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Radiopharmaceutical by AAA

Radiopharmaceutical by AAA

This is Italy Team

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A drug that will cost 44 million euro to beat neuroendocrine tumors. This is what AAA (Advanced Accelerator Applications) hopes to achieve. The Piedmont-based group, leader in Europe in molecular and nuclear medicine, will allocate this amount for the development of the radiopharmaceutical Lutate.

The investment will include the costs of registration of the product, the intellectual property, clinical experimentation and the start of marketing activities, and will be supported by a recapitalization of about 40 million.

The project is part of the BioSynthema operation. BioSynthema is an American company (based in St. Louis, Missouri), owner of Lutate, all of whose shares were acquired last June for about 12 million. It was a strategic move for the expansion of AAA on the market of therapy, a high growth business with exceptional profit margins, and one that is a good match for the other recent acquisition (51%), of the Canadian company Atreus Pharmaceuticals, a biopharmaceutical start-up in Ottawa, acquired a year ago for 6 million dollars.

In 2010 AAA reported a turnover of about 28 million (+22% compared with 2009). The company operates in 10 centers, with production facilities, research and development in five countries in the world (France, Italy, Switzerland, Spain and the U.S.) and a staff of over 140 people. «In addition to expanding the range of products» Stefano Buono, chairman and CEO of the group explains to Panorama Economy, «these acquisitions increase our strategic presence in North America, a huge market with excellent profit potential».

So what is Lutate? It is an innovative somatostatin-analog radiopharmaceutical that acts like radiotherapy, selectively targeting tumor cells. It has already been tested successfully on over 600 patients affected by gastroenteropancreatic tumors, in a clinical experimentation program conducted by the Erasmus Medical Centre of Rotterdam in the Netherlands and, according to estimates by AAA, is appears to be effective on 60% of these tumors. The experimentation confirms that, with respect to traditional therapies, including chemotherapy, Lutate makes it possible to increase the life expectancy of patients affected by these pathologies from three and a half to six years, with a noticeable improvement of the quality. The product has been granted Orphan Drug status by both the FDA and the EMA, which gives it protection from competition for seven years in the U.S. and 10 years in Europe.

Production will start at the Colleretto Giacosa facility, built with an investment of 5 million euro in the Biolndustry Park of the Canavese district, near Ivrea, which has become the first industrial site in the world authorized to manufacture radio-labelled peptides for molecular nuclear therapy. «AAA could already produce sufficient quantities of Lutate to satisfy the needs of the European market with the Colleretto Giacosa site. However, a second structure will be added, at the Irst facility in Meldola (Forlì), which will also produce other radio-labelled drugs» concludes Buono.

Francesco Signor

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