Fourth Quarter Results 2011

Oslo, Norway, February 9, 2012

Clavis Pharma ASA (OSE: CLAVIS); the Norwegian cancer drug development company, announces today its results for the fourth quarter 2011 (period ended December 31, 2011). A presentation to investors, analysts and the press will take place in Oslo at 08:30 CET, see below for details.

 Highlights 

• Promising interim results of a Phase II study of elacytarabine in combination with idarubicin (study 205) were presented at the American Society of Hematology annual meeting in December. Study 205 is recruiting patients with early stage acute myeloid leukaemia (AML) who have failed cytarabine-containing first-course chemotherapy. The interim results, previously announced in August, showed a complete remission (CR/CRi) rate of 46%, independent of the patients’ hENT1 status. In addition, a correlation between hENT1 status and clinical responses to first-line cytarabine-containing therapy was seen, supporting the potential of hENT1 measurement as a means of identifying AML patients who are most likely to benefit from elacytarabine-containing therapy.   
  
• The retrospective 002 study was successfully completed in October and the cut-off level for defining hENT1 low vs. high expression which will be used to assess the results from the on-going pivotal LEAP trial with CP-4216 in metastatic pancreatic cancer patients was established. Approximately two thirds of tumour samples tested were measured as low hENT1 based on this cut-off. The hENT1 cut-off level established shows a highly statistically significant and clinically meaningful difference in overall survival between low and high hENT1 expression in gemcitabine-treated patients in the 002 study. 
   
• Research and development costs and other operating expenses amounted to NOK 57 million for the fourth quarter and NOK 205 million for the full year of 2011.
   
• The Company had cash and cash equivalents of NOK 215 million at 31 December 2011. 
   
• Our partner for CP 4126, Clovis Oncology, successfully completed an IPO in November raising $130 million (NASDAQ: CLVS).   

Post-period Events

• Clavis Pharma’s partner Clovis Oncology was informed by the Independent Data Monitoring Committee for the LEAP trial that, of the 250 patients enrolled at that time, approximately 65 percent have been classified as hENT1 low using the cut-off level established in the 002 study. This result confirms that the LEAP trial is robust and well powered. The 360-patient LEAP study is expected to be fully enrolled at the end of Q1 2012 with top-line results expected to be reported in Q4 2012. 
   
• In January, Clavis Pharma announced a new timeline for the CLAVELA phase III trial with elacytarabine in late-stage AML patients: recruitment is now expected to be completed in H2 2012 and top-line results are expected to be available in Q1 2013 (vs. previous guidance of Q4 2012). The delay is due to a temporary shortage of elacytarabine as a result of factory-wide quality issues at Ben Venue Laboratories (BVL), the current manufacturer of elacytarabine. Clinical trial material from BVL is expected to be released later in Q1 2012. Drug manufacturing for elacytarabine is being switched to Baxter Oncology GmbH (Germany) and the first new supplies are expected in Q2 2012. 
   
• Clavis Pharma successfully raised NOK 163 million in gross proceeds through a private placement of 2.9 million new shares in January. 

Olav Hellebø, Clavis Pharma CEO, commented: "Clavis Pharma can look forward to 2012 with optimism and excitement. Our two pivotal trials continue to progress and we expect to deliver the results for CP-4126 in Q4 2012 and for elacytarabine in Q1 2013. In addition, the recent NOK 163m fundraising has significantly strengthened our financial position.”

Presentation and Webcast
A presentation by Clavis Pharma’s senior management team to investors, analysts and press will take place today in Oslo at 08:30 CET, at: Hotel Continental, Stortingsgaten 24/26, Oslo, Norway

The presentation will start at 08:30 (CET) and will be followed by a Q&A session. Breakfast will be served from 08.00 (CET). 

The presentation will also be webcast live and can be accessed directly from WEBCAST or clavispharma.com . Questions can be submitted live during the presentation. 

The quarterly report and presentation will be available at clavispharma.com/investors .

Contacts:
Olav Hellebø
Chief Executive Officer
+47 24 11 09 50
olav.hellebo@clavispharma.com

Gunnar Manum
Chief Financial Officer
+47 24 11 09 71
+47 95 17 91 90 (mob)
gunnar.manum@clavispharma.com

Mark Swallow / Nina Enegren / David Dible
Citigate Dewe Rogerson
+44 207 282 2948
clavispharma@citigatedr.co.uk

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About Clavis Pharma
Clavis Pharma ASA is a late clinical stage oncology discovery and drug development company based in Oslo, Norway with a portfolio of novel anti-cancer drugs in development. These patented New Chemical Entities (NCEs) are novel, improved versions of commercially successful drugs, made using Clavis Pharma's Lipid Vector Technology (LVT) chemistry. Data generated suggests these potential breakthrough products may offer improved efficacy and reduced side effects through enhanced pharmacokinetic properties, greater tissue penetration, altered metabolism and, in certain cases, additional modes of action.

Clavis Pharma's has several drug candidates in formal development studies:

• Elacytarabine, a leukaemia drug, currently in a randomized, controlled Phase III study in late-stage acute myeloid leukaemia;
• CP-4126, is currently in a pivotal clinical study compared to gemcitabine for the 1st line treatment of pancreatic cancer and a Phase II trial for 2nd line treatment for pancreatic cancer in patients refractory to 1st line gemcitabine treatment;
• CP-4200, an azacitidine derivative, in preclinical development for myelodysplastic syndrome (MDS), a disease that is often a precursor to leukaemia.

Clavis Pharma intends to commercialise its products through strategic alliances and partnerships with experienced oncology businesses and, where and when commercially appropriate, by establishing its own sales and marketing capabilities. 

www.clavispharma.com 

  Forward-looking statements:

This release and any materials distributed in connection with this release may contain certain forward-looking statements. By their nature, forward-looking statements involve risk and uncertainty because they reflect the Company's current expectations and assumptions as to future events and circumstances that may not prove accurate. A number of material factors could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements.