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.