Investors & Media
24 Dec. 2012

FDA approves Kamada the next advanced clinical trial in Cystic Fibrosis with its inhaled AAT

Kamada is the most advanced company in development of inhaled AAT drug for the treatment of CF

Kamada won IND approval for a phase II clinical trial in the US for the treatment of CF

The previous phase II clinical trial showed an excellent safety and tolerability profile in addition to positive efficacy results indicating a substantial decrease in lung inflammation

Kamada's AAT inhalation drug has was designated as an Orphan Drug for the treatment of CF both in Europe and in the US

The biopharmaceutical company, Kamada Ltd. (TASE: KMDA), which develops, produces and markets specialty life-saving therapeutics has announced today that it has received the approval of the IND (Investigational New Drug) for the next phase II clinical trial of its inhaled AAT for the treatment of Cystic Fibrosis (CF). Kamada's inhaled AAT has gained the status of an Orphan Drug for the treatment of CF both in Europe and in the US. The company believes that it is the most advanced company with an inhaled AAT product for this indication as well as for AAT deficiency. The company intends to to develop this indication with a strategic partner and is currently exploring various possibilities toward this end.

The planned study is a phase II in the US for the treatment of CF using its inhaled AAT. The trial will evaluate safety and efficacy of inhaled AAT. Kamada's previous phase II study with CF patients showed high safety and tolerability profile sided to demonstration of significant decrease in lung inflammation which was reflected, among others in the drop of neutrophil elastase enzyme in the lungs of the CF patients, an enzyme that has a major affect in lung inflammation and disease progression as a result.

This current IND approval follows another recent IND approval of a phase II trial in the US for the treatment of the hereditary AAT deficiency. The company intends to begin the trial in 2013. Concomitantly, the company is already in advanced stages of its ongoing phase II/III trial in Europe for AAT deficiency with its inhaled AAT product. The enrollment for this study has been completed earlier this year and study completion is expected late 2013.

Cystic Fibrosis (CF) is an inherited multi-system disorder, which mainly effects the respiratory system, but which can also damage additional systems such as the digestive, dermatological, and reproductive systems. This is one of the most common inherited disorders in western countries. In Israel, there are approximately 600 CF patients occurring in about 1 out of 2500 infants. Although CF is a multisystem disease, lung disease in these patients is the major cause of morbidity and mortality. In CF, mucus-secreting glands within the lining of the lungs' airways (bronchi) produce abnormally thick, sticky secretions. These clog the airways, promote bacterial growth and lead to infection, chronic inflammation, airway obstruction and destruction of the airways which in turn, lead directly to loss in pulmonary function and progression of the lung disease. Loss of pulmonary function is the primary cause of death in CF.

At present most treatments for this genetic disease are treatments dealing with disease symptoms, such as antibiotics, respiratory physiotherapy, steroids, mucolytics and bronchodialators. AAT is expected to assist in neutralizing the NE and other pro inflammatory proteins and by that, prevent destruction of the lung tissue and reduce the inflammatory dysregulation that causes pulmonary dysfunction.

About Kamada
Kamada specializes in the development, manufacture, and marketing of specialty intravenous, injectable, or inhaled life-saving therapeutics. The company manufactures about ten drugs marketed in fifteen countries worldwide, and employs cutting-edge patented technology for protein purification and separation. Kamada has a line of unique products, including some in the advanced stages of clinical trials. Following the development of GLASSIA, which has FDA approval and is exclusively marketed in the US by Baxter, Kamada is developing its “next generation” product, which is currently in Phase II/III of a clinical trial: AAT administered by inhalation, for the treatment of Alpha-1 Antitrypsin deficiency, also known as hereditary emphysema. Kamada also completed Phase I/II of a clinical trial of intravenous AAT for treatment of Diabetes type-1, and is preparing for Phase II/III of a clinical trial in the US of an anti-rabies drug as part of its collaboration with the pharmaceutical company Kedrion SpA.

This announcement includes “prospective information”, as defined in The Securities Law 1968, whose materialization is dependent upon various factors, such as entering into strategic partnerships, completing the recruitment of patients for clinical trials, the results thereof, and receiving the various regulatory approvals required to market the products.

Further information is available on the Kamada website:

For more information:
Gil Efron, CFO