Achillion CEO Michael Kishbauch hasn't been the least bit shy about touting the company's buyout prospects. Quick to boast about the biotech's promising hepatitis C drugs, he's been raising hopes and stirring buyout buzz with every appearance. And today Kishbauch is sporting another feather in his cap: An FDA fast-track designation for a hep C program--ACH-3102--he's claiming as a next-gen NS5A inhibitor.
Normally, fast track designation for a Phase I treatment wouldn't cause much of a stir. It gives a company a chance to shave four months off the review process, putting them in closer contact with regulators as they roll through the trial process in search of an approval. But just last January Achillion ($ACHN) landed fast track status for its mid-stage drug ACH-1625. And the biotech believes that it's on track to produce a combo drug that can work against a broad range of hep C genotypes without interferon.
Those selling points have helped bolster the company's share price in recent months as investors gambled on a possible buyout along the lines of Pharmasset and Inhibitex.
"We are very pleased with the granting of a Fast Track designation for ACH-3102, which we believe highlights this second-generation NS5A inhibitor's attributes that include pan-genotypic coverage of HCV and potential for maintained activity against NS5A mutant strains of HCV," commented Kishbauch in a statement. "We are excited to leverage the superior profile of ACH-3102 in combination with our Phase II protease inhibitor, ACH-1625, as we seek to create an optimized, potentially best-in-class potent, well-tolerated, once-daily regimen to treat HCV, which will enter combination studies during the third quarter of this year."
- get the press release
- here's the AP report