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@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 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)