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Partner : EUSA Pharma Europe

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AVEO Announces Submission of Responses to the EMA Day 120 List of Questions for Marketing Authorization Application for Tivozanib in Renal Cell Carcinoma

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 28, 2016-- AVEO Oncology (NASDAQ:AVEO) today announced that its development partner, EUSA Pharma, a specialty pharmaceutical company with a focus on oncology and oncology supportive care, has submitted its responses to the European Medicines Agency (EMA) Day 120 List of Questions. The Day 120 List of Questions were issued by the Committee for Medicinal Products for Human Use (CHMP) as part of the centralized review process of the Marketing Authorization Application (MAA) for tivozanib for the first-line treatment of advanced renal cell carcinoma (RCC). The next step in the filing process, the EMA Day 180 List of Outstanding Issues, is expected in the first quarter of 2017.

“This submission represents an important step forward in working toward an anticipated first half 2017 European approval decision, one of three potential key tivozanib-related milestones during this period,” said Michael Bailey, president and chief executive officer of AVEO. “Given tivozanib’s unique activity and safety profile, we believe the first line RCC market in Europe represents a meaningful commercial opportunity, and we look forward to working with EUSA Pharma to fully elucidate this potential. In addition to a potential European approval decision, we expect to have initial results from the Opdivo® combination TiNivo study in RCC and may see milestones from Ophthotech for tivozanib in acute macular degeneration in the first half of 2017.”
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Source: press release, 11/28/16. http://investor.aveooncology.com/phoenix.zhtml?c=219651&p=irol-newsArtic...

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EUSA Pharma and AVEO Announce Submission of Marketing Authorization Application for Tivozanib in Advanced Renal Cell Carcinoma

HEMEL HEMPSTEAD, England & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Mar. 1, 2016-- EUSA Pharma, a newly-established specialty pharmaceutical business, and AVEO Oncology (NASDAQ:AVEO) today announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency for tivozanib for the first-line treatment of advanced renal cell carcinoma (RCC). The filing is based on tivozanib’s existing dataset and follows positive interactions with the Rapporteur and Co-Rapporteur during 2015 which indicated support for a filing using the phase III TIVO-1 trial as the pivotal study. EUSA Pharma submitted the application under the European Union’s centralized procedure, which permits the agency to issue a single marketing authorization that is valid across all EU countries.

Under the companies’ license agreement announced in December 2015, EUSA 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, in addition to a range of further indications. Under the terms of the agreement, EUSA Pharma will undertake and fund the commercialization of the product in its territories, assuming approval.

“Survival rates in advanced renal cancer remain low and current therapies can be associated with treatment-limiting toxicities, resulting in significant unmet need where tivozanib has the potential to become an important new first-line therapy,” said Lee Morley, Chief Executive Officer of EUSA Pharma. “We are delighted to have achieved the submission of our Marketing Authorization Application to the European Medicines Agency so soon after licensing this exciting product, and we look forward to the outcome of the regulators’ review. In our short history, we have made great strides in building a strong portfolio of specialist medicines, and our filing of tivozanib in Europe is another milestone in EUSA’s journey to become a leading specialty pharmaceutical business.”

“Filing of an MAA by our partner EUSA Pharma is an important step toward the potential commercialization of tivozanib in territories around the world,” said Michael Bailey, President and Chief Executive Officer of AVEO. “We continue to leverage strong partnerships to advance our pipeline, including tivozanib in areas outside of North America and oncology, while we focus on the development and regulatory path forward for tivozanib in North America. We look forward to making progress on this path in the near-term, including the potential initiation of a Phase 3 trial of tivozanib in third line RCC to potentially enable registration in the first- and third-lines in the U.S.”
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Source: press release, 3/01/16. http://investor.aveooncology.com/phoenix.zhtml?c=219651&p=irol-newsArtic...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Tivozanib - Renal Cell CarcinomaUrologyRenal cell carcinomaVEGFR inhibitorVEGFR (1,2,3)

Mechanism of action: Tivozanib is an orally bioavailable inhibitor of vascular endothelial growth factor receptors (VEGFRs) 1, 2 and 3 with potential antiangiogenic and antineoplastic activities. Tivozanib binds to and inhibits VEGFRs 1, 2 and 3, which may result in the inhibition of endothelial cell migration and proliferation, inhibition of tumor angiogenesis and tumor cell death. VEGFR tyrosine kinases, frequently overexpressed by a variety of tumor cell types, play a key role in angiogenesis.

Phase of Development: Filed

Event Type: Regulatory EMA: CHMP Opinion (Estimate)

Dates: 2017-06-23

Results: Pending