Bentley Pharmaceuticals, Inc., a specialty pharmaceutical company, announced its latest product launch and marketing approvals in the European Union (EU).
John Sedor, president of Bentley commented, "These approvals and product launch are consistent with our expansion strategy to increase our product portfolio in Spain while also accelerating our efforts into other EU markets."
Through the EU's Mutual Recognition Procedure (MRP), approval was granted to Bentley's wholly owned Spanish subsidiaries for lansoprazole in several European countries. Lansoprazole will be marketed through the Company's licensees and distributors where patents have expired. MRP is the process in the EU that allows for the coordination of product approvals between Member States, provided that the Member States apply harmonized conditions for use of the product. Bentley had previously reported approval of lansoprazole in the United Kingdom in 2005 under a national product approval procedure.
Separately, Bentley Pharmaceuticals Ireland Limited has received approval from the Irish Medicines Board to market lansoprazole 15 mg and 30 mg capsules. Lansoprazole is the generic version of Prevacid, innovated by TAP Pharmaceuticals Products, Inc. Bentley Ireland has also launched its previously approved 10 mg, 20 mg and 40 mg capsules of omeprazole in Ireland. Omeprazole is the generic version of Prilosec, innovated by AstraZeneca International. Both products will be distributed and promoted in Ireland by one of the country's largest pharmaceutical distributors.
Lansoprazole and omeprazole are proton pump inhibitors that are commonly used to treat gastrointestinal disorders such as duodenal and gastric ulcers, and gastroesophageal reflux disease. According to Irish General Medical Services (GMS) data, the annual market size in Ireland for omeprazole is approximately $30 million (USD), and approximately $20 million (USD) per year for lansoprazole.
The Company also noted that its subsidiary, Laboratorios Davur, S.L., has obtained approval to market lamotrigine from the Ministry of Health in Spain. Lamotrigine is the generic version of Lamictal, an antiepileptic drug marketed by GlaxoSmithkline. According to IMS Health Inc., lamotrigine has an annual market size of approximately $48 million (USD) in Spain and grew at a rate of 5% over the trailing twelve months.