Clavis Pharma ASA : Clavis Pharma ASA : Fourth Quarter Results 2012

     Clavis Pharma ASA : Clavis Pharma ASA : Fourth Quarter Results 2012

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.

This information is subject of the disclosure requirements pursuant to section
5-12 of the Norwegian Securities Trading Act.
Fourth Quarter Presentation 2012
Fourth Quarter Report 2012

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Source: Clavis Pharma ASA via Thomson Reuters ONE
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