The European Medicines Evaluation Agency (EMEA) has approved the launch of Phase I clinical trials for Israel-based Kamada's alpha 1-proteinase inhibitor (API) inhaler. The API is the company's flagship product, and the only of its products without any current competition.
The inhaled API treats congenital diseases panacinar emphysema and cystic fibrosis. Kamada already produces and markets an API in injectable form, and is now registering the drug in the U.S. and Europe. Other companies also produce injectable API, but Kamada is the first to successfully develop an inhaler. This method is easier for patients and is expected to be more targeted and effective, since panacinar emphysema and cystic fibrosis are pulmonary diseases.
Kamada has obtained orphan drug status from the EMEA for inhalable API, which give the drug 10-year exclusivity in Europe from the date of launch, unless a new product is developed with significantly better effectiveness.