Nuvo Research® announces lawsuit against Mallinckrodt

            Nuvo Research® announces lawsuit against Mallinckrodt

PR Newswire

MISSISSAUGA, ON, Aug. 21, 2013

MISSISSAUGA, ON,  Aug.  21, 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 the Company has
commenced legal action  against Mallinckrodt Inc.  (Mallinckrodt) by filing  a 
Complaint in the United States District Court for the Southern District of New
York.

The  Complaint  asserts  that   Mallinckrodt  has  breached  its   contractual 
obligations to Nuvo as set  out in a Licensing  Agreement dated June 15,  2009 
(License Agreement) pursuant to which Nuvo licensed to Mallinckrodt the rights
to market and sell Pennsaid and Pennsaid 2% in the United States.

The Complaint  asserts that  Mallinckrodt breached  the License  Agreement  in 
several  respects.  Most  significantly,  Mallinckrodt  willfully  failed  to 
conduct certain clinical studies required under the contract that are critical
to regulatory  approval, marketing  and sales  of Pennsaid  2% throughout  the 
world. The Complaint  also alleges, amongst  other things, that  Mallinckrodt 
made  significant  errors  in  certain  clinical  studies  for  which  it  was 
responsible, failed to  apply requisite efforts  to commercialize Pennsaid  in 
the United States and has willfully refused to pay the full milestone payments
due to Nuvo under the License Agreement. Nuvo is seeking damages of not  less 
than $100  million and  a declaration  that it  is entitled  to terminate  the 
License Agreement which would result in the rights to market and sell Pennsaid
and/or Pennsaid  2% in  the United  States  reverting to  Nuvo. Nuvo  has  not 
terminated the License Agreement which continues in accordance with its  terms 
pending the Court's decision. A complete  copy of the Complaint can be  viewed 
at www.nuvoresearch.com.

"We are disappointed that  we have had to  initiate legal proceedings  against 
Mallinckrodt," said John London, Nuvo's President and Co-CEO. "Our board  has 
not taken this  decision lightly. However,  given what we  believe are  clear 
material breaches  of  the License  Agreement  and Mallinckrodt's  refusal  to 
consider appropriate and  fair compensation  to Nuvo, we  have proceeded  with 
legal action to protect the interests of Nuvo and its shareholders."

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  United States  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.

On March 4, 2013,  Mallinckrodt received a Complete  Response Letter from  the 
FDA following the review of  Mallinckrodt's New Drug Application for  Pennsaid 
2%. In the letter, the FDA required that Mallinckrodt successfully complete a
pharmacokinetic (PK) study  comparing diclofenac sodium  topical solution,  2% 
w/w (Pennsaid 2%) to  original Pennsaid. Mallinckrodt successfully  completed 
the PK study and has submitted the results to the FDA. After FDA accepts  the 
submission for  review, Mallincrkodt  expects that  it will  provide a  formal 
response to the filing within 6 months of the resubmission.

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 
plc, 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.

Forward-Looking Statements for Nuvo Research Inc.

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
 
Press spacebar to pause and continue. Press esc to stop.