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Laval, Quebec-based ViroChem Pharma, which has developed a drug in the same class that produced an even more potent ability to kill the virus in the first five patients studied—a 3.5 logarithmic reduction. Based on that body of evidence, and the ability to combine this kind of drug with its own proprietary molecule from a different class, Vertex acquired ViroChem earlier this month for about $375 million in cash and stock. Anadys was one of the keen observers of this deal, since it established a fairly hefty price for a hepatitis C drug that’s still in the very early stages of development, Worland says.
What’s fascinating is how few people saw this pattern repeating itself with hepatitis C a few years ago. A little history is in order:
In the early 1990s, the first generation of non-nucleoside polymerase inhibitors for HIV weren’t potent enough to do much good, Worland says. Boehringer Ingelheim’s nevirapine (Viramune) and Pfizer’s delavirdine (Rescriptor) were the first in that class, and because they weren’t potent enough, they allowed the virus to develop resistance, Worland says. “They spoiled the party for non-nucs,” Worland says. “The lack of potency was incorrectly attributed to the whole class. It was guilt-by-association, and so people wrote off non-nucs as a class.”
By September 1998, Bristol-Myers Squibb won FDA approval for efavirenz (Sustiva), and the rest, as they say, is history. By combining Sustiva with other anti-virals, it generated $1.1 billion in worldwide sales in 2008.
What made that drug work while others flopped was its greater potency, Worland says, along with a longer sustained presence in the bloodstream that helps prevent the virus from developing resistance (hence the name, Sustiva.)
The same historical pattern may be repeating itself now with hepatitis C, he says. Japan Tobacco came out with some data several years ago on non-nucleoside drugs that weren’t potent enough, didn’t last long enough in the blood, and allowed the virus to develop resistance, Worland says. That didn’t help Anadys as it was toiling away in the lab on what it considered a better drug. “People got out their broad brush again and said ‘non-nucs aren’t potent, and allow resistance.’ It caused me to tear my hair out,” he says.
The Anadys candidate in this class of non-nucs, ANA-598, is still in its earliest phase of testing. The company expects to provide a more detailed picture of how the drug is performing next month if its data is accepted for presentation at the European Association for the Study of the Liver in Copenhagen, Denmark. The company revealed some of the data from the first eight patients that took the lowest dose, 200 milligrams, and it expects to have more data from those who took 400 milligrams and 800 milligrams.
Anadys is looking to form a partnership with a larger drug maker, although Worland wouldn’t be specific about the kind of terms he’s looking for, or when he hopes to pull the trigger. He says there are “at least 10 major companies” that are actively pursuing hepatitis C, and he notes that many of them don’t have a non-nucleoside drug in their portfolios. Some of these companies will get to see the Anadys data on a confidential basis before it’s expected to be presented publicly in Denmark. Obviously if the value of the drug appears to be increasing, Worland would like to see multiple bidders entering the fray.
Beyond whatever deal Anadys might strike in the next few months, Worland is keeping his eye on a long-term trend: How is hepatitis C being treated, and how can his company fit into that bigger picture.
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