Clavis Pharma ASA : receives US Orphan Drug Designation for CP-4126 to treat pancreatic cancer

Oslo, Norway, 7 January 2010

Clavis Pharma (OSE: CLAVIS); the Norwegian cancer drug development company,
announced today that the US Food & Drug Administration (FDA) has granted orphan
drug designation to CP-4126 for the treatment of pancreatic cancer. The
designation follows the equivalent designation given by the European Commission
in October last year.

?There is an urgent need for new drugs to treat pancreatic cancer, which
currently has very limited treatment options and high mortality. The incentives
provided by orphan drug designation in US may accelerate the clinical
development of Intravenous CP-4126,? said Geir Christian Melen, CEO of Clavis
Pharma.  ?We are therefore pleased to receive this orphan drug designation for
CP-4126, in addition to the European Commission designation received last year.?

The US Orphan Drug Act provides incentives to encourage the development of drugs
for rare disease conditions affecting fewer than 200,000 persons in the United
States of America (USA). The designation allows for amongst others a possible
exemption from the FDA-user fee and assistance in clinical trial protocol
design. If CP-4126 receives marketing approval for pancreatic cancer in the USA,
the designation will entitle the marketing authorisation holder to exclusive
marketing rights for pancreatic cancer for seven years following the approval.

It should be noted that orphan drug designation does not limit a drug to less
common diseases. The drug may, in parallel or afterwards, be developed for more
common diseases.

Clavis Pharma entered a partnership agreement with Clovis Oncology Inc., in
November last year for the further development and commercialisation of the
Clavis Pharma drug candidate, CP-4126, currently in Phase II development in
pancreatic cancer. CP-4126 is a novel, patented, lipid-conjugated form of the
anti-cancer drug gemcitabine that has the potential to improve treatment
outcomes in a large subset of patients with pancreatic cancer and certain other
solid tumours.

For further information, please contact:
Geir Christian Melen
Chief Executive Officer
Office  : [phone]
Mobile : [phone]
E-mail  :[e-mail]


Gunnar Manum
Chief Financial Officer
Office  : [phone]
Mobile : [phone]
E-mail  :[e-mail] 

For international press enquiries:
Mark Swallow / Nina Enegren / David Dible
Citigate Dewe Rogerson
Office : [phone]
E-mail :  [e-mail] 

About Intravenous CP-4126
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. 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. Clavis
Pharma is developing Intravenous CP-4126 in collaboration with Clovis Oncology.

Clovis Oncology is focused on acquiring, developing and commercializing
innovative anti-cancer agents in the US, Europe and additional international
markets. The company was founded in 2009 by former executives of Pharmion
Corporation, a leading global oncology company, which was acquired by Celgene
Corporation in 2008 for $2.9 billion.

Clovis Oncology secured $146 million in start-up financing from leading
international healthcare-focused investors, including Domain Associates, New
Enterprise Associates (NEA), Versant Ventures, Aberdare Ventures, Abingworth,
Frazier Healthcare Ventures, ProQuest Investments and the Company's management
team in 2009. The Company is headquartered in Boulder, Colorado, and has
additional offices in San Francisco, CA and London, UK.

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 a clinical stage oncology 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, an improved form of Ara-C, a leukaemia drug ? about to
    commence a Phase III randomized, controlled registration study in late-stage
    acute myeloid leukaemia;
  * Intravenous CP-4126, an improved version of gemcitabine ? currently in a
    Phase II comparative study with gemcitabine for the treatment of pancreatic
    cancer;
  * Oral CP-4126 ? currently being evaluated in an escalating dose Phase I study
    in solid tumours; and
  * CP-4200, an azacitidine derivative ? in preclinical development for
    myelodysplastic syndrome (MDS), often a precursor to myeloma or 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. CP-4126 is licensed to Clovis Oncology in the Americas and Europe.
Clavis Pharma has retained rights in other territories and an option to
co-promote CP-4126 in Europe.

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

Disclaimer
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 provided
herein,  and no claims shall  be made by the  recipient hereof by virtue of this
News Announcement or the information contained herein.

Clavis Pharma(TM) is a registered trademark of Clavis Pharma ASA.
This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act)


[HUG#1371708]





    Clavis Pharma receives US Orphan Drug Designation: http://hugin.info/136972/R/1371708/335786.pdf