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Agreements

Date: 2015-07-09

Type of information: Product acquisition

Compound: Entocort® (budesonide)

Company: AstraZeneca (UK) Tillotts Pharma (Switzerland) Zeria Pharmaceutical (Japan)

Therapeutic area: Autoimmune diseases - Inflammatory diseases - Digestive diseases

Type agreement:

product acquisition

Action mechanism:

corticosteroid

Disease: mild to moderate Crohn’s disease, ulcerative colitis

Details:

* On July 9, 2015, AstraZeneca announced that it has entered into an agreement with Tillotts Pharma, part of the Zeria Group, for the divestment of 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.  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.

Financial terms:

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. 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.

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