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Nuvo Research provides update on the PENNSAID Viscous Solutiondevelopment program (prnews)
MISSISSAUGA, ON, Sept. 14, 2011 /PRNewswire/ - NuvoResearch Inc. (TSX: NRI), a specialty pharmaceutical company dedicated tobuilding a portfolio of products for the topical treatment of pain and thedevelopment of its immune modulating drug candidate WF10, today announced thatits U.S. marketing partner, Mallinckrodt Inc., a Covidien company (NYSE: COV),has announced that they intend to pursue the Supplementary New Drug Application(sNDA) regulatory approval pathway for PENNSAID® ViscousSolution instead of using the 505(b)(2) pathway for new drug approval, aspreviously planned. Covidien has advised Nuvo that it believes the dataobtained through its recently completed clinical study can be used to supportthe sNDA. Covidien has also advised Nuvo that an sNDA could be filed with theUnited States Food and Drug Administration (FDA) sooner, that the FDA reviewcycle is expected to be shorter and that PENNSAID Viscous Solution couldtherefore be approved more quickly than if Covidien follows the505(b)(2)pathway.
About PENNSAID Viscous Solution
PENNSAID Viscous Solution 2% w/w is a higher viscosityformulation of PENNSAID (diclofenac sodium topical solution) 1.5% w/w. PENNSAIDis an FDA approved, topical non-steroidal anti-inflammatory drug (NSAID)indicated for the treatment of the signs and symptoms of osteoarthritis (OA) ofthe knee(s). PENNSAID Viscous Solution is currently in development for thetreatment of the signs and symptoms of OA of the knee(s) via twice-dailyadministration with a 2% diclofenac concentration.
The development of PENNSAID Viscous Solution in the United States is being handled byNuvo's licensee, Covidien, pursuant to the terms of the 2009 license agreement(Agreement) between the parties. Under the Agreement, Covidien has assumed allresponsibility for managing, executing and paying for all development activitiesfor PENNSAID Viscous Solution.
About Nuvo Research Inc.
Nuvo Research is a publicly traded, Canadian specialtypharmaceutical company, headquartered inMississauga, Ontario. The Company isbuilding a portfolio of products for the treatment of pain through internalresearch and development and by in-licensing and acquisition. The Company'sPain Group, located in West Chester, Pennsylvania, is focused on the development and commercialization oftopically delivered pain products. The Company's product portfolio includesPENNSAID, Pliaglis and Synera. PENNSAID, a topical non-steroidalanti-inflammatory drug (NSAID), is used to treat the signs and symptoms ofosteoarthritis of the knee. PENNSAID is sold inthe United States by MallinckrodtInc., a Covidien company (NYSE: COV), in Canada by Paladin Labs Inc. (TSX:PLB)and in several European countries. Pliaglis is a topical local anesthetic cream,which is U.S. Food and Drug Administration (FDA) approved to provide topicallocal analgesia for superficial dermatological procedures. The Company haslicensed worldwide marketing rights to Pliaglis to Galderma Pharma S.A., aglobal specialty pharmaceutical company focused on dermatology. Synera is atopical patch that combines lidocaine, tetracaine and heat, approved in the United States to provide localdermal analgesia for superficial venous access and superficial dermatologicalprocedures and in Europe, for surfaceanaesthesia of normal intact skin. Nuvo currently markets Synera in the United States and its licensingpartner, EuroCept International B.V., has initiated a pan-European launch ofSynera (under the name Rapydan) in several European countries. Through itssubsidiary, Nuvo Research GmbH, based in Leipzig,Germany, the Company is also developing the compound WF10, for thetreatment of immune related diseases. For more information, please visit www.nuvoresearch.com.
IMPORTANT RISK INFORMATION ABOUT PENNSAID
Cardiovascular Risk
Non-steroidal anti-inflammatory drugs (NSAIDs) may cause anincreased risk of serious cardiovascular thrombotic events,myocardial infarction, and stroke, which can be fatal. This risk may increasewith duration of use. Patients with cardiovascular disease or risk factors forcardiovascular disease may be at greater risk.
PENNSAID is contraindicated in the perioperative setting of coronaryartery bypass graft (CABG) surgery.
Gastrointestinal Risk
NSAIDs cause an increased risk of serious gastrointestinal adverseevents including bleeding, ulceration, and perforation of the stomach orintestines, which can be fatal. These events can occur at any time during useand without warning symptoms. Elderly patients are at greaterrisk for serious gastrointestinal events.
PENNSAID is also contraindicated in patients:
with a known hypersensitivity to diclofenac sodium or any other component ofPENNSAID
who have experienced asthma, urticaria, or allergic-type reactions aftertaking aspirin or other NSAIDs. Severe, rarely fatal anaphylactic-like reactionsto NSAIDs have been reported in such patients.
Elevation of one or more liver tests may occur during therapywith NSAIDs. PENNSAID should be discontinued immediately if abnormal liver testspersist or worsen.
Use with caution in patients with fluid retention or heartfailure. Hypertension can occur with NSAID treatment. Monitor blood pressureclosely with PENNSAID treatment.
Long-term administration of NSAIDs can result in renalpapillary necrosis and other renal injury.
Use PENNSAID with caution in patients at greatest risk of thisreaction, including the elderly, those with impaired renal function, heartfailure, liver dysfunction, and those taking diuretics and ACE-inhibitors.
Should not be used in pregnant or lactating women and is notapproved for use in pediatric patients.
Anaphylactoid reactions may occur in patients without priorexposure to PENNSAID. NSAIDs can cause serious skin adverse events such asexfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermalnecrolysis (TEN), which can be fatal.
The most common treatment-related adverse events in patientsreceiving PENNSAID were application site skin reactions including dry skin(32%), contact dermatitis characterized by skin erythema and induration (9%),contact dermatitis with vesicles (2%) and pruritus (4%). In a long term safetystudy, contact dermatitis occurred in 13% and contact dermatitis with vesiclesin 10% of patients, generally within the first 6 months of exposure, leading toa withdrawal rate for an application site event of 14%. Other common adverseevents greater than placebo include: dyspepsia (9%), abdominal pain (6%),flatulence (4%), diarrhea (4%) and nausea (4%).
Do not apply to open wounds. Protect treated knee(s) fromnatural or artificial sunlight. Topicals such as sunscreen and bug repellant maybe applied after PENNSAID treated knee(s) are completely dry. Avoid contact ofPENNSAID with eyes and mucous membranes. Wash and dry hands after use.Concurrent use with oral NSAIDs should be avoided unless benefit outweighs riskand periodic laboratory evaluations are conducted.
See FullPrescribing Information for additional Important RiskInformation.
Forward-Looking Statements
This document contains forward-looking statements. Someforward-looking statements may be identified by words like "expects","anticipates", "plans", "intends", "indicates" or similar expressions. Theseforward-looking statements, by their nature, necessarily involve risks anduncertainties that could cause actual results to differ materially from thosecontemplated by the forward-looking statements. Nuvo considers the assumptionson which these forward-looking statements are based to be reasonable at the timethey were prepared, but caution that these assumptions regarding future events,many of which are beyond the control of the Company, may ultimately prove to beincorrect. Factors and risks, which could cause actual results to differmaterially from current expectations, are discussed in the annual report, aswell as in Nuvo's Annual Information Form for the year ended December 31, 2010. Nuvo disclaims anyintention or obligation to update or revise any forward-looking statements,whether as a result of new information or future events, except as required bylaw. For additional information on risks and uncertainties relating to theseforward looking statements, investors should consult the Company's ongoingquarterly filings, annual report and Annual Information Form and other filingsfound on SEDAR at www.sedar.com.
SOURCE Nuvo Research Inc.