Oslo, Norway, December 21 December, 2009
Clavis Pharma ASA (OSE: CLAVIS) announced today that it has received an unsecured loan of NOK 20 million (USD 3.2 million) from Innovation Norway to support the Phase III clinical programme with Elacytarabine in patients with late-stage acute myeloid leukaemia (AML). The loan will mature at the end of 2016.
Elacytarabine is a novel, patented, lipid-conjugated form of the anti-cancer drug cytarabine (Ara-C) that has the potential to improve treatment outcomes in patients with AML and other haematological malignancies (leukaemias). Elacytarabine has Orphan Drug Designation in the USA and Europe for the treatment of AML.
Clavis Pharma is about to begin a 350-patient Phase III randomised, controlled registration study in the USA and Europe designed to demonstrate the superiority of elacytarabine over the investigator's choice of the best alternative therapy in late-stage AML patients.
Phase II data recently presented at the 51st American Society of Hematology (ASH) Annual Meeting showed elacytarabine to have a significantly superior survival benefit compared to published clinical outcome data for 594 late-stage AML patients receiving investigators choice of treatment [1] . Key results for elacytarabine compared to published clinical data are:
- Median survival three times longer (5.3 months vs. 1.5 months)
- Remission rate significantly increased (14.8% vs 2.5%, p<0.0001)
- Well tolerated - short-term mortality substantially lower (13% vs. 25%)
Nils Roald,Credit Director at Innovation Norway, says "Clavis Pharma is one of Norway's most promising companies that draws on the considerable strengths and expertise we have in cancer drug discovery and development in this country. We are very pleased that Innovation Norway can support Clavis Pharma with this loan to advance elacytarabine in this late-stage trial as a potential new treatment for late-stage AML."
Geir Christian Melen, CEO of Clavis Pharma: "We are at an exciting phase of development in Clavis Pharma. This new loan from Innovation Norway adds to our strengthened financial position resulting from both our recent partnering deal with Clovis Oncology for CP-4126 and our June fundraising. Specifically, it will provide further support to our lead programme with elacytarabine, which is scheduled to enter Phase III trials for late-stage AML in the first half of 2010."
Clavis Pharma has also received approval to enrol patients in a Phase II study of elacytarabine in combination with idarubicin in AML patients who have failed their first course of treatment.
For further information, please contact:
Geir Christian Melen
Chief Executive Officer
Office : +47 24 11 09 50
Mobile : +47 91 30 29 65
E-mail : geir.christian.melen@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
NOTES FOR EDITORS
About Leukaemia
Approximately 300,000 new cases of leukaemia are diagnosed globally each year, resulting in around 220,000 deaths. Leukaemia
represents a market with high unmet medical needs, which may open for accelerated approval processes to expedite market access
for new drugs. It is a segmented market covering a broad variety of disorders. A major clinical concern is the high rate of
disease recurrence. The five-year survival for the most common acute leukaemia type, acute myeloid leukaemia (AML), is in
the range of 5-10% for treated elderly patients, and approximately 30% for treated younger adults. The AML market is estimated
to be a multi-hundred USD market and is expected to grow significantly over the coming years.
About Clavis Pharma
Clavis Pharma ASA is a clinical stage oncology focused pharmaceutical company based in Oslo, Norway with a portfolio of novel
anti-cancer drugs in development. These potential breakthough products are New Chemical Entities (NCEs) made using Clavis
Pharma's Lipid Vector Technology (LVT) chemistry to introduce new properties to already established, commercially successful
drugs. Data generated suggests the resulting patentable NCEs 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;
- Intravenous CP-4126, an improved version of gemcitabine - currently in a Phase II comparative study with gemcitabine for the treatment of pancreatic cancer;
- Oral CP-4126 - currently being evaluated in an escalating dose Phase I study in solid tumours; 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 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).
About Innovation Norway
Innovation Norway is a governmental body to promote nationwide industrial development profitable to both the business economy
and Norway's national economy, and contributes towards innovation, internationalisation and promotion. Innovation Norway is
a backer and promoter of entrepreneurs, and small and medium-sized enterprises that seek to grow in an international market,
by providing financing, linking customer enterprises to know-how and helping them build networks for their innovation projects.
Innovation Norway's slogan is "We give local ideas global opportunities".
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 this Information Memorandum or the information or projections contained herein. Any representations or warranties made to an investor in Clavis Pharma will be subject to separate sale and purchase agreements to be negotiated between the parties.
Clavis Pharma(TM) is a registered trademark of Clavis Pharma ASA.
[1] Giles, F et al, Outcome of patients with acute myelogenous leukemia after second salvage therapy. Cancer (2005)104: 547-554