Acceleration of Fracture Healing with CDP7851/AMG785 will not move into phase 3
Brussels (Belgium), 11 February 2013 – 7:00 AM (CET) regulated information - UCB and its partner, Amgen Inc., have decided to not pursue a phase 3 clinical trial program for CDP7851/AMG785 (romosozumab) in acceleration of fracture healing based on the evaluation of currently available Phase 2 results from accelerated fracture healing studies and general regulatory guidance on fracture healing programs. However, the safety profile of this program remains consistent with what has been seen in the post-menopausal osteoporosis program and is not a factor in this decision to not pursue acceleration of fracture healing.
"Our sclerostin antibody project with Amgen is one of the most innovative pipeline programs in UCB’s portfolio. We are very excited about the Phase 3 program in PMO which is on-going as planned and should provide first results at the end of 2015. Safety and other data collected so far indicate the potential for a change of treatment paradigms in postmenopausal osteoporosis", said Prof. Dr. med. Iris Loew-Friedrich, Chief Medical Officer UCB. "At UCB, we strive constantly to allocate our funds and resources to the most promising activities for our pipeline projects to maximize sustainable and superior value for patients and all stakeholders."
Complete phase 2 accelerated fracture healing results will be presented at a future conference.
The decision to no longer pursue a phase 3 program for accelerated fracture healing has no impact on UCB's 2012 financials.
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UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 8 500 people in about 40 countries, the company generated revenue of EUR 3.2 billion in 2011. UCB is listed on Euronext Brussels (symbol: UCB).
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