Analysis of Ulcerative Colitis (UC) Time to Symptom Resolution Data from Pivotal Study of Lialda (mesalamine) Presented at DDW
SAN DIEGO, May 20, 2008 /PRNewswire-FirstCall/ -- A post hoc analysis showing time to symptom resolution data from a study (study 302) of Shire plc's ulcerative colitis (UC) drug, LIALDA(TM), will be presented today at Digestive Disease Week (DDW). Study 302 (further referred to as "Kamm study," led by Dr Michael A. Kamm, from St Mark's Hospital in London, UK), demonstrated LIALDA was effective in inducing remission in patients with active, mild to moderate ulcerative colitis compared to placebo and these study results were published in the January 2007 issue of Gastroenterology.
"The time between initiation of therapy and initial symptom resolution is an important endpoint in the treatment of UC for both patients and physicians," said Gary Lichtenstein, director of the Inflammatory Bowel Disease Program at the , investigator on this post hoc analysis. "This analysis was important as it showed LIALDA benefits patients by significantly lowering the time it takes patients to experience relief from their UC symptoms as compared to placebo."
Time to initial symptom resolution on LIALDA
Poster Presentation: May 20, 2008, San Diego Convention Center -- Sails Pavilion, #T1140
A post hoc analysis of the Kamm study (study 302) examined the treatment time required for patients to experience initial symptom resolution over eight weeks. In this analysis, time to initial symptom resolution was assessed as either the time between the first dose of study medication and the first day of symptom resolution (rectal bleeding or normalization of stool frequency or both) or the time between the first dose of study medication and the first day of three consecutive days of symptom resolution. Initial symptom resolution of rectal bleeding, normalization of stool frequency or both was assessed by a modified UC-Disease Activity Index (UC-DAI) scoring system. Resolution of symptoms was defined for both rectal bleeding and stool frequency as a modified UC-DAI sub-score of 0.
Overall, a total of 341 patients with active, mild to moderate UC were analyzed as part of this post hoc analysis of an 8-week study. Patients in the Kamm study received LIALDA 2.4g/day once daily (n=84), 4.8g/day once daily (n=85), Asacol 2.4g/day three times daily (n=86); or placebo (n=86).
The post hoc analysis found that regardless of the definition used for remission, treatment with LIALDA 2.4g/day, or 4.8g/day, or Asacol 2.4g/day resulted in similar median times to symptom resolution that were shorter than placebo. The Kamm study was not designed to compare LIALDA to Asacol. Asacol was included in the study as a reference arm only.
-- Symptom resolution of rectal bleeding at the first day and first of three days, respectively: -- LIALDA 2.4g/day: 9 days and 18 days -- LIALDA 4.8g/day: 9 days and 17 days -- Placebo: 14 days and 35 days -- Normalization of stool frequency at the first day and first of three days, respectively: -- LIALDA 2.4g/day: 20 days and 33 days -- LIALDA 4.8g/day: 23 days and 38 days -- Placebo: 38 days and 53 days -- Resolution of both rectal bleeding and normalization of stool frequency at the first day and first of three days, respectively: -- LIALDA 2.4g/day: 27 days and 37 days -- LIALDA 4.8g/day: 29 days and 45 days -- Placebo: 44 days and 56 days
Important Safety Information for LIALDA
LIALDA tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. Safety and effectiveness of LIALDA beyond 8 weeks have not been established.
LIALDA is contraindicated in patients with hypersensitivity to salicylates (including mesalamine) or to any of the components of LIALDA. Caution should be exercised when treating patients with pyloric stenosis or those allergic to sulfasalazine. Mesalamine has been associated with an acute intolerance syndrome (3 percent of patients in clinical trials with mesalamine or sulfasalazine) that may be difficult to distinguish from a flare of inflammatory bowel disease. If acute intolerance syndrome is suspected, prompt withdrawal is required.
Mesalamine-induced cardiac hypersensitivity reactions (myocarditis and pericarditis) have been reported. Reports of renal impairment have been associated with mesalamine medications. In patients with renal impairment, caution should be exercised, and LIALDA should be used only if the benefits outweigh the risks. No information is available for patients with hepatic impairment.
LIALDA is generally well tolerated. The majority of adverse events in the double-blind, placebo-controlled trials were mild or moderate in severity. In clinical trials (n=535), the most common treatment-related adverse events with LIALDA 2.4g/day, 4.8g/day and placebo were headache (5.6 percent, 3.4 percent and 0.6 percent, respectively) and flatulence (4 percent, 2.8 percent and 2.8 percent, respectively). Pancreatitis occurred in less than 1 percent of patients during clinical trials and resulted in discontinuation of therapy with LIALDA.
For more information about LIALDA and for Full Prescribing Information, please visit http://www.LIALDA.com.
LIALDA is part of a drug class called aminosalicylates, which contain 5- aminosalicyclic acid (5-ASA). 5-ASA is a well-established drug of choice and often a first-line treatment for UC. LIALDA is indicated for the induction of remission in patients with active, mild to moderate UC. The safety and efficacy of LIALDA have been established for up to eight weeks. LIALDA is the first new formulation in this class to be approved since 2000. LIALDA is the only ulcerative colitis treatment that utilizes MMX(R) 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 the inflammation in ulcerative colitis), with a tablet core containing mesalamine with hydrophilic and lipophilic components.
Shire has licensed from Giuliani SpA the exclusive rights to develop and commercialize LIALDA in the US, Canada, Pacific Rim, and Europe (excluding Italy). LIALDA is known as MEZAVANT XL(TM) in the UK and Ireland, and MEZAVANT(R) elsewhere outside of the US. Giuliani SpA retains the development and commercialization rights in Italy. Cosmo Pharmaceuticals SpA, Milan, developed the MMX technology.
Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit and hyperactivity disorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) and renal diseases. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire's in-licensing, merger, and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe. Shire believes that a carefully selected portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.
For further information on Shire, please visit the Company's website: http://www.shire.com.
For further information please contact: Media Sarah McGee (GolinHarris) +1 312 729 4125 Matthew Cabrey (Shire) +1 484 595 8248
DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 17-22, 2008, at the San Diego Convention Center, San Diego, CA. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit http://www.ddw.org.
THE "SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included herein that are not historical facts are forward- looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire's results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of pharmaceutical research, product development including, but not limited to the successful development of JUVISTA(R) (Human TGFB3) and veleglucerase alfa (GA-GCB); manufacturing and commercialization including, but not limited to, the establishment in the market of VYVANSE(TM) (lisdexamfetamine dimesylate) (Attention Deficit and Hyperactivity Disorder ("ADHD")); the impact of competitive products, including, but not limited to, the impact of those on Shire's ADHD franchise; patents, including but not limited to, legal challenges relating to Shire's ADHD franchise; government regulation and approval, including but not limited to the expected product approval date of INTUNIV(TM) (guanfacine extended release) (ADHD); Shire's ability to secure new products for commercialization and/or development; and other risks and uncertainties detailed from time to time in Shire plc's filings with the Securities and Exchange Commission, particularly Shire plc's Annual Report on Form 10-K for the year ended December 31, 2007.
LIALDA(TM) is a trademark of Shire LLC.
MMX(R) is a trademark owned by Cosmo Technologies Ltd, Ireland, a wholly-owned subsidiary of Cosmo Pharmaceuticals SpA.
CONTACT: Sarah McGee of GolinHarris, +1-312-729-4125, for Shire; orMatthew Cabrey of Shire, +1-484-595-8248
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Posted: May 2008