AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO) announced that a registration dossier seeking to obtain marketing authorization of tivozanib as a first line treatment of advanced renal cell carcinoma (“RCC”) has been accepted by the Ministry of Health (“MoH”) of the Russian Federation. The dossier was submitted in December 2015 by Pharmstandard Group, the largest Russian pharmaceutical group (“Pharmstandard”). In August 2015, AVEO licensed Pharmstandardrights to the development, manufacture and commercialization of tivozanib in the territories ofRussia, Ukraine and the Commonwealth of Independent States (CIS), for all indications other than non-oncologic diseases or conditions of the eye.
Marketing authorization is being sought by Pharmstandard based upon results from TIVO-1, AVEO’s global, randomized, controlled Phase 3 trial evaluating tivozanib compared to sorafenib in patients with advanced RCC. AVEO is eligible to receive $7.5 million in connection with the first marketing authorization of tivozanib in Russia, provided that Russian regulatory authorities grant marketing approval based on the results from TIVO-1. If Russian regulatory authorities require additional studies to be performed prior to approval, the amount potentially payable to AVEO upon approval would be $3.0 million. AVEO is also eligible to receive a high single-digit royalty on net sales, if any, in the above mentioned territories. A percentage of any milestone and royalty payments received by AVEO are due to Kyowa Hakko Kirin as a sublicensing fee.
“Acceptance of a registration dossier marks an important step toward potential approval of tivozanib in RCC in territories outside the United States,” said Michael Bailey, president and chief executive officer of AVEO. “We look forward to MoH review of the dossier as we work toward submitting a marketing authorization application to the European Medicines Agencywith our partner EUSA Pharma. In parallel, we continue to work toward 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., as well as the potential initiation of a combination study with a checkpoint inhibitor. Both studies may provide important strategic datasets in a rapidly evolving treatment landscape in RCC.” (Original Source)
Shares of AVEO closed last Friday at $0.96. AVEO has a 1-year high of $3.50 and a 1-year low of $0.82. The stock’s 50-day moving average is $1.00 and its 200-day moving average is $1.19.
AVEO Pharmaceuticals Inc is a biopharmaceutical company. It is involved in discovering, developing and commercializing novel cancer therapeutics.