16th Mar 2006 07:02
Vernalis PLC16 March 2006 16 March 2006 Vernalis Achieves Primary End Point in Phase IIa Trial of V1003 Vernalis plc (LSE: VER, Nasdaq: VNLS) today announced the achievement of theprimary end point of a Phase IIa study of V1003, a novel, proprietary intranasalformulation of buprenorphine for the management of post-operative pain. Therandomised, double-blind, placebo-controlled single dose Phase IIa study in 360patients undergoing bunionectomy compared V1003 to both placebo and Vicodin(R),one of the most widely prescribed oral pain killers. The primary end point waspain relief over the period of eight hours from drug administration. A range of four doses of V1003 was investigated: 0.1, 0.2, 0.4 and 0.6mg. Thesewere compared to Vicodin(R) (hydrocodone 10mg, paracetamol 1g) and placebo, withan equal number of patients in each of the six study groups. The resultsdemonstrated that doses of V1003 of 0.2mg and above were statistically superiorto placebo for the primary end point. A dose response was demonstrated for V1003and the highest dose tested (0.6mg) was statistically superior to Vicodin(R) forpain relief with a strong trend to superiority at lower doses. A similar patternwas observed in the secondary efficacy measure of time to rescue medication withV1003, once again demonstrating a strong trend to superiority over Vicodin(R). There were no serious adverse events reported in the trial and there were fewreports of local irritancy following the nasal delivery of V1003. The mostfrequent adverse events associated with V1003 were nausea, vomiting, dizziness,sleepiness and were in keeping with its status as a potent opiate analgesic.These events were reported more frequently with V1003 than with Vicodin(R),which is a weaker opiate, or placebo. Simon Sturge, CEO of Vernalis, said, "We are pleased to have met the primary endpoint in this Phase II study. We are now working with our development partner,Reckitt Benckiser on the most appropriate development programme for nasaldelivery of buprenorphine." Vernalis obtained rights to V1003 through its acquisition of Ionix in July 2005and is developing the product in partnership with Reckitt Benckiser, whomanufactures and markets buprenorphine globally. Under the partnershipagreement, Reckitt Benckiser is funding all development costs, with Vernalisreceiving a series of milestone payments and royalties on commercial sales.Vernalis has retained the option to co-market the product in the U.S. in returnfor contributing to a proportion of the on-going costs. Vernalis is currentlyreviewing this option and will make a decision prior to moving forward to thenext stage of development. Vernalis is using Archimedes Pharma's proprietary drug delivery technology forthe intranasal delivery of V1003. This delivery technology is also being usedfor V1004 and V1005, which are in pre-clinical evaluation in partnership withReckitt Benckiser for the treatment of chronic pain and opiate addictionrespectively. -- ends -- Enquiries: Vernalis plc +44 (0) 118 977 3133Simon Sturge, Chief Executive OfficerTony Weir, Chief Financial OfficerJulia Wilson, Head of Corporate Communications Brunswick Group +44 (0) 20 7404 5959Jon ColesWendel Verbeek Notes to Editors About V1003There have been very few breakthroughs in the treatment of pain over the lasttwo decades. The analgesics in use today are broadly of the same type that wereused 40 years ago and remain limited in their efficacy and tolerability. $38billion was spent worldwide on pain medication in the year 2002 and is forecastto grow to $75 billion by 2010. In recent years, the molecular pathology of painhas become better understood, confirming that pain is a complex set of disorderswith many potential pathways for treatment. The discovery of new drug targetsfrom this research has opened up the possibility of completely new classes ofpain drugs. Responding to economic pressures, the length of hospital stay after surgicalprocedures is reducing. This is driving an expansion in the requirement forstrong, easy-to-use pain medicines with improved side-effect and safety profilesover those currently available. In the U.S. alone, over 53 million patientsundergo surgical procedures each year. Despite most patients receiving painmedication, 50-75% of patients report that they experience inadequate paincontrol (Datamonitor). Pain is the most commonly reported reason forre-admission to hospital within 30 days of discharge or for admission directlyafter surgery. There is a substantial opportunity for novel and innovativemedicines to expand and segment this developing market. Two successful Phase I clinical trials of V1003 have been conducted and havedemonstrated rapid attainment of potentially efficacious plasma levels with agood tolerability profile. These qualities, together with the well demonstratedsafety of buprenorphine, aim to offer patients and physicians a drug that isexpected to be superior to currently marketed products and those known to be indevelopment. About BuprenorphineBuprenorphine, a partial mu-opioid agonist which has been in clinical use forover 25 years, has been found to be amenable to new formulation technology basedon its physiochemical and pharmacological profile. Buprenorphine is marketed asparenteral, sublingual and transdermal formulations. Unlike full mu-opioidagonists, at higher doses, buprenorphine's physiological and subjective effects,including euphoria, reach a plateau. This ceiling may limit the abuse potentialand may result in a wider safety margin. Buprenorphine has been used for thetreatment of acute and chronic pain, as a supplement to anesthesia and forbehavioral and psychiatric disorders including treatment for opioid addiction. About Vicodin(R)Vicodin(R) is the brand name for the combination of acetaminophen (Tylenol) andhydrocodone and is prescribed for moderate to moderately severe pain.Hydrocodone binds to the pain receptors in the brain so that the sensation ofpain is reduced. Acetaminophen halts the production of prostaglandins whichotherwise cause pain. Vicodin(R) is available in tablet, capsule and liquid formand is taken every 4-6 hours by mouth. Since hydrocodone can be habit forming,care must be taken to follow the doctor's instructions when taking Vicodin(R). About VernalisVernalis is a specialty pharmaceutical company focused on products marketed tospecialist neurologists. The Company has two marketed products, Frova(R) andApokyn(R), and a development pipeline focused on neurology and central nervoussystem disorders. The company has six products in clinical development andcollaborations with leading, global pharmaceutical companies including Novartis,Biogen Idec and Serono. Vernalis has established a U.S. commercial operation topromote Apokyn(R) and co-promote Frova(R) alongside its North American licensingpartner, Endo Pharmaceuticals, propelling the Company towards its goal ofbecoming a sustainable, self-funding, R&D-driven, specialty pharmaceuticalcompany. For further information about Vernalis, please visit www.vernalis.com. About Archimedes PharmaArchimedes is a European specialty pharmaceutical company. In addition to itscommercial activities, Archimedes has an established development organizationwith a suite of world-class drug delivery technologies and a number of productsin development. Archimedes' patented ChiSys(R), PecSys(TM) and TARGIT(R)technologies have been validated in a series of programmes with pharmaceuticaland biotechnology companies and are available to potential partners for existingand new therapeutic products. For further information about Archimedes, pleasevisit www.archimedespharma.com. Safe Harbour statement: this news release may contain forward-looking statementsthat reflect the Company's current expectations regarding future events.Forward-looking statements involve risks and uncertainties. Actual events coulddiffer materially from those projected herein and depend on a number of factorsincluding the success of the Company's research strategies, the applicability ofthe discoveries made therein, the successful and timely completion of clinicalstudies, the uncertainties related to the regulatory process, the successfulintegration of completed mergers and acquisitions and achievement of expectedsynergies from such transactions and the ability of the Company to identify andconsummate suitable strategic and business combination transactions. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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