- Aveo Pharmaceuticals Inc. has secured European approval for its kidney cancer medication, further elevating drugmaker's stock, which has been on a three-month tear.
- Fotivda is now approved in the European Union, Norway and Iceland for adults with advanced renal cell carcinoma (RCC) as a first line treatment, as well as a second line treatment for patients whose cancer has progressed following cytokine therapy and who haven't received vascular endothelial growth factor receptor (VEGFR) and mechanistic target of rapamycin (mTOR) pathway inhibitors.
- EUSA Pharma Inc., owned by Jazz Pharmaceuticals plc, acquired exclusive rights to Fotivda in the majority of Europe, as well as a host of other ex.-U.S. regions, for all indications related to oncology and the eye back in late 2015. As part of that deal, Aveo stands to receive $4 million for getting the European Medicines Agency's stamp of approval.
Aveo's been having a good summer. The company's stock has climbed steadily since June 22, when the European Medicines Agency recommended Fotivda (tivozanib) for approval in the RCC setting.
The backing by the EU drugs regulator came days after Aveo completed enrollment for its pivotal TIVO-3 trial more than two months ahead of schedule. That study will assess Fotivda against sorafenib, the active ingredient in Bayer AG's Nexavar, as a treatment for refractory advanced RCC. Aveo anticipates having topline data from the 322-patient investigation in the first quarter of 2018.
Importantly, Fotivda's European approval gives its parent cash through the EUSA Pharma deal that it can use to for additional clinical development of the drug, namely in TIVO-3. EUSA Pharma could hand Aveo nearly $400 million worth of research and development funding and milestone payments via their agreement, as well as tiered royalties on the drug's sales.
In addition to the $4 million payment for locking down EMA approval, Aveo could also snag $12 million in milestones from EUSA Pharma related to E.U. member state reimbursement and regulatory approvals.
"These payments would add significant resources to our balance sheet as we work toward the anticipated readout of our U.S. pivotal trial in third-line RCC, the TIVO-3 trial, in the first quarter of 2018," company CEO Michael Bailey said in a June 23 statement.
The approval and milestone payments are much-needed good news for the company, which saw its stock pushed into penny stock territory following several setbacks.
Aveo stock opened at $4.18 on Monday morning, up 10% from Friday's close of market. Shares have since dipped back down, though, trading at $3.25 apiece Wednesday afternoon.