AstraZeneca, a global, innovation-driven biopharmaceutical business, has entered into an agreement with Tillotts Pharma AG (Tillotts), part of the Zeria Group, to divest global rights, outside the US, to Entocort (budesonide), a gastroenterology medicine for patients with mild to moderate Crohn’s disease and ulcerative colitis.

Entocort is currently available in over 40 countries, with total product sales of $53 million outside the US in 2014. A regulatory submission for Entocort in Japan is anticipated in the coming months.

Under the terms of the agreement, Tillotts will pay AstraZeneca $215 million upon completion of the transaction to acquire the rights to sell and develop Entocort capsules and enema formulations outside the US. The transaction does not include the transfer of any AstraZeneca employees or facilities.

Luke Miels, executive vice president, global product and portfolio strategy and corporate affairs, AstraZeneca, said “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.”

Thomas A. Tóth von Kiskér, chief executive officer of Tillotts, commented “Entocort perfectly complements our Asacol portfolio marketed in 50 countries worldwide through our own European affiliates, our Japanese parent company Zeria Pharmaceutical and our trusted network of marketing partners. This acquisition underscores our commitment to continue to position Tillotts as a leading European specialised player in the field of gastroenterology, offering patients a wide range of treatments for the GI tract.”

Sachiaki Ibe, chairman and chief executive officer of Zeria Pharmaceutical, added “We are excited to obtain a well-established brand such as Entocort and to expand its commercial reach to Japan and other countries. With this move, we confirm our expansion strategy of organic growth combined with merger and acquisition activities, while delivering increased value to our shareholders."

As AstraZeneca will no longer retain an interest in the ex-US rights to Entocort, the upfront receipt will be reported in other operating income in the company’s financial statements for 2015. The transaction is expected to complete in the second half of 2015, subject to customary closing conditions, and it does not impact AstraZeneca’s financial guidance for 2015.

In capsule formulation, Entocort is a first-line 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. As an enema, Entocort is indicated for the induction and maintenance of clinical remission of distal ulcerative colitis in the rectum, sigmoid colon and descending colon. AstraZeneca has a partnership with Par Pharmaceutical for the commercialisation of Entocort in the US.