The US Food and Drug Administration (FDA) has given final approval for Phase III clinical trials of Kamada Ltd.’s (TASE: KMDA) API drug. The FDA notified the company that it had lifted the “clinical hold” status, and that the company was authorized to begin clinical trials without the need for further approval from the FDA.
API is intended for chronic replacement therapy for patients with congenital deficiency of Alpha 1-Proteinase Inhibitor with demonstrable panacinar emphysema. So far as is presently known, API is the only ready drug for injection, without the need for pre-dilution or pre-mixing.
Kamada expects that if and when it obtains FDA and/or European Medicines Agency (EMEA) approval for API, the product will greatly contribute to the company’s revenue, because it does not completely cure a patient, but supplements congenital deficiency of Alpha 1-Proteinase Inhibitor. This means that patients will have to take the drug throughout their lives.
Over 200,000 people reportedly suffer from congenital emphysema in the US and Europe, of whom fewer than a tenth have been diagnosed. The same report estimates that only 4,000 people are currently treated worldwide, at a cost of $60,000-100,000 per patient per year.
Kamada CEO David Tsur said the company had recently expanded its R&D investment in order to meet its timetable ahead of the FDA approval and the start of clinical trials.
Founded in 1990, Kamada is controlled by Tsur, Ralph Hahn, and Leon Recanati’s GlenRock Israel. The company specializes in the development and production of injectable drugs for medical emergencies.
Published by Globes [online], Israel business news - www.globes.co.il - on March 9, 2006
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