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.
For further information
France Nivelle, Global Communications UCB
Laurent Schots, Media Relations, UCB
Antje Witte, Investor Relations UCB
T , firstname.lastname@example.org email@example.com firstname.lastname@example.org
UCB, Brussels, Belgium ( ) 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). www.ucb.com
Forward looking statements
This press release contains forward-looking statements based on current plans, estimates and beliefs of management. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, political, regulatory or clinical results and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions which could cause actual results to differ materially 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, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, product liability claims, challenges to patent protection for products or product candidates, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws and hiring and retention of its employees. UCB is providing this information as of the date of this press release and expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report a change in its expectations.There is no guarantee that new product candidates in the pipeline will progress to product approval or that new indications for existing products will be developed and approved. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences between the partners. Also, UCB or others could discover safety, side effects or manufacturing problems with its products after they are marketed.Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement.