The industry (and economy) as a whole may be hurting, but Durect Corp. is doing well enough, thank you, with its second collaboration for pain drugs in two months - this one with Pain Therapeutics Inc. to develop longer-acting opioid drugs.
Pain Therapeutics, of South San Francisco, is providing an undisclosed up-front fee plus milestone payments and royalties, as well as funding certain formulation activities by Cupertino, Calif.-based Durect.
"We haven't been discussing which aspects of their pipeline we'll be working with," said Schond Greenway, senior director of investor relations and strategic planning for Durect, who also declined to give financial details.
But Christi Waarich, manager of investor relations for Pain Therapeutics, said the first focus would be OxyTrex, the company's substitute for oxycodone and other moderately strong opioids.
"We'll do OxyTrex and we might also develop the other ones" using Durect's gel-cap technology, she told BioWorld Today. The drug is a proprietary combination of immediate-release oxycodone and low-dose naltrexone, now in Phase II trials.
"We're on track to initiate Phase III in the second quarter," she said.
Durect is granting Pain Therapeutics exclusive worldwide rights to develop and commercialize opioid drugs formulated with SABER, which consists of a controlled-release system that uses a high-viscosity base component, such as sucrose acetate isobutyrate, or SAIB. The solvent diffuses after administration to leave a viscous, adhesive matrix of the three components - SAIB, the drug and any additives.
Greenway told BioWorld Today Durect is neither a pure drug delivery company nor a pure devices company.
"I guess we're more of a hybrid," he said. "We're what we call a pharmaceutical systems company," which directs its efforts at enabling biotechnology-based treatments for debilitating diseases.
In November, for example, Durect entered a deal to enable Endo Pharmaceuticals Holdings Inc., of Chadds Ford, Pa., to develop and commercialize the former's Chronogesic pain therapy system, which is in Phase III trials and deploys a small, self-driven titanium capsule placed just under the skin that dispenses drug by osmosis at a controlled rate. (See BioWorld Today, Nov. 12, 2002.)
Durect, which sells catheters for use in ear disorders, osmotic pumps for experiments in lab animals and polymers for use in medical applications, has an overall strategy that is multifaceted, Greenway said.
"The two keys would be to develop propriety products and leverage our collaborations," he said. "With our own products, we would try to develop them through to proof of efficacy and then evaluate them. Some products we would partner early to drive near-term revenues, and some others we would partner in a later stage, as we did with Chronogesic."
Durect in July entered another sustained-release deal with Voyager Pharmaceutical Corp., using Durin drug delivery with Raleigh, N.C.-based Voyager's treatment for Alzheimer's disease, leuprolide acetate. Durin involves drug-loaded polymeric implants. (See BioWorld Today, July 30, 2002.)
For its part, Pain Therapeutics' products furthest along are two drugs in Phase II studies - OxyTrex and MorViva, a morphine substitute, which the company says are believed to offer more pain relief with no increase in side effects and lower tolerance or dependence, withdrawal effects and addiction potential, compared to conventional forms of oxycodone and morphine.
Further back in development the company has PTI-601 and PTI-701, for moderate pain.
"We've done some Phase II work with them," Waarich said, noting that the drugs - opioid agonists and low-dose antagonist combinations - have taken a back seat to OxyTrex for now.
"We decided to reduce the burn rate in [the second quarter] of last year, so our primary focus has been on OxyTrex," she said, although the firm recently started a pilot program in irritable bowel syndrome, using low-dose opioid antagonists alone.
"This is the first agreement we've had," Waarich said of the Durect deal. "We intend to keep all rights to all of our products, at least through [submission of a new drug application]."
Durect's stock (NASDAQ:DRRX) closed Tuesday at $2.05, down 4 cents. Pain Therapeutics' shares (NASDAQ:PTIE) ended the day at $2.35, up 2 cents.