MISSISSAUGA, ON, Aug. 21, 2013 /CNW/ - 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
"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."
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
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.
Nuvo Research Inc. Email:email@example.com
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