The European Medicines Agency recommends Orphan Drug Designation of
Intravenous CP-4126 for the Trea
(Thomson Reuters ONE) - Clavis Pharma (OSE: CLAVIS) announces today that the EuropeanMedicines Agency (EMEA) has recommended orphan drug designation toIntravenous CP-4126 for the treatment of pancreatic cancer. ClavisPharma is currently conducting a Phase II study with IntravenousCP-4126 in patients with pancreatic cancer."We are pleased that EMEA has recommended our application for orphandrug designation for Intravenous CP-4126, and we are looking forwardto receiving the final designation from the European Commission in afew weeks," said Geir-Christian Melen, CEO of Clavis Pharma."Patients with pancreatic cancer need more effective therapies ascurrent treatment options are unsatisfactory. This designation willallow Clavis Pharma to accelerate the clinical development ofIntravenous CP-4126 and is an important milestone in the company'sstrategy to achieve marketing approval for this exciting drugcandidate as rapidly as possible."The Company plans to apply for Orphan Drug status for IntravenousCP-4126 in the USA as a potential new treatment for pancreatic cancerfollowing the acceptance by the US Food and Drug Administration (FDA)in July of its Investigational New Drug (IND) to include patients inthe USA in its phase II clinical programme.Intravenous CP-4126 is based on Clavis Pharma's proprietary LipidVector Technology (LVT) and aimed at improving the therapeuticprofile of the current standard treatment for advanced pancreaticcancer, gemcitabine (Gemzar®). Currently it is estimated thatpancreatic tumours in up to two-thirds of patients have a deficientcellular uptake of gemcitabine due to deficient expression of anecessary transport protein, hENT1 (human equilibrative nucleosidetransporter 1) on the tumour cell membrane(1). This is known to limitthe efficacy of gemcitabine treatment in these patients. In contrast,cellular uptake of Intravenous CP-4126 is independent of hENT1, whichoffers a potential clinical advantage for the product in thetreatment of pancreatic cancer. In the phase II programme, cancertissue (biopsies) from each patient will be collected and analysedwith regard to levels of hENT1. The relation between response totreatment and hENT1 levels will be studied.The European Commission grants orphan drug designation to promisingproducts that address life-threatening medical conditions affectingfewer than 230,000 persons in the European Union (EU). Thedesignation allows for the use of the quickest way of placing themedicinal product on the market throughout the EU (known as the"centralised procedure"), regulatory assistance related to thedevelopment process and reduced regulatory fees throughout theproduct's life. If Intravenous CP-4126 receives marketing approval,the designation will entitle Clavis Pharma to exclusive marketingrights for 10 years following the approval. Orphan Drug Designationprovides companies with financial and regulatory incentives to pursueless common diseases. It should be noted that orphan drug designationdoes not limit a drug to less common diseases. The drug may, inparallel or afterwards, also be developed for other diseases.(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, 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.About Pancreatic cancerPancreatic cancer is a very serious disease and an indication with ahigh unmet 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 has 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 fromtreatment.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 alreadyestablished 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, greater tissuepenetration and, in many cases, additional modes of action.Clavis Pharma's objective is to develop its drug candidates untilsignificant value has been created and proof of principle in man hasbeen shown. For further clinical development and commercialisation ofthe products, Clavis Pharma will enter into strategic partnershipswith established pharmaceutical or biotech companies. The company'sproduct portfolio includes four new cancer drugs: Elacytarabine andIntravenous CP-4126 are in Clinical phase II, Oral CP-4126 in phaseI, and CP-4200 is in early preclinical development. Results indicatethat these products have promising potential for several cancerindications 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 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 registered trademark of Clavis Pharma ASA.This announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 14.09.2009 - 13:25 Uhr
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