Interim Report, 1 January - 31 March 2000

Interim Report, 1 January - 31 March 2000 - Medivir expands its research operations through acquisition of a company in Cambridge, UK. - Successful Phase II clinical trial completed with Medivir's shingles agent MIV-606. - Phase II clinical trial with herpes cream ME-609 proceeding as planned with around 360 individuals thus far included. - Profits after financial items amounted to SEK -12.6 (10.4) million. - New share issue successfully completed following substantial - oversubscription. The issue yielded SEK 269 million. - CCS increased sales by 20% to SEK 20 (16.6) million, while also increasing operating profit to SEK 4.4 (2.3) million, an increase of 88% over the corresponding period last year. Medivir expands in Great Britain Medivir acquired the drug development operations of Peptide Therapeutics Ltd, hereafter denoted "Mimetrix", pursuant to an agreement dated 27 March 2000. Mimetrix, located in Cambridge, England, employs 28 highly qualified researchers (of which 20 are Ph.Ds) in the field of preclinical research. Mimetrix has several patent pending technologies which complement in an unusually comprehensive fashion Medivir's existing pharmaceutical research capacity. Alongside its proprietary technologies, Mimetrix has a portfolio of high quality preclinical pharmaceutical projects. With the Mimetrix acquisition Medivir establishes itself as an even more powerful force in European pharmaceutical research with 125 researcher (of which 50 operate in external university collaborations) and a well balanced project portfolio. Successful Phase II clinical trial completed with Medivir's shingles antiviral MIV-606 A successful phase II-study clinical trial regarding treatment of shingles with MIV-606 has now been completed. The results show that MIV-606 has good antiviral activity and is at least as efficacious as the drug currently most used, acyclovir, but at a significantly lower dose. The good results are entirely in line with Medivir's own expectations. The clinical trial further confirmed that MIV-606 has a good safety profile. The results suggest that there is a relationship between the dose of MIV- 606 and the duration of postherpetic neuralgia (the difficult to treat chronic pain). Larger scale phase III clinical trials are now planned to further validate these promising results. The trial provides Medivir with high quality phase II documentation for the coming phase III clinical trials. Phase II studies against resistant HIV planned för MIV-310 Medivir has decided to proceed with the clinical evaluation of MIV-310 (alovudine, earlier FLT) and will submit an application to perform phase II studies. The clinical trials are expected to start during the year 2000. MIV-310 went through phase I and II clinical trials in AIDS patients during 1991 and 1992. At that time multiresistant HIV had not appeared and since no advantage over zidovudine (AZT) was seen the project was put on ice. Since then multiresistant HIV has appeared and recent laboratory tests have shown MIV-310 to be very potent against HIV which has become resistant against HIV drugs presently on the market. Around 30 % of HIV patients do not respond to current therapies, largely due to HIV becoming multiresistant. Safety data is already available to Medivir from the earlier phase I and II studies. A new phase II study is required to evaluate the effect of MIV-310 in patients with multiresistant HIV. Phase II trial of ME-609 herpes cream is progressing well Medivir's collaboration with AstraZeneca regarding a new patent-pending treatment principle for cold sores with herpes cream ME-609. Over 360 individuals are involved in the trials. Phase II is estimated to be completed during Q 3. HIV antiviral MIV-150 - Phase I under way Chiron and Medivir commenced phase I clinical trials with MIV-150 during 1999. The trials are being performed in England and are expected to be completed during the year 2000. New issue of shares in Medivir and completion of Mimetrix acquisition The Board of Directors of Medivir AB (publ) decided on April 9th 2000 to issue 1.405.000 new shares of series B, without reference to existing shareholders' preferential rights. The decision was made under the mandate given by the shareholders' Annual General Meeting on March 29th 2000. The proceeds from the new issue of shares will be used to finance Medivir's future expansion and has also contributed in increasing the company's institutional ownership in Sweden and internationally. The recent announcement of the acquisition of Mimetrix, Cambridge, from Peptide Therapeutics Group plc, was subject to the successful completion of this new issue of shares. Net proceeds to Medivir amount to approximately SEK 296 million. The issue price has been determined to SEK 220 per share through a book-building procedure. The new issue was substantially oversubscribed. Substantially better sales and improved return for CCS. CCS experienced a substantial increase in sales. The skincare cream "Karbasal", launched in summer 1999, showed a particularly good sales development. Karbasal is now the official price reference standard in local pharmacies and is recommended by most regional health boards. The improvements in profitability margins reflect the work commenced last year in rationalising manufacturing and improving purchasing processes. An intensified marketing campaign is planned for the coming quarter which will show in profitability margins. ------------------------------------------------------------ Please visit http://www.bit.se for further information The following files are available for download: http://www.bit.se/bitonline/2000/05/03/20000503BIT00590/bit0001.doc The full report http://www.bit.se/bitonline/2000/05/03/20000503BIT00590/bit0002.pdf The full report