AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO)
AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO) has inched a step closer to gaining European commercialization approval for its renal cell carcinoma treatment, Tivozanib. The company has completed an oral explanation to the Committee for Medicinal Products for Human Use, which will advise the European Commission on its decision to give authorization for the marketing of drugs.
Tivozanib Regulatory Approval
Approval of Tivozanib by the European Commission would be a major achievement for Aveo Oncology’s commercialization plan, paving the way to sell the drug in 28 EU countries.
“We are pleased that the file continues to progress through the CHMP review process with EUSA having completed an oral explanation for Tivozanib. We believe tivozanib’s unique tolerability profile, together with the longest progression-free survival from a Phase 3 first-line RCC study, demonstrates its potential to enhance treatment options for RCC patients,” said chief executive officer Michael Bailey.
Renal Cell Carcinoma is one of the fastest increasing cancers in the world – currently accounting for 49,000 annual deaths in Europe. Even though current treatments have helped suppress the effects of the disease, significant side-effects have been a big concern. It is those side-effects that Aveo Oncology hopes to address with Tivozanib.
The oral, once-daily, drug has already been investigated as a novel treatment for various tumors such as renal cell, colorectal, and breast cancers.
Separately, Aveo oncology has confirmed the appointment of Mathew Dallas as the new Chief Financial Officer effective June 1, 2017. Mr. Dallas will replace the current CFO, Keith Ehrlich, who is set to retire. He will be responsible for the company’s financial strategy as the company inches a step closer to commencing the commercialization of Tivozanib.
Mr. Dallas joins the company with 20 years of financial and management experience after having served as the CFO and Treasurer of CoLucid Pharmaceuticals. Mr. Dallas also served as the Vice President of Finance at Aveo Oncology between 2011 and 2015.
The U.S Patent and Trademark Office has awarded Aveo Oncology a new patent for the company’s humanized anti-Notch 3 antibodies including AV-353. Entitled, ‘notch binding agents and antagonists and methods of use’ the patent is set to expire on December 19, 2032, with the possibility of being extended to December 19, 2037.
AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO) was down by 4.08% in Wednesday’s trading session and ended the day at $0.799 a share.
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About the author: Marc has a degree in economics and a MSc. in Finance. Over his 20-year career, Marc has worked for global investment firms in Europe and the United States as an analyst, fund manager, and consultant.