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

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

PR Newswire

MISSISSAUGA, ON, Aug. 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:

       *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.
  *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.

Contact:

Nuvo Research Inc.
Email:ir@nuvoresearch.com
Website:www.nuvoresearch.com
 
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