Under the terms of the deal, Shire has acquired the global rights and undertaken the further development of Meritage’s Phase 3-ready compound, Oral Budesonide Suspension (OBS), for the treatment of adolescents and adults with eosinophilic esophagitis (EoE), a rare, chronic inflammatory gastrointestinal (GI) disease.
OBS is a proprietary viscous oral formulation of budesonide that is designed to coat the esophagus where the drug can act locally. Budesonide is the active pharmaceutical ingredient in several products approved by the US FDA, including products for the treatment of asthma, allergic rhinitis, ulcerative colitis and Crohn’s disease.
Shire’s Head of R&D Philip Vickers, said: “Adding this Phase 3-ready compound to our late-stage portfolio will allow us to leverage our expertise to further develop this important therapy that, if approved, will give hope to patients living with eosinophilic esophagitis.”
The FDA previously granted Orphan Drug Status designation to OBS for the treatment of patients with EoE. EoE is a chronic disease that is increasingly being diagnosed in children and adults, with an estimated prevalence in the US of about 181,000.
A Shire spokeswoman told us the company does not plan to manufacture OBS in-house. She also said Shire will “continue to work with FDA toward developing the Phase 3 program, and timing will be determined based on the output of those discussions.”
Shire does not expect this acquisition to result in a change to its previously published earnings guidance for 2015. The acquisition follows Shire’s purchase of NPS Pharmaceuticals for $5.2bn, which also boosted its GI and rare disease offerings.
Shire previously obtained the rights to acquire Meritage in connection with its acquisition of ViroPharma in 2014.