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UCB to out-license olokizumab to R-Pharm

  • World-wide exclusive license grant to R-Pharm to develop and commercialize olokizumab in all indications
  • R-Pharm to continue development of olokizumab in rheumatoid arthritis
  • UCB receives upfront payment, future milestone payments and royalties


BRUSSELS, 4 July 2013 - regulated information
– UCB and R-Pharm, a privately owned pharmaceutical company based in Moscow, Russia, today announced that they have entered into a world-wide exclusive license grant to R-Pharm to develop and commercialize olokizumab in all indications, including rheumatoid arthritis.

Under the terms of this agreement, R-Pharm will develop, register, manufacture, distribute and book sales globally. UCB receives an upfront payment and is entitled to receive payments on development and commercialization milestones and royalties. Further details of the agreement are not disclosed.

"We at UCB are very satisfied with the positive phase 2 results for olokizumab. Following the prioritization of UCB’s rich pipeline, we took the portfolio decision to partner olokizumab", says Roch Doliveux, CEO UCB. "We are pleased that R-Pharm will provide a potential new treatment option for patients with immunology diseases."

“We highly appreciate the confidence in us and do believe that the strategic collaboration with UCB will contribute to decrease the burden of diseases. This kind of partnership is an example of experience and technology exchange for the patients’ benefit globally”, noted Alexey Repik, President and Chairman R-Pharm.

September 2012, UCB announced top-line results from a phase 2b study of olokizumab (CDP6038) in adult patients suffering from rheumatoid arthritis (RA) having previously failed anti-TNF therapy. The primary objective of this study was to evaluate the efficacy of various doses and dose administration frequencies of olokizumab relative to placebo. This phase 2b study met its primary endpoint of demonstrating a significant reduction in the disease activity score at week 12 across all olokizumab dose groups relative to placebo. All doses of olokizumab demonstrated statistically significant improvement in disease activity score (DAS 28) (p<0.001) when compared with placebo. Olokizumab was well tolerated across all doses and demonstrated a safety profile consistent with known effects of IL-6 inhibitors.

For further information UCB

Antje Witte, Investor Relations, UCB
T +32 2 559 9414,
antje.witte@ucb.com

France Nivelle, Global Communications, UCB
T +32 2 559 9178,
france.nivelle@ucb.com

Laurent Schots, Media Relations, UCB
T +32.2.559.9264,
laurent.schots@ucb.com

For further information R-Pharm

Evgenya Kasyanenkko – PR manager, R-Pharm
T: +79032205497,
kasyanenko@rpharm.ru

Alexey Ordzhonikidze – Marketing Director, R-Pharm
T: +79037982829,
Ordzhonikidze@rpharm.ru

Notes to the editor

About Olokizumab
Olokizumab is a humanized monoclonal antibody targeting the IL-6 cytokine. IL-6 is involved in several autoimmune and inflammatory pathways. Olokizumab is the first of a new type of IL-6 inhibitor that selectively blocks the final assembly of the IL-6 receptor signaling complex.

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 8 500 people in about 40 countries, the company generated revenue of EUR 3.4 billion in 2012. UCB is listed on Euronext Brussels (symbol: UCB).

About R-Pharm
R-Pharm is a Russian private high-tech pharmaceutical company with focus on hospital/specialty care, founded in 2001. Turnover in 2012 – over 1.8 bn USD. R-Pharm has over 2 800 employees and covers entire territory of Russia and CIS. The company is involved in research and development, manufacturing, marketing, sales and distribution of innovative pharmaceutical and biotech products. www.r-pharm.com

UCB Forward-Looking Statement
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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