AVEO Pharmaceuticals, Inc.
Q1 2013 Earnings Call Transcript

Published: 3 May 2013

[Operator:]

Thank you for holding, and welcome to the AVEO Oncology's Conference Call. [Operator Instructions] Please be advised that this call is being taped at the company's request, and will be archived on the company's website for 2 weeks from today. At this time, I would like to introduce Mr. David Johnston, Chief Financial Officer at AVEO. Please go ahead.

[David B. Johnston:]

Thank you, operator, and thank you, all, for joining us. With me today is Tuan Ha-Ngoc, our President and Chief Executive Officer. Let me remind everyone that certain matters discussed today may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These may include statements about AVEO's future expectations and plans, clinical development and regulatory time lines and the potential approval and success of our product candidates. These statements involve risks and uncertainties, which are described in the Risk Factors section of our most recent Form 10-K, filed with the SEC and available online at sec.gov. While these forward-looking statements represent our views as of today, they should not be relied upon as representing our views in the future. We may update these statements in the future, but we are not taking on an obligation to do so. Now before I pass the call over to Tuan, we want to let you know upfront that we will limiting today's call to our prepared remarks, and we will not be holding a question-and-answer session. We acknowledge that you have a lot of questions, to which we do not yet have answers. While the formal review process for the tivozanib NDA remains ongoing, we're going to refrain from conversations with the investment community and members of the media. We believe this is the most appropriate course of action at this time and appreciate your understanding. Now with that, let me pass the call to Tuan.

[Tuan Ha-Ngoc:]

Thank you, Dave. Good afternoon, everyone, and thank you for joining us. Today, the FDA's ODAC met and discussed the data of -- for tivozanib including in our New Drug Application. We are very disappointed with the outcome and strongly disagree with the views expressed today by members of the Advisory Committee. Although we recognize that the confounding nature of the crossover would be an important topic for discussion at ODAC, we were dismayed by the sentiments expressed today by members of the panel. TIVO-1 was designed in collaboration with key opinion leaders in RCC field, and the primary endpoint of TIVO-1, progression free survival, was achieved. PFS has been agreed upon primary endpoint for approval of all other TKIs in this indication. There remains a need for new treatment option for patients living with kidney cancer, as you heard during the public comment period. We appreciate the perspective and personal stories shared today by several patients, nurses and patient advocates regarding their first-hand experience with tivozanib and the tangible unmet needs in kidney cancer despite the availability of multiple existing treatment options. On behalf of everyone at AVEO, I would like to thank the patients, their families and the investigators for their participation in our clinical trials. In addition, we would like to thank the physician experts who joined us today, in particular, Dr. Motzer and Dr. George, who underscored both the unmet need in treating patients with advanced RCC and the promise of tivozanib in this patient population. I would like to acknowledge the excellent work by AVEO's clinical and regulatory teams in their execution of TIVO-1 and preparing for this ODAC meeting. As you can imagine, we are evaluating the feedback received today and its implications, and we will not be hosting a Q&A session. Let me finish by restating that we are confident in the efficacy, safety and tolerability of tivozanib in patients with RCC and its promise in other tumor types. Thank you for joining us this afternoon, and have a good evening.

[Operator:]

Thank you, ladies and gentlemen. This concludes today's conference call. Thank you for your participation. You may now disconnect.