Medivir, Interim Report, 1 January – 30 September 2008
• Net sales were SEK 31.9 (80.8) m. In May, Medivir signed an additional agreement with Tibotec Pharmaceuticals Ltd. on hepatitis C, triggering a SEK 46.2 m (EUR 5 m) payment. This amount has been allocated over the assessed agreement term, with SEK 9.6 m recognized as revenue.
• The loss after tax amounted to SEK -102.4 (-138.1) m.
• Earnings per share were SEK -4.91 (-8.23).
• Cash flow from operating activities was SEK -30.4 (-129.6) m.
• Liquid assets as of 30 September were SEK 295.7 (264.0) m.
CEO’s statement—comments on the third quarter
In September, we reported the most important clinical results yet for TMC435350, our hepatitis C project conducted together with Tibotec. The results are from the two first dose groups which are completed and analyzed in the ongoing phase IIa study. These results will be presented at the annual meeting of the AASLD (American Association for the Study of Liver Diseases) in early-November.
The results can be summarized as follows:
• TMC435350 had a dose-dependent antiviral activity at doses of 25 mg and 75 mg once daily, both with and without simultaneous SoC (standard of care, peginterferon alpha-2a and ribavirin) treatment.
• The group that received four weeks’ treatment at 75 mg per day of TMC435350 with simultaneous SoC showed undetectable plasma viral load levels (<10 IU/ml) in eight of the nine subjects, corresponding to 89% of RVR (rapid antiviral response). The ninth patient was below the lower limit of quantification (< 25 IU/ml). This activity data was measured on day 28, the final day of treatment with TMC435350, whereupon patients continued with SoC.
• No serious or severe adverse events relating to TMC435350 were observed.
Based on these results together with previously reported clinical and preclinical results, we continue building a strong base for the continued documentation of TMC435350 as a once daily therapy for hepatitis C with a potentially unique profile.
On 1 October, we filed an NDA with the FDA (US regulator, the Food & Drug Administration) for Lipsovir®, a topical product for the prevention and treatment of cold sores. The process of entering partnerships is ongoing, and our objective is to enter one or more agreements to commercialize Lipsovir® globally.
Huddinge, Sweden, 20 October 2008
For more information, please contact:
Rein Piir, CFO and VP, Investor Relations: +46 (0)70 853 7292.