Pharmaceutical company Kamada LTD. has been granted an Orphan Drug Designation for Alpha-1 Antitrypsin (AAT) product, which is used to treat Type 1 diabetes. Kamada LTD. specializes in the development, manufacture and marketing of special life-saving drugs and procedures.
Kamada’s new AAT must be subjected to a Phase I/II clinical trial. The AAT is administered by IV and has been approved by the FDA. “We are excited to enter the diabetes field and hope to bring a global breakthrough in the treatment of juvenile diabetes and potential cure,” said Kamada spokesperson David Tsur, Chief Executive Officer of Kamada.
Kamada will be publishing interim reports in 2012, or final reports if the trials are completed within that time frame.
The FDA approved Kamada’s AAT for treatment of Alpha 1 deficiency in July of 2010. The AAT is marketed in the United States by Baxter.
Type 1 diabetes causes the destruction of pancreatic beta cells, which produce insulin. Due to the reduction in insulin production, the body’s natural insulin levels must be altered so that glucose levels in the bloodstream do not enter dangerous territory. Diabetes treatments with AAT products are intended to reduce or prevent inflammation that destroys the pancreatic beta cells. It has been shown that although AAT is present in diabetics, it does not function at normal capacity.
The United States Juvenile Diabetes Research Fund states that there are 3 million cases of juvenile diabetes in the nation, with 30,000 new cases added each year.
According to the Centers for Disease Control, there are 10 million Type 1 diabetes patients worldwide with 100,000 new diagnoses added each year. The Juvenile Diabetes Research Fund of Israel states that 50,000 Type 1 diabetes cases are known in Israel with 200 new diagnoses each year.
Kamada is a publicly-traded (TASE: KMDA) pharmaceutical company that produces specialty medications and other therapeutics with chromatographic purification techniques. Kamada manufactures over 10 biopharmaceuticals which see distribution in over 15 countries.
Glassia, an FDA-approved pharmaceutical, is Kamada’s flagship product, marketed in the US by Baxter. Kamada is also developing an AAT by inhalation, which is undergoing Phase II/III trials in the EU. Five clinical trials of this inhaled AAT have already been concluded. Kamada will also soon undergo a Phase II/III trial of a rabies IgG treatment product in the US.
