AAA acquires BioSynthema, Inc. (St. Louis, Missouri) to enter radiopharmaceutical cancer therapeutic market

Advanced Accelerator Applications announced that it has signed the definitive Stock Purchase Agreement for the acquisition of BioSynthema, Inc . The purchase is subject to the final completion of the transaction, which is expected in mid-June. As part of the transaction, BioSynthema ’s founding shareholders and top management will become significant shareholders of AAA, an implicit commitment to continuity and a demonstration of the common view by both parties on the potential for new product development and value creation.

BioSynthema, located in St. Louis, Missouri, USA,  discovers and develops unique pharmaceuticals that are targeted to cell surface receptors over-expressed by various lesions, e.g. neuroendocrine cancers. The technology makes specific tumors highly visible using diagnostic imaging methods, which enables earlier and more accurate diagnosis and personalized therapy.BioSynthema is currently developing compounds that will bring new and effective products to the market for the diagnosis and treatment of Gastro-Entero-Pancreatic NeuroEndocrine Tumors (GEPNETs).

AAA will support the continued successful development of Lutathera®, Biosynthema’s lead product, which is forecasted to have the required marketing authorization in 2015.

AAA has a state-of-the-art Good Manufacturing Practice (GMP) facility in the BioIndustry Park of Canavese (Ivrea, Italy), which would be an ideal site for the manufacture of Lutathera®. The request to produce Lutathera® as an Investigational Medical Product has already been filed by AAA with the Italian authorities (AIFA), and approval is expected to be obtained in the course of this summer. AAA is also building a second facility that will produce Lutathera® and other Radio Metabolic Drugs in the IRST(Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori) of Meldola, Italy. Together with the structure of Ivrea, these laboratories will not only develop new drugs, but will also be able to cover the production needs of the entire European Market after the Lutathera® Marketing Authorization has been granted.

For more details and highlights please refer to the official press releases and press articles posted in the “press room” section.

Leading European Manufacturers found EMMA

Five prominent European radiopharmaceutical manufacturers have announced the creation of EMMA (European Molecular Imaging Manufacturers Association), a Consortium designed to take advantage of its Members’ pooling of resources in manufacturing, marketing and distribution of Positron Emission Tomography (commonly known as “PET” scans) products.

This unique European solution will fill the short-term need of supporting new PET tracer compounds that are today in the last phases of clinical research and may soon become valuable products in the field of Oncology, Cardiology and Neurology. Thus, the resources of EMMA’s five strategically positioned private PET tracer manufacturing companies have been combined to offer a European-wide capability and strategic presence, with 16 production facilities already operating and many new projects under development.

EMMA’s members will initially include:
Advanced Accelerators Applications SA (“AAA”) – with laboratories in France, Italy, Switzerland and Spain. Biokosmos SA – Greece Erigal Ltd. – Ireland and the UK Map Medical Oy – Finland PET Net GmbH – Germany. Because of the significant positive impact that this industrial cooperation will have on the European PET market, it is foreseen that future additional partners could be invited to join. The consortium will have one of its members acting as its representative to third parties on a revolving basis. AAA has been appointed at this role for the first 3 years.

For more details and highlights please refer to the official press releases and press articles posted in the “press room” section.

Investment of Advanced Accelerator Applications in Atreus Pharmaceuticals Corporation to develop Annexin Imaging Business

AAA has made an initial investment of US $450K in Atreus Pharmaceuticals Corporation. Depending on successful completion of several milestones, AAA may invest a total of US $6 million to take a majority participation in this company. This investment shall enable the development of a medical imaging technology involving a human plasma protein called Annexin V.

Atreus Pharmaceuticals is a development-stage, biopharmaceutical company headquartered in Ottawa, Canada, developing in-vivo radiopharmaceutical products suitable for Nuclear Medicine (SPECT) imaging and for PET imaging. Atreus Pharmaceuticals’ product line is based on the Annexin V human protein, which binds to phosphatidylserine, a molecule that only shows up on the surface of dead or dying cells.

The technology has the potential to detect conditions such as rheumatoid arthritis, Crohn’s disease and Alzheimer’s disease at their early stage, and when used with the medical isotope Technetium-99, also has the ability to be used to evaluate the response to treatment for lymphoma and lung cancer.

This agreement and partnership will allow AAA to expand into the North American market.

For more details and highlights please refer to the official press releases and press articles posted in the “press room” section.

AAA appoints two additional Board Members

AAA Board appointed two new members, Claudio Costamagna and Andrea Ruben Levi. The newly appointed Board members are well-known representative of the business and scientific community.

Claudio Costamagna is founder and chairman of the financial advisory boutique CC&Co and independent Board member of outstanding Italian and international groups such as Luxottica Group, Bulgari SpA, Autogrill SpA, and DEA Capital SpA. He previously covered major roles in Goldman sachs which he left in May 2006 after 18 years. He was Chairman of the Investment Banking division for Europe, the Middle East and Africa and prior to this position, co-Head of the Investment Banking Division for Goldman Sachs International in Europe, co-Head of the bank’s Investment Banking Services in Europe, Head of the Italian team for the Investment Banking Division in London, and Chairman of Goldman Sachs SIM as well as member of the firm’s partnership and European Management Committee.

Andrea Ruben levi is President, CEO and principal shareholder of Parabensa and Delpa, the holding and administrative companies of an international group developing, designing and producing engine parts for cars. The Group holds companies in Italy, India and Poland. Prior to this, Mr. Levi earned a Ph.D. in Physics from MIT, and he spent several years doing research on nuclear physics, biophysics, and computional physics in Boston, Massachusetts, United States.

The Board of Directors now consists of 9 persons, 4 are from AAA Management, and 5 are non-executive Directors.

AAA announces the production and commercialisation of a new radiopharmaceutical in France

Thanks to a licensing agreement with IASON GmbH, an Austrian-based company specialized in the production of nuclear medicine radiopharmaceuticals, AAA is now allowed to produce and sell IASOFLU in France. IASOFLU is a new 18F sodium fluoride pharmaceutical used to detect and stage skeletal metastasis, a highly common disease in patients suffering from breast and prostate cancer. IASOFLU is produced at the French site in Troyes and is benefiting from the support of the site’s R&D and production teams. The first doses have been delivered to Creil and Tenon hospitals.

AAA awarded by Deloitte Fast Technology 50 as the fastest growing technology company in Rhône-Alpes Auvergne Region

AAA was awarded the first prize of the ninth edition of the Rhône-Alpes Auvergne Deloitte Technology Fast 50, one of the foremost technology award programs which is a ranking of the country’s 50 fastest-growing technology companies based on percentage growth over five years. The Fast 50 program recognizes the achievements, growth and contributions of the fastest-growing technology at a regional and national level.

Citing AAA 5-year revenue growth of over 1,826% (from € 600,000 to € 11.58M), AAA was honored and excited to have its impressive revenue growth be acknowledged by Deloitte, and believe it speaks to the continued committment to translate the outstanding academic research that characterize Molecular Medecine into commercial products. AAA success has mainly been driven by the production and commercialisation of its FDG Pet tracer Gluscan® and by the acquisition and development of GiPharma.

Mr Stefano Buono – AAA President and CEO – and Mr Heinz Mauesli, CFO, received the prize today in Lyon.

AAA to support University of Lausanne Hospitals

The University of Lausanne Hospitals (CHUV) will participate in a study on the impact of F-18 Fluorocholine PET/CT and MR Imaging/Spectroscopy in the Management of primary and recurrent prostate cancer. The sponsors and collaborators of this study are AAA and the Centre d’Imagerie Biomédicale (CIBM) in Lausanne. This study will run in parallel to the work-up of primary prostate cancer, as the F-Choline radiopharmaceutical will be available during the time of study at absolutely no cost to patients or CHUV. A number of studies have demonstrated the benefits of F-18 FCH PET/CT for these patients and this indication is currently not reimbursed by the Swiss obligatory health insurance providers.

GiPharma acquires a new licence in France

Gipharma was recently granted marketing authorization in France for Mibitec, a generic version of the widest used SPECT cardiac imaging agent. Mibitec has approved indications for Myocardial perfusion scintigraphy, detection and localization of coronary artery disease and myocardial infarction, assessment of global ventricular function, detection of suspected breast cancer, and localization of hyper-functioning parathyroid tissue.

AAA enters SNM Clinical Trials Network

Advanced Accelerator Applications, Erigal Limited and IBA Molecular – all European suppliers of radiopharmaceuticals used in PET imaging – have signed up to the SNM Clinical Trials Network, which currently has 201 affiliated PET manufacturing sites globally. The network is an initiative designed to address the need for streamlined drug discovery through the integration of imaging biomarkers into multicenter clinical trials. It also gained investigational new drug status for using fluorothymidine in its multicenter trials.

AAA strengthens the collaborations with Université de la Méditerranée

June 25th, 2009 – AAA signed today a new collaboration agreement with the Marseille-based Université de la Mediterranée after winning the tender for the construction of a production and R&D laboratory in 2008. According to the agreement, AAA will act as a private company hosted in the CERIMED – European Centre for Research in Medical Imaging – premises for the production and sale of radiotracers in France and abroad. AAA will also become one of CERIMED’s privileged partners for the research and development of new radiopharmaceuticals, as well as for the commercial exploitation. The construction of the production and R&D site, which will host three radiopharmaceutical laboratories and two cyclotrons, should start in October 2010, and should be operational and ready for sales at the end of 2011. Headquartered in Marseille, CERIMED is a project aiming at a European centre of excellence for the development of molecular imaging technologies to promote a multidisciplinary community working in the field of medical imaging.