NESS ZIONA, Israel--(BUSINESS WIRE)-- Kamada, a bio-pharmaceutical company engaged in the development, manufacturing and marketing of specialty life-saving therapeutics, announced today that it received the interim report of its phase 2-3 trial to treat Alpha-1 deficiency with its flag product, Alpha-Antitrypsin, delivered by inhalation.
The report, which includes information on 13 months treatment of dozens of patients, shows an excellent safety and tolerability profile. The report adds significant further information to the safety profile of Kamada’s inhaled Alpha-1 Antitrypsin that has already been established in five previous clinical trials, successfully completed by the Company.
The current Phase 2-3 trial is the most advanced stage a company has ever reached with inhaled AAT. The trial is performed at several sites in Europe, including Germany, the United Kingdom, the Netherlands, Denmark, Ireland and Scotland. The report allows Kamada to use the data collected in additional regulatory submissions and provides physicians and regulatory authorities additional confidence in the Kamada drug.
David Tsur, Chief Executive Officer of Kamada said, “We are proud of the results of the interim report and the completion of another important stage in this important development. Kamada aims to be the world's leader and the first company to introduce an inhaled Alpha-1 treatment. These results are encouraging not only to the Alpha-1 patients but also to other patients who suffer from chronic respiratory diseases such as Cystic Fibrosis, Bronchiectasis and COPD and for whom AAT by inhalation could be a treatment option.”
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 for the treatment of Bronchiectasis, Alpha-1 deficiency and Cystic Fibrosis in the U.S. and for 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 contains thousands of small holes to produce the aerosol mist. Compared to other nebulization technologies the 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, the use of eFlow reduces the burden of daily inhalation treatments. The Investigational eFlow Nebulizer System and eFlow Technology are proprietary to PARI Pharma. For additional information see www.paripharma.com.
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’s flagship product, Glassia®, was recently approved by the USFDA and is marketed in the US exclusively by Baxter Healthcare.
Kamada also has a number of products in development and has already completed five clinical trials with its highpurity, liquid formulation of inhaled Alpha-1 Antitrypsin. Additional information is available at www.kamada.com.
For more information please contact Yaron Cherny, Business Development, Kamada, at [email protected] or by phone: +972 8-940 6472.
Yaron Cherny, Business Development
+972 8-940 6472
KEYWORDS: United Kingdom Europe Netherlands Denmark Germany Middle East Ireland Israel
INDUSTRY KEYWORDS: Health Biotechnology Cardiology Clinical Trials Infectious Diseases Medical Devices Pharmaceutical Medical Supplies Nursing General Health