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Biotec Pharmacon ASA (OSL:BIOTEC) Phase III Program Continues As Planned After Interim Analysis

Biotec Pharmacon ASA (OSL:BIOTEC) Results from a blinded interim analysis did not prompt Biotec Pharmacon to make any changes to the sample size of its phase III study with SBG (soluble beta-glucan) for treatment of diabetic ulcers. The interim analysis was carried out on the first of two phase III studies for this indication to assess whether the planned study population of 120 patients would be sufficiently large to provide a conclusive, statistically significant result.

-This is good news in the sense that we can carry on as planned both in terms of timelines and costs. We expect to receive final results from the Nottingham study in Q3 2009, data for analysis from the European diabetic ulcer study at the end of 2009, and data from both of these studies will form the basis for a filing for marketing authorisations for SBG for the treatment of diabetic ulcers by mid-2010, says CEO Lars Viksmoen in Biotec Pharmacon.

An estimated 3.5 million diabetes patients in the OECD-area annually develop foot and leg ulcers. No standard pharmaceutical treatment is currently available, and these diabetic ulcers may develop into chronic conditions with a high risk of infections and amputation as a result. Biotec Pharmacon believes its immune stimulating drug SBG reactivates immune cells in the patients' skin and thus enhances the body's own wound healing capabilities.

The blinded interim analysis was carried out by independent statistician, and did in itself not offer any response data. The statisticians' advise to stick with the planned population of 120 patients can thus mean that comparisons of SBG and placebo are expected to yield a statistically significant difference either in favour of SBG or placebo. A third possibility could be that the difference is too small to be supported even by a large increased number of patients.

-Although we obviously are optimistic that the ongoing study will prove SBG's wound healing capabilities, we cannot take this for granted until the full results are made available upon completion of the study next year, says Professor William Jeffcoate, the chief investigator of the study. But he added that, if the results prove positive, this will be very encouraging for patients suffering from non-healing ulcers of the foot in diabetes.

The blinded interim analysis was based the first 88 -or approximately two-thirds- of the patient population in the first of two phase III-studies with SBG for diabetic ulcers. Biotec Pharmacon has now enrolled more than 80 percent of the patients in the first study. Early November the first patient was enrolled in the second study for this indication, and to date 9 patients are included in this trial.

Biotec Pharmacon is also in phase III with SBG for prevention and treatment of patients with oral mucositis, which is a painful and potentially serious side effect of radiotherapy, in particular for patients with head and neck cancers. As for diabetic ulcers, the company's objective is to file for marketing authorisation for SBG in patients with oral mucositis in mid-2010.

For further information, please contact: CEO Lars Viksmoen, tel: +47 40620870

About Biotec Pharmacon: The biopharmaceutical company Biotec Pharmacon develops pharmaceutical products for prevention and treatment of immune related diseases. The company has developed the bioactive substance SBG (soluble beta glucan), which is in clinical phase III for two indications; treatment of diabetic ulcers and prevention and treatment of oral mucositis. The company's clinical development program also includes immune therapy of cancer, where combination treatments with SBG and monoclonal antibodies are being studied in clinical phase I/II. Biotec Pharmacon also produces and markets non-pharmaceutical health- and diagnostic products. Biotec Pharmacon has 53 employees, and offices in Oslo, Tromsø and in Long Beach, California.

This announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.

Biotec Pharmacon ASA

http://www.biotec.no

ISIN: NO0010014632

Stock Identifier: XOSL.BIOTEC

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