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US FDA Approves Rehovot Pharma Phase III Clinical Trials of an Emphysema Drug
"Kamada (TASE: KMDA), based in Rehovot Rabin Science Park bio-pharmaceutical company which develops, manufactures and markets prescription drugs, today announced the crossing of a major milestone on its API roadmap with the FDA (Food and Drug Administration) announcing the removal of the "Clinical Hold" status. This announcement marks the final approval required by the company to start the third phase of clinical trials with Kamada's flagship drug, Alpha 1-Proteinase Inhibitor (API). The clinical trial will include 50 patients from the USA and will follow the protocol submitted to and approved by the FDA.
API is used to treat Congenital Emphysema, a disease caused by an inborn deficiency of Alpha1 protein. The drug is produced by Kamada using the fourth fraction of human plasma. Kamada has already begun the distribution process of API in several countries. According to available information, API is the only product in its category that is available without the need for preparation or dilution. API's elevated status gained Kamada an advantage in the development of the next generation of the product that will be administered by inhalation instead of injection, delivering the drug directly into the patients lungs, thus reducing the time and cost of treatment.
Kamada's CEO, David Tsur, stated, "The FDA approval is a major step for the company towards debuting commercial distribution in the USA. In order to prepare for the clinical trials, Kamada has allocated extra resources to accelerate the research and development process of API."
Kamada anticipates the final approval by the FDA or EMEA (European Medicines Agency) for the commercial use of API will generate a substantial and sustainable contribution to the company's revenues. This is mainly because API only enables temporary replenishment of the Alpha1 protein. It does not provide a cure. Congenital Emphysema patients undergoing API treatment will require continued medication throughout their life.
The American Alpha1 organization estimates that more than 200,000 people in the USA and Europe suffer from Congenital Emphysema, with only 10% diagnosed. According to the same estimation, only 4,000 patients worldwide are currently under medical treatment with an annual cost of $60,000-$100,000 per patient. According to recent publications, most of these medical expenses are financed, in the USA and several European countries, through health insurance programs."
Source: Kamada Receives Final FDA Approval to Commence Phase III Clinical Trials of API with Congenital Emphysema Patients. Business Wire (March 9, 2006) [FullText]
API is used to treat Congenital Emphysema, a disease caused by an inborn deficiency of Alpha1 protein. The drug is produced by Kamada using the fourth fraction of human plasma. Kamada has already begun the distribution process of API in several countries. According to available information, API is the only product in its category that is available without the need for preparation or dilution. API's elevated status gained Kamada an advantage in the development of the next generation of the product that will be administered by inhalation instead of injection, delivering the drug directly into the patients lungs, thus reducing the time and cost of treatment.
Kamada's CEO, David Tsur, stated, "The FDA approval is a major step for the company towards debuting commercial distribution in the USA. In order to prepare for the clinical trials, Kamada has allocated extra resources to accelerate the research and development process of API."
Kamada anticipates the final approval by the FDA or EMEA (European Medicines Agency) for the commercial use of API will generate a substantial and sustainable contribution to the company's revenues. This is mainly because API only enables temporary replenishment of the Alpha1 protein. It does not provide a cure. Congenital Emphysema patients undergoing API treatment will require continued medication throughout their life.
The American Alpha1 organization estimates that more than 200,000 people in the USA and Europe suffer from Congenital Emphysema, with only 10% diagnosed. According to the same estimation, only 4,000 patients worldwide are currently under medical treatment with an annual cost of $60,000-$100,000 per patient. According to recent publications, most of these medical expenses are financed, in the USA and several European countries, through health insurance programs."
Source: Kamada Receives Final FDA Approval to Commence Phase III Clinical Trials of API with Congenital Emphysema Patients. Business Wire (March 9, 2006) [FullText]
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