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Adolor, GSK enter into agreement over ENTEREG
EXTON, Pa.—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.
Per the terms of the agreement, Adolor will pay GSK $25 million in cash over a six-year period, with $2.5 million payable in 2011, as well 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 rights to ENTEREG held by GSK," said Michael R. Dougherty, President and Chief Executive Officer of Adolor, in a press release about the acquisition. "We see continuing revenue growth ahead for ENTEREG, building upon the solid foundation laid by GSK and Adolor over the past several years. We expect ENTEREG to generate meaningful cash flows for Adolor over the next year and into the future."
ENTEREG is a peripherally acting m-opioid receptor antagonist that accelerates gastrointestinal (GI) recovery. The drug is indicated to accelerate the recovery time for upper and lower GI recovery after large or small bowel resection surgery with primary anastomosis. In Phase III clinical studies, ENTEREG was shown to improve the average time to GI recover by up to a day, about 11 to 26 hours faster than the placebo, according to the drug's website. (GI recovery was determined by toleration of solid foods as well as first bowel movement.) Additionally, ENTEREG also served to reduce the average time to discharge order written by about 13 to 21 hours. The drug works by "blocking the peripheral effects of opioids on GI motility and secretion by competitively binding to GI tract m-opioid receptors," without interfering with the analgesic effects of m-opioid agonists, according to its website. It is a short-term treatment consisting of 15 doses for use in hospitalized patients.
"With full ownership of a key hospital product in ENTEREG and data just ahead from our Phase 2 program with ADL5945 for the treatment of opioid-induced constipation, we believe Adolor is well positioned to create compelling strategic value for our stockholders," Dougherty added in the press release.
Adolor specializes in the discovery, development and commercialization of novel prescription pain and pain management products. ADL5945, and Adolor's other pipeline product ADL7445, are novel m-opioid receptor agonists currently in clinical development for the treatment of opioid-induced constipation.
"Since 2008, nearly 30 Adolor employees have been focused on the marketing and selling of ENTEREG to hospitals and physicians," Michael D. Adelman, Vice President of Marketing and Sales at Adolor, said in a statement regarding the deal. "We have extensive knowledge of this marketplace, and are excited about the prospect of now controlling all aspects of the promotional effort. Over the next several months, we intend to approximately double the size of our ENTEREG team, and anticipate a smooth transition working with GSK."