Israel-Medical-Healthcare

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Kamada to start Phase III API trial in third quarter

The ingredient for treating panacinar emphysema is one of the drugs on which Kamada bases its future.

Gali Weinreb 24 Jan 06 12:49

Israeli company Kamada announced on Sunday that it had obtained US Food and Drug Administration (FDA) authorization to begin Phase III clinical trials for an active pharmaceutical ingredient (API). The company has already started production. The trials are not expected to begin before the third quarter of the year, subject to final FDA approval. According to a protocol already approved by the FDA, the trial will include only 50 patients.
The API, designed to treat panacinar emphysema, is one of the drugs on which Kamada is basing its future.

For Kamada, any registration of a drug for marketing in the US is significant. Most of the company’s sales up until now have been in Third World countries. Kamada recently invested in upgrading its laboratories and its plant, in order to carry out its plan to market its products at much higher prices in the US and Europe.

If Kamada obtains final FDA approval for the API trial, it will be the first sign that the company’s gamble has succeeded.

Published by Globes [online] - www.globes.co.il - on January 24, 2006

http://www.globes.co.il/serveen/globes/docview.asp?did=1000053695&fid=942

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