AVEO Oncology (AVEO - Free Report) is due to receive $2 million from its partner EUSA Pharmaas the latter has been granted positive NICE recommendationfor Fotivda (tivozanib) for the first line treatment of adult patients with advanced renal cell carcinoma (aRCC). EUSA Pharma is the licensee for tivozanib in Europe, North and South Africa, Latin America and Australia.
The recommendation is the first European Union reimbursement approval for Fotivda. This recommendation will help in broadening patient access to Fotivda in key European markets.
Fotivda is an oral, once-daily, potent and highly-selective vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI).
AVEO’s share price movement shows that the stock has significantly outperformed the industry in the past year. AVEO has surged 254.5% during this period, against the industry’s decline of 4.8%.
Fotivda was approved in the European Union, Norway and Iceland in August 2017, for the first line treatment of adult patients with aRCC and for adult patients who are vascular endothelial growth factor receptor (VEGFR) and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for aRCC.
The decision was primarily based on positive preliminary data from a phase III study TIVO-3 study, which demonstrated that the drug achieved superior progression free survival (PFS). Top-line data from what? is expected in the second quarter of 2018.
Per the terms of their agreement EUSA Pharma has agreed to pay AVEO up to $386 million in future research and development funding and milestone payments, subject to the specified regulatory approvals. EUSA Pharma will also pay tiered royalty ranging from a low double-digit up to mid-twenty percent on net sales of Fotivda in the agreement’s territories.
Thirty percent of the milestone and royalty payments received by AVEO, will be paid to Kyowa Hakko Kirin (KHK) as a sublicensing fee in Europe. In the United States, AVEO will pay royalty in the low- to mid-teens on net sales to KHK. AVEO acquired the exclusive rights to develop and commercialize tivozanib in all countries outside Asia and the Middle East under a license from Kyowa Hakko Kirin in 2006.
Fotivda is currently being evaluated in a couple of studies for the third-line treatment of RCC and advanced RCC. Data from the studies will support regulatory approval of Fotivda in the United States.TIVO-3 is being conducted to address the overall survival concerns from the TIVO-1 trial identified by the FDA in the complete response letter issued in June 2013. The data from both the studies is also intended to support a request for regulatory approval of tivozanib in the United States as a third-line treatment and as a first-line treatment for RCC.
Zacks Rank & Stocks to Consider
AVEO carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the health care space are XOMA Corp. (XOMA - Free Report) , Exelixis (EXEL - Free Report) and Enanta Pharmaceuticals, Inc. (ENTA - Free Report) . While XOMA carries a Zacks Rank #1 (Strong Buy), Exelixis and Enanta Pharmaceuticals carry a Zacks Rank #2 (Buy), each. You can see the complete list of today’s Zacks #1 Rank stocks here.
XOMA’s loss per share estimates have narrowed from 99 cents to 42 cents for 2018 in the last 60 days. The company pulled off a positive earnings surprise in one of the last four quarters, with an average beat of 47.92%. Share price of the company skyrocketed 360.2% over a year.
Exelixis’ earnings per share estimates have moved up from 72 cents to 77 cents for 2018 in the last 60 days. The company delivered positive earnings surprise in the last four quarters, with an average beat of 572.92%. Share price of the company surged 30.8% over a year.
Enanta Pharmaceuticals delivered a positive earnings surprise in three of the last four quarters, with an average beat of 373.1%. Share price of the company surged 169.9% over a year.
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