Second Quarter Report 2009
(Thomson Reuters ONE) - SECOND QUARTER REPORT 2009"Successful Completion of Phase II in acute myeloid leukaemia (AML)patients paved the way for important strategic fund raising"Oslo, Norway, August 27, 2009During the second quarter Clavis Pharma announced the successfulcompletion of a Phase II study of its lead development candidate,elacytarabine, in late-stage acute myeloid leukaemia (AML). The studyshowed that compared to historical data for similar patients,elacytarabine may increase survival threefold, increase remissionrates and reduce short-term mortality.Following these positive clinical results, the Company conducted anew equity financing, raising NOK 136.8 million (gross) in a privateplacement and a subsequent offering. Proceeds of the offering will beused to fund the further development of the company's pipeline ofnovel anticancer drug candidates. The fundraising was announced inJune and completed successfully in two stages in July and August.First and second quarter report highlights:- The Company announced in June the successful completion of a PhaseII study of it's lead development candidate, elacytarabine (CP-4055),demonstrating that elacytarabine may increase survival threefold inpatients with late-stage acute myeloid leukaemia (AML). Elacytarabinealso demonstrated improved remission rates and reduced short-termmortality compared to detailed historical outcome analysis of similarAML patients. Based on these encouraging results, the Company is inpreparation for an elacytarabine registration study in late-stageAML.-Encouraging data from the Phase I study of elacytarabine incombination with idarubicin in AML patients was presented at theAmerican Association of Cancer Research (AACR) 100th Annual Meetingin April in Denver, USA. Following the positive results, the Companyis currently initiating a Phase II study in patients with AML whohave failed their 1st course of treatment.- In May, the Company announced pre-clinical data that differentiateCP-4200 from current standard therapy. CP-4200, Clavis Pharma'sfourth drug candidate, represents a new family of Lipid VectorTechnology (LVT) drugs called epigenetic modulators, which areexpected to constitute an important drug class of future cancertherapy.- The Company's R&D programs are progressing well, resulting in R&Dand other operating expenses of NOK 38.7 million for the first sixmonths of 2009. The Company had cash and cash equivalents of NOK 44.1million as of 30 June 2009, prior to the fundraising completed inJuly and August. Major events after 30 June- The Company announced in June a private placement and a subsequentoffering that was completed successfully in July and Augustrespectively. These share offerings raised NOK 136.8 million in grossproceeds. The offerings were substantially oversubscribed and weresupported by existing shareholders, as well as new institutionalinvestors.- In July, the United States Food and Drug Administration (FDA)approved the Investigational New Drug application (IND) forIntravenous CP-4126, thereby giving clearance to enrol patients inthe clinical Phase II programme in newly diagnosed (1st line)pancreatic cancer in the USA. The programme was initiated in Europein April. The objective is to compare the safety and efficacy ofIntravenous CP-4126 to gemcitabine, with primary focus on patientswith deficient levels of a certain nucleoside transporter (hENT1)responsible for the active transport of gemcitabine into cancercells.Commenting on today's announcement, Geir Christian Melen, the CEO ofClavis Pharma, said: "The encouraging elacytarabine phase II data hasbeen a key development in validating the potential of our LipidVector Technology to produce cancer drugs with enhanced performance.This positive news coupled with the new funding that we now have inplace, means that we are in a position to generate furthershareholder value by continuing the development of elacytarabine andprogressing our promising pipeline of differentiated anti cancer drugcandidates."The Second 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.uk About 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/1337412/318670.pdfhttp://hugin.info/136972/R/1337412/318671.pdfhttp://hugin.info/136972/R/1337412/318672.pdfThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 27.08.2009 - 07:30 Uhr
Sprache: Deutsch
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