Staff Writer

Adolor Corp. went shopping for a bowel drug, paying $2 million up front plus $70 million in milestones for rights to Eli Lilly and Co.'s early stage product for opioid-induced bowel dysfunction (OBD).

The Lilly product it acquired will be developed in parallel with Adolor's own pipeline bowel drug, ADL-7445, with the goal of advancing the one with the best data to later-stage testing.

Exton, Pa.-based Adolor plans to have efficacy data for both compounds as early as next year.

Adolor's in-house bowel drug, ADL7445 in OBD, is believed to have a longer patent life, a better pharmacokinetic profile and more consistent oral bioavailability and potency compared to alvimopan (Entereg), a compound that it pulled the plug on last year in OBD. (See BioWorld Today, Dec. 19, 2008.)

Michael R. Dougherty, president and CEO of Adolor, said that the company plans to introduce ADL7445 into the clinic shortly. "This gives us another opportunity in the OBD space," he told BioWorld Today.

Dougherty said that the data would drive the company's decision making on which OBD program to advance. "It would be terrific if we emerge with two candidates for which we have good data." But he said the company would likely proceed with the just one in later-stage studies.

"The company is appropriately resourcing multiple drugs in this area with a chance that one might have an . . . advantage over the other," Gregory Wade, an analyst with Wedbush Morgan Securities, told BioWorld Today.

Adolor is among several companies working to develop new treatments for bowel dysfunction.

Wade said that some drugs being developed for irritable bowel syndrome (IBS) also may work in OBD. He sees room for multiple drugs for IBS, a condition characterized by abdominal pain, bloating and alternating bouts of diarrhea and constipation.

The slow uptake of Entereg, Adolor's approved bowel drug for postoperative ileus, partnered with GlaxoSmithKline plc, is due to issues specific to that drug, which is under a risk minimization plan, Wade said. In addition, he said it is not uncommon for it to take some time for new drugs in a new indication to be adopted.

Currently, Wyeth's Relistor injection is approved for opioid-induced constipation (OIC). It is not, however, approved for other bowel problems such as pain, bloating and straining, stemming from chronic opioid use.

San Carlos, Calif.-based Nektar Therapeutics Inc. is working to develop an oral drug for OIC under a partnership with AstraZeneca plc. The London-based drugmaker has agreed to develop Nektar's late-stage bowel drug and a preclinical pain product in a deal valued at $1.5 billion. (See BioWorld Today, Sept. 22, 2009.)

And earlier this month Salix Pharmaceuticals Ltd. reported positive results from two large Phase III studies of rifaximin. Both trials showed statistically significant reductions in symptoms of IBS.

Raleigh, N.C.-based Salix plans to seek FDA approval of rifaximin as a potential treatment for diarrhea-predominant IBS, or nonconstipation IBS. The company plans to file for regulatory approval of rifaximin during the first half of 2010.

San Diego-based Tioga Pharmaceuticals Inc. also has an IBS drug candidate that is headed for a late-stage trial, which showed significant improvement in diarrhea-predominant IBS and reconfirmed safety data. Tioga licensed Japanese rights to irritable bowel syndrome drug asimadoline in a deal with Ono Pharmaceutical Co. Ltd. (See BioWorld Today, Sept. 3, 2009.)

Amitiza (lubiprostone), made by Bethesda, Md.-based Sucampo Pharma Americas Inc. and partnered with Osaka, Japan-based Takeda Pharmaceutical Co. Ltd., currently is U.S.-approved to treat IBS in adult women and chronic idiopathic constipation (CIC) in adults. Lubiprostone is in an ongoing Phase III trial in Japan as a potential treatment for CIC.

Cambridge, Mass.-based Ironwood, formerly Microbia Inc., and its partner New York-based Forest Laboratories Inc. have a Phase III candidate, linaclotide, for chronic constipation and IBS with constipation (IBS-C).

Tranzyme Pharma, of Research Triangle Park, N.C., has a Phase II second-generation agonist of the ghrelin receptor (TZP-102) that is being studied in diabetes and may hold potential as a treatment for gastrointestinal disorders such as OBD and IBS with constipation.

Tranzyme also is planning a Phase III trial with TZP-101 for postoperative ileus, the symptoms of which include the inability to pass stool.

Shares in Adolor (NASDAQ:ADLR) were down 1 cent at market close Tuesday, at $1.65.

At the end of June, Adolor had about $108.6 million in cash equivalents and short-term investments.