6th Apr 2005 11:18
Shire and Noven announce positive clinical data for transdermal ADHD treatment Embargoed until08:00 ET / 13:00 BSTBasingstoke UK and Philadelphia, US - April 6, 2005 - Shire PharmaceuticalsGroup plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) today announced positivepreliminary results from clinical trials of its methylphenidate transdermalsystem* (MTS) which is being developed in conjunction with NovenPharmaceuticals Inc. for children with attention deficit and hyperactivitydisorder (ADHD).These trial results will be included as part of an amendment to the New DrugApplication for the product currently pending at the FDA. Both Shire and Novenbelieve that the studies will address the issues raised by the FDA's review inApril 2003. The FDA has previously confirmed that the amendment will bereviewed within six months after submission.The two studies, a phase 2 study involving 79 patients over a seven week periodand a phase 3 study involving 268 patients over a seven week period, examinedMTS in children between the ages of 6 and 12 previously diagnosed with ADHD. Inthese studies, use of MTS was well tolerated and the objectives of both studieswere achieved.Shire will release additional details of the trial results following furtheranalysis and as part of an R&D update** in May 2005.Matthew Emmens, Chief Executive Officer of Shire said: "These resultsdemonstrate that MTS has the potential to provide significant benefits forchildren with ADHD, especially those that have difficulty taking oralmedications and those that find a once-a-day patch more appropriate for theirlifestyle. As the ADHD market develops, new choices of treatment are emerging,including specialized delivery systems (such as MTS) to meet the needs ofdifferent patients. Shire aims to have a range of medicines in its ADHDportfolio, with ADDERALL XR‚® being the most prescribed treatment for ADHD inthe US. If approved, this product will be a strong addition and we look forwardto advancing its development further."Robert Strauss, Noven's President, CEO & Chairman said: "Today's news is animportant step forward in the development of our methylphenidate patch. Thenext step is preparation of an amendment to the pending New Drug Application,and we expect to be working closely with our partner Shire to achieve thatgoal."Robert Findling, M.D., Professor of Psychiatry at Case Western ReserveUniversity in Cleveland, Ohio commented: "Methylphenidate has been shown to bean effective treatment, used orally, for children with ADHD for decades. Uponapproval, MTS holds the promise of being a welcome additional treatment optionfor children with ADHD."Shire acquired the worldwide sales and marketing rights to MTS from Noven inFebruary 2003.For further information please contact:Investor Relations Clƒ©a Rosenfeld (Rest of the World) +44 1256 894 160 Brian Piper (North America) +1 484 595 8252 Media Jessica Mann (Rest of the World) +44 1256 894 280 Matthew Cabrey (North America) +1 484 595 8248 Notes to editors*Formerly referred to as METHYPATCH‚®** Details of the Shire R&D update will be issued in due courseThe Methylphenidate Transdermal SystemThe most common adverse events reported by patients who received themethylphenidate transdermal system in previous clinical trials were:application site reactions such as skin redness, insomnia (difficultysleeping), anorexia (loss of appetite), headache, abdominal pain, suddenchanges in emotions, viral infection (symptoms of a virus), vomiting, weightloss, nervousness, twitching, increased cough, inflammation of the nose,inflammation of the throat, irritability, overall body discomfort, apathy (lackof interest or emotion), fever, anxiety, impaired body movement, and accidentalinjury.Preliminary evaluation of adverse events seen in the two trials referenced inthis press release included abdominal pain, anorexia (loss of appetite),application site reactions, headache, insomnia, and nausea.About Adderall XRThe most common adverse events in pediatric trials included loss of appetite,insomnia, abdominal pain, and emotional lability. The most common adverseevents in the adult trial included dry mouth, loss of appetite, insomnia,headache, and weight loss.The effectiveness of ADDERALL XR for long-term use has not been systematicallyevaluated in controlled trials. As with other psychostimulants indicated forADHD, there is a potential for exacerbating motor and phonic tics andTourette's syndrome. A side effect seen with the amphetamine class ispsychosis. Caution also should be exercised in patients with a history ofpsychosis.Abuse of amphetamines may lead to dependence. Misuse of amphetamine may causesudden death and serious cardiovascular adverse events. ADDERALL XR generallyshould not be used in children or adults with structural cardiac abnormalities.ADDERALL XR is contraindicated in patients with symptomatic cardiovasculardisease, moderate to severe hypertension, hyperthyroidism and glaucoma, knownhypersensitivity to this class of compounds, agitated states, history of drugabuse, or current or recent use of MAO inhibitors. ADDERALL XR should beprescribed with close physician supervision.Shire Pharmaceuticals Group plcShire is a global specialty pharmaceutical company with a strategic focus onmeeting the needs of the specialist physician and currently focuses ondeveloping projects and marketing products in the areas of central nervoussystem (CNS), gastrointestinal (GI), and renal diseases. Shire has operationsin the world's key pharmaceutical markets (US, Canada, UK, France, Italy, Spainand Germany) as well as a specialist drug delivery unit in the US.For further information on Shire, please visit the Company's website: www.shire.com"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF1995Statements included herein that are not historical facts are forward-lookingstatements. Such forward-looking statements involve a number of risks anduncertainties and are subject to change at any time. In the event such risks oruncertainties materialize, Shire's results could be materially affected. Therisks and uncertainties include, but are not limited to, risks associated withthe inherent uncertainty of pharmaceutical research, product development,manufacturing and commercialization, the impact of competitive products,including, but not limited to, the impact of those on Shire's Attention Deficit& Hyperactivity Disorder (ADHD) franchise, patents, including but not limitedto, legal challenges relating to Shire's ADHD franchise, government regulationand approval, including but not limited to Health Canada's suspension ofADDERALL XR sales in Canada and the expected product approval dates ofMETHYPATCH‚® (MTS) (ADHD), SPD503 (ADHD), SPD 465 (ADHD), SPD 476 (ulcerativecolitis), and NRP104 (ADHD), including its scheduling classification by theDrug Enforcement Agency in the United States, Shire's ability to secure newproducts for development, and other risks and uncertainties detailed from timeto time in Shire's filings with the Securities and Exchange Commission,including its Annual Report on Form 10-K for the year ended December 31, 2004.Noven Pharmaceuticals, Inc.Noven Pharmaceuticals, Inc., headquartered in Miami, Florida, is a leadingdeveloper of advanced transdermal drug delivery technologies and prescriptiontransdermal products. Noven's prescription patches are sold in over 30countries, and a range of new patches are being developed in collaboration withNovartis Pharma AG, Shire Pharmaceuticals Group plc, P&G Pharmaceuticals, EndoPharmaceuticals Inc. and others. With the most advanced and broadly applicabletransdermal technology in its class, Noven is committed to expanding theuniverse of available transdermal therapies for the benefit of patients,partners and shareholders. See www.noven.com for additional information.Page 2 of 3Shire Pharmaceuticals Group plc Hampshire International Business Park Chineham Basingstoke Hampshire RG24 8EP United Kingdom Tel +44 (0)1256 894000 Fax +44 (0)1256 894708 www.shire.com Press Release Registered in England 2883758 Registered Office as aboveENDShire Pharmaceuticals Group PLCRelated Shares:
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