Strengthened collaboration confirms IBA's leadership in radiopharmaceuticals, Aposense's drug development capabilities and, their shared mission to provide the new generation of tracers that will take disease diagnostic and treatment to the next level.
Louvain-la-Neuve, Belgium and Petach-Tikva, Israel, September 21, 2009 - IBA (Ion Beam Applications S.A.: Reuters IBAB.BR and Bloomberg IBAB.BB), the leading global provider of PET radiopharmaceuticals, and Aposense Ltd., the leader in the development of agents targeting apoptosis (programmed cell death) for molecular imaging and therapy, today announced an exclusive collaboration agreement for commercializing Aposense® [18F]-ML-10, Aposense's novel agent for molecular imaging of apoptosis.
[18F]-ML-10 is a small molecule radiotracer which allows the imaging of apoptosis, a fundamental biological process of controlled cell death, from the early stages of the death process. Given the broad, 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. In particular, [18F]-ML-10 may assist oncologists in evaluating tumor response to treatment much earlier than conventional imaging modalities such as CT or MRI. This may allow clinicians to identify earlier the most effective treatment within their therapeutic arsenal and provide personalized, safer and more cost-effective care. Among other clinical fields of potential applications of [18F]-ML-10 are Cardiology and Neurology.
[18F]-ML-10 illustrates the capability of Nuclear Molecular Imaging to become a central discipline in healthcare and to deliver the clinical and economic benefits of Personalized Medicine.
The long-term, global 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 proprietary ML-10 precursor and IBA will 18F-label and distribute the final drug product to clinical sites through its global network of PET radio-pharmacies.. IBA and Aposense will share in revenue and development costs. Specific financial terms were not disclosed. Multi-center phase II clinical trials of [18F]-ML-10 are underway in a number of leading cancer centers in the United States, and are expected to be completed in 2010, to be followed by phase 3 trials during 2011/2012 for obtaining regulatory approvals.
This deal is putting to use the set of capabilities that IBA Molecular has developed in Pharmaceutical development, Manufacturing and Global Distribution. IBA demonstrates its capability to transform a valuable compound into a PET radiopharmaceutical product routinely available to the major Nuclear Medicine Departments worldwide.
"This collaboration is an important milestone in the expansion of our leading position in the field of radiopharmaceutical products", said Pierre Mottet, Chief Executive Officer of IBA. "As a leading supplier of PET radiopharmaceuticals worldwide, this partnership with Aposense underscores our strategy of offering cutting edge technology, materials and services to medical imaging centers from a single source. We believe that Aposense [18F]-ML-10 will be a leader in our PET product portfolio and we very much look forward to this enhanced collaboration."
"IBA's largest network of PET Radiopharmaceuticals production and distribution centers in the world makes them the ideal partner for helping us to distribute and commercialize [18F]-ML-10 to the clinicians, who will use our imaging agent to image and follow the treatment of cancer and hopefully improve clinical outcomes for patients," said Yoram Ashery, CEO of Aposense. "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."
This agreement expands the successful relationship established between IBA and Aposense in August 2008, when they entered into an agreement for 18F-labeling and distributing of ML-10 by IBA for Aposense's multi-center clinical trials.
Founded in 1986 in Louvain-la-Neuve, Belgium, IBA is primarily active in the medical industry. It develops and markets state-of-the-art equipment and radiopharmaceuticals for cancer diagnosis and treatment. In addition, it uses the scientific expertise thus gained to provide electron accelerators for industrial sterilization and ionization. Listed on the pan-European stock exchange Euronext, IBA is included in the BEL Mid Index (IBA: Reuters IBAB.BR and Bloomberg IBAB.BB).
About Aposense Ltd.
Aposense Ltd. (formerly NST NeuroSurvival Technologies) is a molecular imaging and drug development company, leading the translation of the science of apoptosis (programmed cell death) into clinical practice. Aposense developed a proprietary, novel class of rationally-designed, small molecules that selectively identify and accumulate within apoptotic (dying) cells in vivo. Apoptosis plays a role in many diseases across numerous clinical areas, including oncology, neurology and cardiology. Molecular imaging with Aposense may enable real-time visualization of the biological activity of disease, its onset, change in course and response to therapy, and to personalize treatment for the individual patient. In addition, Aposense also develops novel targeted anti-cancer therapies based on its platform technology, whereby apoptotic cells in tumors are used as targets for specific delivery of cytotoxic agents. For more information, visit http://www.aposense.com
About Molecular Imaging
Molecular imaging is an emerging field which aims to visualize non-invasively biological processes in-vivo. The ability to image disease-related biological processes may allow to detect disease early, characterize it better and to personalize treatment by real-time monitoring of its therapeutic effect. Molecular imaging depends on special molecules (probes) that can selectively target these biological processes, while carrying an imaging moiety for visualization, such as 18F or other positron emitting radio-isotopes that can be visualized by positron emission tomography (PET).
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