Kamada Ltd. (TASE: KMDA) rejects the claims made by a Danish study that treatments alpha-1 antitrypsin (AAT) deficiency related to congenital lung diseases were ineffective. In today's response to Thursday's report, Kamada said that the Danish researchers incorrectly reviewed current medical data that supports AAT replacement therapy, and that there was extensive data demonstrating the treatment's effectiveness.
Earlier this month, Kamada's intravenous AAT treatment, Glassia, obtained US Food and Drug Administration (FDA) marketing approval.
In the response, Kamada provided a range of opinions that completely contradict the Danish study.
Kamada said that Dr. Asger Dirksen, whose name originally appeared as a co-author of the Danish article asked the other authors, Dr. Peter Gotzsche and his wife, Dr. Helle Krogh Johansen, to remove his name from the publication. "After seeing the first draft I realized that our points of view were so far apart that collaboration with Peter Gøtzsche and his wife (Helle Krogh Johansen) would not be possible," said Dirksen, who was the lead researcher in the two studies cited by Gotzsche and Johansen.
On Friday, the Alpha1 Foundation responded to the Danish study, rejecting it out of hand. The Alpha1 Foundation said that the Gotzsche and Johansen study was flawed and partial, and that its conclusions flew in the face of carefully crafted guidelines from the American Thoracic Society, the European Respiratory Society, the American College of Chest Physicians, and the American Association for Respiratory Care.
The Alpha1 Foundation said that AAT augmentation therapy has approved by the FDA for over 20 years.
Kamada's share price rebounded in morning trading from Thursday's plunge, rising 2% to NIS 21.91, giving a market cap of NIS 589 million.
Published by Globes [online], Israel business news - www.globes-online.com - on July 11, 2010
© Copyright of Globes Publisher Itonut (1983) Ltd. 2010