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Transparency and Sharing: UCB Expands Access to Clinical Study Data

  • First midcap company to enter Multi-Sponsor Environment for data sharing
  • Reinforces UCB’s commitment to the advancement of medical science and improved patient care
  • In line with EFPIA and PhRMA principles for Responsible Clinical Trial Data Sharing
  • Online portal will provide access to key studies of UCB’s core medicines

Brussels, Belgium01 August 2014, 0700 CEST UCB announces that it has joined the Multi-Sponsor Environment which allows for the responsible sharing of clinical study data as a way to uncover new scientific knowledge or insights, advance medicine and ultimately benefit patients and other stakeholders. In line with its vision for patient-centered leadership, UCB is the first midcap biopharma company to join this new environment.

The environment (https://clinicalstudydatarequest.com) allows researchers to request access to anonymised patient level data and supporting documents from clinical studies to conduct further research. Research proposals are reviewed by an Independent Review Panel. At present, UCB will accept requests relating to all clinical studies that were considered ‘pivotal studies’ for purposes of regulatory approval of the core UCB medicines. Requests for access to additional clinical study data will be considered on a case-by-case basis.

“Because we believe that this will lead to better solutions for patients, we have committed to sharing data from our clinical studies in a responsible way. We hope this will enhance disease understanding, generate new insights and help develop new treatments,” said Professor Dr. Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President, UCB.

UCB’s policy on data sharing embraces the Principles for Responsible Clinical Trial Data Sharing released by the U.S. and European pharmaceutical trade associations, PhRMA and EFPIA.

Further information on UCB’s policy on disclosure of clinical study information can be found on our website.

For further information UCB

Corporate Communications

France Nivelle, Global Communications, UCB

Investor Relations

Antje Witte, Investor Relations, UCB

T +32.2.559.9178, france.nivelle@ucb.com

T +32.2.559.94.14, antje.witte@ucb.com

Laurent Schots, Media Relations, UCB

Alexandra Deschner, Investor Relations, UCB

T+32.2.559.92.64, Laurent.schots@ucb.com

T +32.2.559.9283, alexandra.deschner@ucb.com


About UCB

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 8500 people in approximately 40 countries, the company generated revenue of € 3.4 billion in 2013. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news

Forward looking statements - UCB

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.


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