AVEO Pharmaceuticals, Inc.


May 31, 2013 – Robbins Geller Rudman & Dowd LLP (“Robbins Geller”) (http://www.rgrdlaw.com/cases/aveo/) today announced that a class action has been commenced in the United States District Court for the District of Massachusetts on behalf of purchasers of AVEO Pharmaceuticals, Inc. (“AVEO”) (NASDAQ:AVEO) publicly traded securities during the period between January 3, 2012 and May 1, 2013 (the “Class Period”).

If you wish to serve as lead plaintiff, you must move the Court no later than 60 days from May 9, 2013.  If you wish to discuss this action or have any questions concerning this notice or your rights or interests, please contact plaintiff’s counsel, Darren Robbins of Robbins Geller at 800/449-4900 or 619/231-1058, or via e-mail at djr@rgrdlaw.com.  If you are a member of this class, you can view a copy of the complaint as filed or join this class action online at http://www.rgrdlaw.com/cases/aveo/.  Any member of the putative class may move the Court to serve as lead plaintiff through counsel of their choice, or may choose to do nothing and remain an absent class member.

The complaint charges AVEO and certain of its officers and directors with violations of the Securities Exchange Act of 1934.  AVEO is a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics. The Company’s lead product is an oral inhibitor of the vascular endothelial growth factor (“VEGF”) receptors.

The complaint alleges that specifically, throughout the Class Period, defendants violated the federal securities laws by disseminating false and misleading statements to the investing public about the viability of the Company’s leading drug Tivopath, or tivozanib, for the treatment of advanced kidney cancer.  Investors were led to believe that tivozanib would receive approval from the U.S. Food and Drug Administration (“FDA”) through materially false and misleading statements regarding the Phase 3 trial design and results.  As a result of defendants’ false statements, AVEO’s stock traded at artificially inflated prices during the Class Period, reaching a high of $14.97 per share on January 12, 2012.

On April 30, 2013, the FDA released its Oncologic Drugs Advisory Committee (“ODAC”) meeting briefing document (the “Briefing Document”) that, among other matters, took particular issue with the rigor of the tivozanib trial: “In considering the results from a single randomized trial submitted in support of marketing approval of a new molecular entity, FDA expects that the trial will be adequately designed and well conducted and that the results will be internally consistent.  We are asking the ODAC’s advice on whether this single trial is sufficient to support approval of tivozanib for the indication of treatment of patients with advanced renal cell cancer or whether an additional trial is necessary before considering marketing approval.”

The Briefing Document also highlighted the regulatory history of Tivopath, and the fact that the Company disregarded explicit FDA recommendations for the Company to conduct an additional Phase 3 trial, “[a] pre-NDA meeting was held in May 2012.  Here, the FDA expressed concern about the adverse trend in overall survival in the single Phase 3 trial [TIVO-1] and recommended that the sponsor [AVEO] conduct a second adequately powered randomized trial in a population comparable to that in the US.”

On this news, AVEO’s stock plummeted $2.33 per share to close at $5.11 per share on April 30, 2013, a one-day decline of 31% on high volume of over 15 million shares.

On May 2, 2013, the Company and the FDA made presentations to the ODAC regarding the new drug application of tivozanib.  The FDA noted in its presentation to the ODAC that: (a) tivozanib was studied in a Phase 3 trial with inconsistent results; (b) tivozanib increased potential risk of death by 25% compared to the control drug, sorafenib; (c) tivozanib therapy induced higher rates of hypertension, hemorrhage and dysphonia than sorafenib; (d) TIVO-1 had a flawed trial design; (e) TIVO-1 provided internally inconsistent trial results; (f) TIVO-1 provided uninterpretable overall survival results; and (g) TIVO-1 provided inconclusive risk-benefit assessment data.

Then, on May 2, 2013, the ODAC voted not to recommend approval of tivozanib, as AVEO reported in a press release that day:

[T]he application for investigational agent tivozanib did not demonstrate a favorable benefit-to-risk evaluation for the treatment of advanced renal cell carcinoma (RCC) in an adequate and well-controlled trial.

On this news, AVEO’s stock declined $2.61 per share to close at $2.65 per share on May 2, 2013, a one-day decline of nearly 50% on volume of over 15 million shares.

As a result of defendants’ false statements, AVEO stock traded at artificially inflated levels during the Class Period.  However, after the above revelations seeped into the market, the Company’s shares were hammered by massive sales, sending them down 82% from their Class Period high.

Plaintiff seeks to recover damages on behalf of all purchasers of AVEO publicly traded securities during the Class Period (the “Class”).  The plaintiff is represented by Robbins Geller, which has expertise in prosecuting investor class actions and extensive experience in actions involving financial fraud.

Robbins Geller represents U.S. and international institutional investors in contingency-based securities and corporate litigation.  With nearly 200 lawyers in nine offices, the firm represents hundreds of public and multi-employer pension funds with combined assets under management in excess of $2 trillion.  The firm has obtained many of the largest recoveries in history and has been ranked number one in the number of shareholder class action recoveries in MSCI’s Top SCAS 50 every year since 2003.  Please visit http://www.rgrdlaw.com for more information.

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