GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Kamada’s Intravenous AAT Hits Primary Endpoint in Phase-3 Trial

[Oddly, this PR does not say that a BLA will be submitted forthwith for the hereditary deficiency indication.]

http://biz.yahoo.com/bw/080402/20080401007031.html

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Wednesday April 2, 1:53 am ET

NESS ZIONA, Israel--(BUSINESS WIRE)--Kamada (TASE:KMDA), a biopharmaceutical company developing, producing and marketing a line of specialty, life-saving therapeutics, announced today that it has successfully met the primary endpoint in the Phase III US clinical trials with its intravenous Alpha-1 Antitrypsin (AAT). The product is used to treat hereditary AAT deficiency which leads to Congenital Emphysema.

David Tsur, Chief Executive Officer of Kamada, commented, "It is a major achievement for Kamada toward the future entry to US market, that further demonstrates the quality of our products and capabilities for the benefit of AAT deficient patients worldwide. The company's intravenous AAT is the only ready-to-use AAT product that does not require reconstitution before use. Concurrently, Kamada is developing the next generation AAT for various indications, to be delivered by inhalation, directly to the lungs."

Tsur added that "The role of the Alpha-1 Foundation, the US patient organization dedicated to advance the case of the AAT deficient patients, as well as the dedication of the clinicians who conducted the trial with a high level of efficiency, cannot be underestimated in reaching this milestone. The trial was truly a collaborative effort with significant contributions from all parties involved."

"On behalf of the Alpha-1 Foundation we would like to congratulate Kamada for this outstanding achievement," said John W. Walsh, President and Chief Executive Officer of the Alpha-1 Foundation, and added: "The Alpha-1 Foundation estimates that more than 100,000 potential patients in the U.S. alone suffer from Congenital Emphysema (otherwise known as “Genetic COPD” or “Alpha-1”), a disease caused by an inherited deficiency of AAT, with less than 10 percent currently diagnosed and many of them not treated. In light of Kamada's recent progress and the potential of its AAT product, many US Alpha-1 patients eagerly anticipate the product launch."

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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