Pharma Naming

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Biogen Idec, Elan withdraw Tysabri
Biogen Idec Inc. and Elan Corp. Plc voluntarily suspended marketing of Tysabri (natalizumab), a multiple sclerosis treatment, after a patient receiving the drug in a clinical trial died. News of the suspension pushed both companies' shares down by 45.1 percent and 67.4 percent, respectively, in heavy afternoon trading.

The two firms stopped supply of the drug from commercial distribution, as well as dosing in all clinical trials. They also sent a letter to health care professionals advising them to suspend dosing of Tysabri until further notification.

The decision to withdraw the drug was made after consultation with the Food and Drug Administration regarding recent reports of two serious adverse events occurring in patients being treated with a combination of Tysabri and Biogen Idec's Avonex (interferon beta-1a) for more than two years in clinical trials.

One patient died of progressive multifocal leukoencephalopathy (PML), a rare and often fatal disease of the central nervous system, and it is believed another patient may have developed the same disease. Neither patient had a history of immunosuppression. PML was first considered when progressive neurological deterioration and MRI findings atypical for MS were observed.

Approximately 3,000 patients have received Tysabri so far in clinical trials of the drug for the treatment of MS, Crohn's disease and rheumatoid arthritis. Biogen Idec and Elan said they have not received reports of PML among MS patients who were receiving Tysabri monotherapy or in patients with Crohn's disease or rheumatoid arthritis during these trials, nor has Biogen Idec received reports of PML development in patients treated with Avonex monotherapy.

Both companies plan to work with clinical investigators to evaluate patients treated with Tysabri and the possible risk of PML. Results from these evaluations will be used to determine whether the drug's dosing in the clinical trials should be re-initiated and if the drug will return to the market.

"Because we believe in the promising therapeutic benefit of Tysabri, we are working to evaluate this situation thoroughly and expeditiously," said Dr. Burt Adelman, an executive vice president at Biogen Idec. "While we work through this matter, we must place patient safety above all other considerations."

Based on one-year data from two Phase III trials, Tysabri received accelerated approval from the FDA in November for treating MS. Two-year results were not expected until the first half of this year.

The Wall Street Journal reported in November that analysts expected the drug to possibly generate more than $2 billion in annual sales throughout the next two years. Sales of Avonex grew to $1.42 billion last year and, according to a report by Reuters earlier this month, Biogen Idec had expected Tysabri to attain a similar level of sales by the end of 2007.

Elan told Reuters Monday that it will probably adjust its 2005 forecasts within the next 10 days.

Shares of Biogen Idec were at $36.93, down $30.35, on the Nasdaq, while shares of El

Pharma Naming