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Clavis Pharma ASA Clavis Pharma Receives US Orphan Drug Designation for ELACYT(TM) Oslo, Norway, June 25, 2008
Clavis Pharma today announced that the US Food & Drug Administration (FDA) has granted orphan drug designation to ELACYT(TM) for the treatment of Acute Myeloid Leukaemia (AML). Within haematology, Clavis Pharma is currently conducting a Phase II study with ELACYT in patients undergoing second salvage therapy for AML, and a Phase I study with ELACYT in combination with idarubicin, in patients undergoing first salvage treatment (patients with refractory /relapsed AML).
"We are pleased to receive this orphan drug designation for ELACYT, in addition to the European Commission designation received last year" says Geir Christian Melen, CEO of Clavis Pharma. "Patients with AML need better agents as current treatment options are highly unsatisfactory. This designation is an important milestone in Clavis Pharma's strategy to achieve marketing approval for ELACYT as swiftly as possible."
The US Orphan Drug Act provides incentives to encourage the development of drugs for rare disease conditions affecting fewer than 200,000 persons in the United States of America (USA). The designation allows for amongst others a possible exemption from the FDA-user fee and assistance in clinical trial protocol design. If ELACYT receives marketing approval for AML in the USA, the designation will entitle Clavis Pharma to exclusive marketing rights for AML for seven years following the approval.
It should be noted that orphan drug designation does not limit a drug to less common diseases. The drug may as well, in parallel or afterwards, be developed for more common diseases.
Contacts: Geir Christian Melen, CEO Office : +47 24 11 09 65 Mobile : +47 91 30 29 65 E-mail : geir.christian.melen@clavispharma.com
Gunnar Manum, CFO Office : +47 24 11 09 71 Mobile : +47 95 17 91 90 E-mail : gunnar.manum@clavispharma.com
About Clavis Pharma Clavis Pharma ASA is an oncology focused pharmaceutical company using its proprietary Lipid Vector Technology (LVT) platform to create New Chemical Entities (NCEs), by significantly improving already established drugs. The improvements are achieved by chemically binding specific unsaturated lipids to existing, and well understood, approved pharmaceuticals. Data generated suggests the resulting patentable NCEs offer improved efficacy and reduced side effects through enhanced pharmacokinetic properties, greater tissue penetration and, in many cases, additional modes of action. Clavis Pharma's objective is to develop its drug candidates until significant value has been created and proof of principle in man has been shown. For further clinical development and commercialisation of the products, Clavis Pharma will enter into strategic partnerships with established pharmaceutical or biotech companies. The company's product portfolio includes three new cancer drugs, of which the first ELACYT(TM) , is in Clinical Phase II, the second, CP-4126, is in Clinical Phase I, and the third, CP-4200, is in Preclinical Development. Results indicate that these products have promising potential for several cancer indications within solid tumours and leukaemia. The shares of Clavis Pharma ASA are listed on the Oslo Stock Exchange (ticker: CLAVIS). Additional information on Clavis Pharma can be found at: http://www.clavispharma.com/ .
About Leukaemia and AML Approximately 300,000 new cases of leukaemia are diagnosed globally each year, resulting in around 220,000 deaths. Leukaemia represents a market with high unmet medical needs, which may open for accelerated approval processes to expedite market access for new drugs. It is a segmented market covering a broad variety of disorders. A major clinical concern is the high rate of disease recurrence. The five-year survival for the most common acute leukaemia type, acute myeloid leukaemia (AML), is in the range of 5-10% for treated elderly patients, and approximately 30% for treated younger adults.
Disclaimer The information contained herein shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities referred to herein in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration, exemption from registration or qualification under the securities laws of any such jurisdiction. This news release contains forward-looking statements and forecasts based on uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on results of operations and the financial condition of Clavis Pharma. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements. Theses factors include, among other things, risks associated with technological development, the risk that research & development will not yield new products that achieve commercial success, the impact of competition, the ability to close viable and profitable business deals, the risk of non-approval of patents not yet granted and difficulties of obtaining relevant governmental approvals for new products. No expressed or implied representations or warranties are given concerning Clavis Pharma or the accuracy or completeness of the information or projections provided herein, and no claims shall be made by the recipient hereof by virtue of this Information Memorandum or the information or projections contained herein. Any representations or warranties made to an investor in Clavis Pharma will be subject to separate sale and purchase agreements to be negotiated between the parties. Clavis Pharma(TM) and ELACYT(TM) are registered trademarks of Clavis Pharma ASA.
