Shire says it disagrees with agency's decision not to allow drugs for mild Alzheimer's disease patients

By E. Janene Geiss

Philadelphia, Jan. 23 - Shire plc said Monday that it agrees with the National Institute for Health and Clinical Excellence announcement that Alzheimer's disease drugs should remain available for patients already prescribed treatment and for new patients diagnosed with moderate Alzheimer's disease while the agency conducts a review of the drugs.

But the company said it disagrees with the institute's decision not to allow prescription of these drugs for new patients diagnosed with mild Alzheimer's disease until their condition deteriorates, according to a company news release.

Shire said it will work with other stakeholders to make the case that patients with mild Alzheimer's disease should also continue to have access to these drugs, officials said.

"Shire is encouraged that the new NICE appraisal consultation document ... acknowledges that the acetylcholinesterase inhibitor class of drugs are both clinically effective and cost-effective for the treatment of moderate Alzheimer's disease and that they will remain available," John Freeman, managing director of Shire Pharmaceuticals' U.K. operation, which markets Reminyl and Reminyl XL, said in the release.

Freeman added that the company will express its concern to the agency.

"All the acetylcholinesterase inhibitors are licensed to treat mild to moderately severe Alzheimer's disease patients. Clinical trials demonstrate that mild Alzheimer's disease patients improve cognition skills above their baseline score more than patients with moderate Alzheimer's disease. There is also evidence in clinical practice that patients initiated on treatment earlier have a cumulative advantage in that the progression of their disease is slowed with patients remaining stable for longer and with some patients retaining treatment benefits for years," Ian Howe, Shire's medical director, said in the release.

The consultation period closes on Feb. 13, officials said.

Shire, based in Basingstoke, England, is a specialty pharmaceutical company that focuses developing drugs for conditions of the central nervous system and gastrointestinal disorders, along with general products and human genetic therapies.

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