MISSISSAUGA, ON, Feb. 23, 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 provided an update on the
status of its Pennsaid franchise.
Pennsaid Opportunity Due to Voltaren Gel U.S. Product Shortage
Endo Pharmaceuticals Holdings Inc. (Endo) and Novartis Consumer Health
(Novartis) recently announced that the Novartis manufacturing facility
at which Voltaren Gel is manufactured, has been closed due to
manufacturing issues unrelated to Voltaren Gel. Votaren Gel is the
main competitive product to Pennsaid in the U.S. Endo, which licenses
Voltaren Gel from Novartis for the U.S. market, has indicated there may
be shortages of Voltaren Gel as Novartis transfers manufacturing to
another facility. This unexpected development may be contributing to a
recent increase in Pennsaid U.S. prescriptions and may provide
Mallinckrodt Inc., a Covidien company (NYSE: COV), Nuvo's U.S.
licensing partner, with an opportunity to further increase U.S.
Pennsaid U.S. Reimbursement Status
Covidien has advised Nuvo that since the beginning of 2012, new
contracts with a number of large, well known insurance providers have
taken effect that will enhance Medicare Part D and commercial insurance
coverage for an additional 11 million U.S. Pennsaid patients. Covidien
is continuing its efforts to increase the number of insurance plans
under contract for Pennsaid.
Pennsaid Greek Sales Update
Nuvo has recently received additional orders for Pennsaid from our Greek
distributor. In 2010 and 2011, Greece represented the second largest
market for Pennsaid unit sales, although in 2011, our Greek sales
declined after the Greek government, as part of its austerity measures,
discontinued reimbursement for all topical NSAIDs, the class of
prescription drugs that includes Pennsaid. Our Greek distributor has
repositioned Pennsaid as an over-the-counter product available without
a doctor's prescription. We believe that recent increased orders for
Pennsaid in Greece may suggest that this initiative is gaining
Pennsaid 2% Regulatory Status
Covidien has advised Nuvo that in the second quarter of 2012, it will be
filing a supplementary New Drug Application (sNDA) with the U.S. Food
and Drug Administration (FDA) for Pennsaid 2%, the follow-on product to
Pennsaid. Covidien has advised that it believes this filing will make
Pennsaid 2% eligible for FDA approval in the fourth quarter of 2012 or
the first quarter of 2013. Nuvo believes that Pennsaid 2% offers
significant improvements over currently available topical non-steroidal
anti-inflammatory drugs (NSAIDs) for the treatment of the signs and
symptoms of knee osteoarthritis in the U.S. due to (1) its more
convenient dosing regimen - Pennsaid 2% is twice per day dosing as
compared to current Pennsaid and its main competitive product, Voltaren
Gel, which are four times per day dosing and (2) it is easier to apply
- Pennsaid 2% is more viscous than Pennsaid and dispensed via a simple
to use metered dose pump. Nuvo has a U.S. patent application pending
for Pennsaid 2%.
"The start to 2012 has brought renewed momentum to our Pennsaid
franchise," stated Bradley Galer, M.D. President of Nuvo's Pain Group.
"In addition, we are excited about our recent launch of Synera® into the U.S. market and the anticipated Pliaglis'® U.S. and European approvals and launches by our partner Galderma Pharma
S.A. later this year."
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 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.
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.
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