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What happened
Investors in DURECT Corporation (DRRX +0.00%), a specialty pharmaceutical company that develops anti-abuse drug technology, are having a rough start to the trading week. Shares are down by more than 32% as of 12:15 p.m. EDT after news broke that the Food and Drug Administration has rejected Pain Therapeutics' (NASDAQ: PTIE) application for Remoxy ER, which is a drug that utilizes Durect's technology.
So what
More than a decade ago, Pain Therapeutics licensed the rights to develop and commercialize Remoxy ER from Durect. The terms of the agreement called for Pain Therapeutics to fund all development work and provide Durect with development and regulatory milestone payments as they are achieved. Durect would also be entitled to receive a royalty of up to 11.5% of net sales of Remoxy ER if it reached the market.
Unfortunately, it looks like shareholders will have a bit more waiting to do before they will learn if this agreement will ultimately bear fruit. Pain Therapeutics announced today that the FDA had rejected its NDA for Remoxy ER. The agency stated that they could not approve the application in its current form. Specifically, the FDA said that it wasn't satisfied with the drug's labeling and abuse-deterrent properties.
Pain Therapeutics said that they are evaluating the letter and are already planning for another round of studies that will address the FDA's concerns. However, coming up with the new data is expected to cost around $5 million and take a year to complete.
Given that this news delays Durect from pulling in revenue for at least another year, it is no surprise to see that Wall Street is dumping the company's shares today.
Now what
The only positive takeaway from this announcement is that the FDA did not seem to have any issues with the drug's clinical safety profile or efficacy. That hints that the problems with the application should be fixable.
However, the market's clearly are not happy about the delay and rightly so. Last quarter, Durect lost $9 million and it only held $34 million in cash on its books. If that burn rate persists, then another round of fundraising could be on the horizon.
With questions in the air surrounding Remoxy ER's future and a dwindling cash position, I think the smart move is to stay far away from Durect's shares.
