The Case for Yes, page-12

Big Pharma doesn't get its way all the time.

"The FDA all along had said that it would revoke BTDs if the circumstances warranted a reversal. Breakthrough status was intended to reward cutting-edge research with an open-door policy at the FDA that would speed an approval. Being switched from a beauty contest to the less-fashionable list of follow-ups has to sting--though Bristol-Myers has had plenty of experiences with setbacks on the hep C front."

Breakthrough? Not anymore says FDA as Bristol-Myers joins Merck in hep C's coach section

February 10, 2015 | By John Carroll
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Merck's ($MRK) not the only big player in the hepatitis C competition to face losing bragging rights to the FDA's "breakthrough" drug designation for a late-stage program. It turns out that Bristol-Myers Squibb ($BMY), another laggard in the race to hatch new therapies for the virus, also finds its daclatasvir on the FDA's chopping block.

The big biotech tells FierceBiotech in a statement that the agency has "informed Bristol-Myers Squibb that, due to the evolving HCV treatment landscape, the agency intends to rescind the breakthrough therapy designation for certain genotype 1 hepatitis C regimens related to daclatasvir." Bristol-Myers then went on to add that the decision will not impact its timetable on an NDA for daclatasvir, which faces a unique set of challenges all its own.

Bristol-Myers was once considered a leader in hep C, before Gilead Sciences ($GILD) and AbbVie ($ABBV) came along to snag approvals for their radically improved cocktails. Then one of its programs blew up in the clinic, with the nucleotide polymerase inhibitor--or "nuc"--proving to be a danger to anyone who took it. And daclatasvir has limped along, recently earning a slap down by the agency, which wants to see more data on combos before it will consider approving the drug for sale. That setback occurred weeks after Bristol-Myers surprised analysts by opting to drop its application to gain an approval in the U.S. for asunaprevir, its NS3/4A protease inhibitor, deciding not to go after an OK to use a combination of daclatasvir and asunaprevir for genotype 1b patients.

Pushed to the sideline, Bristol-Myers had to watch from a distance as Gilead's Harvoni and AbbVie's follow-up drug gained approvals and quickly snagged big chunks of the U.S. market. Merck reported a few days ago that the FDA was yanking its BTD, which clearly rankled R&D chief Roger Perlmutter as the one-time starring program began to look more and more like a me-too product; offering a shot at a more competitive price but too late to look like a game-changer to patients.

The FDA all along had said that it would revoke BTDs if the circumstances warranted a reversal. Breakthrough status was intended to reward cutting-edge research with an open-door policy at the FDA that would speed an approval. Being switched from a beauty contest to the less-fashionable list of follow-ups has to sting--though Bristol-Myers has had plenty of experiences with setbacks on the hep C front.