Kamada has announced that an agreement with Chiesi for European distribution of Kamada’s inhaled Alpha-1 Antitrypsin (AAT) has been terminated. According to Kamada, the companies mutually agreed to end the agreement because Kamada recently withdrew its MAA for inhaled AAT, and “a European distribution agreement within the pact’s defined timeframe is not currently warranted.”
The MAA was submitted to the EMA in early 2016. At the time, Kamada CEO Amir London said he was optimistic for approval and that the EMA had said that it would evaluate “the totality of data” from the company’s Phase 2/3 study even though that study missed its primary and secondary endpoints.
The withdrawal of the MAA, the company said in June, came after it “concluded that the EMA does not view the data submitted to date as sufficient for approval of the MAA, and that the supplementary data needed for approval requires an additional clinical trial.”
In the current announcement, London said, “As previously announced, we expect to begin a Phase 3 trial for our Inhaled AAT in 2018, once we receive the required regulatory approvals, and if successful, we intend to utilize the data to be obtained from this pivotal study to resubmit our MAA in Europe. The clinical profile of our inhaled AAT continues to provide us confidence in its potential to be a safe and effective treatment for AATD, and we look forward to proceeding with the Phase 3 program for the potential benefit of the global AATD patient population.”
Read the Kamada press release on withdrawal of the MAA.
Read the Kamada press release on termination of the agreement with Chiesi.
