Four years after Aveo Oncology $AVEO was handed a humiliating rejection for its cancer drug tivozanib, the Cambridge, MA-based biotech has turned an important corner in its drive to rehabilitate itself and turn the company around. The EU has sanctioned its lead drug tivozanib for marketing, a decision which triggers a $4 million bonus from its European partner with a big step toward another $12 million laid out for reimbursement and regulatory milestones.
EUSA will roll out the drug, now approved as a frontline therapy for advanced renal cell carcinoma. EUSA committed to a total of $394 million in milestones when it struck the deal.
Aveo shares surged 9% this morning.
Back in the spring of 2016 the new management at Aveo agreed to pay $4 million to settle SEC charges that the biotech had misled investors on tivo, failing to divulge the critical fact that regulators were demanding a second confirmatory Phase III ahead of an approval. Separate from that deal are the fates of three former top execs at the company — CEO Tuan Ha-Ngoc, CFO David Johnston, and CMO William Slichenmyer — involved in positioning the company as they allegedly continued to keep investors in the dark as they raised fresh funds.
FDA oncology chief Richard Pazdur led a brutal slapdown of Aveo when he took to the floor during the panel review. He argued vehemently against tivozanib, saying that a vote in favor of a drug that had produced data of an increased risk of death would set a dangerous precedent. In the end, the panel voted 13 to one against an approval and the FDA soon formally said no.
Now Aveo wants a do-over, and will likely get it.
“The European Commission’s decision is the first regulatory approval of tivozanib globally, and a tremendous accomplishment for Aveo and its partner, EUSA Pharma. We are very pleased that tivozanib is now available to patients in Europe,” said Michael Bailey, president and chief executive officer of Aveo. “We also continue to make progress on the next two pillars in our tivozanib strategy: U.S. registration, driven by the pivotal Phase III TIVO-3 trial, which is expected to read out in the first quarter of 2018; and immunotherapy combination trials, starting with the TiNivo trial, our Opdivo combination trial.”
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