Pharm Exec's 2012 Pipeline Report - Pharmaceutical Executive

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Pharm Exec's 2012 Pipeline Report


Pharmaceutical Executive


Hepatitis C: From Protease to NUC




Hepatitis C is the 'It' category of the moment, with a bevy of fast-track, disease-curing, oral treatments in the pipeline, plus a wave of M&A action to underscore the science. Despite Incivek's performance out of the gate—the Vertex/J&J protease inhibitor could reach blockbuster status in nine months, faster than any other drug—there is reason to believe that a new crop of hep C drugs could put a cap on Incivek's sales, making it a three- or four-year trick pony. (Same goes for Merck's Victrelis, a second-to-market protease inhibitor.) Other, presumably better protease inhibitors, among them Medivir/J&J's simeprevir, which Thomson Reuters expects to hit $1.3 billion by 2016, may be bested by the same new drugs that undo Incivek.

The most promising of the new oral drugs, according to several analysts and evidently Gilead Sciences, is Pharmasset's PSI-7977, a nucleoside analog polymerase (NUC) inhibitor. Gilead announced that it would pay $10.8 billion—an 89 percent premium—to acquire Pharmasset, just days after the latter company raised eyebrows at the American Association for the Study of Liver Diseases meeting in November, with the announcement of a 100 percent cure rate in an early, 40-patient trial designed to test efficacy without interferon. "That's never been seen before," says Selvaraju. "By comparison, Incivek only showed clinical cure rates of around 60 percent to 70 percent, in combination with interferon and ribavirin." Sidestepping interferon, an injectable with flu-like side effects and injection-site reactions that lead to less-than-perfect compliance would be a marked improvement in a therapeutic area estimated to reach $16 billion by 2015, according to Decision Resources. The World Health Organization says upwards of 170 million people carry the virus globally, and 350,000 die from related illnesses each year. Pharmasset had a well-established collaboration with Roche, which may complicate things for Gilead, but "no other development-stage company has multiple shots on goal the way Pharmasset does," says Selvaraju.

Another NUC, Inhibitex's INX-189, saw its stocks double after the release of early-stage results, but Pharmasset's PSI-7977 remains the NUC of choice for now. Achillion Pharmaceuticals and Idenix both have oral, once-a-day hep C drugs in development, but they'll need stellar mid-stage data to leapfrog Pharmasset in the race to market.

Pharmasset's data in Phase III will be crucial, too, given the number of contenders on its flank. Roche acquired the most advanced member of a third type of hep C treatments, non-nucleoside polymerase inhibitors (non-NUC), in its acquisition of Anadys Pharmaceuticals, and setrobuvir. FDA fast-tracked setrobuvir in 2008, as well as mericitabine in 2007, another small molecule, oral polymerase inhibitor licensed by Roche and discovered by Pharmasset. Roche believes in the non-NUCs, but analysts—for now—are waiting for the NUCs to hit. "It's a race, there's no question about it," says Ben Weintraub, director of research, inThought. Any oral treatment will need a cure rate above 80 percent, or no one will use it, since Incivek and Victrelis are already on the market. "In the best of all possible worlds, we're going to run out of hepatitis C patients," says Weintraub, "so many companies are going after this market" —including Big Pharmas such as Abbott, Bristol-Myers Squibb and GlaxoSmithKline, in addition to Merck and Johnson & Johnson—that patients "are essentially taken care of ... but I'm not sure about the commercial implications."

Howard Liang, equity research managing director, biotechnology, at Leerink Swann, is more upbeat. "We see hepatitis C as a rare opportunity for the biopharma industry with millions of potential patients, cancer drug-like pricing, and dramatic ongoing improvement in therapy." Either way, ears perk up when the word "cure" surfaces at medical meetings, and despite who makes it across the finish line first with a once-daily, interferon-free oral drug, it seems likely that hepatitis C could go the way of polio in a relatively short time period.

Sales figures in info boxes are Pharm Exec projections;
Minibuster = $400 million-plus,
Blockbuster = $1 billion
Superblockbuster = $2 billion-plus,
N/A = Not Available

Wolters Kluwer's Adis Insight database, and Thomson Reuters Life Sciences Consulting database were both relied upon as research tools for this article


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