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.
“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 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.
