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Interim Report - Promising Early Results for UCB SA's New Products


10/22/2009 10:30:05 AM

BRUSSELS, BELGIUM--(Marketwire - October 22, 2009) -


* Financial performance in line with expectations

* Strong early roll-out of major new products Cimzia®, Vimpat® and Neupro®

* Diversification of debt begun with successful offering of EUR 500 million convertible bonds

* Financial outlook 2009 confirmed

Brussels (Belgium), October 22, 2009 - 07:00 (CEST) - regulated information - UCB announced today its interim report for the first nine months of 2009.

"While it is still early in the launch roll-out of our major new products, Cimzia®, Vimpat® and Neupro®, we are pleased with trends in prescription uptake." said Roch Doliveux, CEO of UCB.

As expected, revenue declined in the first nine months of 2009 compared to the same period in 2008 as a consequence of generic competition to Keppra® (levetiracetam) in the U.S. This was partially compensated by the strong performance of Keppra® in Europe which continued to show double-digit percentage net sales growth and by the similarly strong growth of Xyzal (levocetirizine) in the U.S. and of Zyrtec® (cetirizine) in Japan. Net sales of Tussionex® (hydrocodone polistirex and chlorpheniramine polistirex) declined due to the mild cough and cold season in the U.S. earlier in the year, while net sales of Metadate™ CD (methylphenidate) increased.

Prescription data for Cimzia (certolizumab pegol) in the treatment of Crohn's disease (CD) and rheumatoid arthritis (RA) in the U.S. are promising with a 20.2%[1] and a 2.9%[2] share respectively of new prescriptions (NRx) in the subcutaneous anti-TNF market. Progress with reimbursement in the U.S. is also being made with around 95% of insured people able to have Cimzia reimbursed for CD, and around 60% for RA. Cimzia was recently approved in Europe for the treatment of RA. Patients were treated with Cimzia the following day in Germany while other European countries are expected to launch in the coming months.

The new anti-epileptic drug, Vimpat® (lacosamide), available in Europe since late 2008 and launched in the U.S. in June 2009 as an add-on therapy for the treatment of partial-onset seizures, continues to gain market share. At the end of July, more than 15 000 patients were being treated with Vimpat® in Europe and, at the end of September, more than 10 000 patients were being treated with Vimpat® in the U.S. The prescription take-off by Vimpat® in the U.S. exceeds that of Keppra® and of Keppra XR making it the most successful launch in the U.S. epilepsy market. In Europe, Vimpat® has just been launched in France and Spain in addition to Germany, the U.K. and nine smaller markets. Launches in other European markets will follow in the coming months, following local pricing reimbursement approvals.

Since the approval by the European Commission in June 2009 for UCB to again promote Neupro® for Parkinson's disease, and to launch the drug for restless legs syndrome, more than 33 000 patients are currently being treated with the drug in Europe. European neurologists have welcomed the drug's return and the cold-chain storage and distribution system is well-accepted. Neupro® is now available in Germany, Italy, Spain and the U.K. and in nine smaller European markets for Parkinson's disease. It is launched in Germany and the U.K. and two smaller European markets for restless legs syndrome. Launches in other European markets will follow in the coming months. In the U.S., an extensive update on Neupro® and cold-chain storage and distribution was submitted to the Food and Drug Administration (FDA) in June 2009. Dialogue with the FDA continues. UCB expects to be able to make Neupro® available for U.S. patients again during 2010.

UCB will communicate its view on the sales potential of Cimzia, Vimpat and Neupro with the publication of its 2009 results on 2 March 2010.

SHAPE

By mid-2009, UCB had completed the implementation of its SHAPE programme, designed to focus the organisation and its resources on future product and market opportunities. All targets were either met or exceeded. The company continues to focus on its core assets, to look for additional efficiencies, and to optimise its non-core assets.

Development pipeline

In August 2009, UCB and Immunomedics announced positive top-line results from UCB's Phase IIb clinical study comparing epratuzumab to placebo in patients with systemic lupus erythematosus. A Phase III clinical trial programme is expected to be put in place after completion of the detailed analysis of the full Phase IIb study data and after consultation with regulatory authorities in the US and EU. UCB expects to communicate details of its next steps in the development of epratuzumab with the publication of its 2009 results on 2 March, 2010.

Also with the publication of its 2009 results, UCB expects to communicate its next steps in the development of brivaracetam in epilepsy and of Vimpat® in diabetic neuropathic pain following consultation with regulatory authorities in the U.S. and Europe expected at the end of this year or early next year.

Finance

On 30 September 2009, UCB announced that it had successfully completed the offering of EUR 500 million senior unsecured convertible bonds, due 2015. The Bonds will be issued and redeemed at 100% of their principal amount and will have a coupon of 4.5% per annum, and unless previously converted, repurchased or redeemed will mature on the sixth anniversary of their issue, in 2015. The initial conversion price is EUR 38,746 per share and is set at a premium of 35% to the volume-weighted average price of the Company's shares on Euronext Brussels from launch to pricing. If all of the Bonds were to be converted into new shares at the initial conversion price, 12 904 558 new shares would be issued, representing a dilution of 6.6% of the Company's share capital. The net proceeds from the issue of the Bonds will be used by UCB for general corporate purposes and form part of UCB's diversification of funding.

Outlook 2009

As communicated in July 2009, revenue for the full year 2009 is expected to reach between EUR 3.1 - 3.3 billion, underlying profitability (recurring EBITDA) is expected to end the year greater than EUR 680 million, and net profit as reported is expected to increase from the previous year to EUR 550 million.


For further information
Richard Simpson, Investor Relations, UCB
T +32.2.559.9494, richard.simpson@ucb.com

Michael Tuck-Sherman, Investor Relations, UCB
T +32.2.559.9712, michael.tuck-sherman@ucb.com

Nancy Nackaerts, External Communications, UCB
M: +32 473 86 44 14, nancy.nackaerts@ucb.com

About UCB

UCB, Brussels, Belgium (www.ucb.com) is a biopharmaceutical company dedicated to the research, development and commercialization of innovative medicines with a focus on the fields of central nervous system and immunology disorders. Employing approximately 10 000 people in over 40 countries, UCB generated revenue of EUR 3.6 billion in 2008. UCB is listed on Euronext Brussels (symbol: UCB).

Forward-looking statements

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.

[1] IMS Xponent weekly prescriptions for CD in U.S., week ending 25 September 2009

[2] IMS National Prescription Audit (NPA) Weekly for RA in U.S., week ending 9 October 2009


For the pdf-version of this press release, please click on the link below:

http://hugin.info/133973/R/1349065/325044.pdf

This announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.

Copyright © Hugin AS 2009. All rights reserved.





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