MISSISSAUGA, ON, Jan. 29, 2013 /PRNewswire/ - Nuvo Research Inc. (Nuvo) (TSX:
NRI) announced today that it has entered into a settlement agreement
with Apotex Inc. and Apotex Corp. (together Apotex) respecting patent
infringement litigation brought by Nuvo and Nuvo's U.S. licensing
partner, Mallinckrodt Inc. (Mallinckrodt), in response to Apotex's
filing of an abbreviated new drug application (ANDA) with the U.S. Food
and Drug Administration (FDA) seeking approval to market a generic
version of PENNSAID (diclofenac sodium topical solution) 1.5% w/w
Under the terms of the settlement agreement, Nuvo and Mallinckrodt
granted a license to Apotex that permits Apotex, upon approval of its
ANDA by the FDA, to launch its generic version of PENNSAID on a date
that is the earlier of 45 days after Mallinckrodt or Nuvo makes a first
commercial shipment of PENNSAID (diclofenac sodium topical solution) 2%
w/w (PENNSAID 2%) in the United States and April 1, 2014, or earlier
under certain circumstances.
PENNSAID 2% is pending approval by the FDA and is expected to be the
follow-on product to original PENNSAID. PENNSAID 2% is designed to be
dosed twice per day with a metered dose pump bottle. In 2012,
Mallinckrodt submitted a New Drug Application (NDA) for PENNSAID 2%
with the FDA. The FDA has set a Prescription Drug User Fee Act (PDUFA)
date of March 4, 2013 for action on the submission.
PENNSAID is a non-steroidal anti-inflammatory drug (NSAID) used for
treating the signs and symptoms of osteoarthritis of the knee(s).
PENNSAID is the only FDA-approved topical NSAID for the treatment of
knee osteoarthritis which demonstrated statistically significant
differences in all three primary efficacy endpoints: pain and physical
function (WOMAC®), patient overall health assessment (POHA), and patient global
assessment of knee osteoarthritis.
PENNSAID is a registered trademark of Nuvo Research Inc.
WOMAC is a registered trademark of Nicholas Bellamy.
WOMAC® is a proprietary health status questionnaire. For further information
visit the WOMAC® website at www.WOMAC.com.
About PENNSAID 2%
PENNSAID 2%, which is not yet approved by the FDA, is a topical
non-steroidal anti-inflammatory drug (NSAID) containing 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 was
studied in clinical trials using twice daily dosing compared to four
times a day for original 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 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 which will
be launching Pliaglis in the U.S. and E.U. in the first half of 2013.
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 anesthesia 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 ABOUT PENNSAID®
|Cardiovascular Risk |
- 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 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 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.
See Full Prescribing Informationfor additional Important Risk Information.
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.