Featured Company News – AVEO Pharma’s FOTIVDA(R) Licensed in EU for the Treatment of Advanced Renal Cell Carcinoma

Research Desk Line-up: Axovant Sciences Post Earnings Coverage

LONDON, UK / ACCESSWIRE / August 30, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO) (“AVEO”), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=AVEO. The Company announced on August 28, 2017, the approval of FOTIVDA® (tivozanib) by European Commission (EC) for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union (EU), also in Norway and Iceland. For immediate access to our complimentary reports, including today’s coverage, register for free now at:

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Tivozanib is indicated for the first line treatment of adult patients with advanced RCC and who are vascular endothelial growth factor receptor (VEGFR) and mTOR pathway inhibitor-naïve, following disease progression after one prior treatment with cytokine therapy for advanced RCC.

EUSA Pharma, a specialty pharmaceutical company, is the European licensee for tivozanib. The Company intends to work with the necessary health authorities to make tivozanib available to advanced RCC patients across Europe as quickly as possible.

AVEO Announced Positive CHMP Opinion for Tivozanib as a Treatment of Advanced RCC in June 2017

The approval from the EC follows the recommendation from the Committee for Medical Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA). On June 23, 2017, AVEO announced the recommendation of tivozanib by CHMP for approval as a treatment for patients with advanced RCC.

The decision was primarily based on data from a global, open-label, randomized, multi-center Phase-3 trial (TIVO-1) which evaluated the efficacy and tolerability of tivozanib compared to a currently available comparator VEGFR-TKI treatment (sorafenib) in 517 patients with advanced RCC. Results indicated that patients treated with tivozanib experienced superior Progression Free Survival (PFS) versus sorafenib, with an improved side effect profile with tivozanib. Additionally, fewer people on tivozanib experienced burdensome side effects.

European Approval Provides AVEO the Opportunity to Achieve Multiple Potential Commercial Milestone Payments

Michael Bailey, President and CEO of AVEO, expressed his happiness upon the availability of tivozanib for patients in Europe. He stated that the EC’s decision is the first regulatory approval of tivozanib globally, and a tremendous accomplishment for AVEO and its partner, EUSA Pharma. AVEO also continues to make progress on the next two pillars in its tivozanib strategy: US registration, driven by the pivotal Phase-3 TIVO-3 trial, and immunotherapy combination trials, starting with the TiNivo trial, Opdivo® combination trial. Michael further commented that European approval further strengthens the balance sheet by triggering an R&D payment to AVEO and provides AVEO the opportunity to achieve multiple potential commercial milestone payments, as well as royalty payments on sales, that would support the Company’s execution of the tivozanib strategy.

Licensing of Tivozanib Crucial in Expanding Treatment Options for RCC Patients in Europe

Commenting on the approval, Dr Jon Morgan, Medical Director at EUSA Pharma, mentioned that the licensing of tivozanib by the EC is an important step in expanding treatment options for patients with advanced RCC, where, despite advancements in therapy, survival rates in advanced disease remain low. The licensing of tivozanib is supported by results from the TiVO-1 pivotal study which demonstrated efficacy of tivozanib as a first-line treatment.

AVEO Oncology Awarded EUSA Pharma European Rights to Tivozanib in December 2015

The News release suggests that on December 21, 2015, AVEO Oncology granted EUSA Pharma European rights to tivozanib for advanced RCC, pursuant to which, EUSA Pharma holds exclusive commercialization rights to tivozanib in RCC in Europe and in a number of other territories outside North America, including South America and South Africa. AVEO retains the rights to commercialize the product in North America.

Under terms of the agreement, EUSA Pharma would pay AVEO an upfront research and development funding payment of $2.5 million, and up to $394 million in potential payments and milestones, assuming successful achievement of specified development, regulatory, and commercialization objectives, as well as a tiered royalty ranging from a low double-digit up to mid-twenty percent on net sales of tivozanib in the agreement’s territories.

About Tivozanib and RCC

Tivozanib, discovered by Kyowa Hakko Kirin, is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI). Tivozanib has been investigated in several tumors types, including renal cell, colorectal and breast cancers. It is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.

RCC is the most common form of kidney cancer, accounting for 80% of total kidney cancer cases in Europe, and an estimated 49,000 deaths each year. Tyrosine Kinase Inhibitor (TKI) vascular endothelial growth factor (VEGF) inhibitors are the standard of care treatment for advanced RCC in Europe, however, patients on current treatments can often experience significant side effects.

Last Close Stock Review

At the closing bell, on Tuesday, August 29, 2017, AVEO Pharma’s stock tumbled 12.24%, ending the trading session at $3.37. A total volume of 15.77 million shares have exchanged hands, which was higher than the 3-month average volume of 6.99 million shares. The Company’s stock price soared 374.65% in the last three months, 290.95% in the past six months, and 249.19% in the previous twelve months. Moreover, the stock skyrocketed 524.07% since the start of the year. The stock currently has a market cap of $367.23 million.

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