'Ruconest
The hereditary angioedema (HAE) treatment developed by the Netherlands’ Pharming faces an FDA decision date after a delay from April. It will be the first event for US licensee Salix Pharmaceuticals since the company announced a merger with Cosmo Pharmaceuticals’ Irish-based subsidiary earlier this week.
Marketed as Rhucin outside the US, the biological treats acute disease episodes in patients who are deficient in or lack a functional plasma protein C1 inhibitor. HAE attacks are marked by swelling of the hands, feet, abdomen, face and airway, which can lead to suffocation.
If the FDA approves the Ruconest, it will be competing against Shire’s Firazyr, a product that recorded $235m in sales last year. Ruconest is forecast as a modest competitor, $41m in 2020, according to EvaluatePharma’s consensus.
Salix acquired Ruconest with its buyout of Santarus last year, a transaction driven more by the desire to buy a primary care sales force than marketed products or an R&D pipeline (Salix plays the long game with $2.6bn Santarus swoop, November 8, 2013). As EP Vantage argued at the time, Ruconest does not really fit in with the gastrointestinal focus of the combined company, and thus Salix may want to find it a home elsewhere.
FDA approval may represent the perfect catalyst for such a sale.'
UP! :-)