MISSISSAUGA, ON, May 29, 2014 /CNW/ - Nuvo Research Inc.
(TSX: NRI), a specialty pharmaceutical company with a diverse
portfolio of topical and immunology products today announced that a
third party has received U.S. Food and Drug Administration (FDA)
approval to market and sell a topical diclofenac sodium 1.5%
solution in the United States.
The product is a generic version of Nuvo's PENNSAID
(diclofenac sodium topical solution) 1.5% w/w (PENNSAID 1.5%).
Mallinckrodt Inc. (NYSE:MNK) is Nuvo's U.S. commercial licensee
for the sale of both PENNSAID 1.5% and its follow-on product
PENNSAID (diclofenac sodium topical solution) 2% w/w (PENNSAID
2%). PENNSAID 2% was approved by the FDA on January 16, 2014 and was launched by Mallinckrodt in February
2014. PENNSAID 2% is the first twice per day dosed
topical non-steroidal anti-inflammatory drug (NSAID) available in
the U.S. for the treatment of the pain of osteoarthritis of the
knee. It is protected by 5 U.S. patents that are listed in
the FDA's Approved Drug Products with Therapeutic Equivalence
Evaluations database or "Orange Book".
Mallinckrodt has advised Nuvo that
its strategy is to convert PENNSAID 1.5% patients and prescribers
to PENNSAID 2%. Since the launch of PENNSAID 2%, U.S.
prescriptions for PENNSAID 1.5% have declined and been offset by
increased PENNSAID 2% prescriptions. The most recent IMS data
for the week ended May 16, 2014,
indicated that the number of PENNSAID 2% prescriptions exceeded the
number of PENNSAID 1.5% prescriptions. Nuvo receives a 20% of
net sales royalty on Mallinckrodt's
U.S. sales of both PENNSAID 1.5% and PENNSAID 2%.
About PENNSAID 1.5%
PENNSAID 1.5% is used to
treat the signs and symptoms associated with knee osteoarthritis
(OA). The drug combines the transdermal carrier (containing
dimethyl sulfoxide, popularly known as DMSO) with 1.5% diclofenac
sodium, an NSAID and delivers the active drug through the skin
directly to the site of inflammation and pain. PENNSAID is
currently marketed in the U.S. by Mallinckrodt, in Canada by Paladin Labs Inc. and marketed under
license and/or distribution agreements in Greece, Italy
and the U.K.
About PENNSAID 2%
PENNSAID 2% is a topical
product containing 2% diclofenac sodium compared to 1.5% for
original PENNSAID 1.5%. It is approved in the U.S. for pain
of OA of the knee. It is more viscous than PENNSAID 1.5%, is
supplied in a metered dose pump bottle and has been approved for
twice daily dosing compared to four times a day for PENNSAID 1.5%.
PENNSAID 2% was approved by the FDA on January 16, 2014 and is protected by 5 U.S.
patents that are listed in the FDA's Approved Drug Products with
Therapeutic Equivalence Evaluations database or "Orange Book".
About Nuvo Research Inc.
Nuvo (TSX:NRI) is a
specialty pharmaceutical company with a diverse portfolio of
products and technologies. The Company operates two distinct
business units: the Topical Products and Technology (TPT) Group and
the Immunology Group. The TPT Group has four U.S. Food and
Drug Administration (FDA) approved commercial products, a pipeline
of topical and transdermal products focusing on pain and
dermatology and four drug delivery platforms that support the
creation of patented formulations that can deliver actives into or
through the skin. The Immunology Group has two commercial
products, a development program for the treatment of allergic
rhinitis and an immune system modulation platform that has the
potential to support treatments for a broad range of immune system
related disorders. For additional company information
visit www.nuvoresearch.com.
PENNSAID® (diclofenac sodium topical solution) 2%
w/w
IMPORTANT RISK INFORMATION
WARNING: CARDIOVASCULAR AND GASTROINTESTINAL
RISK
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 serious gastrointestinal
events.
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CONTRAINDICATIONS
- 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
WARNINGS AND PRECAUTIONS
- 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.
- 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.
- Wash and dry hands before and after use. Avoid contact of
PENNSAID with the eyes and mucous membranes
- PENNSAID was not evaluated under the conditions of heat
application, occlusive dressings overlay, or exercise; therefore,
concurrent use of PENNSAID under these conditions is not
recommended.
- Do not:
apply PENNSAID to open wounds.
shower for at least 30 minutes after
applying PENNSAID.
wear clothing over the PENNSAID treated
knee until the treated knee is dry
- Protect treated knee(s) from natural or artificial sunlight.
Topicals, such as sunscreen and bug repellent, may be applied after
PENNSAID treated knee(s) are completely dry.
- Concurrent use with oral NSAIDs should be avoided unless
benefit outweighs risk and periodic laboratory evaluations are
conducted
ADVERSE REACTIONS
- The most common adverse events in a phase 2 clinical trial of
PENNSAID 2% were application site reactions, such as dryness (22%),
exfoliation (7%), erythema (4%), pruritus (2%), pain (2%),
induration (2%), rash (2%), and scabbing (<1%). Other
adverse reactions occurring in >1% of patients receiving
PENNSAID 2% included urinary tract infection (3%), contusion (2%),
sinus congestion (2%), and nausea (2%).
- The most common treatment-related adverse events in patients
receiving PENNSAID 1.5% 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%).
USE IN SPECIFIC POPULATIONS
- PENNSAID should not be used in pregnant or lactating women and
is not approved for use in pediatric patients.
Click here for Full Prescribing Information for
additional Important Risk Information including boxed
warning.
PENNSAID is a registered trademark of Nuvo Research Inc.
Forward-Looking Statements
Certain statements in
this news release constitute forward-looking statements within the
meaning of applicable securities laws. Forward-looking statements
include, but are not limited to the Company's anticipated use of
proceeds from the Private Placement, the Company's future share
price and the Company's possible election to accelerate the expiry
date of any of the warrants or the brokers warrants and similar
statements concerning anticipated future events, results,
circumstances, performance or expectations that are not historical
facts. Forward-looking statements generally can be identified by
the use of forward-looking terminology such as "outlook",
"objective", "may", "will", "expect", "intend", "estimate",
"anticipate", "believe", "should", "plans" or "continue", or
similar expressions suggesting future outcomes or events. Such
forward-looking statements reflect management's current beliefs and
are based on information currently available to management.
Forward-looking statements involve risks and uncertainties that
could cause actual results to differ materially from those
contemplated by such statements. Factors that could cause such
differences include general business and economic uncertainties and
adverse market conditions as well as other risk factors included in
the Company's Annual Information Form dated February 20, 2014 under the heading "Risks
Factors" and as described from time to time in the reports and
disclosure documents filed by the Company with Canadian securities
regulatory agencies and commissions. This list is not exhaustive of
the factors that may impact the Company's forward-looking
statements. These and other factors should be considered carefully
and readers should not place undue reliance on the Company's
forward-looking statements. As a result of the foregoing and other
factors, no assurance can be given as to any such future results,
levels of activity or achievements and neither the Company nor any
other person assumes responsibility for the accuracy and
completeness of these forward-looking statements. The factors
underlying current expectations are dynamic and subject to change.
Although the forward-looking information contained in this news
release is based upon what management believes are reasonable
assumptions, there can be no assurance that actual results will be
consistent with these forward-looking statements. All
forward-looking statements in this news release are qualified by
these cautionary statements. The forward-looking statements
contained herein are made as of the date of this news release and
except as required by applicable law, the Company undertakes no
obligation to publicly update or revise any forward-looking
statement, whether as a result of new information, future events or
otherwise.
SOURCE Nuvo Research Inc.