AstraZeneca is selling outside-U.S. rights to its gastrointestinal drug Entocort® (budesonide) to Tillotts Pharma, part of the Zeria Group, for $215 million, the companies said today.

AstraZeneca said the sale is intended to sharpen its focus on its primary therapeutic areas—cancer, cardiovascular/metabolic disease, and respiratory, inflammatory, and autoimmune disease—by selling off Entocort to a buyer that specializes in GI treatments.

“Our agreement with Tillotts reinforces our strategic focus on selected therapy areas and puts this important medicine in the hands of a company with specialist expertise in gastroenterology, which will benefit patients,” Luke Miels, evp, global product and portfolio strategy and corporate affairs with AstraZeneca, said in a statement.

The deal includes rights to sell and develop Entocort capsules and enema formulations outside the U.S.—but does not include the transfer of any AstraZeneca employees or facilities.

AstraZeneca said it will continue to market Entocort in the U.S., through a commercialization partnership with Par Pharmaceutical.

The capsule formulation of Entocort is a first-line locally acting glucocorticosteroid therapy indicated for the induction and maintenance of clinical remission of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon. Entocort’s enema formulation is indicated for the induction and maintenance of clinical remission of distal ulcerative colitis in the rectum, sigmoid colon, and descending colon.

The Entocort portfolio last year generated $53 million in total product sales outside the U.S., where it is available in more than 40 countries. Those numbers are expected to increase since a regulatory filing is being planned for the drug in Japan. AstraZeneca earlier this year estimated the Japanese filing would be submitted during the third quarter.

“This agreement underscores our commitment to continue to position Tillotts as a leading European specialist in the field of gastroenterology, offering patients a wide range of treatments for the GI tract,” stated Tillotts CEO Thomas A. Tóth von Kiskér.

He added that Entocort “perfectly” complements Tillotts’ Asacol® portfolio, also indicated for mild to moderate Crohn's and ulcerative colitis, and marketed in 50 countries worldwide.

Tillotts will pay AstraZeneca $215 million upon completion of the transaction, which is expected in the second half of 2015, subject to customary closing conditions. According to AstraZeneca, the deal will not impact its financial guidance for 2015, which calls for a mid-single digit decline in total revenue and a low-single-digit increase in core earnings per share, both at constant exchange rates.

Swiss-based Tillotts focuses on pharmaceutical products, medical devices and diagnostics, all in gastroenterology. In addition to Asacol, Tillotts markets its own products Colpermin® for bowel spasms and bloating in irritable bowel syndrome, and VistaPrep® for preparation of the bowel for colonoscopy; as well as in-licensed products, such as Simtomax®, a point-of-care diagnostic designed to detect celiac disease in 10 minutes.

Tillotts is part of Japanese-based Zeria Pharmaceutical, which focuses on R&D, manufacturing and sales of prescription drugs as well as over-the-counter products.

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