December 19, 2010

Advanced Accelerator Applications receives GMP approval to manufacture Lutathera® for treatment of NeuroEndocrine Tumors

Advanced Accelerator Applications, an emerging international leader in molecular nuclear medicine, has received GMP approval for the manufacture of Lutathera®, a radioactively labelled peptide that can be used to treat metastatic GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs).

The approval by the Italian Pharmaceutical Regulatory Authority will enable AAA to manufacture Lutathera® at its facility in Colleretto Giacosa, near Turin, Italy, making it the first industrial facility in the world approved to produce radio-labelled peptides for molecular nuclear therapy.

Lutathera® has been shown to be an effective and safe treatment for GEP-NETs in an investigator-sponsored clinical study at the Erasmus Medical Center, Rotterdam,  Netherlands, where over 600 patients have been treated with this innovative radiopharmaceutical. The study showed Lutathera® extended patients’ lives by between 3.5 and six years in comparison to current treatments, including chemotherapy. It was also shown to significantly improve quality of life, as measured by a number of function and symptom scales, especially in patients with proven tumor regression.

The US FDA and the EMEA have indicated the need for a Phase III study in order to prepare Lutate for registration. AAA has started a Parallel Scientific Advice from the EMEA and FDA to discuss its Phase III protocol. The PSA system was introduced in 2006 to allow both agencies to exchange scientific views during the development phase of new drugs. AAA hopes to start a multicenter Phase III study in 2011 in both Europe and the United States, with potential approval anticipated in 2015. Lutathera®has been granted Orphan Drug status by both the FDA and EMEA.

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

November 22, 2010

AAA ranked the third fastest growing company in the “Deloitte Technology Fast 50 Award 2010”

AAA was awarded the third prize of the tenth edition of the Rhône-Alpes Auvergne “Deloitte Technology Fast 50 Award”, one of the leading technology award programs, which provides a ranking of the 50 fastest-growing technology French companies – both at a national as well as at a regional level – on the bases of the growth of revenues over five years, technological innovation and entrepreneurial spirit.

The prize – which follows the first-ranking awarded last year – rewarded AAA 602% growth in revenues in the term 2005/2009 (from €3,214Mln to 22,570Mln€) confirming its successful business model and deep expertise in the molecular nuclear medicine market.

Mr Heinz Mauesli, CFO, received the prize in Lyon.

July 1, 2010

AAA Announces Research Collaboration Partnership with the Institut Curie in Paris

July 1, 2010 – AAA has signed an agreement with the Institut Curie to build, install and operate a pharmaceutical laboratory for radiopharmaceuticals production at the Institut Curie’s René Huguenin specialist cancer hospital in Saint-Cloud, Paris.

The cyclotron will guarantee the supply of high quality radiopharmaceuticals for the hospital’s two PET (Positron Emission Tomography) scanners, which are increasingly used in the diagnosis and treatment of cancers, enabling clinicians to track the progress of treatments such as chemotherapy as well as the appearance of secondary tumors and metastases.

René Huguenin is AAA’s fifth production center in France. It will allow AAA to supply other hospitals in western France. The new cyclotron is expected to be fully operational in 2013.

This partnership provides an exciting opportunity for both organizations to develop new and innovative oncology markers, and to offer the most up to date, innovative and targeted imaging techniques to patients. There is a growing need for better oncology treatments and AAA is committed to developing innovative diagnostics and therapeutics. This collaboration agreement with the Institut Curie will significantly strengthen AAA’s position in this market and reinforce René Huguenin Hospital’s leadership in the field of nuclear medicine.

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

June 21, 2010

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 ofBioSynthema, 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.

April 15, 2010

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.

March 10, 2010

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.

January 16, 2010

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.