UCB plans to accelerate its US transition to a purely specialty-focused biopharmaceutical company and will exit the primary care market in the US, effective 1 March 2010. This strategic decision impacts the reported 2009 net profit with one-time restructuring charges, while freeing more resources for core products. This transition is part of the company's long-term strategy to become the patient-centric global biopharmaceutical leader focused on immunology and neurology.
"Following the successful US launches of our core products Cimzia (certolizumab pegol) and Vimpat (lacosamide) and awaiting US FDA approval for the US launch of Neupro (rotigotine transdermal patch), we are focusing the resources of the total US organisation and strengthening the foundation for the company's focus on immunology and neurology. After the exit of the primary care market in most of Western Europe 18 months ago, UCB will now exit the US primary care market, and focus its resources on providing solutions to patients who suffer from severe diseases with Cimzia, Vimpat as well as prepare for Neupro," said Roch Doliveux, UCB's chief executive officer.
UCB has plans in place to ensure the continued commercialisation of all primary care products. Effective 1 March 2010, sanofi-aventis U.S. will assume all of the commercialisation responsibility for allergy drug Xyzal (levocetirizine dihydrochloride) in the US. UCB will continue to receive a percentage of Xyzal profits. Also effective 1 March 2010, the co-promotion agreement for ProAir HFA (albuterol sulfate) with Teva's respiratory division will end and Teva will assume full commercialisation responsibility for ProAir.
UCB will continue to support its cough medication, Tussionex (hydrocodone polistirex), which has significant brand recognition in the US market, through direct-to-physician and trade promotional activities that do not require sales force support. UCB remains fully committed to the commercialisation of venlafaxine extended-release tablets (VERT) through its subsidiary, Upstate Pharma.
"UCB is extremely grateful to our entire U.S. primary care team. Their hard work and dedication for more than a decade laid a strong foundation for UCB's future success in the US," said Greg Duncan, UCB's president for North America. "Additionally, through many partnerships in the pharmaceutical industry, we have identified continued employment opportunities for some of our colleagues affected by this organisational change."
This transition, the organisational changes in Europe and the debt re-financing trigger non-recurring (one-time) charges to be accounted for in 2009. These non-recurring charges are expected to reach approx. €70m (after tax), lowering UCB's 2009 expected net profit as reported. However, UCB's 2009 total revenue and underlying profitability (recurring earnings before interests, taxes, depreciation and amortization, "recurring EBITDA") are not impacted by these one-time, non-recurring charges. Further information will be available with the publication of the company's full year results on 2 March 2010.
Xyzal (levocetirizine dihydrochloride) is indicated for the relief of symptoms associated with perennial allergic rhinitis and the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children six months of age and older, and for relief of symptoms of seasonal allergic rhinitis in adults and children two years of age and older.
Tussionex (hydrocodone polistirex) is indicated for the relief of cough and upper respiratory symptoms associated with allergy or a cold in adults and children six years of age and older.
UCB is a biopharmaceutical company dedicated to the research, development and commercialization of innovative medicines with a focus on the fields of central nervous system and immunology disorders.