Shire wins LIALDA patient trial against Watson

Shire has won its litigation against Watson Pharmaceuticals, relating to an abbreviated new drug application for a generic version of LIALDA (mesalamine).

The solution is formed of delayed release tablets to induct remission in adults with active, mild-to-moderate ulcerative colitis, while it will also maintain the remission of the disease.

After a five-day bench trial in the Southern District of Florida, Judge Middlebrooks issued a ruling upholding the validity of the patent covering LIALDA (the ‘720 patent), while holding that the proposed ANDA formulation infringes the claims of the patent.

Judge Middlebrooks explained that Shire is entitled to an injunction, which he will issue separately to prohibit the FDA from approving the ANDA formulation until the ‘720 patent expires.

Roger Adsett, head of Shire’s GI Business Unit, said: “Shire is very pleased that the court has ruled in our favour. We rely on our patents to be able to continue to invest in therapies that bring value to our patients and their caregivers. This ruling supports the innovative therapies that we develop in order to improve the lives of ulcerative colitis patients.”

Shire is focussing on developing and marketing innovative speciality medicines to meet substantial unmet patient requirements.

It provides treatments in neuroscience, rare diseases, gastrointestinal, internal medicine and regenerative medicine, along with solutions for symptomatic conditions in other therapeutic fields.

Recently, Shire’s new chief executive Flemming Ornskov outlined a strategy of growth for the business, explaining that it is introducing a flatter and more scalable structure, while its business development will be focussed on later stage assets in a bid to grow sales in Latin America and Asia.

Mr Omskov noted that the company will work to achieve commercial excellence and develop its pipeline of medicines through improved research and business development practices.

Posted by Fiona Griffiths