MISSISSAUGA, ON, Sept. 14, 2011 /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 that its U.S.
marketing partner, Mallinckrodt Inc., a Covidien company (NYSE: COV),
has announced that they intend to pursue the Supplementary New Drug
Application (sNDA) regulatory approval pathway for PENNSAID® Viscous Solution instead of using the 505(b)(2) pathway for new drug
approval, as previously planned. Covidien has advised Nuvo that it
believes the data obtained through its recently completed clinical
study can be used to support the sNDA. Covidien has also advised Nuvo
that an sNDA could be filed with the United States Food and Drug
Administration (FDA) sooner, that the FDA review cycle is expected to
be shorter and that PENNSAID Viscous Solution could therefore be
approved more quickly than if Covidien follows the 505(b)(2)pathway.
About PENNSAID Viscous Solution
PENNSAID Viscous Solution 2% w/w is a higher viscosity formulation of
PENNSAID (diclofenac sodium topical solution) 1.5% w/w. PENNSAID is an
FDA approved, topical non-steroidal anti-inflammatory drug (NSAID)
indicated for the treatment of the signs and symptoms of osteoarthritis
(OA) of the knee(s). PENNSAID Viscous Solution is currently in
development for the treatment of the signs and symptoms of OA of the
knee(s) via twice-daily administration with a 2% diclofenac
The development of PENNSAID Viscous Solution in the United States is
being handled by Nuvo's licensee, Covidien, pursuant to the terms of
the 2009 license agreement (Agreement) between the parties. Under the
Agreement, Covidien has assumed all responsibility for managing,
executing and paying for all development activities for PENNSAID
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 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. For more information, please
IMPORTANT RISK INFORMATION ABOUT PENNSAID
|Cardiovascular Risk |
- Non-steroidal anti-inflammatory drugs (NSAIDs) may cause an increased
risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk
may increase with duration of use. Patients with cardiovascular disease
or risk factors for cardiovascular disease may be at greater risk.
- PENNSAID is contraindicated in the perioperative setting of coronary
artery bypass graft (CABG) surgery.
- NSAIDs cause an increased risk of serious gastrointestinal adverse
events including bleeding, ulceration, and perforation of the stomach
or intestines, which can be fatal. These events can occur at any time
during use and without warning symptoms. Elderly patients are at greater risk for
serious gastrointestinal events.
PENNSAID is also contraindicated in patients:
with a known hypersensitivity to diclofenac sodium or any other
component of PENNSAID
who have experienced asthma, urticaria, or allergic-type reactions after
taking aspirin or other NSAIDs. Severe, rarely fatal anaphylactic-like
reactions to NSAIDs have been reported in such patients.
Elevation of one or more liver tests may occur during therapy with
NSAIDs. PENNSAID should be discontinued immediately if abnormal liver
tests persist or worsen.
Use with caution in patients with fluid retention or heart failure.
Hypertension can occur with NSAID treatment. Monitor blood pressure
closely with PENNSAID treatment.
Long-term administration of NSAIDs can result in renal papillary
necrosis and other renal injury.
Use PENNSAID with caution in patients at greatest risk of this reaction,
including the elderly, those with impaired renal function, heart
failure, liver dysfunction, and those taking diuretics and
Should not be used in pregnant or lactating women and is not approved
for use in pediatric patients.
Anaphylactoid reactions may occur in patients without prior exposure to
PENNSAID. NSAIDs can cause serious skin adverse events such as
exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic
epidermal necrolysis (TEN), which can be fatal.
The most common treatment-related adverse events in patients receiving
PENNSAID were application site skin reactions including dry skin (32%),
contact dermatitis characterized by skin erythema and induration (9%),
contact dermatitis with vesicles (2%) and pruritus (4%). In a long term
safety study, contact dermatitis occurred in 13% and contact dermatitis
with vesicles in 10% of patients, generally within the first 6 months
of exposure, leading to a withdrawal rate for an application site event
of 14%. Other common adverse events greater than placebo include:
dyspepsia (9%), abdominal pain (6%), flatulence (4%), diarrhea (4%) and
Do not apply to open wounds. Protect treated knee(s) from natural or
artificial sunlight. Topicals such as sunscreen and bug repellant may
be applied after PENNSAID treated knee(s) are completely dry. Avoid
contact of PENNSAID with eyes and mucous membranes. Wash and dry hands
after use. Concurrent use with oral NSAIDs should be avoided unless
benefit outweighs risk and periodic laboratory evaluations are
See Full Prescribing Information for additional Important Risk Information.
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.