Replies to post #6820 on GTC Biotherapeutics (fka GTCB)

[gym gravity]

good thought!

[DewDiligence]

Re: Orphan status for inhaled AAT

>I can see a third way: Kamada has a small plant limiting their AAT production capability.<

Good point, although Kamada’s production capacity could presumably be increased at some point.

I think the strongest argument for GTC’s breaking Kamada’s orphan exclusivity (assuming that inhaled AAT products from Kamada and GTC are eventually approved) is the safety benefit of a recombinant product. The FDA is presumably convinced of this already insofar as it granted an orphan designation for ATryn in HD. Regards, Dew

[DewDiligence]

Kamada Completes Phase-1 Trial for Inhaled AAT

http://biz.yahoo.com/bw/080115/20080115005510.html

>>
Tuesday January 15, 3:37 am ET

EMEA Has Already Approved the Company's Clinical Plans for Phases II-III Enabling the Company to Move Forward With the Development of Its Flagship Product

WEIZMANN SCIENCE PARK, Israel--(BUSINESS WIRE)--Kamada (TASE:KMDA), a biopharmaceutical company (www.kamada.com) developing, producing and marketing specialty life-saving therapeutics, has successfully concluded Phase I clinical studies designed to test the safety and tolerability of the aerosolized version of its flagship product, Alpha-1 Antitrypsin (AAT) using an optimized eFlow® Electronic Nebulizer (PARI Pharma GmbH) to treat various lung diseases.

According to David Tsur, Kamada’s CEO, "we are very pleased with the successful completion of Phase I clinical trial with Kamada's aerosolized AAT product and the eFlow® device. This next generation AAT product holds numerous advantages over current products, among them: providing greater patient convenience, reduced treatment costs, larger treatment population and additional potential indications, all pending successful completion of the company's clinical development plan for aerosolized AAT." Tsur added that “Kamada is strategically progressing towards registration of its AAT formulations in the European and US markets."

Kamada has already obtained Orphan Drug Designation (ODD) from both the US FDA and the EMEA for aerosolized AAT for the treatment of Congenital Emphysema and Cystic Fibrosis. ODD designation, and subsequent ODD status, present significant commercial advantages during the development process, registration and distribution of the product throughout its lifecycle, notably exclusive distribution rights for periods of 7 years in the U.S. and 10 years in Europe, should Kamada be the first to successfully complete the clinical trials and obtain regulatory approvals for these indications.

About eFlow

eFlow®, an electronic, portable nebulizer, enables extremely efficient aerosolization of liquid medications via a vibrating, perforated membrane. Compared to other nebulizer systems, eFlow® can produce aerosols with a very high density of active drug, a precisely defined droplet size, and a high proportion of respirable droplets delivered in the shortest possible amount of time. Combined with its silent mode of operation, small size (it fits in the palm of your hand), light weight, and battery use, eFlow® helps reduce the burden of taking daily inhaled treatments.

About PARI Pharma

PARI Pharma develops aerosol delivery devices and inhaled therapies. Based on PARI's 100-year history working with aerosols, PARI Pharma specializes in treatments for pulmonary and nasal administration optimized to advanced delivery platforms, such as eFlow®.

About Kamada

Kamada is a public biopharmaceutical company (TASE:KMDA) developing, producing and marketing a line of specialty life-saving therapeutics using its proprietary chromatographic purification technologies. Licensed and marketed in more than 15 countries, several of these specialty therapeutics hold registered and pending patents and are currently in advanced clinical trials. For additional information, please visit www.kamada.com.
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