AVEO Pharmaceuticals, Inc. announced that its development partner, EUSA Pharma, has submitted its response to the Day 120 List of Questions issued by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use as part of the regulatory authority’s centralized review process of the company’s marketing authorization application for tivozanib.
Note that tivozanib is under review in the EU for the first-line treatment of patients with advanced renal cell carcinoma (RCC). Meanwhile, the next step in the filing process, which includes the EMA Day 180 List of Outstanding Issues, is anticipated in the first quarter of 2017. A final response on the approval status of the candidate is expected in the first half of 2017.
We remind investors that in Dec 2015, AVEO entered into a license agreement granting EUSA Pharma the right to develop and commercialize tivozanib for all diseases and conditions, excluding non-oncologic diseases or conditions of the eye in Europe (excluding Russia, Ukraine and the Commonwealth of Independent States), Latin America (excluding Mexico), Africa, Australasia and New Zealand.
Tivozanib’s approval in the EU would trigger a milestone payment to AVEO by EUSA Pharma. In fact, the candidate’s approval will be a huge boost for the company, given the lucrative first-line RCC market in Europe.
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In addition to the EU approval decision, AVEO anticipates a milestone-rich calendar over the upcoming months across both its proprietary and partnered programs. The company expects initial data from the phase I portion of the phase I/II study(TiNivo) evaluating tivozanib, in combination with Bristol-Myers Squibb Company’s (BMY - Free Report) Opdivo (anti-PD-1 therapy), for the treatment of advanced RCC in the first half of 2017.
Moreover, AVEO expects to receive milestones from Ophthotech Corporation (OPHT - Free Report) for tivozanib in acute macular degeneration also in the first half of 2017. AVEO has a research and exclusive option agreement granting Ophthotech an option to develop and commercialize tivozanib outside Asia for the diagnosis, prevention and treatment of non-oncologic diseases or conditions of the eye.
Zacks Rank & a Key Pick
AVEO currently carries a Zacks Rank #3 (Hold). Vanda Pharmaceuticals, Inc. (VNDA - Free Report) is a better-ranked stock in the health care sector sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Vanda’s loss estimates narrowed from 68 cents to 56 cents for 2016, while its earnings estimates increased from 16 cents to 17 cents for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%. Its share price has surged approximately 84% year to date.
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