Nuvo Sues Mallinckrodt Over Pennsaid Studies
Nuvo Research® announces lawsuit against Mallinckrodt
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."
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.
Posted: August 2013