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Ness Ziona, Israel, October 21, 2012. Kamada, Ltd. (TASE: KMDA), a biopharmaceutical company engaged in development, manufacturing and marketing of specialty life-saving therapeutics, announced today it has completed its patient recruitment for the company's Phase II/III of inhaled Alpha-1 antitrypsin for treatment of alpha-1 antitrypsin deficiency (AATD-IH). Kamada expects the trial to be completed during the last quarter of 2013.
The recruitment completion has been decided following consultation with the EMA (European Medical Agency) and after achieving the necessary statistical power for efficacy goals.
With the support of EMA, the company proposes active treatment to all patients who have completed participation in the trial. Clinical information gathered from this additional extension may further provides added drug safety data and patients experience and will support the Company's efforts for receiving marketing approval and support its preparations to enter the market.
In August 2012, Kamada has entered into an exclusive distribution agreement with Chiesi Farmaceutici S.p.A, a fully integrated European Pharmaceutical company focused on respiratory disease and special care products, for the distribution of its inhaled alpha-1 antitrypsin for treatment of alpha-1 antitrypsin deficiency (AATD-IH). Kamada estimates that the sales potential from the distribution agreement, if and as long as its AATD-IH product completes its Phase II/III clinical trials successfully and receives the EMA approval, may reach hundreds of millions of dollars in the coming years.
The AATD-IH has orphan drug designation both in the Europe and the US, which may provide 7-10 years marketing exclusivity from the date of approval, various incentives including tax breaks and exemptions on regulatory fees.
The Phase II/III AAT inhaled alpha-1 antitrypsin trial is conducted at several medical centers in Western Europe and Canada, and is a placebo controlled, double-blind, randomized trial. This study was designed to investigate the safety and efficacy of inhaled AAT drug for treatment of severe lung disease of alpha-1 patients. During 2011, Kamada announced interim report of the clinical trial, which strengthened the safety results received also in previous clinical trials and showed an excellent safety and tolerability profile.
Kamada's drug may be the world's first drug designed to treat patients suffering from genetic Alpha1-Antitrypsin Deficiency through inhalation. This medical and technological breakthrough adds to Kamada's additional Alpha-1 through intravenous product (AATD-IV), being the sole approved liquid, ready to use and high purity level product for the treatment of Alpha-1 antitrypsin Deficiency. Chronic emphysema due to congenital deficiency of AAT (Alpha-1 Antitrypsin) is an under-diagnosed hereditary condition, which causes irreversible damage to lung tissue, severe lung disease, and even death. Kamada's AATD-IV intravenous drug for the treatment of Alpha-1 antitrypsin deficiency is sold in several countries worldwide. In the last 2 years the intravenous drug has been sold in the US market by Baxter for tens of millions of dollars per year.
"We are very pleased with completing another significant step in the development of our flagship product and continue moving ahead towards completing and publishing the trial's final results, which could serve as a global breakthrough in the treatment of Alpha-1 patients", said David Tsur, Kamada CEO. "The simplicity of using this drug, its high quality and advantages are expected to provide patients significant improvements in their life style, in addition to providing efficient treatment. Reaching this step is a significant achievement for the company, which brings us closer to adding another ethical product to a new market in Europe. Together with the strategic agreement we have recently signed with Chiesi, we expect the AATD-IH to produce significant revenues for Kamada".
Tsur added "We believe using the inhalation drug would allow treating many more patients than using the intravenous product. Consequently, we expect the accumulative revenues from the AATD-IH in inhalation to be higher than the expected revenues from the AATD-IV (intravenous). The inhalation product has additional potential indications (Cystic Fibrosis, Bronchiectasis), in which Kamada completed several clinical trials with positive results reflecting the drug's efficacy in treating lung infection, and which we intend to continue development".
Kamada is a public biopharmaceutical company traded in the Tel-Aviv Stock Exchange (TASE: KMDA) developing, manufacturing and marketing specialty, life-saving therapeutics using a sophisticated chromatographic purification platform technology. Utilizing its proprietary know-how, Kamada manufactures more than 10 high quality biopharmaceuticals which are marketed in more than 15 countries around the world. Kamada also has a number of products in clinical trials for the development of its high-purity, liquid formulation of alpha-1 antitrypsin protein which is suitable for inhalation and intravenous use. The results of Phase II/III clinical trials of AATD-IH in Europe are expected in 2013 and completion of registration and commencement of sales not earlier than 2015. Kamada will announce the results of its Phase I/II clinical trial of the intravenous AAT drug for the treatment of Type 1 (juvenile) diabetes in the end of 2012 and is preparing for a phase II/III clinical trial for its Rabies IgG drug as part of it's strategic cooperation with Kedrion.
Additional information is available at www.kamada.com.
This notice contains forward-looking statements including, with respect to the finalization and results of the II/III clinical trial, the regulatory recognition of such results and future sales. Such statements express the current beliefs and expectations of Kamada's management and involve a number of known and unknown risks and uncertainties that could cause Kamada's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements.