Oslo, Norway, 20 September 2007
Clavis Pharma today announced that the European Commission has granted orphan drug designation to ELACYTTM for the treatment of Acute Myeloid Leukaemia (AML). Clavis Pharma is currently conducting a Phase I/II study with ELACYT in patients with hematologic cancers, as well as Phase II studies in colorectal cancer and malignant melanoma.
"We are pleased to receive orphan drug designation for ELACYT," said Tom Pike, CEO of Clavis Pharma. "Patients with acute leukaemia 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 rapidly as possible".
The European Commission grants orphan drug designation to promising products that address life-threatening medical conditions affecting fewer than 230,000 persons in the European Union (EU). The designation allows for the use of the quickest way of placing the medicinal product on the market throughout the EU (known as the "centralised procedure"), regulatory assistance related to the development process and reduced regulatory fees throughout the product's life. If ELACYT receives marketing approval, the designation will entitle Clavis Pharma to exclusive marketing rights for 10 years following the approval. Orphan Drug Designation provides companies with financial and regulatory incentives to pursue less common diseases. It should be noted that orphan drug designation does not limit a drug to less common diseases. The drug may, in parallel or afterwards, also be developed for other diseases.
Contact:
Tom Pike, Chief Executive Officer
Telephone: +47 24 11 09 50
tom.pike@clavispharma.com
About Clavis Pharma
Clavis Pharma ASA
is a public oncology focused pharmaceutical company leveraging its proprietary Lipid Vector Technology (LVT) platform to
create New Chemical Entities (NCEs) by significantly improving approved drugs. The improvement is 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 intends 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 strategic
partnerships with established pharmaceutical or biotech companies. The company's product portfolio includes three new cancer
drugs, of which the first
ELACYTTM
, is in clinical phase II, the second,
CP-4126
, is in clinical phase I, and the third
CP-4200
is in the pre-clinical phase. Results indicate that ELACYTTM has a promising potential for several cancer indications within leukaemia and solid tumours.
Clavis Pharma ASA is listed on the Oslo Stock Exchange (ticker: CLAVIS). Additional information on Clavis Pharma can be found at: www.clavispharma.com
Leukaemia
Approximately 300,000 new cases in leukaemia are diagnosed globally each year, resulting in around 220,000 deaths. Leukaemia
represents a market with high unmet medical needs. The high unmet medical need may open for accelerated approval pathways
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 reoccurrence. 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 (the majority receive no specific anti-AML therapy)
and is about 30% in 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 PharmaTM and ELACYTTM are registered trademarks of Clavis Pharma ASA.