Date: 2012-08-05
Type of information: Distribution agreement
Compound: inhaled alpha-1 antitrypsin
Company: Chiesi Farmaceutici (Italy) Kamada (Israel)
Therapeutic area: Genetic diseases - Rare diseases
Type agreement:
Action mechanism: Alpha-1 antitrypsin is a protein made in the liver. Normally the protein travels through the bloodstream and helps protect the body's organs from the harmful effects of other proteins. The lungs are one of the main organs that the AAT protein protects. AAT deficiency (AATD) occurs if the AAT proteins made in the liver are not the right shape, and they get stuck inside liver cells and cannot get into the bloodstream. As a result, not enough AAT proteins travel to the lungs to protect them, which increases the risk of lung disease. Also, liver disease can develop because too many AAT proteins are stuck in the liver. Severe AATD occurs when blood levels of the AAT protein fall below the lowest amount needed to protect the lungs.
Disease: Alpha-1 Antitrypsin Deficiency (AATD, or Inherited Emphysema)
Details: * On August 5, 2012, Kamada announced it 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 breakthrough inhaled alpha-1 antitrypsin for treatment of alpha-1 antitrypsin deficiency (AATD-IH). The agreement is for 12 years and Kamada estimates that the sales potential from the distribution agreement, if and as long as its AATD-IH product, which has orphan drug designation, 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 results of Phase II/III clinical trials of AATD-IH in Europe are expected in 2013 and Kamada estimates to complete the drug registration and begin sales no earlier than 2015.
Financial terms: Under the terms of the agreement, Kamada will receive milestone payments of $60 million, subject to achievement of certain regulatory and sales targets. In addition, Chiesi is committed to minimum purchases tens of millions USD during the first 5 years following the acceptance of the required regulatory approvals.
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