Pennsaid® royalties and revenues from our recently launched Synera® product, will help support our efforts to build Nuvo into a successful
specialty pharmaceutical company focused on the treatment of pain."
Rest of the World Regulatory Status
Pliaglis was recently approved for sale and marketing in Argentina.
Galderma was advised by Health Canada on February 10 2012 that its New
Drug Submission for Pliaglis has been accepted for review. In
September 2011, Galderma filed marketing applications in Switzerland
and Brazil and is expected to file for marketing approval in other
countries around the world, including additional South American
countries, select Asian countries, South Africa, and Australia.
Nuvo will receive revenue from worldwide Pliaglis sales via royalties
that average in the mid-teens.
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., a Covidien company, 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 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. 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 annual report, as well as in
Nuvo's Annual Information Form for the year ended December 31, 2010.
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.