MISSISSAUGA, ON, July 23, 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 is providing an
update on the status of its PENNSAID franchise.
PENNSAID (diclofenac sodium topical solution) 1.5% w/w U.S. Patent
The United States Patent Office has issued Patent # 8,217,078 relating
to a method of using PENNSAID (PENNSAID Patent). The PENNSAID Patent
expiry date is July 10, 2029.
Nuvo's U.S. licensing partner, Mallinckrodt Inc. (Mallinckrodt), the
Pharmaceuticals business of Covidien plc, has listed the PENNSAID
Patent in the U.S. Food and Drug Administration's (FDA) Orange Book.
The Orange Book listing requires any Abbreviated New Drug Application
(ANDA) applicant seeking FDA approval for a generic version of PENNSAID
prior to expiration of the patent to notify Nuvo and Mallinckrodt of
its ANDA before it can obtain FDA approval. Prior to the Orange Book
listing, there was no such requirement on the generic applicants.
Subsequent to the Orange Book listing, Nuvo and Mallinckrodt received
Paragraph IV certification notices from three companies advising Nuvo
and Mallinckrodt that they have filed an ANDA with the FDA seeking
approval to market a generic version of PENNSAID. Nuvo and
Mallinckrodt are evaluating the notice letters and have the right to
commence legal action against each of the ANDA applicants to enforce
its patent rights.
Nuvo is currently prosecuting additional patent applications in the
United States that would cover methods of using PENNSAID. In addition,
Nuvo is prosecuting patent applications throughout the world that
provides protection for PENNSAID 2%.
PENNSAID 2% Regulatory Filing
Mallinckrodt has advised Nuvo that the FDA has accepted the New Drug
Application (NDA) for PENNSAID 2% for review. Mallinckrodt had
submitted a supplemental New Drug Application (sNDA) for PENNSAID 2% to
the FDA which the FDA requested Mallinckrodt revise to an NDA.
Mallinckrodt complied with the request and resubmitted the
application. The FDA has set a Prescription Drug User Fee Act (PDUFA)
date of March 4, 2013 for action on the submission.
Under the terms of a U.S. Licensing and Development Agreement signed in
June 2009, Mallinckrodt assumed full responsibility for managing,
executing and paying for all development activities for PENNSAID 2%.
"We are extremely pleased that we have been able to secure patent
protection for the use of PENNSAID and have made progress with the
PENNSAID 2% regulatory filing," said Dan Chicoine, Nuvo's Chairman and
Co-CEO. "The new patent provides us with IP protection for PENNSAID
and an approaching PDUFA date in early 2013 allows us to move forward
with our strategy of obtaining FDA regulatory approval for PENNSAID
PENNSAID is a nonsteroidal 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% 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
convenient metered dose pump bottle and is applied twice each day
compared to four times a day for original PENNSAID. Nuvo has filed a
patent application on the PENNSAID 2% formulation. Upon FDA approval,
PENNSAID 2%, like PENNSAID, will be indicated for the treatment of the
signs and symptoms of osteoarthritis (OA) of the knee.
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., 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 company
dedicated to 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 ABOUT PENNSAID®
- 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 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 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.