Replies to post #3702 on GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Re: Inhaled AAT

>Kamada – In a conference I attended in May, David Tsur, kamada's CEO, said that they already know that the inhaled dose is about 25% of the injectable one. Given the limitation of plasma supply, these are good news. If efficacy will work fine, they will try the inhaled delivery for other indications such as Cystic Fibrosis which suppose to be more profitable.<

As you may know, PPG (the “Dolly” company) had an inhaled-AAT program launched in the late 1990’s that was partnered with Bayer in 2000. The data they reported in CF was not exactly stellar.

The PPG-Bayer partnership was also supposed to test inhaled AAT for hereditary deficiency, but I never saw any data on that and PPG is now long gone. Regards, Dew

[DewDiligence]

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

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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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