That's a respectable sum, but not enough to pay back the roughly $1 billion it can take to develop and launch a new drug. Back in October 2009, Wall Street had delusional beliefs about Multaq's sales potential. Here were the peak revenue estimates from several banks, according to this Reuters story:
- Sanofi forecast annual sales of more than â‚¬1 billion ($1.32 billion).
- Morgan Stanley estimated â‚¬3 billion.
- Citi estimated â‚¬1.5 billion.
- UBS said â‚¬1.4 billion.
- The consensus was about â‚¬1 billion.
no more than a niche product because the entire U.S. market for atrial-fibrillation products was just $324 million.)
The FDA's warning is hugely embarrassing for Sanofi. The drug is approved for "persistent atrial fibrillation (AF) or atrial flutter (AFL)," yet the company's own study -- on which the FDA's warning is based -- found a two-fold risk of death, stroke and hospitalization for heart failure. The FDA said:
Do not prescribe Multaq to patients with permanent atrial fibrillation.There's a difference between persistent and permanent atrial fibrillation, but the former if untreated often leads to the latter. It wasn't even priced right -- Sanofi attempted to sell it in the U.K. for Â£2.25 per day, compared to 5 pence a day a generic competitor, amiodarone.
Back to the drawing board; enter the lawyers.