Aeterna Zentaris files demand with FDA for Fast Track designation for AEZS-130 Aeterna Zentaris Inc.

This means we could submit certain modules of our NDA progressively, with the expectation that overview of those portions of the NDA will be finish or well underway before we finish the NDA submission. Should we obtain agreement on our Fast Monitor designation and rolling submission technique, we would expect to begin filing modules before year-end and full the NDA submission in the first quarter of 2013. Furthermore, we believe our request for Fast Track designation is usually warranted since there happens to be no approved diagnostic test for AGHD in North America, and AEZS-130 could provide a secure and efficient test which would be more convenient because it is administered orally.’..Beneath the collaboration, Allos will receive an upfront payment of $50 million and potential regulatory and commercial progress – and sales-dependent milestone payments as high as $310.5 million. Allos is also eligible for receive tiered double-digit royalties based on net product sales of FOLOTYN within Mundipharma’s licensed territories. Allos and Mundipharma will jointly fund advancement costs, initially on a 60:40 basis, that will change to a 50:50 basis if certain pre-defined milestones are accomplished, including approval of the MAA in review to market FOLOTYN in europe currently. Development funding by Mundipharma will support agreed-upon clinical development activities jointly, including, but not really limited to, the planned Phase 3 research of FOLOTYN in previously undiagnosed PTCL and in combination with bexarotene in relapsed or refractory cutaneous T-cell lymphoma .