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DewDiligence

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Re: DewDiligence post# 13803

Monday, 10/13/2008 12:49:26 AM

Monday, October 13, 2008 12:49:26 AM

Post# of 19309
Kamada Announces Phase-2 Results for Inhaled AAT in CF

[There are no actual efficacy data here; judging by the wording in this PR, the efficacy results (to be presented later) were somewhere between modest and negligible.

In addition to the phase-2 trial in CF (the subject of this PR), Kamada’s inhaled AAT is in phase-2 for AAT HD (#msg-25990907) and bronchiectasis (#msg-26698235). Kamada’s injected AAT hit its primary endpoint in a phase-3 trial in CF, but data have not yet been reported (#msg-28121695).

All of the aforementioned Kamada programs rely on plasma-derived AAT. Please see #msg-25174719 and #msg-25848126 for musings on how GTC may eventually be able to break Kamada’s orphan designation for inhaled AAT by virtue of having a recombinant product.]

http://biz.yahoo.com/bw/081012/20081012005039.html

›Sunday October 12, 12:38 pm ET

The Results Demonstrate the Product Has an Excellent Safety Profile and Shows Promising Signs of Efficacy, as Indicated by a Reduction in Lung Inflammation

NESS ZIONA, Israel--(BUSINESS WIRE)--Kamada (TASE:KMDA), a biopharmaceutical company engaged in the development, manufacturing and marketing of specialty life-saving therapeutics, announced today positive data from its Phase II study evaluating inhaled Alpha-1 Antitrypsin (AAT) delivered via an Investigational eFlow® Nebulizer System (PARI Pharma GmbH), in the treatment of cystic fibrosis. The results demonstrate the product has an excellent safety profile and shows promising signs of efficacy, as indicated by a reduction in lung inflammation.

The Phase II trial was a double-blind, placebo controlled study, performed at the world renowned Cystic Fibrosis Center at the Hadassah University Hospital, Mount Scopus Jerusalem, Israel, led by Prof. Eitan Kerem, Head of the Department of Pediatrics and a world expert for Cystic Fibrosis. The trial was designed to evaluate safety of the inhaled product in cystic fibrosis patients and to assess its potential efficacy in decreasing lung inflammation. Study results revealed that daily inhalation of AAT for a period of 28 days reduced lung inflammation in comparison to placebo, as measured by neutrophil count and neutrophil elastase levels. There were no serious adverse events reported in either the active or the placebo group and no safety concerns were raised. This study was performed in accordance with clinical guidance received from the EMEA and under the ODD of the product.

Kamada plans to present the study data at an upcoming major medical meeting. In order to pursue clinical development of this product, Kamada will approach the regulatory authorities for guidance.

Kamada’s Chief Executive Officer David Tsur said: “This is a breakthrough for Kamada. This product is the next generation of AAT treatment that may be used, subject to success of clinical trials and regulatory approval, as an effective treatment for CF patients, to improve their quality of life. We believe that the inhaled product will offer significant advantages to cystic fibrosis patients and we are very optimistic about its further development in this and in other respiratory patient populations."

Professor Eitan Kerem, the Principal Investigator in this study, said, "I would like to congratulate Kamada for successfully completing this trial. Kamada's inhaled version of AAT is an innovative approach for the treatment of chronic inflammatory processes, including cystic fibrosis. Interventions that reduce these destructive processes could potentially prevent degeneration of lung function and could have a positive impact on patient lives. I look forward to monitoring the product’s progress in future clinical trials.”

About Inhaled AAT

Kamada’s Inhaled AAT, which utilizes an Investigational eFlow® Nebulizer System (PARI Pharma GmbH), has been designated Orphan Drug, in both Europe and the U.S. for the treatment of cystic fibrosis and Alpha-1 Antitrypsin Deficiency as well as in the U.S. for the treatment of Bronchiectasis. This designation grants Kamada various benefits such as research fund support, tax incentives, reduced official fees and 7 to 12 years of exclusive distribution rights, if the company’s product is first on the market.

About PARI Pharma and the Investigational eFlow® Nebulizer System

Kamada’s Inhaled AAT is delivered by the Investigational eFlow® Nebulizer System (PARI Pharma GmbH). The Investigational eFlow® Nebulizer System uses eFlow® Technology to enable extremely efficient aerosolization of liquid medications via a vibrating, perforated membrane that includes thousands of small holes that produce the aerosol mist. Compared to other nebulization technologies, eFlow® Technology produces 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 period 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® Technology reduces the burden of taking daily, inhaled treatments. The Investigational eFlow® Nebulizer System and eFlow® Technology are proprietary to PARI Pharma and can be optimized to specific drug formulations.

PARI Pharma focuses on the development of aerosol delivery devices and therapies. Based on PARI’s 100-year history working with aerosols, PARI Pharma develops treatments for pulmonary and nasal administration optimized with advanced delivery technologies, such as eFlow® technology. Online at PariPharma.com.

About Kamada

Kamada is a public biopharmaceutical company (TASE:KMDA) developing, producing and marketing a line of specialty life-saving biopharmaceuticals using its proprietary chromatographic purification technologies. Licensed and marketed worldwide, several of these specialty therapeutics are currently undergoing advanced clinical trials.‹

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