BASINGSTOKE, England and PHILADELPHIA, March 19 /PRNewswire/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) today announced theavailability of LIALDATM (mesalamine) with MMXTM Technology, indicated forthe induction of remission in patients with active, mild to moderateulcerative colitis (UC), a type of inflammatory bowel disease. LIALDA is thefirst and only FDA-approved once daily oral formulation of mesalamine. TheU.S. Food and Drug Administration (FDA) approved LIALDA on January 16, 2007.
LIALDA is available to patients by prescription for oral administrationin dosages of 2.4 g/day and 4.8 g/day, allowing patients to take as few astwo tablets once daily. Other currently available mesalamines require threeto four times daily dosing and six to 16 pills a day. A study found thatpatients who are not compliant with their mesalamine medications have afive-fold greater risk of disease flares, a serious worsening of symptoms,than compliant patients.
"In clinical trials, LIALDA was superior to placebo in inducingremission. Additionally, LIALDA's convenient once daily dosing may helpaddress the compliance issues facing so many ulcerative colitis patients,"said Mike Cola, President of Shire's Specialty Pharmaceuticals business."Shire is pleased to offer this latest advancement in the treatment ofulcerative colitis, which complements our existing GI portfolio andreinforces our commitment to improving the treatment of gastrointestinaldiseases."
"Although not everyone's experience is the same, taking the pills for mydisease seemed to consume my life - my next dosage was constantly on mymind," said Becky Pace, a LIALDA clinical trial patient. "I could not believetaking medication once a day would help as much as it did. LIALDA brought mydisease into remission."
About LIALDA
LIALDA is part of a drug class called aminosalicylates, which contain5-aminosalicyclic acid (5-ASA). 5-ASA is a well-established drug of choiceand often a first-line treatment for UC. LIALDA is indicated for theinduction of remission in patients with active, mild to moderate UC. LIALDAis the first new formulation in this class to be approved since 2000. Thesafety and efficacy of LIALDA has been established for up to eight weeks.LIALDA is the only ulcerative colitis treatment that utilizes MMX Technology.LIALDA with MMX Technology combines a pH dependent gastro-resistant coating,which delays the release of the medication to the colon (the site of theinflammation in ulcerative colitis), with a tablet core containing mesalaminewith hydrophilic and lipophilic excipients.
Shire has licensed from Giuliani SpA the exclusive rights to develop andcommercialize LIALDA in the U.S., Canada, Europe -- known as MEZAVANT(TM) --(excluding Italy) and the Pacific Rim. Giuliani SpA retains the developmentand commercialization rights in Italy. Cosmo Pharmaceuticals SpA, Milan,developed the MMX technology.
LIALDA Effectively Induces Remission
The approval of LIALDA was based on the results of two Phase III clinicalstudies. The first study assessed the efficacy and safety of LIALDA 2.4 g/daygiven in divided doses twice daily and 4.8 g/day given once daily againstplacebo in 262 patients. At eight weeks, both doses demonstrated superiorityover placebo in the induction of remission (34.1 percent with 2.4 g/day, 29.2percent with 4.8 g/day, and 12.9 percent with placebo). These study resultswere recently published in the January 2007 issue of ClinicalGastroenterology and Hepatology.
The second study assessed the efficacy and safety of LIALDA 2.4g/day and4.8g/day (both given once daily) against placebo in 255 patients. At eightweeks, both once daily doses demonstrated superiority over placebo in theinduction of remission (40.5 percent with 2.4 g/day, 41.2 percent with 4.8g/day, and 22.1 percent with placebo). These study results were published inthe January 2007 issue of Gastroenterology.
Important Safety Information
LIALDA tablets are indicated for the induction of remission in patientswith active, mild to moderate ulcerative colitis. Safety and effectiveness ofLIALDA beyond eight weeks have not been established.
LIALDA is contraindicated in patients with hypersensitivity tosalicylates (including mesalamine) or to any of the components of LIALDA.Caution should be exercised when treating patients with pyloric stenosis orthose allergic to sulfasalazine. Mesalamine has been associated with an acuteintolerance syndrome (three percent of patients in clinical trials withmesalamine or sulfasalazine) that may be difficult to distinguish from aflare of inflammatory bowel disease. Symptoms include cramping, acuteabdominal pain and bloody diarrhea, and sometimes fever, headache and rash.If acute intolerance syndrome is suspected, prompt withdrawal is required.Mesalamine-induced cardiac hypersensitivity reactions (myocarditis andpericarditis) have been reported. Reports of renal impairment have beenassociated with mesalamine medications. Caution should be exercised, andLIALDA should be used only if the benefits outweigh the risks. No informationis available for patients with hepatic impairment; therefore caution isrecommended.
LIALDA is generally well tolerated. The majority of adverse events in thedouble-blind, placebo-controlled trials were mild or moderate in severity. Inclinical trials (N=535), the most common treatment-related adverse eventswith LIALDA 2.4g/day, 4.8g/day and placebo were headache (5.6 percent, 3.4percent and 0.6 percent, respectively) and flatulence (four percent, 2.8percent and 2.8 percent, respectively). Pancreatitis occurred in less thanone percent of patients during clinical trials, and resulted indiscontinuation of therapy with LIALDA.
About Ulcerative Colitis
Ulcerative colitis is a type of inflammatory bowel disease that producesinflammation and sores or ulcers along the inside of the large intestine,also called the bowel or colon. The sores may interfere with the normaldigestive process, often causing cramping, bloating, diarrhea, bleeding,fatigue, weight loss and frequent bowel movements. This serious, chronicautoimmune disease affects approximately 500,000 Americans. For moreinformation on ulcerative colitis, visit www.managinguc.com.
Notes to Editors:
SHIRE PLC
Shire's strategic goal is to become the leading specialty pharmaceuticalcompany that focuses on meeting the needs of the specialist physician. Shirefocuses its business on attention deficit and hyperactivity disorder (ADHD),human genetic therapies (HGT), gastrointestinal (GI) and renal diseases. Thestructure is sufficiently flexible to allow Shire to target new therapeuticareas to the extent opportunities arise through acquisitions. Shire believesthat a carefully selected portfolio of products with a strategically alignedand relatively small-scale sales force will deliver strong results.
Shire's focused strategy is to develop and market products for specialtyphysicians. Shire's in-licensing, merger and acquisition efforts are focusedon products in niche markets with strong intellectual property protectioneither in the US or Europe.
For further information on Shire, please visit the Company's website:www.shire.com.
GIULIANI SpA
Giuliani SpA, founded in 1889, is a privately owned specialtypharmaceutical company strategically focused in gastroenterology anddermatology. It is currently marketing proprietary products for the treatmentand management of ulcerative colitis, Crohn's disease, food intolerances anddermatological disorders. Giuliani's R&D pipeline includes new chemicalentities and biotechnological products targeted to treat inflammatory andautoimmune diseases.
COSMO Pharmaceuticals SpA
Cosmo is a speciality pharma company that aims to become a global leaderin optimised therapies for certain gastrointestinal diseases. The company'sproprietary clinical development pipeline specifically addresses innovativetreatments for IBD, such as ulcerative colitis and Crohn's disease, and coloninfections. Cosmo's most advanced development product is LIALDA(TM)/MEZAVANT(TM) a treatment for ulcerative colitis that is licensed globally toGiuliani and Shire Pharmaceuticals. Cosmo's proprietary MMX technology is atthe core of the company's product pipeline and was developed from itsexpertise in formulating and manufacturing gastrointestinal drugs forinternational clients at its GMP (Good Manufacturing Practice) facilities inLainate, Italy. For further information on Cosmo, please visit the Company'swebsite: www.cosmopharmaceuticals.com.
"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORMACT OF 1995
Statements included herein that are not historical facts areforward-looking statements. Such forward-looking statements involve a numberof risks and uncertainties and are subject to change at any time. In theevent such risks or uncertainties materialize, Shire's results could bematerially affected. The risks and uncertainties include, but are not limitedto, risks associated with: the inherent uncertainty of pharmaceuticalresearch, product development, manufacturing and commercialization; theimpact of competitive products, including, but not limited to the impact ofthose on Shire's Attention Deficit and Hyperactivity Disorder (ADHD)franchise; patents, including but not limited to, legal challenges relatingto Shire's ADHD franchise; government regulation and approval, including butnot limited to the expected product approval dates of SPD503 (guanfacineextended release) (ADHD), SPD465 (extended release triple-bead mixedamphetamine salts) (ADHD); Shire's ability to secure new products forcommercialization and/or development; Shire's planned acquisition of NewRiver Pharmaceuticals announced February 20, 2007; and other risks anduncertainties detailed from time to time in Shire's and its predecessorregistrant Shire Pharmaceuticals Group plc's filings with the Securities andExchange Commission, particularly Shire plc's Annual Report on Form 10-K forthe year ended December 31, 2005.
LIALDA is a trademark of Shire LLC.
MMX is a trademark owned by Cosmo Technologies Ltd, Ireland, awholly-owned subsidiary of Cosmo Pharmaceuticals SpA.
Shire PLC
For further information please contact: Investor Relations Cléa Rosenfeld (Rest of the World) +44-1256-894-160; Eric Rojas (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
