Business and Finance
"Aligning with TAP, one of the most successful and well-respected GI
sales organizations in the industry, is a tremendous benefit for Shire as it
will quadruple the Lialda sales force across the
LIALDA is the first and only FDA-approved once-daily oral formulation of mesalamine indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. Mesalamines are a part of a drug class called aminosalicylates, which contain 5-aminosalicyclic acid (5-ASA), a well-established drug of choice and often a first-line treatment for patients with mild to moderate ulcerative colitis.
"Building on the successful introduction of Lialda, which Shire launched in the first quarter of last year, we are excited to work with the Shire team as together we take this medicine to the next level, increasing awareness among key physicians of the distinguishing benefits of this once-daily treatment for patients diagnosed with mild to moderate ulcerative colitis," said Tim Rudolphi, vice president of TAP's Gastroenterology Marketing Franchise. "This connection with Shire is a natural fit for our sales force, and is a win for all involved, especially the patient population who may benefit most."
Once-daily LIALDA with MMX technology contains the highest mesalamine dose per tablet (1.2 g), so patients can take as few as two tablets once daily. Other currently available mesalamines require three to four times daily dosing and 6 to 16 pills a day.
The TAP sales force will begin detailing LIALDA to specialists and
targeted primary care physicians in
About LIALDA
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 ulcerative colitis. LIALDA is indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. 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.
Shire has licensed from Giuliani SpA the exclusive rights to develop and
commercialise LIALDA in the US,
For more information about LIALDA and for Full Prescribing Information, please visit http://www.LIALDA.com
Important Safety Information
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 (four percent, 2.8 percent and 2.8 percent, respectively). Pancreatitis occurred in less than one percent of patients during clinical trials and resulted in discontinuation of therapy with LIALDA.
Notes to Editors
Shire plc
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
For further information on Shire, please visit the Company's website: http://www.shire.com.
"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 TGFbeta3) and veleglucerase alfa (GA-GCB);
manufacturing and commercialisation including, but not limited to, the
establishment in the market of YVANSE(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 commercialisation 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
About TAP Pharmaceutical Products Inc.
TAP Pharmaceutical Products Inc., located in Lake Forest, Ill., is a
joint venture between Abbott, headquartered in Abbott Park, Ill., and Takeda
Pharmaceutical Company Limited, of
|
|