Ion Beam Applications SA (IBA) and Aposense has entered into an collaboration agreement for commercialising Aposense [18F]–ML-10, Aposense’s novel agent for molecular imaging of apoptosis.
The agreement includes the collaboration and joint-funding by IBA and Aposense of phase III and subsequent clinical development of [18F]-ML-10. In addition, the companies will jointly market and sell [18F]-ML-10, with IBA primarily focusing on its core PET imaging and nuclear medicine market, and Aposense marketing to the referring clinical specialist market.
Aposense will manufacture the ML-10 precursor and IBA will 18F-label and distribute the final drug product to clinical sites through its network of PET radio-pharmacies. IBA and Aposense will share in revenue and development costs, the company reported.
[18F]-ML-10 is a molecule radiotracer which allows the imaging of apoptosis, a fundamental biological process of controlled cell death, from the early stages of the death process. Cross disease role of apoptosis in a wide range of medical disorders, molecular imaging with [18F]-ML-10 is expected to play an important role in early detection of disease, monitoring of disease course, assessment of effect of treatment or development of novel therapies.
Earlier in August 2008, both the companies entered into an agreement for 18F-labeling and distributing of ML-10 by IBA for Aposense’s multi-center clinical trials.
Yoram Ashery, CEO of Aposense, said: “In addition to a long-term supply chain solution, this collaboration provides a strategic partnership for accelerating the availability of apoptosis imaging with [18F]-ML-10 to clinicians and enables Aposense to establish an integrated commercial operation.”
IBA will finance the trial and also invest in Aposense. Multi-center phase II clinical trials of [18F]-ML-10 are expected to be completed in 2010, to be followed by phase 3 trials during 2011/2012 for obtaining regulatory approvals.