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14-09-2009 16:59

Clavis Pharma (OSE: CLAVIS) announces today that the European Medicines Agency (EMEA) has recommended orphan drug designation to Intravenous CP-4126 for the treatment of pancreatic cancer. Clavis Pharma is currently conducting a Phase II study with Intravenous CP-4126 in patients with pancreatic cancer.

“We are pleased that EMEA has recommended our application for orphan drug designation for Intravenous CP-4126, and we are looking forward to receiving the final designation from the European Commission in a few weeks,” said Geir-Christian Melen, CEO of Clavis Pharma. “Patients with pancreatic cancer need more effective therapies as current treatment options are unsatisfactory. This designation will allow Clavis Pharma to accelerate the clinical development of Intravenous CP-4126 and is an important milestone in the company’s strategy to achieve marketing approval for this exciting drug candidate as rapidly as possible.”

The Company plans to apply for Orphan Drug status for Intravenous CP-4126 in the USA as a potential new treatment for pancreatic cancer following the acceptance by the US Food and Drug Administration (FDA) in July of its Investigational New Drug (IND) to include patients in the USA in its phase II clinical programme.

Intravenous CP-4126 is based on Clavis Pharma’s proprietary Lipid Vector Technology (LVT) and aimed at improving the therapeutic profile of the current standard treatment for advanced pancreatic cancer, gemcitabine (Gemzar?). Currently it is estimated that pancreatic tumours in up to two-thirds of patients have a deficient cellular uptake of gemcitabine due to deficient expression of a necessary transport protein, hENT1 (human equilibrative nucleoside transporter 1) on the tumour cell membrane(1). This is known to limit the efficacy of gemcitabine treatment in these patients. In contrast, cellular uptake of Intravenous CP-4126 is independent of hENT1, which offers a potential clinical advantage for the product in the treatment of pancreatic cancer. In the phase II programme, cancer tissue (biopsies) from each patient will be collected and analysed with regard to levels of hENT1. The relation between response to treatment and hENT1 levels will be studied.

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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 Intravenous CP-4126 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.

(1) Ref: Giovannetti et al., Cancer Research 66, 3928-3935, April 1, 2006

Contact:
Geir Christian Melen
Chief Executive Officer
Office : +47 24 11 09 50
Mobile : +47 91 30 29 65
E-mail : [email protected]

Gunnar Manum
Chief Financial Officer
Office : +47 24 11 09 71
Mobile : +47 95 17 91 90
E-mail : [email protected]

For international press enquiries:
Mark Swallow / Nina Enegren / David Dible
Citigate Dewe Rogerson
Office : +44 207 282 2948
E-mail : [email protected]

About Intravenous CP-4126
CP-4126 is a novel Lipid Vector Technology analogue of gemcitabine (Gemzar?), one of the world’s leading cancer drugs, used in the treatment of several cancers, such as pancreatic cancer, ovarian cancer and non-small cell lung cancer. Gemzar is a blockbuster cancer drug, with 2008 sales of USD 1.7 billion. Clavis Pharma is developing Intravenous CP-4126, which has a different therapeutic profile and may potentially have effect in patients who are resistant or refractory to gemcitabine treatment.

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About Pancreatic cancer
Pancreatic cancer is a very serious disease and an indication with a high unmet medical need. Approximately 37,000 new cases of pancreatic cancer were recorded in the USA in 2007. The 1-year and 5-year overall survival rates are estimated at 23% and 4%, respectively. The majority of these patients has unresectable disease or will recur after surgery. Median overall survival in these patients is approximately 8-12 months. The standard first-line therapy for patients with unresectable disease is gemcitabine monotherapy. Unfortunately, many of these patients fail to benefit from treatment.

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 four new cancer drugs: Elacytarabine and Intravenous CP-4126 are in Clinical phase II, Oral CP-4126 in phase I, and CP-4200 is in early preclinical development. Results indicate that these products have promising potential for several cancer indications within solid tumours and leukaemia.

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The shares of Clavis Pharma ASA are listed on the Oslo Stock Exchange (ticker: CLAVIS).

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 is a registered trademark of Clavis Pharma ASA.

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