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DewDiligence

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Re: genisi post# 3702

Thursday, 07/05/2007 9:13:10 AM

Thursday, July 05, 2007 9:13:10 AM

Post# of 19309
Kamada’s Inhaled AAT to Start Pivotal Trials

[For background on Kamada’s injectable AAT program, which is already in phase-3, see #msg-10073726. Both the inhaled-AAT and the injectable-AAT programs use AAT derived from plasma.]

http://biz.yahoo.com/bw/070705/20070705005257.html?.v=1

>>
EMEA Approves Kamada's Plans for Phase II / III Clinical Trials of the Aerosolized Form of AAT for the Treatment of Congenital Emphysema

Thursday July 5, 9:01 am ET

NESS ZIONA, Israel--(BUSINESS WIRE)--Kamada (TASE:KMDA), a biopharmaceutical company which develops, manufactures and markets life-saving medicines, has been granted approval by the European Agency for the Evaluation of Medicinal Products (EMEA) for its plans for phase II / III clinical trials of the inhaled version of its Alpha-1 Antitrypsin (AAT) product. AAT is used in treatment of Congenital Emphysema, caused by inborn deficiency of AAT.

Kamada's CEO, David Tsur, stated that this approval marks significant progress in the registration process of AAT, Kamada's flagship product, for inhalation. AAT for inhalation has been designated by both the FDA and the EMEA as an Orphan Drug. This designation grants Kamada a range of support mechanisms such as research fund support, tax incentives, reduced fees and 7 to 10 years of exclusive distribution rights, if the company's product is first on the market. Tsur added that Kamada will accelerate its inhaled AAT related plans to leverage the Orphan Drug designation for penetrating the European market. According to information available to Kamada, it has progressed to the most advanced stages in the development of an inhaled version of Alpha-1 Antitrypsin, when compared with competitors.

Kamada's injectable AAT is now undergoing phase III clinical trials in the U.S. under the auspices of the FDA. The company is testing AAT also for other lung disease indications.

About Kamada

Kamada manufactures a line of highly-safe specific immunoglobulins and other plasma-derived therapeutics, using sophisticated chromatographic purification technology. Licensed and marketed in more than 15 countries, several of these specialty biopharmaceuticals hold registered and pending patents and are in advanced clinical trials.
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