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Kamada Ltd. (TASE: KMDA), a biopharmaceutical company specializing in development, manufacturing and marketing of specialty life-saving therapeutics announced today the approval of the U.S. Food and Drug Administration's (FDA) to its application for an Investigational New Drug (IND) to conduct a phase II clinical trial in the US for the company's inhaled alpha-1 antitrypsin for treatment of alpha-1 antitrypsin deficiency (AATD-IH). In paralel, Kamada continues with its pivotal, Phase II/III trial of AATD-IH, which is already underway in Europe and Canada, results of which are expected late 2013.
Kamada is expecting that once positive results from the Phase II/III clinical trial are received, the FDA may recognize both these Phase II/III results from the trial in Europe and the results from the Phase II trial in the US, which is the subject of this IND Approval, when considering the drug's marketing authorization. Recognition of the Phase II/III clinical trial in Europe may lead to faster FDA marketing application authorization and shorter time to market.
The company is currently evaluating strategic collaborations for conducting its inhaled alpha-1 antitrypsin clinical trial (AATD-IH) in the US.
The AATD-IH clinical trial in the US is designed to test the efficacy and safety of the drug through inhalation in accordance with the FDA requirements. Kamada's intravenous drug for the treatment of Alpha-1 Antitrypsin deficiency (AATD-IV) has already been approved by the FDA and is being marketed in the US over the past two years for tens of millions of dollars per year.
Kamada has recently entered into an exclusive distribution agreement with Chiesi Farmaceutici S.p.A, a fully integrated European pharmaceutical company focused, among others, on respiratory diseases and special care products, for the distribution of Kamada's inhaled alpha-1 antitrypsin for treatment of alpha-1 antitrypsin deficiency (AATD-IH) in Europe. This agreement is estimated to reach hundreds of millions of dollars in the coming years.
The AATD-IH may be the first drug in the world given by inhalation for patients with Alpha-1 Antitrypsin Deficiency. This is a technological and medical breakthrough, which stems from Kamada's product advantages, including, its presentation as a liquid, ready-to-use product without any stabilizers or preservatives with extremely high purity level. Genetic Alpha-1 Deficiency causes, among others, COPD, lung emphysema, bronchial inflammation and fatal damage to the lung tissue.
"We are pleased with the IND approval and the opportunity to begin an additional trial with the US patient population, sided with the ongoing Phase II/III clinical trial conducted in Europe", said David Tsur, Kamada's CEO. "We are now considering potential partners for conducting the clinical trials in the US, which may be the last and final trial before applying for marketing authorization".
Kamada has met its development and commercialization objectives for the AAT drug for treatment of Alpha-1 Antitrypsin deficiency including receiving FDA approval for the AAT intravenous drug in the US, entering into a strategic agreement (Baxter), steady revenue growth of tens of millions of dollars per year, promoting the clinical trials and the regulatory approval for the inhaled alpha-1 antitrypsin in Europe (AATD-IH) and receiving IND approval for beginning with the clinical trials for the inhaled alpha-1 antitrypsin (AATD-IH) in the US. Following these achievements, the company continues to promote the AATD-IH drug, which is considered as its flagship product, both in Europe and the US taking advantage of the business capabilities of the company.
The strategic agreement we have recently signed with Chiesi also indicates the market's recognition and clinical potential of the inhaled alpha-1 antitrypsin. We believe that as we proceed with successfully completing our clinical trials we will reach the drug's great business potential".