Kamada- Since Kamada got Orphan Drug Designation for the Inhaled AAT, does this mean that for 7 and 10 years (USA, Europe) other products including recombinant will be blocked?
This morning Kamada released a note at TASE that they received a positive review regarding its program to test its inhaled AAT in phase II clinical trials for the treatment of Cystic Fibrosis.
[A phase-2/3 program for inhaled AAT has already started in Europe (#msg-20971257). Please see #msg-10073726 for background on Kamada’s injectable AAT program, which is in phase-3. Both the inhaled and injectable programs use AAT derived from plasma.]
NESS ZIONA, Israel--(BUSINESS WIRE)--Kamada (TASE:KMDA), a bio-pharmaceutical company, has submitted its clinical development program to the FDA for its flagship drug, Alpha-1 Antitrypsin (AAT) with its aerosolized (inhaled) form for the treatment of Congenital Emphysema caused by Alpha-1 Antitrypsin Deficiency (AATD). The company plans to commence clinical development in the US concurrently with the trials already underway towards registration in Europe.
“The potential number of AATD subjects worldwide is estimated by the US Alpha -1 patients' organization at approximately 200,000. According to an independent survey, only 5,000 of these are currently treated. We therefore see a significant potential in the treatment of AATD with the aerosolized AAT drug. The cost of treatment with the aerosolized version is expected to be lower than with intravenously administered AAT. Furthermore, there is continuously growing clinical evidence from all over the world indicating that the rationale in treating Congenital Emphysema with AAT is also valid for treating other respiratory diseases, such as: Cystic Fibrosis, and possibly others. Therefore, development of the product for additional indications is underway. We are collaborating with the leading worldwide physicians in this field,” said Kamada's CEO, David Tsur.
According to John Walsh, President of US Alpha One Foundation, “the US Alpha-1 community is extremely excited about this submission and the progress made in Kamada’s European trials for aerosolized delivery of augmentation therapy. The Alpha-1 Foundation has prioritized the development of aerosolized AAT and is committed to supporting this application.”
The AAT drug, also known as API (Alpha-1 Proteinase Inhibitor), is currently indicated for treating Congenital Emphysema. This disease, caused by an inborn deficiency in the Alpha-1 Antitrypsin protein and manifested by a gradual destruction of the lung tissue, may lead to severe deterioration of lung function and eventually to death. To date, the only available treatment for the disease is intravenous administration of AAT. This treatment, performed by means of intravenous infusion on a weekly basis, is time consuming. Kamada's development of the aerosolized version is expected to make a significant difference in patient's quality of life by allowing a simple and non-invasive route of administration.
According to Tsur, “the AAT product of Kamada holds numerous advantages over competitive products, among them its being liquid and its ready to use formulation allowing easier drug handling. These features, together with the product's exceptional purity level and exclusive rights for the use of an inhalation device by PARI (a Germany-based world leader in inhalation solutions), formed the route of a strong and sound basis for the development of an aerosolized AAT drug by Kamada.”
Kamada's aerosolized AAT drug was designated by both the US-FDA and the European Agency for the Evaluation of Medicinal Products (EMEA) as an Orphan Drug for two indications - Congenital Emphysema and CF. This important attribute has granted the company research funds benefits, waiver of user fees and free scientific advise by the regulatory authorities. Furthermore, if Kamada is the first company to successfully complete clinical trials and receive marketing approval in the US or the EU, the company shall gain exclusive marketing rights for the duration of seven years in the US, and for 10 or 12 years in Europe.
At present, Kamada manufactures and markets its intravenous AAT drug in several countries around the world. A Phase III clinical trial in the US is currently underway.
Kamada is a public company traded on the Tel Aviv Stock Exchange (TASE:KMDA). The company was founded in 1990 and specializes in the development, manufacturing and marketing of specialty bio therapeutics indicated for medical emergencies. <<
News 
Market Data 
Discover 
AI
