A shift in rights over the hemophilia B gene therapy, AMT-060, has seen uniQure re-acquire the full rights to the development and commercialization of the candidate. Subsequently, AMT-060 is being dropped by Italian healthcare group Chiesi Farmaceutici who held rights to the therapy in Europe and other select territories. Finally, the move signals the termination of the co-development and licensing agreement between the two companies.
AMT-060 is comprised of an adeno-associated virus (AAV) carrying the Factor IX gene, which is mutated in hemophilia B patients. This year the therapy has been granted a breakthrough designation in the US, and PRIME status in Europe. uniQure will now be solely responsible for the therapy, including $3 million of expenses incurred this year which would have been split with Chiesi under the previous deal. The company is confident however that this will not impact their cash guidance; the expectation is that funds will be available to run operations well into 2019.
A statement by uniQure CEO Matthew Kapusta said’We are very pleased to reach an agreement with Chiesi to acquire back European and other territorial rights to our lead gene therapy program in hemophilia B. By regaining unencumbered, global rights to a late-stage program that has demonstrated significant clinical benefit for patients with hemophilia B, we believe uniQure is better positioned to accelerate the global clinical development plan, maximize shareholder return on our pipeline and take advantage of new potential opportunities related to the program. We are grateful for the substantial investments that Chiesi has made in AMT-060, and we have been fortunate to have them as a collaboration partner over the years.’
Source: uniQure Reacquires Development and Commercialization Rights for its Gene Therapy Candidate in Hemophilia B Press Release