"Wait" seems to be the operative word for the obesity drug industry these days. Investors in VIVUS (NASDAQ:VVUS) are still waiting to see if Qsymia can attain the levels of commercial success that they anticipated. Arena Pharmaceuticals (NASDAQ:ARNA) anxiously awaits finalization of scheduling for Belviq by the slow-moving U.S. Drug Enforcement Administration. But the biggest wait of all belongs to Orexigen Therapeutics (NASDAQ: OREX). Here's the latest on the waiting game for the third potential weight-loss drug to hit the market -- Orexigen's Contrave.
In a hurry
After the initial New Drug Application, or NDA, for Contrave was not approved by the U.S. Food and Drug Administration, Orexigen hurried to move forward with the cardiovascular study needed to satisfy the FDA. The company launched this additional research, called the Light Study, in June. By early July, Orexigen announced that enrollment was going much faster than initially expected and could wrap up in first quarter of 2013 -- taking around half the time originally anticipated.
That outlook actually proved to be pessimistic. Orexigen completed screening for the Light Study by mid-December, enrolling around 9,000 patients to participate in the study and cutting off more than a year from the initial timetable. The next major milestone for the research will be an interim analysis. That analysis can't occur until 87 or so major adverse cardiovascular events, or MACE, occur with the patients. After the herculean efforts to get the study going so rapidly, Orexigen must now essentially wait for bad things to happen.
In January, the company announced that the resubmission process for the Contrave NDA could be hurried along somewhat. The FDA will allow a summary report from the Light Study interim analysis to be used with the NDA in lieu of a complete report. While the complete clinical study report will be required within 60 days of the resubmission, this decision cuts time out of the process.
How long will the waiting game take? Orexigen says that plans are to submit the NDA again by the end of this year. However, company executives have hedged in recent comments, stating that this time frame could be pushed back to early 2014 if the MACE rate is on the low end of the target 1% to 2% range.
Late to the game?
A key question for investors looking at Orexigen relates to how successful Contrave can be as a late entrant to the obesity drug market. With Qsymia already on the market and Belviq likely to launch in the U.S. any day now, will Contrave be too late to the game? The answer is: "It depends."
If Arena and VIVUS manage to achieve tremendous success and develop great patient and prescriber loyalty for their drugs, Contrave could face an uphill battle to gain a foothold. VIVUS recently introduced promotions that appear to be designed to attract and hold on to customers in anticipation of near-term competition from Belviq. With the earliest possible commercial launch of Contrave still over a year away, Orexigen's late arrival could be a significant handicap.
On the other hand, others point to factors that they think will differentiate Contrave and allow it to achieve success despite the slower start. If the Light Study goes as well as supporters hope it will, Orexigen will have solid clinical data to back up the safety claims for Contrave. The company's partnership with Takeda should also help tremendously with the commercial launch. Takeda has committed to call on more than 50,000 physicians assuming that Contrave gains approval. The larger company's experience in the diabetes market should be another big plus.
I don't doubt for a minute that Orexigen executives would much prefer to enjoy the first-mover status held by VIVUS. And I suspect that they would gladly trade the frustration that Arena has experienced with waiting on DEA scheduling in exchange for hitting the market a year earlier. They don't have those options, though, so they're forced to play the hand that they have been dealt.
That hand isn't all that bad in my view. Back in November, Orexigen discussed a physician survey that it commissioned that found plenty of opportunity in the market for multiple obesity drugs. I suspect those findings were on target. I also think that the company's partnership with Takeda will pay dividends. All this assumes, of course, that the Light Study goes well and the FDA ultimately approves Contrave. For now, we continue to wait.