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 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.
