Long-Term Safety Data on Lialda (mesalamine) for Patients With Ulcerative Colitis Published in Leading GI Journal
BASINGSTOKE, UK and PHILADELPHIA, US June 17, 2008 /PRNewswire-FirstCall/ -- Shire Limited , the global specialty biopharmaceutical company, today announced the publication of data from a randomized, long-term safety and tolerability study (study 303) of ulcerative colitis (UC) drug Lialda(TM) (mesalamine). The primary endpoints of this study were to assess the safety and tolerability of Lialda in mild-to-moderate UC patients over 12 months. Data were published in the July issue of Gut, the official journal of the British Society of Gastroenterology, a leading international journal in gastroenterology.
"This published data demonstrates that Lialda is generally well tolerated and has a strong safety profile," said Gary R. Lichtenstein, MD, co-author of study 303 and director of the Center for Inflammatory Bowel Diseases at the Hospital of the . "Not only does this data demonstrate Lialda's safety and tolerability, but secondary endpoints from the maintenance phase of the 303 study show that a majority of patients on Lialda continued to remain in remission through 12 months."
Specifically, the primary endpoints of the Phase III, open-label, 12-month extension study were to evaluate the safety and tolerability of Lialda dosed once (2.4g/day) or twice daily (1.2g twice daily) over 12 months, including adverse events (AEs), treatment exposure, and time to withdrawal. AEs refer to any untoward medical occurrence that happens in a clinical trial patient. AEs can be "treatment-related" (TRAEs) and occur as a result of the study drug or they can be considered unrelated to the study drug. In study 303, all AEs were classified in one of three categories according to severity: mild, moderate, or severe.
Results of the study showed Lialda demonstrated a good safety profile, with 37.9 percent of patients (safety population n=459) experiencing AEs, the majority of which were mild or moderate in intensity. Treatment-related AEs were experienced by a total of 10.2 percent of patients [11.1 percent of patients (n=225) in the once-daily group and 9.4 percent of patients (n=234) in the twice-daily group]. A total of 3.9 percent of patients experienced serious AEs [4 percent of patients (n=225) in the once-daily group and 3.8 percent of patients (n=234) in the twice-daily group], most of which were gastrointestinal disorders, and only one serious AE was considered to be related to study treatment.
The secondary endpoints of the study evaluated maintenance of remission and relapse rates over 12 months. In the efficacy population at entry (month 0), 78.1 percent of patients (n=219) in the once-daily group and 82.3 percent of patients (n=232) in the twice-daily group were in clinical and endoscopic remission. At month 12, 64.4 percent of patients in the once-daily and 68.5 percent of patients in the twice-daily group were in strictly defined clinical and endoscopic remission (P=0.351). Thus, there was no significant difference between the once-daily and twice-daily groups with respect to strictly defined clinical and endoscopic remission at month 12. Further, 88.9 percent and 93.2 percent of patients in each group, respectively, had maintained clinical remission and were considered "relapse-free".
A total of 459 patients were enrolled and randomized in the 303 long-term safety study (246 directly from the parent studies 301 and 302 -- Lialda's eight-week, Phase III, placebo-controlled trials that demonstrated efficacy for the induction of remission in active, mild to moderate UC -- and 213 patients who received an additional 8 weeks of treatment with Lialda 4.8 g/day to induce remission). Remission was defined using stringent clinical and endoscopic measures: modified UC Disease Activity Index (UC-DAI) score of .1, with scores of 0 for rectal bleeding and stool frequency, and a combined Physician's Global Assessment and sigmoidoscopy score of .1 with a sigmoidoscopy score reduction of .1 point from baseline and no mucosal friability.
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 eight 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 (three 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.
For further information please contact: Investor Relations Clea Rosenfeld (Rest of the World) +44 1256 894 160 Eric Rojas (North America) +1 484 595 8252 Media Blythe Bertolo (GolinHarris on behalf of Shire) +1 312 729 4463 Matthew Cabrey (North America) +1 484 595 8248 Jessica Mann (Rest of the World) +44 1256 894 280 Notes to editors
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 Web site: http://www.shire.com.
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 velaglucerase 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 Ltd's filings with the Securities and Exchange Commission, particularly Shire Ltd'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 registered trademark owned by Cosmo Technologies Ltd, Ireland, a wholly-owned subsidiary of Cosmo Pharmaceuticals SpA.
CONTACT: investors, Clea Rosenfeld, Rest of the World, +44 1256 894 160,Eric Rojas, North America, +1-484-595-8252, both of Shire Limited; ormedia, Blythe Bertolo of GolinHarris, +1-312-729-4463, for Shire Limited;or Matthew Cabrey, North America, +1-484-595-8248, or Jessica Mann, Rest ofthe World, +44 1256 894 280, both of Shire Limited
Web site: http://www.shire.com/
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Posted: June 2008