It's the season for tacky reindeer sweaters and looking back at the year in pharma. The Food and Drug Administration approved 35 novel drugs this year, and that field produced some early victors and disappointments. Three drugs in particular stumbled out of the gates, forcing the companies to recalibrate. Sanofi (NASDAQ:SNY) responded to critics with a price slash. Amarin (NASDAQ:AMRN) prepped for going it alone after regulatory delays. And VIVUS (NASDAQ:VVUS) offered free trials as prescriptions lagged.
Here's a review of the top drug disappointments of 2012 -- and what they could mean for 2013.
Sanofi's colorectal cancer treatment Zaltrap, approved in August, faced early pushback . Doctors wrote a high-profile article about the drug's cost being twice that of Roche's competing Avastin -- with almost equal efficacy. Sanofi went on the defense but then blinked, slashing Zaltrap's price in half.
The reduction benefits doctors, not patients, in an effort to increase prescription rates. Zaltrap had sales of 7 million euros last quarter. Time will determine how the new pricing will pay off.
Zaltrap is a collaborative effort between Sanofi and Regeneron. Both companies are robust enough to support this misstep. But the drastic price drop could set a standard that other companies can't reach. I previously tagged Dendreon as a potential victim, since its expensive prostate cancer treatment Provenge continues to falter.
Amarin's Vascepa had investor attention going into its FDA approval in July. The treatment for severely high triglyceride levels performed well in trials and would become the company's first approved drug. But continued delays on a new chemical entity, or NCE, status decision left investors worried.
NCE status would grant five years of market exclusivity rather than the standard three years. Its importance lays mainly in making Amarin an attractive buy for a larger company. Rumors of interest swirled this year, naming AstraZeneca (NYSE:AZN) among the potential buyers, but nothing came to fruition.
Now Amarin's poised to take the drug to market next year on its own. The company recently obtained a $100 million loan to fund the launch, and shares fell more than 20% after the announcement. Amarin's cash burn was nearly $40 million in the most recent quarter, with cash and equivalents of $215 million, so it looks to be in a good financial position. The company could still use a partner, but it remains to be seen if any big pharma companies are still interested.
Ardent followers of the year's obesity drug battle divided into two camps: Arena's (NASDAQ:ARNA) Belviq and VIVUS' Qsymia. Belviq received approval first but needed to go through DEA scheduling, clearing the way for Qsymia.
Problems mounted fast for VIVUS. The approval included a requirement for pregnancy testing, and an associated risk evaluation and mitigation system -- or REMS -- meant that Qsymia would only be available through mail-order pharmacies. A European committee later declined approval for the drug. But optimism remained in the air -- until the drug power-walked out of the gates.
Health insurers seemed initially wary of including Qsymia, and prescription rates remained low. Aetna (NYSE:AET) and Express Scripts (NASDAQ:ESRX) have since come around. VIVUS also began offering up free 14-day trial packs. And the tide seems to be slowly changing, with filled prescriptions on the rise. But investor doubts remain, and its main competition -- Belviq -- should hit the market next year.
Foolish final thoughts
The disappointments of 2012 came down to management and regulatory issues rather than efficacy problems. These missteps will bleed over into 2013. Sanofi will announce whether Zaltrap's sales are increasing due to the price cut. Amarin should receive its NCE decision and push Vascepa to market. And investors will learn how VIVUS can stare down the competition with its wounded position.