Aeterna Zentaris has regained North American rights to its Phase III-stage Akt inhibitor anticancer candidate perifosine from Keryx Biopharmaceuticals, for all potential indications. All IP and development data generated by Keryx have now been transferred to Aeterna Zentaris. The latter will, in return, pay Keryx a low single-digit royalty on future sales of perifosine in North America.
Termination of the firms’ licensing agreement comes just over a month after Aeterna Zentaris reported that a Phase III colorectal cancer trial evaluating perifosine in combination with capecitabine (Xeloda) failed to meet its primary endpoint of improving overall survival compared with capecitabine therapy alone. Aeterna Zentaris has confirmed it will, however, continue an ongoing Phase III study evaluating perifosine as part of combination therapy against multiple myeloma.
The multiple myeloma study, being carried out under a Special Protocol Assessment, is evaluating perifosine combined with bortezomib (Velcade®) and dexamethasone therapy in the treatment of about 400 patients with relapsed or relapsed/refractory multiple myeloma. Aeterna Zentaris says data from the trial are expected to be sufficient for registration of perifosine in Europe and the U.S.
“Our decision to continue the Phase III trial in multiple myeloma is based first and foremost on the existing solid preclinical and clinical data, and on the support for this drug among key opinion leaders in this field,” states Juergen Engel, Ph.D., Aeterna Zentaris president and CEO. “Perifosine in multiple myeloma remains a key component of our deep pipeline focused on providing novel, targeted treatment options for cancer patients facing unmet medical needs.”
Perifosine is separately being evaluated either as monotherapy or as part of combination therapy for a range of cancer indications including breast cancer, sarcoma, non-small cell lung cancer, and other cancers. Aeterna Zantaris holds rights to perifosine in North America and Europe. Development rights to the drug in Japan, Korea, and the Middle East and North Africa (MENA) have been licensed out to Yakult Honsha, Handok, and Hikma Pharmaceuticals, respectively.