Æterna Zentaris Inc, a global biopharmaceutical company focused on endocrine therapy and oncology, signed a development, commercialization and licensing agreement with sanofi-aventis for the development, registration and marketing of cetrorelix in benign prostatic hyperplasia (BPH) for the US market.
Cetrorelix, a luteinizing hormone-releasing hormone (LHRH) antagonist, is currently in a phase-3 programme in BPH, a non-cancerous enlargement of the prostate, affecting more than 20 million men in the US alone.
Under the terms of the agreement, sanofi-aventis will make an initial $30 million upfront payment to Æterna Zentaris which will also be entitled to receive up to $135 million in additional payments upon achieving certain pre-established regulatory and commercial milestones. Furthermore, Æterna Zentaris will be entitled to receive escalating double-digit royalties on future net sales of cetrorelix for BPH in the United States. Sanofi-aventis will be responsible for the commercialization and booking of sales in the US; however, Æterna Zentaris has retained certain rights to co-promote cetrorelix for BPH in the US market. Finally, sanofi-aventis may perform future phase-3b and phase-4 clinical trials, while Æterna Zentaris will have free access to all data for other territories.
"We are delighted to have a partner such as sanofi-aventis who has a proven track record in urology. This partnership marks an important milestone in our quest to bring cetrorelix to market which could provide millions of men with a novel treatment for BPH. Furthermore, this compound could generate significant long-term revenue for the Company while building value for our shareholders," said Juergen Engel, president and CEO of Æterna Zentaris.
Cetrorelix pamoate is an investigational agent that has shown in Phase 2 studies to provide fast and long lasting relief of BPH symptoms and was well tolerated, with a low incidence of sexual side effects.
Æterna Zentaris is a global biopharmaceutical company focused on endocrine therapy and oncology, with proven expertise in drug discovery, development and commercialization.