UCB announced today that the U.S. Food and Drug Administration (FDA) has approved the anti-muscarinic agent Toviaz(R) (fesoterodine fumarate) extended-release tablets for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
The NDA approval was granted to Pfizer Inc., New York, USA, which in April 2006 acquired the exclusive world-wide rights to Toviaz(R) from Schwarz Pharma, now a member of the UCB Group. UCB will be entitled to receive royalties on the combined sales of Toviaz(R) and Pfizer’s current Detrol(R) (tolterodine) product line. Upon this approval, UCB will also receive a milestone payment from Pfizer. Details of the agreement are not disclosed.
TOVIAZ is structurally related to Pfizer’s OAB medication Detrol(R) LA (tolterodine tartrate extended-release capsules). The 4 mg and 8 mg doses of TOVIAZ allow dosing flexibility to optimize treatment based on individual patient response and tolerability.
Toviaz(R) is approved in the EU and was launched by Pfizer mid-2008.
About UCB
UCB (Brussels, Belgium, www.ucb-group.com) is a biopharmaceutical company dedicated to the research, development and commercialization of innovative medicines with a focus on central nervous system and immunology disorders. Employing around 12,000 people in over 40 countries, UCB achieved revenue of EUR 3.6 billion in 2007. UCB is listed on Euronext Brussels (symbol: UCB).
Forward Looking Statement
This press release contains forward-looking statements based on current plans, estimates and beliefs of management. Such statements are subject to risks and uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, effects of future judicial decisions, changes in regulation, exchange rate fluctuations and hiring and retention of its employees.
French and Dutch translations will be available as of Monday November 3rd on www.ucb-group.com
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Further information Antje Witte Corporate Communications & Investor Relations UCB Group T +32.2.559.9414 Email Contact Mareike Mohr Investor Relations UCB Group T +32.2.559.9264 Email Contact Michael Tuck-Sherman Investor Relations UCB Group T +32.2.559.9712 Email Contact
SOURCE: UCB
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