UK drugmaker Shire says that it has launched Lialda, its new treatment for mild-to-moderate ulcerative colitis, in the USA.
The US Food and Drug Administration granted marketing approval for Lialda (mesalamine) in January to treat the condition which is a type of inflammatory bowel disease that produces inflammation and sores or ulcers along the inside of the large intestine. About half a million Americans have the disorder.
Lialda, which is known in Europe as Mezavant, is available for oral administration in dosages of 2.4 and 4.8 g/day, allowing patients to take as few as two tablets once daily and Shire noted that other currently available mesalamines require three to four times daily dosing and six to 16 pills a day. A study found that patients who are not compliant with their mesalamine medications have a five-fold greater risk of disease flares.
Shire licensed the exclusive rights to Lialda from Italian firm Giuliani in North America, Europe (excluding Italy) and the Pacific Rim. The drug uses MMX technology, which delays the release of the medication to the colon and was developed by Milan-based Cosmo Pharmaceuticals.
Acquisition of New River moves a step nearer
Meantime, Shire also announced that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act had ended for its proposed $2.6 billion acquisition of New River Pharmaceuticals. The purchase still needs to be approved by Shire shareholders and meet other conditions.