FOURTH QUARTER REPORT 2009
(Thomson Reuters ONE) -
Clavis Pharma delivers strong performance in the last quarter of 2009
- CP-4126 development accelerated through partnership
- Financial position further strengthened
Oslo, Norway, 17 February 2010
Clavis Pharma ASA (OSE: CLAVIS); the oncology company, announces today its
results for the fourth quarter 2009.
* In November 2009, the Company and Clovis Oncology Inc. signed a US$380
million (NOK 2.1 billion) partnership agreement for the development and
commercialisation of novel anti-cancer agent CP-4126. CP-4126 is a
lipid-conjugated form of gemcitabine designed by Clavis Pharma to improve
treatment outcomes in patients with pancreatic and other solid tumours.
Under the terms of the agreement, Clovis Oncology will take over
responsibility for product development and manufacturing of CP-4126, and for
filing of marketing approvals in the United States, Europe, Canada, Central
and South America. Clovis Oncology will also be responsible for
commercialisation of CP-4126 in those territories. Clavis Pharma retained
the option to co-develop and co-promote CP-4126 in Europe and retained all
rights in all other territories.
* In October 2009, the European Medicines Agency (EMEA) granted Orphan Drug
Designation to Intravenous CP-4126 for the treatment of pancreatic cancer in
Europe, and in January 2010 the designation was also granted in the USA by
the US Food & Drug Administration (FDA). The Orphan drug designation secures
10 and 7 year exclusive marketing rights in Europe and the USA,
respectively.
* Clavis Pharma continues to make progress with the further development of
elacytarabine in acute myeloid leukaemia (AML), and the preparation for the
Phase III randomised, controlled study in the USA and Europe is progressing
well. The study is designed to demonstrate elacytarabine's superiority over
the available alternative therapy in late-stage acute myeloid leukemia
patients.
* In November 2009, the Company received an up-front payment of US$15 million
(NOK 84 million) in connection with licensing agreement for CP-4126, which
will be deferred and recognised as income over a period of 48 months in
compliance with IFRS. Research and development costs and other operating
expenses amounted to NOK 32 million for the fourth quarter of 2009. The
Company had cash and cash equivalents of NOK 223 million as of 31 December
2009.
* In January 2010, Clavis Pharma appointed Olav Hellebø as its new Chief
Executive Officer. Mr Hellebø was formerly Senior Vice President, UCB Pharma
and President of Immunology Operations. He has also been Chief Operating
Officer of Novartis UK and head of Schering Plough's Oncology Biotech
Division in the USA. Mr Hellebø took up his position on 1 February 2010.
Commenting on today's announcement, Olav Hellebø, the CEO of Clavis Pharma,
said: "Clavis Pharma had a very successful year in 2009 culminating in what we
believe is an excellent partnership for CP-4126 with Clovis Oncology. In
addition, the encouraging clinical results for elacytarabine we have seen in
patients with acute myeloid leukamia will pave the way for phase III trials to
start in 2010. These important events combined with our strengthened finances
mean that Clavis Pharma is well positioned to deliver its vision of becoming a
fully fledged international oncology company."
The Fourth Quarter 2009 Report and Presentation are available on
www.clavispharma.com
Contact:
Olav Hellebø, CEO
Office: +47 24 11 09 65 / Mobile UK: +44 783 390 4901
E-mail:olav.hellebo(at)clavispharma.com
Gunnar Manum
Chief Financial Officer
Office : +47 24 11 09 71
Mobile : +47 95 17 91 90
E-mail :gunnar.manum(at)clavispharma.com
For international press enquiries:
Mark Swallow / Nina Enegren / David Dible
Citigate Dewe Rogerson
Office : +44 207 282 2948
E-mail : clavispharma(at)citigatedr.co.uk
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;
* CP-4126, an improved version of gemcitabine - currently in a Phase II
comparative study with gemcitabine for the treatment of pancreatic cancer;
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. These
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 registered trademarks of Clavis Pharma ASA.
This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act)
[HUG#1385113]
Fourth_Quarter_Financial_Presentation_2009: http://hugin.info/136972/R/1385113/343871.pdf
Fourth_Quarter_2009_Press_Release: http://hugin.info/136972/R/1385113/343863.pdf
Fourth_Quarter_Financial_Report_2009: http://hugin.info/136972/R/1385113/343860.pdf
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Datum: 17.02.2010 - 01:05 Uhr
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