Nuvo Research announces settlement agreement with Apotex in PENNSAID® generic
MISSISSAUGA, ON, Jan. 29, 2013 /CNW/ - 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 (PENNSAID).
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
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
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. |
|Gastrointestinal Risk |
| -- 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 |
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
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 nausea (4%).
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 conducted.
See Full Prescribing Information for 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
Nuvo Research Inc. Email:firstname.lastname@example.org
SOURCE: Nuvo Research Inc.
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