Clavis Pharma - Second Quarter and First Half Report 2010
(Thomson Reuters ONE) -
Oslo, Norway, August 25, 2010
Clavis Pharma ASA (OSE: CLAVIS); the Norwegian cancer drug development company,
announces today its results for the second quarter and the first half 2010
(three and six months ended June 30, 2010).
Highlights:
· The elacytarabine randomised Phase III trial in late-stage AML (CLAVELA
study) was initiated in the US and Europe during June following positive
feedback from FDA on the final protocol. The first patient entered the study in
August.
· A randomised Phase II study of CP-4126 (also known as CO-1.01) vs.
gemcitabine in pancreatic cancer patients was initiated in June by Clavis
Pharma's co-development partner for CP-4126, Clovis Oncology. The first patients
entered the study in August.
· Clovis Oncology signed an agreement in April with Ventana Medical Systems to
develop a companion diagnostic for hENT1 in pancreatic cancer and at the same
time Clavis Pharma licensed the rights to the hENT1 antibody to Ventana.
· The formal toxicology programme for CP-4200, a potential new treatment option
for haematological cancers was initiated in June.
· Olav Hellebø assumed his responsibilities as CEO in February and Dr Athos
Gianella-Borradori was appointed Chief Medical Officer (CMO) in June - to start
1 September.
· Anders P. Wiklund (Chairman) and Annette V. Clancy (Board Member) were
elected to the Board of Directors at the Company's Annual General Meeting in
May.
· Research and development costs and other operating expenses amounted to NOK
55 million for the first six month of 2010.
· The Company had cash and cash equivalents of NOK 208 million as of 30 June
2010.
Commenting on today's results, Olav Hellebø, CEO of Clavis Pharma, said: "The
second quarter has been tremendously important to Clavis Pharma. With the start
of the CLAVELA study we have transformed into a Phase III company. This is of
great importance as it means that we are in the final phase of development
before regulatory review and, hopefully, commercial launch".
The Second Quarter and First Half 2010 Report and Presentation are available on
www.clavispharma.com.
Contact:
Olav Hellebø, CEO
Office: +47 24 11 09 65 / Mobile: +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 optimised form of cytarabine, a leukaemia drug - currently
in Phase III, a 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;
* CP-4200, an azacitidine derivative - in preclinical development for
myelodysplastic syndrome (MDS), 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 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 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#1439991]
Second Quarter Financial Report 2010:
http://hugin.info/136972/R/1439991/384330.pdf
Second Quarter Financial Presentation 2010:
http://hugin.info/136972/R/1439991/384355.pdf
Second Quarter Press Release 2010:
http://hugin.info/136972/R/1439991/384343.pdf
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(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.
All reproduction for further distribution is prohibited.
Source: Clavis Pharma ASA via Thomson Reuters ONE
Unternehmensinformation / Kurzprofil:
Datum: 25.08.2010 - 07:01 Uhr
Sprache: Deutsch
News-ID 39947
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contact information:
Town:
Oslo
Kategorie:
Business News
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