|Vivus' weight-loss drug Qsymia--courtesy of Vivus.|
The FDA has agreed to take down one of the big hurdles hampering U.S. sales of Vivus' newly approved weight drug Qsymia, but plenty more remain.
Vivus ($VVUS) says the agency has agreed to lift a provision restricting sales to mail-order pharmacies, paving the way to getting the obesity drug into thousands of retail pharmacy outlets around the country. The biotech cheered the move, but also cautioned that it will take a full 90 days to make its way onto store shelves. And investors pushed shares up about 6% on the news.
"The FDA enabling us to go out to retail pharmacies is a huge win," CEO Peter Tam told the Wall Street Journal. "It's like a Formula One race car--we know we can go really fast, but we've been held in the pit lane."
Some analysts, though, say Vivus is still a long way from getting into first gear. The FDA dropped the mail-order requirement--which was initially seen as necessary for making sure people received the requisite safety warnings--in favor of a new software-based system that certified pharmacists can use to track orders and make sure patients are counseled on the side effects. Women of child-bearing age, for example, could give birth to babies with birth defects if they take the drug while pregnant.
As Vivus races to make Qsymia available in places like Wal-Mart and Walgreen's, though, the company still faces harsh criticism from First Manhattan, which owns 9.1% of the company's stock. First Manhattan said days ago that even if the FDA did remove the mail-order roadblock, tiny Vivus would still be unable to reach the highest sales peak available. That would require a new commercial strategy, says the firm, which is looking to get a rebel board elected and force Vivus to steer a new course.
Analysts also note that the therapy is still only rarely covered by insurers, and some maintain that only a much bigger pharma outfit with a national sales force will be able to make a success out of Qsymia. Still, the biotech has taken a step in the right direction after achieving only feeble results through the mail-order approach. Physicians aren't at all happy about getting orders sent straight to mail-order outlets. And more may now be more willing to pen a prescription for their overweight patients.
- read the Vivus release
- get more from the WSJ