Third Quarter Report 2009
(Thomson Reuters ONE) - THIRD QUARTER REPORT 2009Oslo, Norway, October 22, 2009Clavis Pharma ASA (OSE: CLAVIS); the clinical stage oncology focusedpharmaceutical company, announces today its results for the thirdquarter 2009.Following positive Phase II results for elacytarabine in acutemyeloid leukaemia (AML) announced in June, the Company continues tomake progress with the further development of this new potentialanti-cancer drug.- Preparations for a randomised clinical Phase III study ofelacytarabine vs. investigator's choice in late stage AML are wellunder way.- The Phase II study of elacytarabine in combination withidarubicin in AML patients who have failed their first course oftreatment has received approval to enrol patients.- Preliminary results from a small Phase II study ofelacytarabine in ovarian cancer did not show significant efficacy atthe selected dose and the Company has decided not to pursue furtherdevelopment in solid cancers but to focus the development ofelacytarabine instead on AML and other blood cancers.Progress has continued in the clinical development of IntravenousCP-4126, the Company's second potential new anti-cancer agent, inthe treatment of pancreatic cancer. Enrolment has completed in thesingle-arm feasibility part of the Phase II study and the mainrandomised part of the study comparing CP-4126 with gemcitabine isnow ready to start. Preliminary results from the first patients inthe pilot feasibility phase are encouraging. Several important othermilestones for the Intravenous CP-4126 programme have been reached inthe third quarter.- In July, the United States Food and Drug Administration(FDA) accepted the Investigational New Drug (IND) application forIntravenous CP-4126. This approval opens the Phase II programme forinclusion of pancreatic cancer patients in the USA.- In August, the Company received a NOK 6.9 million grantfrom Innovation Norway to accelerate the CP-4126 Phase II programme.- In September, the European Medicines Agency (EMEA)recommended orphan drug designation to Intravenous CP-4126 for thetreatment of pancreatic cancer. The final designation from theEuropean Commission is expected shortly.Research and development costs and other operating expenses amountedto NOK 20 million for the third quarter of 2009. Following thesuccessful new equity raising of NOK 137 millions (gross) in July andAugust, the Company had cash and cash equivalents of NOK 157 millionas of 30 September 2009.Commenting on today's announcement, Geir Christian Melen, the CEO ofClavis Pharma, said: "We have made great progress during this pastquarter. Our development programs are progressing well and ourfinancial position is strong following the completion of this summersfundraising. We look forward to continue to advance our pipeline ofanti-cancer drug candidates and to generate further shareholdervalue."The Third Quarter 2009 Report and Presentation are available onwww.clavispharma.com.Contact:Geir Christian MelenChief Executive OfficerOffice : +47 24 11 09 50Mobile : +47 91 30 29 65E-mail : geir.christian.melen(at)clavispharma.comGunnar ManumChief Financial OfficerOffice : +47 24 11 09 71Mobile : +47 95 17 91 90E-mail : gunnar.manum(at)clavispharma.comFor international press enquiries:Mark Swallow / Nina Enegren / David DibleCitigate Dewe RogersonOffice : +44 207 282 2948E-mail : clavispharma(at)citigatedr.co.ukAbout Clavis PharmaClavis Pharma ASA is an oncology focused pharmaceutical company usingits proprietary Lipid Vector Technology (LVT) platform to create NewChemical Entities (NCEs), by significantly improving already wellestablished drugs. The improvements are achieved by chemicallybinding specific unsaturated lipids to existing, and well understood,approved pharmaceuticals. Data generated suggests the resultingpatentable NCEs offer improved efficacy and reduced side effectsthrough enhanced pharmacokinetic properties and improved penetrationinto cells.The Company's business strategy is to develop innovative oncologydrug candidates until safety and efficacy has been demonstrated inhumans and to establish partnerships with pharmaceutical or biotechcompanies for further development and commercialisation. The companymay consider retaining marketing or co-marketing rights in certainterritories and may develop its own sales and marketing capacity inthese regions.The company's product portfolio includes four new cancer drugs:Elacytarabine and Intravenous CP-4126 are in Clinical Phase II, OralCP-4126 in Phase I, and CP-4200 is in early preclinical development.Results indicate that these products have promising potential forseveral cancer indications within solid tumours and leukaemia.The shares of Clavis Pharma ASA are listed on the Oslo Stock Exchange(ticker: CLAVIS).DisclaimerThe information contained herein shall not constitute an offer tosell or the solicitation of an offer to buy, nor shall there be anysale of the securities referred to herein in any jurisdiction inwhich such offer, solicitation or sale would be unlawful prior toregistration, exemption from registration or qualification under thesecurities laws of any such jurisdiction.This news release contains forward-looking statements and forecastsbased on uncertainty, since they relate to events and depend oncircumstances that will occur in the future and which, by theirnature, will have an impact on results of operations and thefinancial condition of Clavis Pharma. There are a number of factorsthat could cause actual results and developments to differ materiallyfrom those expressed or implied by these forward-looking statements.Theses factors include, among other things, risks associated withtechnological development, the risk that research & development willnot yield new products that achieve commercial success, the impact ofcompetition, the ability to close viable and profitable businessdeals, the risk of non-approval of patents not yet granted anddifficulties of obtaining relevant governmental approvals for newproducts.No expressed or implied representations or warranties are givenconcerning Clavis Pharma or the accuracy or completeness of theinformation or projections provided herein, and no claims shall bemade by the recipient hereof by virtue of this information or theinformation or projections contained herein.Clavis Pharma(TM) is registered trademarks of Clavis Pharma ASA.http://hugin.info/136972/R/1349246/325055.pdfhttp://hugin.info/136972/R/1349246/325056.pdfhttp://hugin.info/136972/R/1349246/325059.pdfThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 22.10.2009 - 07:33 Uhr
Sprache: Deutsch
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