UCB and Immunomedics announce positive results for epratuzumab phase
IIb study in systemic lupus ery
(Thomson Reuters ONE) - * Data from phase IIb dose and regimen-ranging study demonstrate clinically meaningful treatment effect * Treatment advantage of epratuzumab over placebo reached 24.9% at week 12Brussels, Belgium & Morris Plains, New Jersey, 27 Aug 2009 - 7:00 AM(CEST) - press release, regulated information - UCB and Immunomedics(NASDAQ: IMMU) announced today top-line results from UCB's Phase IIbclinical study comparing epratuzumab to placebo in patients withsystemic lupus erythematosus (SLE, also commonly known as lupus). Thedata from the 12-week dose and regimen-ranging study demonstratedclinical meaningful treatment effect of epratuzumab over placebo inSLE patients. The 227 patients in this study had moderately (30%) toseverely (70%) active disease in multiple organ systems.The primary efficacy measure was a combined index endpoint, whichincluded several indices of SLE disease activity, primarilyemphasizing BILAG* measured improvement. Treatment advantage ofepratuzumab over placebo reached 24.9% at week 12."Epratuzumab is the most advanced pipeline program in UCB'simmunology disease portfolio and the positive results are significantfor UCB as we continue to move our antibody based programs ahead",said Roch Doliveux, Chief Executive Officer of UCB. "These resultsmay provide new hope for the hundreds of thousands of people aroundthe world living with SLE as no new treatment has been approved forthis life altering disease for over five decades."UCB is committed to finding treatments for immunological disordersand providing patients with therapeutic options that are effectivewith minimal adverse effects. In depth analysis of the data isongoing in preparation of the phase III program.Epratuzumab, developed by Immunomedics and licensed to UCB for allautoimmune disease indications in 2006, is a humanised anti-CD22monoclonal antibody with the potential to modulate B cell activity.Although the exact role of CD22 is not fully understood, it isconsidered to be a negative regulator of B cell function. B cells areknown to contribute to SLE by producing antibodies against the body'sown cells and tissues, causing the immune system to turn on itself,resulting in inflammation and tissue damage."We are delighted that this randomized, placebo-controlled, studyconducted by UCB demonstrates the activity of epratuzumab in SLE,which has proven to be difficult to treat with currently availabledrugs," remarked Cynthia L. Sullivan, President and Chief ExecutiveOfficer of Immunomedics, Inc. "Epratuzumab is a unique anti-B celltherapeutic, because of its ability to modulate B cell functionwithout depleting a large portion of these lymphocytes," she added.* BILAG (British Isles Lupus Assessment Group) is a comprehensivescoring system for assessing both current SLE disease activity andchanges in that activity since the patient was last seen.For further informationNancy Nackaerts, External Communications, UCBM: +32 473 86 44 14, nancy.nackaerts(at)ucb.comScott Fleming, Global Communications Manager - ImmunologyT +44.770.277.7378, Scott.fleming(at)ucb.comMichael Tuck-Sherman, Investor Relations, UCBT +32.2.559.9712, michael.tuck-sherman(at)ucb.comNotes to the EditorsAbout epratuzumabEpratuzumab is a humanized anti-CD22 monoclonal antibody underinvestigation for the treatment of SLE. CD22 is a B cell specificsurface protein that is considered to be involved in B cell function. The product was licensed from Immunomedics, Inc., Morris Plains, NJ,USA.About systemic lupus erythematosus (SLE)SLE, commonly referred to as lupus, is a chronic and potentiallyfatal autoimmune disease with a variable and unpredictable course.Antibodies are generated against the body's own nuclear proteinscausing the immune system to attack its own cells and tissuesresulting in inflammation and tissue damage. This can occur in anypart of the body, but most often targets the heart, joints, skin,lungs, blood vessels, liver, kidneys and nervous system.Lupus is characterized by periods of flares, or exacerbations,interspersed with periods of improvement or remission. The LupusFoundation of America estimated that between 1.5-2 million Americanshave a form of lupus, 90 percent of which are women. Symptoms anddiagnosis occur most often between the ages of 15 and 45. In theU.S., lupus is more common in African Americans, Latinos, Asians, andNative Americans than in Caucasians.A Lupus Foundation of America survey demonstrated the potentialeconomic impact of the disease, as two of three lupus patientsreported a complete or partial loss of their income because they areunable to work due to complications.About 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).About ImmunomedicsImmunomedics is a New Jersey-based biopharmaceutical companyprimarily focused on the development of monoclonal, antibody-basedproducts for the targeted treatment of cancer, autoimmune and otherserious diseases. Immunomedics has built a pipeline of therapeuticproduct candidates that utilize several different mechanisms ofaction.Forward-looking statements related to UCBThis 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.Forward looking statements relating to ImmunomedicsThis release, in addition to historical information, may containforward-looking statements made pursuant to the Private SecuritiesLitigation Reform Act of 1995. Such statements, including statementsregarding clinical trials, out-licensing arrangements (including thetiming and amount of contingent payments), forecasts of futureoperating results, and capital raising activities, involvesignificant risks and uncertainties and actual results could differmaterially from those expressed or implied herein. Factors thatcould cause such differences include, but are not limited to, risksassociated with new product development (including clinical trialsoutcome and regulatory requirements/actions), our dependence on ourlicensing partners for the further development of epratuzumab forautoimmune indications and veltuzumab for non-cancer indications,competitive risks to marketed products and availability of requiredfinancing and other sources of funds on acceptable terms, if at all,as well as the risks discussed in the Company's filings with theSecurities and Exchange Commission. The Company is not under anyobligation, and the Company expressly disclaims any obligation, toupdate or alter any forward-looking statements, whether as a resultof new information, future events or otherwise.For the pdf-version of this press release, please click on the linkbelow:http://hugin.info/133973/R/1337304/318686.pdfThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 27.08.2009 - 07:01 Uhr
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