7 September 2005
Clavis Pharma, a biopharmaceutical company focusing on the development of improved cancer therapeutics, today announced that
the United States Food and Drug Administration (FDA) has approved the Investigational New Drug application (IND) for the clinical
development of its lead drug candidate, ELACYTTM, for the treatment of cancer.
ELACYT is Clavis Pharma's most advanced drug candidate in development for solid tumours and leukaemia. The company has successfully
finalized a Phase I study in Europe where the product's safety profile was established and clinical benefit (defined as tumour
response or stable disease) was reported in 41% of the patients, all suffering from advanced stage solid tumours. In parallel,
ELACYT is in the final stage of a schedule optimizing study with the aim to prepare for combination use with established anti-cancer
drugs. A Phase II program for single agent and subsequent combination use is currently being initiated. The approval of the
IND gives Clavis Pharma the possibility to start patient recruitment in the US.
"The approval of the IND is an important milestone for us and a new step towards the world's largest oncology market" says
Tom Pike, Chairman and CEO of Clavis Pharma. "The results from our European clinical studies with ELACYT are very encouraging
and we are pleased to have been given the go-ahead by FDA for the continuation of the development in the US."
For more information, contact Clavis Pharma:
Tom Pike
Chairman & CEO
(+ 47) 24 11 09 50
tom.pike@clavispharma.com
Ole Henrik Eriksen
President and COO
(+47) 24 11 09 50
ole.henrik.eriksen@clavispharma.com
About Clavis Pharma
Clavis Pharma develops new and superior pharmaceuticals based on its proprietary Lipid Vector Technology (LVT). LVT involves
the chemical binding of specific fatty acids to pharmaceutical agents, thereby creating new chemical entities with improved
biological properties. LVT has the potential to improve drug performance and dosing characteristics and to open new indications
for existing pharmaceuticals in a variety of therapeutic areas such as cancer and viral diseases. The technology is based
on more than a decade of research conducted by Norsk Hydro, a major Norwegian industrial group. The intellectual property
currently consists of more than 150 internationally granted patents from 5 patent families.
Clavis Pharma was established in 2001 in order to develop new pharmaceuticals based on the application of the LVT. Clavis
Pharma's strategy is to demonstrate the efficacy of its drug candidates in humans through clinical studies and then to commercialize
them in strategic collaborations with larger pharmaceutical companies.
About ELACYTTM
ELACYTTM (CP-4055), the company's lead drug candidate, is a novel cytotoxic cancer drug. ELACYT is an analogue of cytarabine, an approved
and well-established drug for the treatment of leukaemia. ELACYT is designed to target the larger solid tumour market as well
as offering an improved therapy for leukaemia. ELACYT has to date shown clinical benefit in more than 10 different cancer
types including malignant melanoma, lung, colorectal, ovarian, breast and prostate cancer. In the first Phase I study ELACYT
provided clinical benefit in 41% of the patients. The safety and efficacy results constitute a proof of principle in man for
ELACYT and for LVT.
Additional information on Clavis Pharma can be found on at: www.clavispharma.com
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. 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.