Irish drugs firm Elan and its US partner Biogen Idec today announced new data on the global utilization, safety and overall patient exposure of the multiple sclerosis (MS) drug Tysabri.

As of late December 2007, more than 21,000 patients were on commercial and clinical therapy worldwide. To date, the firms say that the safety data continue to support a favourable benefit-risk profile for Tysabri. These data will be presented Monday at the 26th Annual JPMorgan Healthcare Conference in San Francisco.

According to data available to the companies as of late December 2007:

-- In the US, approximately 12,900 patients were on Tysabri therapy commercially and approximately 2,500 physicians have prescribed the therapy;

-- Internationally, approximately 7,500 patients were on Tysabri therapy commercially;

-- In global clinical trials, approximately 700 patients were on Tysabri therapy; and

-- There have been no cases of progressive multifocal leukoencephalopathy (PML) since re-launch in the US and launch internationally in July 2006.

In addition, as of mid-December 2007:

-- Cumulatively, in the combined clinical trial and postmarketing settings, up to 30,900 patients have been treated with Tysabri; and

-- Of those patients, up to 6,300 have received at least one year of Tysabri therapy.

Tysabri is available in the United States through the TOUCH. Safety information is also collected through ongoing clinical trials and registries, including TYGRIS and the pregnancy registry, making this the largest long-term patient follow-up effort undertaken for any MS therapy, according to the firms

Before initiating treatment, all US patients, prescribers and infusion sites must be enrolled in the TOUCH Prescribing Program (Tysabri Outreach: Unified Commitment to Health). TOUCH is designed to determine the incidence of and risk factors for serious opportunistic infections (OIs), including PML, and to monitor patients for signs and symptoms of PML while promoting informed benefit-risk discussions prior to initiating Tysabri treatment. 

Tysabri sales revenue was almost $100m in the three months from July to September 2007.