Kamada (TASE:KMDA), a bio-pharmaceutical company engaged in the development, manufacturing and marketing of specialty life-saving therapeutics, announced today that it has entered into an exclusive agreement with a large US specialty pharmaceutical distributor company for the distribution of its flagship product, intravenous alpha-1 antitrypsin (AAT-IV) in the United States.
Under the terms of the agreement, the US Company will be responsible for the product’s distribution and additional activities relating to sales and marketing. Kamada will be responsible for the production and delivery of AAT-IV to the US Company, following its approval by the US Food and Drug Administration.
Furthermore, in order to maintain exclusivity of the distribution in the US, the US Company will be required to purchase from Kamada minimum quantities of AAT-IV of at least $15 million within the first eighteen months following approval of the product. Thereafter, minimum quantities will depend on sales and reimbursement rates of AAT-IV each year, for the remainder of the term of the agreement.
David Tsur, Chief Executive Officer of Kamada said, “We are delighted to have formed this relationship with a leading US specialty products distributor. This is another strategic milestone for Kamada as we focus on bringing our products to the US and EU markets.” David Tsur added, “The Biologics License Application for AAT-IV for the treatment of alpha-1 antitrypsin deficiency was recently accepted for review by the US Food and Drug Administration and a decision on its approval is expected in Q2 2010. Alpha-1 deficiency is a debilitating respiratory disease and we look forward to working with our experienced partner to deliver this product to patients as quickly as possible.” David Tsur concluded, “We are also developing an inhaled version of AAT that has recently completed three separate Phase II trials, and that we hope to add to our portfolio of specialty products in the coming years.”