Clavis Pharma - Fourth Quarter Results 2010
Oslo, Norway, February 11, 2011
Clavis Pharma ASA (OSE: CLAVIS); the Norwegian cancer drug development company,
announces today its results for the fourth quarter 2010 and the increased size
of pivotal study for CP-4126.
Highlights
   · CLAVELA, the pivotal Phase III trial investigating elacytarabine in late-
stage acute myeloid leukaemia (AML) patients, is progressing according to plan.
Patient enrolment is underway in the US and Europe and expected to complete by
the end of 2011.
   · The elacytarabine development programme was granted fast track designation
by the US Food & Drug Administration in December.
   · In November, the Company and Clovis Oncology Inc. extended their
relationship with a new $205 million partnership agreement for the development
and commercialisation of novel anti-cancer agent CP-4126 (also known as CO-101)
in Asia and Rest of the World. Clovis Oncology will now be responsible for the
commercialisation of CP-4126 globally, while Clavis Pharma retains an option to
co-promote in Europe. This agreement builds upon the existing partnership
between the companies (signed in November 2009) for the development and
commercialisation of CP-4126 in the Americas and Europe. The total potential
value of the amended and restated global licence agreement is $585 million.
   · hENT1 biomarker test for pancreatic cancer now commercially available
through Ventana (CE mark obtained).
   · NOK 175 million was raised in a private placement (completed in December)
and subsequent offering (completed in January 2011).
   · R&D costs and other operating expenses amounted to NOK 55 million in the
fourth quarter of 2010 and NOK 149 million for the full year.
   · Following the private placement and offering, and the receipt of a USD 10
million upfront payment from Clovis Oncology, the Company had cash and cash
equivalents of NOK 349 million at year end.
Post-Period Update
   · In February 2011, Clavis Pharma and Clovis Oncology decided to increase the
patient population from 250 to 360 in the ongoing pivotal study in first-line
pancreatic cancer (study 001, the LEAP study). This will strengthen the
likelihood of the study reaching the primary end point and potential subsequent
regulatory filings.
   · In February 2011, the first patient was enrolled in a new Phase II study of
CP-4126 in pancreatic cancer patients who are refractory to gemcitabine
treatment, and where the resistance is likely to be due to impaired drug entry
into tumour cells.
Olav Hellebø, the CEO of Clavis Pharma, said: "The fourth quarter of 2010
concluded a year of transformation for Clavis Pharma where we became a Phase III
company with our fully-owned compound elacytarabine, strengthened our
partnership with Clovis Oncology for the development of CP-4126, and
successfully completed a fundraising that will enable us to advance our core
development activities at full speed and deliver the crucial read-outs from our
trials."
The Fourth Quarter 2010 Report and Presentation are available on
www.clavispharma.com
Contact:
Olav Hellebø, CEO
Office: +47 24 11 09 65
E-mail:olav.hellebo@clavispharma.com
Gunnar Manum, CFO
Office : +47 24 11 09 71
Mobile : +47 95 17 91 90
E-mail :gunnar.manum@clavispharma.com
For international press enquiries:
Mark Swallow / Nina Enegren / David Dible
Citigate Dewe Rogerson
Office : +44 207 282 2948
E-mail :Â clavispharma@citigatedr.co.uk
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 1(st) line treatment of pancreatic cancer and a Phase II trial for
2(nd) line treatment for pancreatic cancer in patients refractory to 1(st)
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. CP-4126 is licensed to Clovis Oncology globally. Clavis Pharma has
an option to co-promote CP-4126 in Europe.
Disclaimer
The information contained herein shall not constitute an offer to sell or the
solicitation of an offer to buy, nor shall there be any sale of the securities
referred to herein in any jurisdiction in which such offer, solicitation or sale
would be unlawful prior to registration, exemption from registration or
qualification under the securities laws of any such jurisdiction.
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 or projections
provided herein, and no claims shall be made by the recipient hereof by virtue
of the information or projections contained herein. Clavis Pharma is a
registered trademark of Clavis Pharma ASA.
This information is subject of the disclosure requirements pursuant to section
5-12 of the Norwegian Securities Trading Act.
Fourth Quarter Financial Presentation 2010:
http://hugin.info/136972/R/1487874/423388.pdf
Fourth Quarter Financial Report 2010:
http://hugin.info/136972/R/1487874/423304.pdf
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(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Clavis Pharma ASA via Thomson Reuters ONE
[HUG#1487874]
