Interim Report - Promising early results for UCB's new products
(Thomson Reuters ONE) - * 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 confirmedBrussels (Belgium), October 22, 2009 - 07:00 (CEST) - regulatedinformation - UCB announced today its interim report for the firstnine months of 2009."While it is still early in the launch roll-out of our major newproducts, Cimzia®, Vimpat® and Neupro®, we are pleased with trends inprescription uptake." said Roch Doliveux, CEO of UCB.As expected, revenue declined in the first nine months of 2009compared to the same period in 2008 as a consequence of genericcompetition to Keppra® (levetiracetam) in the U.S. This was partiallycompensated by the strong performance of Keppra® in Europe whichcontinued to show double-digit percentage net sales growth and by thesimilarly strong growth of Xyzal (levocetirizine) in the U.S. and ofZyrtec® (cetirizine) in Japan. Net sales of Tussionex® (hydrocodonepolistirex and chlorpheniramine polistirex) declined due to the mildcough and cold season in the U.S. earlier in the year, while netsales of Metadate(TM) CD (methylphenidate) increased.Prescription data for Cimzia (certolizumab pegol) in the treatment ofCrohn's disease (CD) and rheumatoid arthritis (RA) in the U.S. arepromising with a 20.2%[1] and a 2.9%[2] share respectively of newprescriptions (NRx) in the subcutaneous anti-TNF market. Progresswith reimbursement in the U.S. is also being made with around 95% ofinsured people able to have Cimzia reimbursed for CD, and around 60%for RA. Cimzia was recently approved in Europe for the treatment ofRA. Patients were treated with Cimzia the following day in Germanywhile other European countries are expected to launch in the comingmonths.The new anti-epileptic drug, Vimpat® (lacosamide), available inEurope since late 2008 and launched in the U.S. in June 2009 as anadd-on therapy for the treatment of partial-onset seizures, continuesto gain market share. At the end of July, more than 15 000 patientswere being treated with Vimpat® in Europe and, at the end ofSeptember, more than 10 000 patients were being treated with Vimpat®in the U.S. The prescription take-off by Vimpat® in the U.S. exceedsthat of Keppra® and of Keppra XR making it the most successful launchin the U.S. epilepsy market. In Europe, Vimpat® has just beenlaunched in France and Spain in addition to Germany, the U.K. andnine smaller markets. Launches in other European markets will followin the coming months, following local pricing reimbursementapprovals.Since the approval by the European Commission in June 2009 for UCB toagain promote Neupro® for Parkinson's disease, and to launch the drugfor restless legs syndrome, more than 33 000 patients are currentlybeing treated with the drug in Europe. European neurologists havewelcomed the drug's return and the cold-chain storage anddistribution system is well-accepted. Neupro® is now available inGermany, Italy, Spain and the U.K. and in nine smaller Europeanmarkets for Parkinson's disease. It is launched in Germany and theU.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 storageand distribution was submitted to the Food and Drug Administration(FDA) in June 2009. Dialogue with the FDA continues. UCB expects tobe able to make Neupro® available for U.S. patients again during2010.UCB will communicate its view on the sales potential of Cimzia,Vimpat and Neupro with the publication of its 2009 results on 2 March2010.SHAPEBy mid-2009, UCB had completed the implementation of its SHAPEprogramme, designed to focus the organisation and its resources onfuture product and market opportunities. All targets were either metor exceeded. The company continues to focus on its core assets, tolook for additional efficiencies, and to optimise its non-coreassets.Development pipelineIn August 2009, UCB and Immunomedics announced positive top-lineresults from UCB's Phase IIb clinical study comparing epratuzumab toplacebo in patients with systemic lupus erythematosus. A Phase IIIclinical trial programme is expected to be put in place aftercompletion of the detailed analysis of the full Phase IIb study dataand after consultation with regulatory authorities in the US and EU.UCB expects to communicate details of its next steps in thedevelopment of epratuzumab with the publication of its 2009 resultson 2 March, 2010.Also with the publication of its 2009 results, UCB expects tocommunicate its next steps in the development of brivaracetam inepilepsy and of Vimpat® in diabetic neuropathic pain followingconsultation with regulatory authorities in the U.S. and Europeexpected at the end of this year or early next year.FinanceOn 30 September 2009, UCB announced that it had successfullycompleted the offering of EUR 500 million senior unsecuredconvertible bonds, due 2015. The Bonds will be issued and redeemed at100% of their principal amount and will have a coupon of 4.5% perannum, and unless previously converted, repurchased or redeemed willmature on the sixth anniversary of their issue, in 2015. The initialconversion price is EUR 38,746 per share and is set at a premiumof 35% to the volume-weighted average price of the Company's shareson Euronext Brussels from launch to pricing. If all of the Bondswere to be converted into new shares at the initial conversionprice, 12 904 558 new shares would be issued, representing a dilutionof 6.6% of the Company's share capital. The net proceeds from theissue of the Bonds will be used by UCB for general corporate purposesand form part of UCB's diversification of funding.Outlook 2009As communicated in July 2009, revenue for the full year 2009 isexpected to reach between EUR 3.1 - 3.3 billion, underlyingprofitability (recurring EBITDA) is expected to end the year greaterthan EUR 680 million, and net profit as reported is expected toincrease from the previous year to EUR 550 million.For further informationRichard Simpson, Investor Relations, UCBT +32.2.559.9494, richard.simpson(at)ucb.comMichael Tuck-Sherman, Investor Relations, UCBT +32.2.559.9712, michael.tuck-sherman(at)ucb.comNancy Nackaerts, External Communications, UCBM: +32 473 86 44 14, nancy.nackaerts(at)ucb.comAbout UCBUCB, Brussels, Belgium (www.ucb.com) is a biopharmaceutical companydedicated to the research, development and commercialization ofinnovative medicines with a focus on the fields of central nervoussystem and immunology disorders. Employing approximately 10 000people in over 40 countries, UCB generated revenue of EUR 3.6 billionin 2008. UCB is listed on Euronext Brussels (symbol: UCB).Forward-looking statementsThis press release contains forward-looking statements based oncurrent plans, estimates and beliefs of management. Such statementsare subject to risks and uncertainties that may cause actual resultsto be materially different from those that may be implied by suchforward-looking statements contained in this press release. Importantfactors that could result in such differences include: changes ingeneral economic, business and competitive conditions, effects offuture judicial decisions, changes in regulation, exchange ratefluctuations and hiring and retention of its employees.[1] IMS Xponent weekly prescriptions for CD in U.S., week ending 25September 2009[2] IMS National Prescription Audit (NPA) Weekly for RA in U.S., weekending 9 October 2009For the pdf-version of this press release, please click on the linkbelow:http://hugin.info/133973/R/1349065/325044.pdfThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 22.10.2009 - 07:01 Uhr
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