Baxter International Inc. announced a definitive agreement with Kamada Ltd. for exclusive commercial rights to Glassia [Alpha 1-Proteinase Inhibitor (Human)], the first and only liquid alpha1-proteinase inhibitor, in the United States, Australia, New Zealand and Canada.

Glassia, which was approved by the FDA on July 1, 2010, is indicated for chronic augmentation and maintenance therapy in individuals with emphysema due to congenital deficiency of alpha1 -proteinase inhibitor (Alpha1 -PI), also known as alpha1 -antitrypsin (AAT) deficiency. AAT deficiency is an under-diagnosed hereditary condition that may result in early onset emphysema. Baxter expects to introduce Glassia in the United States during the fourth quarter of 2010, and will pursue distribution licenses for Glassia in the other countries for which it has obtained rights.

"The agreement with Kamada underscores Baxter's commitment to expanding the diagnosis of alpha1 -antitrypsin deficiency by bringing new and innovative therapeutic options to Alpha-1 patients and their treating physicians," said Larry Guiheen, president of Global BioPharmaceuticals, Baxter BioScience.

The distribution agreement includes an upfront cash payment by Baxter of $20 million. The agreement also includes a provision under which Kamada has agreed, for a limited period of time, not to initiate or enter any discussions or agreements relating to the commercialization of Glassia in certain other geographies and for Kamada's investigational next-generation inhaled therapy. Under a separate license agreement, Baxter has been granted the right to process Glassia and will seek necessary regulatory approvals to enable it to do so. Also under this agreement, Baxter may make additional payments of up to $25 million related to the achievement of certain commercial milestones and the execution of a technology transfer related to the production of the therapy by Baxter, as well as royalties on product sales.

Alpha-1 antitrypsin deficiency is a hereditary condition that is characterized by a low level of alpha-1 protein in the blood and the lungs. This naturally occurring protein, which is made in the liver, helps protect lung tissue from damaging enzymes released by white blood cells. The most common symptoms of AATD include shortness of breath and cough.

The American Thoracic Society/European Respiratory Society Standards recommend that all patients with Chronic Obstructive Pulmonary Disease (COPD) be tested once for AATD.

Baxter sponsors the AlphaTest kit to make it easy for physicians to test patients. To date, Baxter has assisted in screening more than 80,000 people for AATD, making it an industry leader in AATD awareness and early diagnosis.

ARALAST NP [Alpha 1-Proteinase Inhibitor (Human)] is a lyophilized powder indicated for chronic augmentation therapy in patients having congenital deficiency of ? 1-PI with clinically evident emphysema and is available in the United States, Puerto Rico and Argentina. Both Glassia and ARALAST NP therapies are administered by intravenous infusion once a week to increase the levels of alpha-1 antitrypsin in the blood and lungs.

The American Lung Association estimates that there are approximately 100,000 people in the United States who have inherited AATD, and that less than 10 percent of those people living with Alpha-1 have been properly diagnosed. Worldwide epidemiology estimates suggest there may be more than 3.4 million people who have the genetic phenotypes associated with AATD.

Alpha 1-Proteinase Inhibitor (Human), Glassia is indicated for chronic augmentation and maintenance therapy in individuals with emphysema due to congenital deficiency of alpha1 -proteinase inhibitor (alpha1-PI), also known as alpha1 -antitrypsin (AAT) deficiency.

The effect of augmentation therapy with Glassia or any alpha1-PI product on pulmonary exacerbations and on the progression of emphysema in alpha1 -PI deficiency has not been demonstrated in randomized, controlled clinical trials.

Clinical data demonstrating the long-term effects of chronic augmentation and maintenance therapy of individuals with Glassia are not available.

Glassia is not indicated as therapy for lung disease in patients in whom severe alpha1 -PI deficiency has not been established.

ARALAST NP is indicated for chronic augmentation therapy in patients having congenital deficiency of ?1-PI with clinically evident emphysema. ARALAST NP is not indicated as therapy for lung disease patients in whom congenital ?1-PI deficiency has not been established.

The effect of augmentation therapy with ARALAST NP on pulmonary exacerbations and on the progression of emphysema in alpha1 -antitrypsin deficiency has not been demonstrated in randomized, controlled clinical trials.

Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with haemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions.