Weizmann Science Park, Ness Ziona, Israel, February 8th 2010 – Kamada, a bio-pharmaceutical company engaged in the development, manufacturing and marketing of specialty life-saving therapeutics, announced today that it has enrolled the first patient into its pivotal clinical trial with its new breakthrough compound of inhaled alpha-1 antitrypsin (AAT) delivered by an Investigational eFlow Nebulizer System (PARI Pharma GmbH), in patients with alpha-1 antitrypsin deficiency.
The Phase 2-3, multi-center, randomized, double-blind, placebo-controlled and international study will evaluate the efficacy and safety of inhaled, human AAT in alpha-1 deficient patients with emphysema. The trial will be conducted across several European countries. The study protocol has been designed in agreement with the EMEA under the product's orphan drug designation status.
David Tsur, Chief Executive Officer of Kamada said, “We are very pleased with the advancement of the trial and hope that the rate of enrollment would reflect the excitement of the patients of this potential new treatment. We recognize the importance of bringing this product to this unique patient population for whom, at the moment, there is no therapeutic resolution.
About Inhaled AAT
Kamada’s Inhaled AAT is a high purity alpha-1 antitrypsin preparation manufactured using sophisticated, in house developed proprietary chromatographic purification methods. Inhaled AAT is delivered via an Investigational eFlow Nebulizer System (PARI Pharma GmbH) and has been designated orphan drug status for the treatment of bronchiectasis, alpha-1 deficiency and cystic fibrosis, in the U.S. and the treatment of alpha-1 deficiency and cystic fibrosis, in Europe. This designation grants Kamada various benefits such as research fund support, tax incentives, reduced official fees and seven years of exclusive distribution rights, if the company’s product is first on the market.
About the Investigational eFlow Nebulizer System and eFlow Technology
Kamada’s Inhaled AAT is delivered by an Investigational eFlow Nebulizer System developed by PARI Pharma GmbH. The Investigational eFlow Nebulizer System uses eFlow Technology to enable highly efficient aerosolization of medication via a vibrating, perforated membrane that includes thousands of small holes to 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 quiet mode of operation, small size (it fits in the palm of the patient’s hand), light weight, and battery use, products incorporating eFlow Technology reduce the burden of taking daily, inhaled treatments. The Investigational eFlow Nebulizer System and eFlow Technology are proprietary to PARI Pharma. Online at www.paripharma.com.
About Kamada
Kamada is a public biopharmaceutical company (TASE: KMDA) developing, producing and marketing a line of specialty, life-saving therapeutics using a sophisticated chromatographic purification technology. Utilizing its proprietary know-how, Kamada manufactures more than 10 high quality biopharmaceuticals which are marketed in over 15 countries around the world. Kamada also has a number of products in development and has recently completed six clinical trials for its high-purity, liquid formulation of alpha-1 antitrypsin which is suitable for inhalation and intravenous use. Additional information is available at www.kamada.com.
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