Aveo Pharmaceuticals Inc. of Cambridge announced a partnership that could be worth more than $1.3 billion with Astellas Pharma on Aveo’s lead drug candidate, the cancer treatment tivozanib.
Japanese drugmaker Astellas agreed to pay Aveo $125 million up front. Aveo could receive $575 million if tivozanib reaches clinical development and regulatory milestones, while sales milestone payments could be worth another $780 million.
The companies will equally divide profits and expenses in North America and Europe. In other regions, Astellas will handle all development and marketing. If the drug is approved in the United States, Aveo will get royalties of more than 10 percent on sales.
Aveo agreed to handle sales of tivozanib in North America, and Astellas will be in charge of sales in the European Union. Kyowa Hakko Kirin discovered tivozanib and holds the rights to the drug in Asia.
The upfront payment includes a $75 million licensing payment and $50 million in research funding. Aveo is running a late-stage clinical trial of tivozanib as a treatment for a type of advanced kidney cancer called renal cell carcinoma, and it expects to report data from that study in the middle of this year.
The drug is designed to affect three types of vascular endothelial growth factor receptors, which are involved in the formation of new blood vessels. Without the new blood vessels, the cancer cells are starved of blood and nutrients.
The late-stage trial compares tivozanib to Nexavar, a drug marketed by Onyx Pharmaceuticals Inc. and Bayer Healthcare as a treatment for kidney cancer and liver cancer.
The Cambridge company is also testing tivozanib as a treatment for colorectal cancer, gastrointestinal cancers, breast cancer and lung cancer — alone or in combination with other drugs. The drug was awarded orphan drug status in Europe, meaning that if tivozanib is approved in that market as a treatment for renal cell carcinoma, competing drugs will be barred from the market for up to 10 years.
The companies said approximately 200,000 people worldwide were diagnosed with renal cell carcinoma in 2010, and about 100,000 patients with the disease died. It accounts for about 90 percent of kidney cancer cases and is the eighth-most common cancer in the U.S.
The National Institutes of Health say chemotherapy and radiation treatment are generally not effective against the disease. Approved drugs for renal cell carcinoma include Nexavar and Pfizer Inc.’s drug Sutent. Aveo and Astellas said current therapies extend survival by less than a year and have significant side effects. In a mid-stage clinical trial, patients who had had a kidney removed and were treated with tivozanib had median survival of 14.8 months before they died or their disease progression resumed.