With New Drug, Cambridge-Based Vertex On The Verge Of New Era

Update: The Food and Drug Administration approved Vertex's new drug Incivek (telaprevir) to treat hepatitis C.

Vertex Pharmaceuticals is on the verge of a new era. The Cambridge biotech company is widely expected to have its first major commercial drug approved Monday by the Food and Drug Administration.

The drug is to treat hepatitis C, and it could be a blockbuster. But it will have to share a multibillion-dollar market with a competitor, another new hepatitis C drug from the pharmaceutical giant Merck.

The stage is set for a battle between the Cambridge upstart and the industry heavyweight.

WBUR's Bob Oakes spoke with WBUR’s Business and Technology Reporter Curt Nickisch about the milestone.

Bob Oakes: What’s so remarkable about the drug Vertex is expected to get approved Monday?

The drug is called telaprevir (although it's going to be marketed under the name Incivek), and it's leading a new generation of promising drugs to more effectively treat the hepatitis C virus, which more than 3 million Americans suffer from. Telaprevir doubles cure rates of existing treatments, which have fairly harsh side effects.

Merck's competing drug was approved this month and it similarly attacks how the virus replicates. Vertex's expected approval is a remarkable achievement for the Cambridge company, and really marks the transition from a scientist-driven shop to one that's now going out and selling drugs internationally.

You mentioned Merck’s new drug is similar, so I’m wondering how Vertex can compete if it is going up against a Goliath industry veteran?

One thing that Vertex has going for it is the facts. The drug appears to be a little bit superior to Merck’s in many applications. And because these drugs are so promising compared to the existing treatment, patients and physicians have been watching the testing rounds and subsequent approval. Howard Liang, an analyst at the Boston investment bank Leerink Swann, said this helps Vertex:

There is very good awareness of the drugs among physicians as well as patients. It has to do with the fairly significant improvement over standard care.

On the other hand, there's something to be said for marketing prowess, because Vertex’s and Merck’s drugs still have to be used in some combination with existing treatments to work altogether. Merck has announced it is partnering with the maker of one of those, Roche, another industry titan, to co-market their hepatitis C drugs together. This means Vertex is not just going up against one company, but two.

So despite its drug's superiority, it sounds like an uphill battle for Vertex?

It's a battle Vertex has been preparing for for years. A few years back they replaced the CEO, the scientific driver of the company, with someone with more commercial experience (who incidentally also worked at Merck). Vertex has a sales team in place of around 180 people, with 14 years of experience in the field on average, at companies such as Merck. Liang told me he’s heard from physicians that they’ve been pretty aggressive about getting the word out about the upcoming therapy from Vertex:

I’ve been pretty impressed with the commercial work they’ve done. I think they’re in good shape. Obviously we’ll only find out when they’re out there in the market.

So how do you handicap this drug fight?

It’s clear that both Vertex and Merck are going to share the market. It’s really going to come down to execution. Because a slightly larger share, a few more percentage points one way or the other — a bigger or smaller slice of the pie -– means millions and millions of dollars.

But analysts think that Vertex will outsell Merck in the market, and if you look at the company's stock price, it appears investors think Vertex is going to sell very well. It's exciting times at the company, because they're also planning to move into new headquarters on the Boston waterfront.

It's remarkable, because it was kind of unthinkable 15 or 20 years ago, that an almost boutique biotech company could take on a major drug market. But Vertex coming of age and taking on a big player is another example of just how far the Cambridge biotech sector has come.