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Nuvo announces Mallinckrodt submits PK study report in response to PENNSAID® 2% FDA complete response letter

August 15, 2013

MISSISSAUGA, ON, Aug. 15, 2013 /PRNewswire/ – Nuvo Research Inc. (Nuvo)
(TSX:NRI), a specialty pharmaceutical company dedicated to building a
portfolio of products for the topical treatment of pain and the
development of its immune modulating drug candidate WF10 today
announced that its U.S. licensing partner for PENNSAID(® )(diclofenac sodium topical solution) 1.5% w/w and PENNSAID 2%
(diclofenac sodium topical solution) 2% w/w, Mallinckrodt (NYSE:MNK)
has submitted the results of a pharmacokinetic (PK) study to the U.S.
Food and Drug Administration (FDA) in support of its New Drug
Application for PENNSAID 2%. 

On March 4, 2013, Mallinckrodt received a Complete Response Letter (CRL)
from the FDA following the review of Mallinckrodt’s New Drug
Application for PENNSAID 2%.   In the CRL, the FDA required that
Mallinckrodt complete a PK study comparing PENNSAID 2% to original
PENNSAID.  Mallinckrodt completed the PK study and on August 7, 2013
submitted the clinical study report to the FDA.  The FDA is expected to
advise Mallinckrodt if the resubmission is acceptable for review within
14 days of the filing and to provide a formal response to Mallinckrodt
within 6 months of the filing.

About PENNSAID

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% is a follow-on product to original PENNSAID which is
currently marketed in the U.S. by Mallinckrodt under license from
Nuvo.  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
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 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.  The Company’s product portfolio includes
Pennsaid(®), Pliaglis and a heated lidocaine/tetracaine patch (HLT patch). 
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 U.S. by Mallinckrodt Inc. 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 pharmaceutical company specialized in dermatology.  Galderma
launched the marketing and sale of Pliaglis in the U.S. in March of
2013 and in the E.U. in April of 2013.  The HLT patch is a topical
patch that combines lidocaine, tetracaine and heat and is approved in
the U.S. to provide local dermal analgesia for superficial venous
access and superficial dermatological procedures and in Europe, for
surface anaesthesia of normal intact skin.  Nuvo’s licensing partner,
Galen US Incorporated markets the HLT patch (under the name Synera) in
the U.S.  In Europe, Nuvo’s licensing partner, Eurocept International
B.V., has initiated a pan-European launch of the HLT patch (under the
name Rapydan).  The Company is also developing WF10, for the treatment
of immune related diseases.

Further information on Nuvo Research is available on the company’s
website www.nuvoresearch.com or by contacting:

Investor Relations Email: ir@nuvoresearch.com

PENNSAID(®) (diclofenac sodium topical solution) 1.5% w/w

INDICATIONS AND USAGE

PENNSAID(®) (diclofenac sodium topical solution) 1.5% w/w is a nonsteroidal
anti-inflammatory drug (NSAID) indicated for the treatment of signs and
symptoms of osteoarthritis of the knee(s).

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._____________________________|

 

CONTRAINDICATIONS

        --  PENNSAID is also contraindicated in patients:
            o with a known hypersensitivity to diclofenac sodium or any
              other component of PENNSAID
            o 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.
        --  Do not apply to open wounds. 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. 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

ADVERSE REACTIONS

        --  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%).

USE IN SPECIFIC POPULATIONS

PENNSAID should not be used in pregnant or lactating women and is not
approved for use in pediatric patients.

See Full Prescribing Information for additional Important Risk Information.

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, statements
concerning the Company’s future objectives, strategies to achieve those
objectives, as well as statements with respect to management’s beliefs,
plans, estimates, and intentions, 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 the
need for additional financing, the current economic environment,
dependence on sales and marketing partnerships, competitive
developments, as well as other risk factors included in the Company’s
annual information form dated March 27, 2013 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.  Certain statements included in this news
release may be considered “financial outlook” for purposes of
applicable securities laws, and such financial outlook may not be
appropriate for purposes other than this news release.  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.


Source: PR Newswire