Novartis investigates death of Gilenya patient

Mon Dec 12, 2011 12:02pm EST

* Patient dies one day after initiating Gilenya therapy

* No evidence yet on whether death was linked to drug

ZURICH Dec 12 (Reuters) - Swiss drugmaker Novartis said on Monday it was investigating whether its multiple sclerosis pill Gilenya, a potential blockbuster, caused the death of a 59-year-old patient who had just initiated therapy with the drug.

Novartis said the patient, who had been suffering from multiple sclerosis for over 10 years, died on Nov. 23, one day after receiving his first dose of Gilenya, also known as fingolimod, confirming a research note from broker Bernstein.

"At this stage, the exact cause of death has not been established, and a role for Gilenya can neither be confirmed nor excluded at this time," company spokesman Eric Althoff said.

"This is the first reported death event occurring within 24 hours of the first dose of Gilenya in more than 28,000 patients who have received fingolimod to date," he said.

The patient had been monitored for six hours without incident. "Gilenya can temporarily slow the heart rate but this usually returns to normal after a few hours," Althoff said.

Gilenya is a potential multibillion-dollar seller that could help Novartis cope with price pressures and competition from generics. Broker Bernstein expects Gilenya sales to rise to $1.4 billion by 2015 from $385 million this year.

"If uptake of the drug were to falter -- either because of new safety issues or because of intensified competition -- it could dent sentiment on Novartis but it would not likely have a substantial impact on the company's overall financial health," Bernstein analysts said in a note.

The European Commission approved Gilenya in spring for people with highly active relapsing-remitting multiple sclerosis (RRMS), the commonest form of the debilitating disease.

More than 500,000 people in the European Union live with MS, a neurological condition that leads to a range of complex and unpredictable symptoms.

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