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Clavis Pharma ASA receives USD 1.1 million Grant from Innovation
Norway

ID: 1003694
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(Thomson Reuters ONE) - Clavis Pharma ASA receives USD 1.1 million Grant from InnovationNorway to Accelerate the Phase II Programme of Intravenous CP-4126 in Pancreatic CancerOslo, Norway, August 27, 2009Clavis Pharma ASA (OSE: CLAVIS) announced today that it has receiveda government grant of up to USD 1.1 mill (NOK 6.9 mill) to acceleratethe Phase II clinical programme with Intravenous CP-4126 in patientswith newly diagnosed, advanced pancreatic cancer. The grant award wasmade by Innovation Norway.CP-4126 is based on Clavis Pharma's proprietary Lipid VectorTechnology (LVT) and is aimed at improving the therapeutic profile ofthe current standard treatment for advanced pancreatic cancergemcitabine (Gemzar®).Research suggests that the treatment of pancreatic cancer and anumber of other cancers could be improved by increasing the amount ofanti-cancer agent that enters the tumour cells. In the case ofpancreatic tumours published research demonstrates that up totwo-thirds of patients respond poorly to gemcitabine due to deficientexpression of a transport protein, hENT1 (human equilibrativenucleoside transporter 1) on the cell membrane1 and sub-optimalcellular uptake of gemcitabine. The transport protein is necessaryfor the uptake of gemcitabine into the tumour cell and therefore itis believed that the lack of hENT1 limits the efficacy of thetreatment for patients with deficient protein levels. IntravenousCP-4126 has been designed to overcome this problem as its cellularuptake is independent of hENT1 levels on the surface of the tumourcell. This means that Intravenous CP-4126 could be an attractivetreatment option in pancreatic patients with a deficient hENT1transport system.In the phase II programme, cancer tissue (biopsies) from each patientwill be collected and analysed in order to determine their levels ofhENT1. The relationship between response to treatment and hENT1levels will be an important output from this phase II study as thisrelationship could allow clinicians to predict which patients areunlikely to respond to gemcitiabine prior to therapy - patients whopotentially would benefit from Intravenous CP-4126.The USD 1.1 million grant is provided by Innovation Norway throughits public R&D programme (Norwegian: Offentlig Forsknings- ogUtviklingskontrakt, OFU) wherein an enterprise develops a novelproduct in collaboration with a University Hospital. In this case thecontract partner for Clavis Pharma is the Oslo University Hospitalwith Dr. Tone Ikdahl acting as Coordinating Investigator. The grantis payable to Clavis Pharma based on project accounts in 2009 and2010.Wilhelm R. Wold, Senior Advisor at Innovation Norway, says "We arehappy that Innovation Norway through the OFU programme can be a keycontributor to the development of Intravenous CP-4126 by supportingthis collaborative project that Clavis Pharma and Oslo UniversityHospital have set up to provide proof-of-principle for this newtherapy in the treatment of pancreatic cancer. Clavis Pharma is oneof the promising biotech companies in Norway and it is important forInnovation Norway to contribute to this growing industry"."This government grant will support the clinical Phase II programmewe have recently started with Intravenous CP-4126 in pancreaticcancer and provide further validation of the potential of our LipidVector Technology to generate new products with real benefits tocancer patients around the world," says Geir Christian Melen, CEO ofClavis Pharma. "The support by Innovation Norway and Oslo UniversityHospital is an acknowledgment of the exciting novel approach we havetaken with Intravenous CP-4126, a drug which has the potential tobecome a new first-line treatment for patients with pancreaticcancer."1 Ref: Giovannetti et al., Cancer Research 66, 3928-3935, April 1,2006Contact: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 Intravenous CP-4126CP-4126 is a novel Lipid Vector Technology analogue of gemcitabine(Gemzar®), one of the world's leading cancer drugs. It is used in thetreatment of several cancers, such as pancreatic cancer, ovariancancer and non-small cell lung cancer. Gemzar is a blockbuster cancerdrug, with 2008 sales of USD 1.7 billion. Clavis Pharma is developingIntravenous CP-4126, which has a different therapeutic profile andmay potentially have effect in patients who are resistant orrefractory to gemcitabine treatment. An Investigational New Drugapplication (IND) for CP-4126 was approved by the US Food and DrugAdministration in July 2009.About Pancreatic cancerPancreatic cancer is a very serious disease and an indication with anunmet medical need. Approximately 37,000 new cases of pancreaticcancer were recorded in the USA in 2007. The 1-year and 5-yearoverall survival rates are estimated at 23% and 4%, respectively. Themajority of these patients have unresectable disease or will recurafter surgery. Median overall survival in these patients isapproximately 8-12 months. The standard first-line therapy forpatients with unresectable disease is gemcitabine monotherapy.Unfortunately, many of these patients fail to benefit from treatment.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).About Innovation NorwayInnovation Norway is a governmental body to promote nationwideindustrial development profitable to both the business economy andNorway's national economy, and contributes towards innovation,internationalisation and promotion. Innovation Norway is a backer andpromoter of entrepreneurs, and small and medium-sized enterprisesthat seek to grow in an international market, by providing financing,linking customer enterprises to know-how and helping them buildnetworks for their innovation projects. Innovation Norway's slogan is"We give local ideas global opportunities".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 Memorandumor the information or projections contained herein. Anyrepresentations or warranties made to an investor in Clavis Pharmawill be subject to separate sale and purchase agreements to benegotiated between the parties. Clavis Pharma is a registeredtrademark of Clavis Pharma ASA.http://hugin.info/136972/R/1337600/318860.pdfhttp://hugin.info/136972/R/1337600/318862.pdfThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.



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Date: 08/27/2009 - 15:26
Language: English
News-ID 1003694
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