Clavis Pharma - Fourth Quarter Results 2012


Oslo, Norway, 15 February 2013

Clavis Pharma ASA (OSE: CLAVIS), the Norwegian cancer drug development company, announces its results for the fourth quarter 2012. A presentation to investors, analysts and the press will take place in Oslo at 08:30 CET, see below for details. 

Highlights

  • Recruitment into the 380-patient CLAVELA Phase III trial of elacytarabine in relapsed or refractory AML was completed in December 2012 and the Company anticipates announcing top-line results in late Q1 2013. The primary endpoint of the randomised study is overall survival and the objective is to demonstrate superiority of elacytarabine over current therapies. 
  • Encouraging results from a Phase II trial with elacytarabine in combination with idarubicin in patients with early stage AML (study 205), and for whom cytarabine-containing first-course chemotherapy has failed, were presented at the American Society of Hematology annual meeting in December 2012. The study found that treatment with the elacytarabine/idarubicin combination resulted in a response rate of approximately 43% in patients who had failed to respond to first-course cytarabine treatment. 
  • In November, Clavis Pharma announced the results of the 360-patient pivotal Phase II LEAP study of CP-4126 versus gemcitabine in metastatic pancreatic cancer. The study, which was conducted by Clovis Oncology, Inc., did not meet its primary or secondary endpoints, as it showed no difference in overall survival between patients treated with CP-4126 or gemcitabine. All development work with CP-4126 across all indications has been terminated by both Clavis Pharma and Clovis Oncology. 
  • Research and development costs and other operating expenses amounted to NOK 48 million for Q4 2012 and NOK 189 million for the full year. 
  • The Company had cash and cash equivalents of NOK 223 million at 31 December 2012.

Olav Hellebø, Clavis Pharma CEO, commented, “The fourth quarter 2012 was disappointing as one of our two late-stage compounds, CP-4126, was discontinued following the failure of the Phase II LEAP trial in metastatic pancreatic cancer. Despite this, we made good progress with our lead compound, elacytarabine, in AML and remain on track to report top-line results of the CLAVELA Phase III study in late Q1 2013. The Company is preparing for a potential partnering deal and regulatory filing for elacytarabine in 2013 on the basis of a positive outcome of this trial, during which the Company will also consider its plans to establish a commercial operation in Europe.”

Presentation and Webcast
Clavis Pharma will present its fourth quarter 2012 results on Friday 15 February 2013 at Hotel Continental, Stortingsgaten 24/26, Oslo, Norway.

The presentation will start at 08:30 (CET). 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

Peter Rahmer (US Investor enquiries)
The Trout Group
+1 646 378 2973 Direct / + 646 272 8526 Cell
prahmer@troutgroup.com

About Clavis Pharma
Clavis Pharma ASA is a clinical-stage pharmaceutical company developing novel anti-cancer drugs and companion diagnostics to identify patient populations that may benefit from treatment with these agents. Clavis’ development pipeline includes novel patented versions of well-established and commercially successful drugs, made using the Company’s proprietary Lipid Vector Technology (LVT), which may offer a better efficacy /safety profile compared to the parent compounds.

The Company’s lead product, Elacytarabine, is in a randomized, controlled Phase III study (the CLAVELA study) that recently completed recruitment in relapsed or refractory acute myeloid leukaemia. The Company is also investigating CP-4200, an azacitidine derivative, in preclinical studies for myelodysplastic syndrome, 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.

Clavis Pharma is based in Oslo, Norway and listed on the Oslo Stock Exchange (ticker: CLAVIS).

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.