Inside HCV: An Interview with Janssen

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Our job here is to examine companies through an investing perspective. But in churning out numbers and comparing potential product sales, we sometimes overlook the human element. Right now, the Food and Drug Administration is on the cusp of approving two hepatitis C drugs that could revolutionize patient cure rates.

I recently discussed simeprevir, the promising HCV candidate from Johnson & Johnson (NYSE: JNJ) subsidiary Janssen. The drug achieved impressive cure rates in mid-stage trials when paired with Gilead’s (NASDAQ: GILD) sofosbuvir. Simeprevir remains in mid-stage trials with a variety of partners including Vertex (NASDAQ: VRTX)

I spoke last Friday with Dr. Gaston Picchio, Hepatitis Disease Area Leader for Janssen, about the company’s willingness to collaborate -- and how now is the best time in history to be a hepatitis C patient.

Collaboration prospects

Brandy Betz: The priority review news was fantastic, but analysts are watching for the interferon-free results. Would you please discuss the all-oral trials involving simeprevir and Janssen’s willingness to form partnerships for the best combo therapy?

Dr. Picchio:  We are absolutely committed to partnerships.

Some people believe that there are companies that have all of the necessary ingredients to come up with these interferon-free regimens. And the companies basically say, “We have all of the components. We feel very confident with what we have and we’re going on our own.”

We have internal components -- but we’re also looking at external components. I think a reflection of that is the fact that we have four ongoing collaborations today. We have one with Gilead. We have one with Idenix. We have one with Bristol-Myers Squibb. And we have one with Vertex.

We’re at the stage where we’re exploring simeprevir’s potential. Simeprevir has so far reported data in combination with sofosbuvir, and the results are extremely promising. If I were a null responder patient -- the toughest to cure patients -- I would see that simeprevir plus sofosbuvir for 12 weeks resulted in a 93% cure rate. And I would be very excited, because this is what’s coming.

So we continue to explore with other companies, and with our internal assets, for what is the best possible combination for the safest possible regimen, the shortest possible regimen and the most efficacious one. But we’re in a stage where we’re generating data. So I cannot say what will be the best possible collaborations that we could pursue.

Commercialization prospects

GP: There’s an important part to clarify. I’m always asked about commercial agreements and I want to be very clear that, at this point in time, we don’t have any commercial agreements in the partnerships I just described. We have clinical collaborations to understand simpeprevir’s safety and efficacy in combination with all of these drugs.

BB: It's hard to answer commercialization questions when you're in mid-stage trials. 

GP: People want more definitions about commercial things, and those are equally important. I’ll give you an interesting example.

Simeprevir and sofosbuvir are the two drugs that are right now under review. They could come to approval towards the end of next year, depending on the FDA. You hear a lot at the conferences, talking to experts. They say, “Oh, simeprevir and sofosbuvir are going to be approved with the use of ribavirin and interferon. Why not take these two drugs and combine them?”

So that’s just the beginning of the era of being interferon-free. As you know, companies like Gilead or AbbVie or Janssen come with regimens already formulated and things like that. But this may be the beginning of that era.

The most important thing happening is that this is going to benefit patients so much that I don’t think we understand the dimensions of that.

BB: This is one of the most important times in recent medical history. These new treatments, particularly for patients with genotype 1, are going to open up a whole new world.

GP: Absolutely. Imagine a world where there are no financial restrictions and you say, “I want to give treatment to everyone.” Even if you want to do that, you can’t --  because the vast majority of patients can’t tolerate or have contraindications with interferon-ribavirin.

But if we have interferon-free treatments, the story’s completely different. Because we can deliver a very simple regimen over a relatively short period of time -- perhaps 12 weeks or less -- and that’s when it’s gong to get very interesting. And these new regimens appear more efficacious. But we have to be careful there because we don’t have a lot of data.

But you look at our studies, you look at other people’s studies. Talking about null responders ... some people with cirrhosis who’re getting cured at a very high rate. It looks very good for patients. It’s probably the best time ever to have hepatitis C. There are very promising treatments coming along.

BB: I’ve spoken to hepatitis C patients in the past couple of weeks as I’ve increased my coverage, and there's universal excitement about what's coming down the pipes. 

GP: I think it is the fastest-moving field in the history of medicine. I cannot think of anything else. I was just talking to people with expertise in other areas, trying to understand it. They’ve never seen such a fast evolution over such a short period of time.

Before 2010,  it was taking 48 weeks to cure 40% of the patients. And now we’re talking about 8 weeks with cure rates of 95% with minimal side effects. It’s amazing.

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