French radiopharmaceutical startup Advanced Accelerator Applications has filed for an IPO to raise up to $100 million. It already markets a half-dozen molecular imaging agents and is raising the money, at least in part, to gain pivotal data and regulatory approval for its first therapeutic.
The startup is in a pivotal Phase III trial with Lutathera to treat inoperable progressive midgut carcinoid tumors. The data are expected during the first half of 2016 with regulatory submissions to follow later that year; the study is expected to be sufficient for both the EMA and FDA.
Lutathera is a molecular nuclear therapy, specifically a Lu-177-labeled somatostatin analogue peptide. It's already available on a compassionate use or named-patient basis in the U.S. and EU, respectively, since there's no approved treatment for midgut neuroendocrine tumors.
In a Phase I/II trial, Lutathera had progression-free survival of 45.1 months in subgroup of 51 patients with midgut neuroendocrine tumors and of 30 months in a subgroup of 103 pancreatic neuroendocrine tumor patients.
By the end of next year, the company expects to start an additional Phase III trial in pancreatic neuroendocrine tumor patients. It also has several earlier stage clinical and preclinical candidates.
Advanced Accelerator was founded in 2002 by Italian academics as a spinoff from the European Organization for Nuclear Research (CERN). It had $45.5 million in sales during the first 6 months of 2014, up from $36 million during the same period in 2013.
In September, Advance Accelerator acquired the Italian fluorodeoxyglucose positron emission tomography business for an undisclosed amount from GE Healthcare ($GE), which includes the conglomerate's SteriPET imaging agents.
Investors in Advanced Accelerator include HBM Healthcare Investments (7.9% pre-IPO stake), Life Sciences Capital (6.8%) and Carpefin (5.6%).
Earlier this month, another medical imaging agent company, Lantheus Holdings, refiled for an IPO. It had been slated to go public in July but postponed the offering. The company hasn't offered a target amount to raise yet, but last time around it was $125 million.
- here is the SEC filing