AstraZeneca grants Teva license to market generic Entocort in USA; Teva's talampanel fails to meet primary endpoint

Anglo-Swedish drug major AstraZeneca today announced that it has entered into an agreement with the US subsidiary of Israeli generics giant Teva Pharmaceutical Industries (formerly Barr Laboratories) to settle patent litigation regarding Teva's proposed copy version of AstraZeneca's Crohn's disease drug Entocort EC (budesonide) capsules.

Under the terms of the accord, often referred to as 'pay-to-delay' deals, UK-headquartered AstraZeneca has granted Teva a license to enter the US market with its generic version of oral budesonide on February 15, 2012, subject to regulatory approval, or earlier in certain circumstances. Teva has conceded that both patents-in-suit in Teva's US Entocort patent litigation are valid and enforceable. Teva has also conceded that both Entocort patents-in-suit would be infringed by the manufacture or sale of Teva's generic version of oral budesonide. The US District Court for the District of Delaware will enter a Consent Judgment and the corresponding patent litigation will be dismissed. Other terms of the settlement are confidential.

US drug giant Merck & Co, which has had a longstanding relationship with AstraZeneca, under a 1998 restructuring of their deal is entitled to a royalty on US sales of certain AstraZeneca drugs, has also entered into the agreement with Teva. Entocort has not been a big seller, generating worldwide turnover of just around $100 million last year.