Enanta Pharmaceuticals – 2012 Fierce 15

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Jay Luly, CEO of Enanta Pharmaceuticals

Based: Watertown, MA
Founded: 1998
CEO: Jay Luly
Clinical Focus: Hepatitis C and antibiotics
Website: enanta.com

The Scoop: Over just a few months, Enanta has seen its big partner grab solid efficacy data for an interferon-free approach to hepatitis C. After establishing itself with a protease inhibitor, the biotech struck a rich pact with Novartis ($NVS) for an NS5A inhibitor, another key building brick in the hepatitis C world. It's made headway on the antibiotics front and is now working on new "nucs."

If it can just skirt the kind of R&D disaster that has afflicted other prominent players, Enanta may well survive to carve out a thriving spot for itself in one of the most competitive arenas in drug development today.

What Makes it Fierce?

Whatever else you want to say about the hepatitis C drug development field, it's not boring.

"It certainly has been exciting," agrees Enanta CEO Jay Luly. "There's certainly a lot of excitement and dare I say drama about 'nucs' lately."

In case you missed it, Luly's referring to the Bristol-Myers Squibb ($BMY) disaster with the sudden implosion of BMS-094, the centerpiece of its recent $2.5 billion deal to buy Inhibitex, which has now been linked to some severe adverse events in a clinical study. Soon after, Idenix ($IDIX) had clinical holds put on two of its "nucs," which offer some similarities to 094, devastating its share price.

Back in April, Enanta and its partner Abbott ($ABT) announced that the protease inhibitor ABT-450--developed by the two companies in a collaboration--along with ribavirin and ABT-072 in an interferon-free combo delivered a sustained viral response at 24 weeks after 12 weeks of treatment for 91% of genotype 1 patients. And 82% of patients achieved SVR 36. Just in case you missed it, ABT-450 is a non-nuc. And Enanta doesn't mind at all that it's not been drawn into the anxious conversation about adverse events.

That leaves the treatment on track for a late-stage study in 2013, with a target for a regulatory filing in 2014 and a possible approval in 2015. Three years can be a lifetime for anyone in the hepatitis C field, but Luly likes his chances for an interferon-free approach with the potential of conclusively demonstrating high cure rates after a quick course of treatment in a big hepatitis C patient group.

"At the end of the day that's what is really going to matter," says the CEO. "We think we'll have a chance for a very competitive product in a competitive time frame. This is a very large market." Others may be angling to become the first on the market with an interferon-free treatment. But Luly believes that multiple winners could emerge from a multibillion-dollar market with the potential for doubling in size over the next decade.

"We only work on treatments for serious infections using validated mechanisms," says Luly. That approach has allowed the company to strike some valuable deals, which in turn have funded its operations without a venture raise since 2006. And it has a couple of years of operating capital, a remarkable accomplishment.

"The roller coaster has been flying down the track," adds Luly. "Some molecules may fall out, but I don't see the roller coaster slowing down."

Investors: Shionogi & Co., Techno Venture Management, Oxford Bioscience Partners, BioVentures Investors and Global Biomedical Partners.

-- John Carroll (Twitter | LinkedIn)