Israel-Medical-Healthcare

[midastouch017]

Kamada’s API wins EMEA OK for cystic fibrosis trial
Last week, the EMEA approved the drug for Phase II and III trials to treat congenital emphysema.
Gali Weinreb 8 Jul 07 16:23
Kamada Ltd. (TASE: KMDA) has obtained European Medicines Agency (EMEA) approval for Phase II clinical trials of the company’s company’s flagship product, an inhalable Alpha-1 Antitrypsin (AAT) drug Alpha-1 Proteinase Inhibitor (API) for the treatment of cystic fibrosis.
Last week, the EMEA approved the drug for Phase II and III trials to treat congenital emphysema. This is a very rare disease affecting 5,500 persons worldwide. Cystic fibrosis is known to affect 70,000 persons, and the actual number is probably much higher.

Inhalable API is Kamada’s only product with no corresponding drug on the market. Until now, the company has focused API’s development for congenital emphysema, while deferring its development for cystic fibrosis. The decision to proceed with clinical trials of API for the disease is therefore something of a surprise. In fact, there is little reason to do, because API will be approved for cystic fibrosis even before it is approved for the treatment of congenital emphysema. Approval for treating both diseases is expected before 2009.

Kamada CEO David Tsur said the company may register API for the treatment of other lung diseases in the future.

IBI analyst Noa Weisberg gives Kamada a “Buy” recommendation with a target price of NIS 40-50, compared with it current price of NIS 35.60. She says that Kamada is now targeting a much larger market than before. She cautions, however, by noted that there are already available inhalable treatments for cystic fibrosis, which cost $10,000-15,0000, and that Kamada’s treatment is liable to be more expensive.

In contrast, there are no available inhalable treatments for congenital emphysema, and existing treatments cost more than $60,000 per patient, which could give it an edge in the market. Another problem is that Kamada may not have enough of the active pharmaceutical ingredient (API) for inhalable API to treat all cystic fibrosis patients.

Published by Globes [online], Israel business news - www.globes.co.il - on July 8, 2007