Kamada Was Granted New Orphan Drug Designation by the FDA, for the Treatment of Type 1 Diabetes

NESS ZIONA, Israel--(BUSINESS WIRE)-- Kamada LTD., a bio-pharmaceutical company engaged in the development, manufacturing and marketing of specialty life-saving therapeutics, was granted an Orphan Drug Designation for its Alpha-1 Antitrypsin (AAT) product to treat type 1 diabetes.

Kamada is currently undergoing a Phase I/II clinical trial with its FDA approved AAT by IV route of administration, for the treatment of type 1 diabetes, also known as juvenile diabetes.

Kamada plans to publish an interim and/or the final reports during 2012.

David Tsur, Chief Executive Officer of Kamada said: "We are excited to enter the diabetes field and hope to bring a global breakthrough in the treatment of juvenile diabetes and potential cure.”

Kamada’s AAT IV was granted FDA approval during July 2010 for the treatment of Alpha 1 deficiency and is exclusively marketed in the US by Baxter.

About Type 1 Diabetes

Diabetes is an autoimmune disease that causes pancreatic beta cells destruction, the insulin producing cells. As a result of this destruction – Insulin augmentation is required to balance the level of glucose in the blood stream. This new scientific concept of AAT treatment is based, on the anti-inflammatory properties of AAT and possibly the fact that although the level of AAT in diabetes patients is normal, its activity of is significantly lower. It is well known, that the AAT has a significant anti-inflammatory properties. These properties may potentially interfere or even prevent the inflammation causes the destruction process of the beta cells in the pancreas. Researchers believe that treatment with alpha-1 in relatively early stages of the disease after diagnosis, might prevent, or even stop this inflammation.

According to the U.S. JDRF, the number of juvenile diabetes patients is estimated at 3 million and each year about 30 thousand new patients are being diagnosed.

According to the Centers for Disease Control (CDC) there are more than 10 million patients diagnosed with type 1 diabetes with the more than 100,000 new patients diagnosed each year.

According to the Israeli JDRF (juvenile diabetes association) there are about 50 thousand patients in Israel and each year additional 200 new patients are being diagnosed.

About Kamada

Kamada is a public biopharmaceutical company (TASE: KMDA) developing, producing and marketing a line of specialty, life-saving therapeutics using a sophisticated chromatographic purification technology. Utilizing its proprietary know-how, Kamada manufactures more than 10 high quality biopharmaceuticals which are marketed in over 15 countries around the world.

Kamada’s flagship product, Glassia®, is USFDA approved and is marketed in the US exclusively by Baxter Healthcare. Kamada’s next generation AAT by inhalation is currently undergoing a phase 2-3 trial in the EU.

Kamada already completed five clinical trials with its high purity, liquid formulation of inhaled Alpha-1 Antitrypsin.

Kamada is preparing to initiate a phase 2-3 trial in the US with its rabies IgG product.

Additional information is available at www.kamada.com.


Yaron Cherny, Business Development
+972 8-940 6472
[email protected]

KEYWORDS:   Middle East  Israel

INDUSTRY KEYWORDS:   Health  Biotechnology  Clinical Trials  Pharmaceutical  Diabetes  FDA