Oslo, Norway, 30 October, 2009
Clavis Pharma ASA (OSE: CLAVIS); the clinical stage oncology focused pharmaceutical company, announces today that the European Commission has granted Orphan Drug Designation (Orphan Medicinal Product) for Intravenous CP-4126 for the treatment of pancreatic cancer. The designation follows the recommendation given by the European Medicines Agency (EMEA) in September this year.
The Company has applied for Orphan Drug status for Intravenous CP-4126 in the USA as a potential new treatment for pancreatic cancer following the acceptance by the US Food and Drug Administration (FDA) in July of its Investigational New Drug (IND) to include patients in the USA in its phase II clinical programme, and a decision is expected early next year.
For pancreatic cancer, there is a strong need for new drugs to treat the disease, which has very limited treatment options and high mortality. "The incentives provided by orphan drug designation in Europe may enable Clavis Pharma to accelerate the clinical development of Intravenous CP-4126 and is an important milestone in the company's strategy to achieve marketing approval for this exciting drug candidate as fast as possible," said Geir Christian Melen, CEO of Clavis Pharma.
Intravenous CP-4126 is based on Clavis Pharma's proprietary Lipid Vector Technology (LVT) and aimed at improving the therapeutic profile of the current standard treatment for advanced pancreatic cancer, gemcitabine (Gemzar®). Currently it is estimated that pancreatic tumours in up to two-thirds of patients have a deficient cellular uptake of gemcitabine due to deficient expression of a necessary transport protein, hENT1 (human equilibrative nucleoside transporter 1) on the tumour cell membrane1. This is known to limit the efficacy of gemcitabine treatment in these patients. In contrast, cellular uptake of Intravenous CP-4126 is independent of hENT1, which offers a potential clinical advantage for the product in the treatment of pancreatic cancer. In the phase II programme, cancer tissue (biopsies) from each patient will be collected and analysed with regard to levels of hENT1. The relation between response to treatment and hENT1 levels will be studied.
The European Commission grants orphan drug designation to promising products that address life-threatening medical conditions affecting fewer than 230,000 persons in the European Union (EU). The designation allows for the use of the quickest way of placing the medicinal product on the market throughout the EU (known as the "centralised procedure"), regulatory assistance related to the development process and reduced regulatory fees throughout the product's life. If Intravenous CP-4126 receives marketing approval, the designation will entitle Clavis Pharma to exclusive marketing rights for 10 years following the approval. Orphan drug designation provides companies with financial and regulatory incentives to pursue less common diseases. It should be noted that orphan drug designation does not limit a drug to less common diseases. The drug may, in parallel or afterwards, also be developed for other diseases.
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
About Intravenous CP-4126
CP-4126 is a novel Lipid Vector Technology analogue of gemcitabine (Gemzar®), one of the world's leading cancer drugs,
used in the treatment of several cancers, such as pancreatic cancer, ovarian cancer and non-small cell lung cancer. Gemzar
is a blockbuster cancer drug, with 2008 sales of USD 1.7 billion. Clavis Pharma is developing Intravenous CP-4126, which has
a different therapeutic profile and may potentially have effect in patients who are resistant or refractory to gemcitabine
treatment.
About Pancreatic cancer
Pancreatic cancer is a very serious disease and an indication with a high unmet medical need. Approximately 37,000
new cases of pancreatic cancer were recorded in the USA in 2007. The 1-year and 5-year overall survival rates are estimated
at 23% and 4%, respectively. The majority of these patients has unresectable disease or will recur after surgery. Median overall
survival in these patients is approximately 8-12 months. The standard first-line therapy for patients with unresectable disease
is gemcitabine monotherapy. Unfortunately, many of these patients fail to benefit from treatment.
About Clavis Pharma
Clavis Pharma ASA is an oncology focused pharmaceutical company using its proprietary Lipid Vector Technology (LVT)
platform to create New Chemical Entities (NCEs), by significantly improving already established drugs. The improvements are
achieved by chemically binding specific unsaturated lipids to existing, and well understood, approved pharmaceuticals. Data
generated suggests the resulting patentable NCEs offer improved efficacy and reduced side effects through enhanced pharmacokinetic
properties, greater tissue penetration and, in many cases, additional modes of action.
Clavis Pharma's objective is to develop its drug candidates until significant value has been created and proof of principle in man has been shown. For further clinical development and commercialisation of the products, Clavis Pharma will enter into strategic partnerships with established pharmaceutical or biotech companies. The company's product portfolio includes four new cancer drugs: Elacytarabine and Intravenous CP-4126 are in Clinical phase II, Oral CP-4126 in phase I, and CP-4200 is in early preclinical development. Results indicate that these products have promising potential for several cancer indications within solid tumours and leukaemia.
The shares of Clavis Pharma ASA are listed on the Oslo Stock Exchange (ticker: CLAVIS).
Disclaimer
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there be any sale of the securities referred to herein in any jurisdiction in which such offer, solicitation or sale would
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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.
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