Shire hit by safety worries over Alzheimer's treatment

US drug regulators will examine data this week which shows a higher death rate among elderly people trialling Shire Pharmaceuticals' Alzheimer's disease drug, Reminyl.

US drug regulators will examine data this week which shows a higher death rate among elderly people trialling Shire Pharmaceuticals' Alzheimer's disease drug, Reminyl.

Health authorities in 69 countries are being presented with the latest analysis of trial results, a revelation which sent Basingstoke-based Shire's shares down nearly 2 per cent yesterday.

Three times as many patients using Reminyl died during the course of a two-year study completed last August, as those on a placebo, and additional data also showing higher mortality with Reminyl was published last week.

The studies involve people suffering mild senility, because Shire and its development partner Johnson & Johnson had hoped to use the results to extend Reminyl's use beyond Alzheimer's. The results showed no significant benefit to patients.

Shire shares dropped 12p to 625p as it looked increasingly unlikely that the drug would now be used in milder conditions. Investors were also fearful of the damage that publicity for the studies could do to sales.

City analysts and doctors warned against reading too much into the mortality statistics, particularly since the patients were mainly in their seventies and died from a range of causes, and even the placebo group showed a mortality rate below average.

But authorities in Canada and Sweden demanded more information to judge if there could be a link between Reminyl and the higher death rate seen compared with the placebo group.

A meeting with the Food and Drug Administration (FDA) is planned for this week, the outcome of which will be crucial to the fortunes of the drug in the lucrative US market. The FDA has not requested additional information since seeing the original trial data last year.

J&J said it was analysing additional data from the studies, including from subjects who had dropped out of the trials, and would discuss the results with health authorities.

Reminyl will no longer be pursued as a possible senility treatment, J&J said, but stays on the market as an Alzheimer's pill. Earlier trials in Alzheimer's did not show any increased mortality. Shire is not pushing for the extension of Reminyl's use in the UK, the one country where it is not partnered with J&J.

About 3 per cent of Shire's revenues come from royalties on Reminyl, which was developed from daffodil bulbs.

Kerry Holford, an analyst at Lehman Brothers, said: "With no clear benefit in mild cognitive impairment and questions over increased mortality risk, we believe the likelihood of any label expansion for Reminyl is ever diminishing. These studies may cause some physicians and patients to reconsider Reminyl therapy for Alzheimer's and other dementia-related diseases. As such, there is a risk that current Reminyl sales will suffer."

Even after yesterday's setback, Shire's shares have risen 14 per cent since the start of the year. The company is close to making the first use of its £700m cash pile, licensing in a new attention deficit drug from New River Pharmaceuticals of the US. The two sides are in exclusive talks over the financial details, although New River can begin talking with other potential partners from next week.