Shire plc, the global specialty biopharmaceutical company, announced a co-promotion agreement with TAP Pharmaceutical Products Inc. for Lialda (mesalamine) with MMX technology, indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis (UC).
This three year agreement is for the US only and will add more than 500 additional sales representatives from TAP to increase the reach and frequency of the Shire sales force, which consists of 120 representatives who are currently detailing Lialda primarily to gastroenterologists, a Shire press release stated.
"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 United States," said Mike Yasick, senior vice president of Shire's Gastrointestinal Business Unit. "With the added expertise of the TAP team, we'll be able to reach more GI specialists as well as primary care providers with messages about Lialda. Shire's GI team has made Lialda the fastest growing brand of mesalamine and with this collaboration we will bolster the frequency of sales calls to our existing base of specialist physicians."
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 April 2008. Shire shall compensate TAP based upon TAP's success under the co-promotion agreement. Upon dissolution of the TAP joint venture, Takeda will promote Lialda under the agreement.
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 commercialize Lialda in the US, Canada, Pacific Rim and Europe (excluding Italy). Lialda is known as Mezavant XL in the UK and Ireland, and Mezavant elsewhere outside of the US. Giuliani SpA retains the development and commercialization rights in Italy. Cosmo Pharmaceuticals SpA, Milan, developed the MMX technology.