FDA opens floodgates to generics of Bristol-Myers' Abilify

Just hours after Bristol-Myers Squibb ($BMY) beat Wall Street expectations with earnings that got a goose from antipsychotic Abilify, the FDA opened the floodgates to generics of the blockbuster.

The FDA approved generics in different doses and strengths from Alembic Pharmaceuticals, Hetero Labs, Teva Pharmaceuticals ($TEVA) and Torrent Pharmaceuticals. The drug is approved to treat such mental disorders as schizophrenia and bipolar disorder, but the FDA pointed out it comes with a Boxed Warning about an increased risk of death associated with the off-label use for behavioral problems tied to dementia. The agency also pointed out there are no drugs in the class approved for treating dementia-related psychosis.

BMS has been bracing for the patent cliff hit, having already warned investors to expect 2015 sales somewhere between $14.4 billion and $15 billion, which would be a 10% drop on the low end, far short of analysts' predicted $15.6 billion for the year.

Abilify last year sold more than $5.5 billion, but BMS shares the drug with Japanese partner Otsuka and so it got $2.02 billion of that. And sales of the drug last year had already slipped 12%. But a last-ditch effort by the companies resulted in bigger-than-expected Abilify sales for Bristol-Myers in Q1, which Tuesday reported it brought in $554 million for the quarter, a 3% increase that was helped by extra royalty fees.

BMS has been preparing for the onslaught of generics for some time, making cuts while pushing hard in new areas. Its first quarter was helped by two of its newer drugs, next-gen anticoagulant Eliquis and recently approved Opdivo, a cancer immunotherapy that performed so well in trials that it garnered fast-track attention from regulators and wowed analysts who have pushed peak sales projections to $7.3 billion by 2020, up from the $5 billion that was forecast only weeks before. The company also has been keeping a tight fist on spending and reported that first-quarter marketing, selling and administrative expenses decreased 7% to $894 million while advertising and promotional spending dropped 17%.

- here's the FDA release

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