Oslo, Norway, 24 April 2008
Highlights from the first quarter 2008 report:
Clavis Pharma announced on 3 April the initiation of the ELACYTTM clinical Phase II in acute myelogenous leukaemia (AML). The initiation was based on the positive assessment of the Phase I data by an independent international clinical expert group.
On 13 March 2008, the Company announced the initiation of a new clinical Phase II study with ELACYT in ovarian cancer. The study is designed to show activity of ELACYT in women who have relapsed after prior chemotherapy regimens, and will explore a more prolonged treatment regimen compared to Clavis Pharma's other ongoing Phase II studies in solid tumours.
The Phase II combination study of ELACYT and NexavarTM (sorafenib) in malignant melanoma, and the ELACYT Phase II study in metastatic colorectal cancer, are progressing according to plan.
The Intravenous CP-4126 Phase I study in solid tumours is progressing towards maximum tolerated dose. The tolerability of CP-4126 is proving better than expected, potentially suggesting a wide therapeutic window.
The Company has completed the formal preclinical safety study, for the Oral CP-4126 program, required before clinical studies are initiated.
Geir Christian Melen assumed his new position as Chief Executive Officer (CEO) of Clavis Pharma on 1 April 2008. The Election Committee has proposed Tom E. Pike, the previous CEO, as a new Board Member.
The Company's R&D programs are progressing well resulting in R&D and other operating expenses of NOK 21 million for the first quarter 2008. The Company has cash and cash equivalents of NOK 146 million as at 31 March, 2008.
Commenting on the progress made during the last quarter, the CEO, Geir Christian Melen said: "Having just assumed my new position as CEO of Clavis Pharma, I am pleased to see the progress made by the team. Starting the Phase II program in AML, where the parent drug, cytarabine, is the gold standard for treatment of blood cancer, is particularly encouraging. With an even broader development program, we believe we have an exciting period ahead of us".
For further information, please contact:
Geir Christian Melen, CEO (geir.christian.melen@clavispharma.com) or
Gunnar Manum, CFO (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
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.
About Orphan Drugs
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 a product receives marketing
approval, the designation will entitle the company 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.
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.