Tuan Ha-Ngoc has served as president and chief executive of Cambridge-based AVEO Pharmaceuticals Inc. since 2002. A native of Vietnam who was educated in France and has worked in the biotechnology industry for more than 25 years, Ha-Ngoc, 60, has been leading AVEO’s efforts to win federal approval of its first commercial drug. He spoke with Globe business writer Robert Weisman recently at the AVEO headquarters near MIT.
AVEO’s application for tivozanib, your lead drug candidate, was accepted for review last month by the Food and Drug Administration. What does that drug do, and why do patients need it?
That drug is for the treatment of advanced renal cell carcinoma — kidney cancer. And there are about 200,000 patients worldwide. New patients each year in the United States are in the range of 12,000 to 15,000. There have been drugs approved for that disease, starting in the early part of 2006. They do extend the life [of patients] and extend the period in which you can control the tumor but also have a lot of toxicity.
So the patients have a hard time staying on the drugs. Indeed, half the patients started with a full dose and needed either to get reduced down or get out of that drug. And that is really the limitation of today’s therapy. Tivozanib throughout pivotal studies has shown not only that it can have efficacy, but it has much less side effects.
When do you expect a decision from the FDA on tivozanib?
The date that they’ve communicated to us, when they have to take action, is July 28, 2013.
How do you plan to commercialize the drug?
Tivozanib is under a partnership with [Japanese drug maker] Astellas. We are leading the commercialization in North America, and Astellas will be leading the commercialization in Europe. In North America, we will be setting up our own commercial infrastructure.
We had a chief commercial officer join me about two years ago, Michael Bailey, and last month we announced the hiring of the vice president of sales, Brad Bailey — same last name, but no relation. During the first quarter of next year, we will put in place our sales leadership. And then we’ll put the full sales force, around 40 people in the US, in the field in the second quarter.
How big is the market opportunity for this drug?
As I said, the total number of patients is about 200,000. From that, the sales of this class of drugs worldwide is about $2.3 billion, of which $1 billion is in the United States. That’s the entire market. So we view that with the [clinical] data that we have obtained, tivozanib has positioned itself to be among the standard of care to be used by physicians.
In October, AVEO announced a strategic restructuring. What was that designed to do?
As a biotech company, we try to base all our decisions on science. We’ve just talked about tivozanib, but we have other products in the pipeline. And when we see that the science is not what we thought it should be, we need to make a decision not to pour good money on projects that did not measure up.
Now that we have a firm timeline toward the commercialization of tivozanib, most of our resources need to be devoted toward approval and commercialization. So the number one, two, and three priorities of the company now is to get it to the patients. It’s a strategic change in where we invest our money and where we need the people.
You have about 225 employees now. How many do you expect to have by the end of next year?
We will probably be around 300, more or less, by the end of 2013. And indeed, we will start moving to the Kendall Square area because we are running out of room.
I heard you’re going to be located between Genzyme and Biogen Idec. Does that mean you expect to get as big as those companies?
We expect that our products will have a similar kind of impact as those companies.