A candid conference call with investors by Pain Therapeutics Inc. CEO Remi Barbier didn't stop Wall Street from pummeling the company's shares after partner Pfizer Inc. made known that it's returning all rights to Remoxy, the long-acting, tamper-resistant form of oxycodone stalled at the FDA.

"The wording of Pfizer's press release suggests the whole thing is an unmitigated disaster," Barbier said, but the New York-based pharma giant last Friday verbally shared encouraging topline results from five new trials. "We think the data absolutely support a refiling" of Remoxy's storm-tossed new drug application (NDA), he said.

Pain's stock (NASDAQ:PTIE) closed Monday at $2.10, down $2.13, or 51 percent. Shares of Cupertino, Calif.-based Durect (NASDAQ:DRRX) ended the day at 71 cents, down 67 cents, or 48 percent.

"We have not received actual, physical data," Barbier said, so he did not want to go on record as affirming that the Pfizer trials met their endpoints. The pact officially ends in six months, but the data should be in-house shortly.

The set of outcomes put together by Pfizer amounts to "a very strong package that addresses the issues previously identified by the FDA in previous complete response letters [CRLs]," Barbier said. "I think we're good to go."

How soon Austin, Texas-based Pain might file the NDA depends on how the trial results are formatted by Pfizer. "If they ship 12 boxes of data to us and say, 'Good luck,' I would say that's an effort," Barbier said.

The company came up with Remoxy using Durect's Oradure technology, and in 2005 licensed development and commercialization rights to King Pharmaceuticals Inc., of Bristol, Tenn., which submitted an NDA in 2010, about two years after Pain got its first CRL. Pfizer took on Remoxy at the February 2011 closing of its $3.6 billion takeover of King. (See BioWorld Today, Oct. 13, 2010.)

In the middle of last year, Pfizer disclosed in SEC earning paperwork that the firm had met in March with the FDA to discuss a June 2011 CRL, and the pharma giant warned that it might decide not to pursue Remoxy further. By August, things were looking up. Pfizer said it had begun more clinical work with the compound, though Barbier cautioned that Pain was "still not out of the woods." (See BioWorld Today, May 13, 2013, and Aug. 20, 2013.)

As investor timbers shivered Monday, Barbier sought to reassure backers of Pain. He pointed out that the company would start looking for a new suitor right away. "We can start the partnership discussions right after this phone call," he said, and odds seem high for signing a new deal. "At the end of the day, even if there are two or three or four of us competing in this market, it's a heck of a market, and it's expected to grow organically."

Pfizer did not provide a reason for giving Remoxy back. "I'm not an insider, I'm not privy to what goes on inside of Pfizer, and frankly at this point I don't really care why they returned it," he said, but noted that Pfizer has its own pain program. "They're under tremendous cost pressure and probably lacked the internal resources to launch and support two drugs in the same space that sit on the same shelf," he said.

NO BLOCK TO FENROCK

Similar pressures bear on other pharma firms, "desperate" for unencumbered assets for broad indications, Barbier said, adding that Pain has made $175 million in cash off Remoxy. "We look forward to the prospects of getting even more" by way of a new agreement and ultimate approval by the FDA, he said. "My opinion is that it's a seller's market right now, and the reason has to do with big pharma feeling all the constraints that they're under. We have the goods."

The company expects to end the year with about $40 million in cash. "Clearly, we don't have the in-house people anymore to file the NDA by ourselves," Barbier said. "On the other hand, the biotech ecosystem is such that there are plenty of vendors that, on a fee-for-service basis, would gladly take the data, format it properly, and do the heavy lifting for us." Consulting firms may cost "quite a bit of money" to get the NDA under way, he said. "I don't have any hard costs in front of me, but back of the envelope suggests that perhaps a half million to $1 million, maybe up to $2 million may do it."

Pfizer had planned to file the NDA around the middle of next year, and Pain will stick to that goal, Barbier said.

Still at the pre-investigational new drug application stage is Pain's Fenrock, an abuse-deterrent pain patch. Asked whether the latest news on Remoxy would affect the candidate, Barbier said getting the patch through proof of concept would "not require a large investment. I want to be clear that our top priorities revolve around Remoxy [but] I don't anticipate we would drop Fenrock – in fact maybe quite the opposite." More maturity with Fenrock could "make us a much more attractive prospect for a potential third party," he said.

With Remoxy, "we think we may have a tiger by the tail," Barbier said. "Have we approached anyone yet? Obviously not. We know that several companies are very much interested in entering the pain space. We know that several pain companies are very interested in expanding their presence [there]."