Shares of Pain Therapeutics (NASDAQ:PTIE) continue to rise as partner Pfizer (NYSE:PFE) continues to send signals that Remoxy’s New Drug Application (NDA) could be resubmitted in the coming months. Remoxy is Pain Therapeutics’ lead compound and is an extended-release formulation of the widely used painkiller, oxycodone, similar to blockbuster drug Oxycontin. Analysts estimate that Remoxy, an abuse-resistant formulation of oxycodone, has potential to achieve annual sales in the billion-dollar range, however, Pfizer, the company’s marketing partner, must get the drug back in front of the FDA, which requested more information before the drug can gain U.S. approval. (see PropThink’s prior report). While sales could be huge and the economics to Pain Therapeutics are significant, making money on PTIE in the near term primarily hinges on Pfizer getting the drug candidate back in front of the FDA for review. Analysts and investors are waiting to hear more information on Pfizer’s plans later this year, as the large drug manufacturer is expected to meet with the FDA next month to discuss new clinical data generated on Remoxy and the potential resubmission of the NDA.
Importantly, last Thursday, Pfizer presented at the UBS Global Life Sciences investor conference and its slide presentation included a list of Key Late Stage Assets, with Remoxy featured as part of the select group.
We view the inclusion of Remoxy on this slide as a strong indication that Pfizer remains committed to the project, notably after the clinical studies supporting the NDA have been completed, although not released publicly. We wouldn’t be surprised if plans for a Remoxy NDA resubmission are announced in late October or early November.
The economics of Remoxy’s approval provide significant upside for PTIE from current levels. Analyst price targets call for the stock to reach $10 over the next 12 months, and downside risk in PTIE is limited by its strong balance sheet, featuring approximately $2.00 per share in cash, with minimal cash burn. Expect PTIE shares to keep rising into next month’s FDA meeting and potential disclosure from Pfizer on the Remoxy NDA.