Oslo, Norway, 29 April 2010
Clavis Pharma ASA (OSE: CLAVIS); the Norwegian cancer drug development company, announces today its results for the first quarter 2010.
Highlights:
- FDA supports plan for elacytarabine Phase III clinical trial in late-stage acute myeloid leukaemia (AML). First patient is expected to enter study in June 2010.
- Clavis Pharma's licensing partner for CP-4126 (a proprietary lipid-conjugated form of gemcitabine), Clovis Oncology, has signed an agreement with Ventana Medical to develop a companion diagnostic for hENT1 in pancreatic cancer.
- Clavis Pharma and Clovis Oncology have, for commercial reasons, decided to focus efforts on the intravenous use of CP-4126 and halt further development of an oral formulation.
- Clavis Pharma has commissioned a toxicology programme for CP-4200 (a lipid-conjugate form of azacytidine) - due to start in June 2010.
- Olav Hellebø assumed his responsibilities as CEO on 1 February.
- Research and development costs and other operating expenses amounted to NOK 21 million for the first quarter of 2010.
- The Company had cash and cash equivalents of NOK 202 million as of 31 March 2010.
Commenting on today's results, Olav Hellebø, CEO of Clavis Pharma, said: "Clavis Pharma has continued to make steady progress during the first quarter of 2010. All three of our current programmes are advancing well and we are proud to initiate two large important clinical studies in the next few months."
The First Quarter 2010 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@clavispharma.com
Gunnar Manum
Chief Financial Officer
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 : clavispharma@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 PharmaTM is registered trademarks of Clavis Pharma ASA.