Baxter Acquires Exclusive Commercial Rights to GLASSIATM in the United States and Other Select Markets
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.
About AATD
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 α1-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.
About GLASSIA™
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.
Important Risk Information for GLASSIA
GLASSIA™ is contraindicated in Immunoglobulin a (IgA) deficient patients with antibodies against IgA. GLASSIA™ is contraindicated in individuals with a history of severe immediate hypersensitivity reactions, including anaphylaxis, to Alpha1 -PI products.
GLASSIA™ is made from human plasma. It may carry a risk of transmitting infections agents, such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
Administer GLASSIA™ at room temperature at a rate not greater than 0.04 mL/kg body weight per minute. IF ANAPHYLACTIC OR SEVERE ANAPHYLACTOID REACTIONS OCCUR, DISCONTINUE THE INFUSION IMMEDIATEL