Adolor, GSK enter into agreement over ENTEREG

Adolor Corporation and GlaxoSmithKline have entered into an agreement by which Adolor will reacquire all rights to Adolor’s U.S. Food and Drug Administration (FDA)-approved product ENTEREG (alvimopan), which is currently co-promoted by the two companies in the United States. The deal is expected to close in September.

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EXTON, Pa.—Adolor Corporation and GlaxoSmithKline haveentered into an agreement by which Adolor will reacquire all rights to Adolor'sU.S. Food and Drug Administration (FDA)-approved product ENTEREG (alvimopan),which is currently co-promoted by the two companies in the United States. Thedeal is expected to close in September. 
Per the terms of the agreement, Adolor will pay GSK $25million in cash over a six-year period, with $2.5 million payable in 2011, aswell as tiered, mid-single digit royalties on annual net sales and a one-time,sales-related milestone of $15 million.
"We are thrilled to have an agreement to acquire the rightsto ENTEREG held by GSK," said Michael R. Dougherty, President and ChiefExecutive Officer of Adolor, in a press release about the acquisition. "We seecontinuing revenue growth ahead for ENTEREG, building upon the solid foundationlaid by GSK and Adolor over the past several years. We expect ENTEREG togenerate meaningful cash flows for Adolor over the next year and into thefuture."
ENTEREG is a peripherally acting m-opioidreceptor antagonist that accelerates gastrointestinal (GI) recovery. The drugis indicated to accelerate the recovery time for upper and lower GI recoveryafter large or small bowel resection surgery with primary anastomosis. In PhaseIII clinical studies, ENTEREG was shown to improve the average time to GIrecover by up to a day, about 11 to 26 hours faster than the placebo, accordingto the drug's website. (GI recovery was determined by toleration of solid foodsas well as first bowel movement.) Additionally, ENTEREG also served to reducethe average time to discharge order written by about 13 to 21 hours. The drugworks by "blocking the peripheral effects of opioids on GI motility andsecretion by competitively binding to GI tract m-opioid receptors,"without interfering with the analgesic effects of m-opioidagonists, according to its website. It is a short-term treatment consisting of 15 doses for use inhospitalized patients.
"With full ownership of a key hospital product in ENTEREGand data just ahead from our Phase 2 program with ADL5945 for the treatment ofopioid-induced constipation, we believe Adolor is well positioned to createcompelling strategic value for our stockholders," Dougherty added in the pressrelease.
Adolor specializes in the discovery, development andcommercialization of novel prescription pain and pain management products.ADL5945, and Adolor's other pipeline product ADL7445, are novel m-opioidreceptor agonists currently in clinical development for the treatment ofopioid-induced constipation.
"Since 2008, nearly 30 Adolor employees have been focused onthe marketing and selling of ENTEREG to hospitals and physicians," Michael D.Adelman, Vice President of Marketing and Sales at Adolor, said in a statementregarding the deal. "We have extensive knowledge of this marketplace, and areexcited about the prospect of now controlling all aspects of the promotionaleffort. Over the next several months, we intend to approximately double thesize of our ENTEREG team, and anticipate a smooth transition working with GSK."

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