Italy OKs first large-scale unit for making radiolabelled peptides
pharmafile | December 20, 2010 | News story | Manufacturing and Production | AIFA, Advanced Accelerator Applications, BioSynthema, Italy
The world’s first industrial-scale manufacturing facility for radiolabelled peptides used in nuclear medicine has been approved by the Italian Pharmaceutical Regulatory Authority (AIFA).
The facility in Colleretto Giacosa, near Turin, is owned by Advanced Accelerator Applications (AAA) and has been cleared to manufacture clinical supplies of Lutate (177 lutetium‑DOTA0-tyr3-octreotate), a peptide in development for a range of cancers.
Lutate is an orphan drug under development by AAA’s wholly-owned subsidiary BioSynthema, which it acquired earlier this year. The drug is a radiolabelled somatostatin analogue which selectively targets somatostatin receptors over-expressed in a range of cancer types, including neuroendocrine tumours (NETs) and gastroenteropancreatic tumours (GEPs).
AAA’s chief executive Stefano Buono said that the approval was a milestone for the firm, and hopefully will mean that Lutate will be used to treat patients “in many countries” while the firm continues its development.
The Colleretto Giacosa site, plus a second facility that is planned for construction at the IRST (Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori) in Meldola, Italy, “would be able to produce sufficient quantities of Lutate to meet European demand,” he added.
The potential of Lutate in GEP and NET tumours was shown in an investigator-sponsored clinical study at the Erasmus Medical Centre in the Netherlands. This 600-patient study demonstrated that the drug extended patients’ lives by between 3.5 and six years in comparison to standard treatment.
AAA is discussing a phase III clinical trial protocol with the European Medicines Agency and its US regulatory counterpart the FDA, and hopes to start a pivotal study next year with a view to gaining approval for Lutate in 2015.
Dr Jack Erion, chief executive of of BioSynthema, said company development teams have been working hard since the merger with AAA to reformulate Lutate into a ready-to -use injectable drug.
Phil Taylor
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