Adolor Corp. and GlaxoSmithKline plc entered a worldwide agreement to commercialize Adolor’s alvimopan in a deal with an up-front payment of $50 million to Adolor followed by the potential of $220 million more in milestones.
Adolor said it plans to file a new drug application in the United States during the first half of 2003. The drug candidate is in three pivotal Phase III trials for postoperative ileus and one pivotal Phase III for opioid bowel dysfunction. Alvimopan, formerly ADL 8-2698, is a mu opioid antagonist.
The plan is to submit alvimopan for approval in two indications: postoperative ileus and constipation related to the use of opioids. The triggering events for the milestones were not disclosed, but Adolor President and CEO John Farrar said they all were clinical and regulatory in nature, and not tied to marketing.
Farrar said his company was looking to partner before signing the deal with GlaxoSmithKline, of London.
“The basic rationale is this: A first-in-class product, which has to be marketed to a hospital formulary to be accepted and to surgeons who don’t prescribe a lot of drugs, requires a skilled sales force within those market segments,” Farrar said.
Adolor’s stock (NASDAQ:ADLR) jumped $2.94 Monday, or 30 percent, to close at $12.79.
The agreement calls for Exton, Pa.-based Adolor and GlaxoSmithKline to co-develop and co-promote alvimopan and share in development expenses and commercial returns. Adolor will take the lead in the development, marketing and co-promotion strategy for acute-care indications, targeted to hospitals and surgeons. GlaxoSmithKline will have the same responsibility but for chronic-care indications targeted to community-based physicians.
The agreement also offers Adolor the right, in other indications, to elect to participate in Phase III development and co-promotion and to receive a share of U.S. profits.
Farrar told BioWorld Today that the deal is a “pivotal event for Adolor. It puts us in a great position to achieve commercial success with this product.”
Also, Farrar said that without the help of a partner, Adolor would have been at “a bit of a disadvantage.”
“It clearly made sense to establish a co-promotion and sales agreement with a partner with experience in these marketing segments,” he said, explaining that even though Adolor has “great financial resources” it would have been difficult to market the product “effectively and optimally” without a partner.
Another benefit, Farrar said, is that the money from GlaxoSmithKline will free up resources that Adolor could now devote to its internal drug development pipeline or the in-licensing of other drug candidates.
“GlaxoSmithKline will have responsibility for development of the product outside the U.S., and they intend to get going on that pretty aggressively,” he said.
Adolor will start out with a relatively small marketing and sales force for its share of the responsibilities, with between 30 and 50 people, Farrar said. “[GSK] will start out obviously with much larger numbers,” he said.
As part of the agreement, Adolor will have the right to co-promote a GlaxoSmithKline hospital product to sell in the United States, which Farrar explained was to give his sales force more than one product to offer.
Farrar said he expects to launch the product a year after filing the NDA.
“We haven’t been terribly specific about what quarter,” he said. “We need more steady stage accrual information from the Phase III before we could be precise about what month we will submit the NDA.”
Elsewhere in its pipeline, Adolor reported a few weeks ago that unfavorable results from three early Phase II studies of ADL 10-0101 prompted the company to return to Phase I. ADL10-0101 is a stimulant of peripherally restricted kappa opioid analgesic used for visceral or inflammatory pain. (See BioWorld Today, April 2, 2002.)