MISSISSAUGA, ON, Sept. 5, 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 issued United States Patent #
8,252,838 relating to compositions and methods of using PENNSAID® (diclofenac sodium topical solution) 2.0% w/w (PENNSAID 2% Patent).
The patent expires on April 21, 2028.
Nuvo's U.S. licensing partner, Mallinckrodt Inc. (Mallinckrodt), the
pharmaceuticals business of Covidien, has advised Nuvo that the U.S.
Food and Drug Administration (FDA) had accepted a New Drug Application
(NDA) for PENNSAID (diclofenac sodium topical solution) 2.0% w/w for
review and set a Prescription Drug User Fee Act (PDUFA) date of March
4, 2013 for action on the submission. Mallinckrodt will take the
necessary steps to have the new patent listed in the FDA Orange Book
upon FDA approval.
"We are very pleased that we have been able to secure additional patent
protection for PENNSAID 2%," said Tina Loucaides, Nuvo's Vice President
and General Counsel. "This patent, together with our recently
announced method of use patent for PENNSAID and PENNSAID 2% gives us a
strong patent portfolio that will support the PENNSAID franchise."
About PENNSAID 2%
PENNSAID 2% is the follow-on product to original PENNSAID, a topical
non-steroidal anti-inflammatory drug (NSAID). PENNSAID 2%, which is
not approved by the FDA, contains 2% diclofenac sodium compared to 1.5%
for original PENNSAID. It is more viscous than original PENNSAID, is
supplied in a metered dose pump bottle and is designed to be applied
twice each day compared to four times a day for original PENNSAID. If
approved by the FDA, PENNSAID 2%, like PENNSAID, will be indicated for
the treatment of the signs and symptoms of osteoarthritis (OA) of the
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 non-steroidal 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
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.
PENNSAID® is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the
treatment of signs and symptoms of osteoarthritis of the knee(s).
IMPORTANT RISK INFORMATION
Nonsteroidal 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 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 ACE-inhibitors.
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
Concurrent use with oral NSAIDs should be avoided unless benefit
outweighs risk and periodic laboratory evaluations are conducted.
For additional important risk information, including boxed warning, see Full Prescribing Information.
PENNSAID is a registered trademark of Nuvo Research Inc.
Forward-Looking Statements for Nuvo Research Inc.
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.