"Reuters" cites a Danish study which claims that expensive treatments made for a genetic disorder called alpha-1 antitrypsin (AAT) deficiency should be withdrawn because the drugs have no benefit. Kamada Ltd. (TASE: KMDA) is one of the company's that produces such a treatment. Its intravenous AAT treatment, Glassia, obtained US Food and Drug Administration (FDA) marketing approval last week.
Kamada's share price dropped 9.4% by early afternoon on the TASE to NIS 20.31, giving a market cap of NIS 610 million.
The study, led by Peter Gotzsche of the Nordic Cochrane Center at Rigshospitalet in Copenhagen, Denmark, reviewed data from two trials on 140 patients. It concluded that the drugs do no good. The researchers concluded that the treatment, which costs up to $150,000 a year in the US, should not be recommended by doctors and advocacy groups.
The study reviewed AAT treatments developed by Kamada, Talecris Biotherapeutics Holdings Corporation (Nasdaq: TLCR), Australia's CSL Ltd. (ASX: CSL), and Baxter International Inc. (NYSE: BAX). The study, published in The Cochrane Library journal, calls recommendations for AAT replacement therapy by the American Thoracic Society and European Respiratory Society as "misguided",
In one trial, patients were given intravenous AAT or a placebo every four weeks for three years and in the other, the treatment or a placebo was given weekly for a minimum of two years. The study concluded that there was no difference between treatment and control groups in terms of exacerbations of lung disease, or quality of life.
AAT deficiency affects less than one in 1,600 people. People who inherit the disorder have low levels of the protein AAT, also called alpha-1 proteinase inhibitor, which protects the tissue of the lungs from destruction by the body's own white blood cells. AAT replacement therapy aims to give the patient back the missing protective protein, in order to limit damage to lungs and prevent early death. The protein is usually extracted from blood donated by healthy volunteers.
Published by Globes [online], Israel business news - www.globes-online.com - on July 8, 2010
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