Interim report January-September 1998

Interim report January - September 1998 edical Products Agency has approved RescueFlow® for marketing in Sweden. of the Phase III studies of Krillase® have shown several advantages compared with competing products. n signed with Active Biotech concerning research y the effects of hyaluronidase on tumours. Experimental testing on animals has shown that treatment with BP-04 icant increases in tumour absorption of marker substances. The operating result for the period amounted to a loss of SEK 35.4 M. Research and development Research and development costs during the period amounted to SEK 26.1 M, an increase of 6% compared with the year-earlier period. R&D costs in the second and third quarters were lower than in the corresponding quarters in 1997. On November 17, RescueFlow® was approved for marketing in Sweden. With regard to registration in other EU countries, the procedure for mutual recognition will be followed. As a result, other EU countries are expected to approve the product beginning in the first half of 1999, based on the Swedish Medical Products Agency's registration and investigation. Negotiations are now in progress concerning licensing of the marketing rights. Analyses of data from the phase III studies of Krillase® and other forms of treatment have shown that the effects of treatment with Krillase® are at least comparable with and, in some cases, significantly superior to other alternatives. It has been confirmed that Krillase® cleans chronic wounds quickly. Analyses are now being made of all variables included in the study. Discussions with potential licensees are proceeding according to plan. Results of these discussions will affect the time plan for submitting a registration application for the product. A co-operation agreement has been signed with Active Biotech in Lund. The agreement concerns research co-operation for a new project focused on the effects of the hyaluronidase enzyme on tumours, BP-05. The work, in preclinical phase, which until now has been conducted by BioPhausia, will be continued at the Sidney Kimmel Cancer Center in San Diego. BioPhausia AB (publ) AR 4, S-741 74 Uppsala, Sweden Phone: +46 18 34 99 00 Fax: +46 18 34 94 95 E-mail: info@biophausia.se The project concerning the use of hyaluronidase to treat traumatic swellings, BP-03, is proceeding according to plan. Previous preclinical studies have shown that BP-04 reduces the pressure in certain tumours. This has been assumed to show the possibility of increased absorption of substances such as cytostatics. Additional preclinical studies into the BP-04 project have now been conducted in Sweden and Norway. The results of both studies show a significant increase in the absorption of marker substances in tumours after treatment with BP-04. This conclusion provides a strong foundation for continued, more comprehensive studies with the objective of starting clinical studies within two years. ------------------------------------------------------------ Please visit http://www.bit.se for further information The following files are available for download: http://www.bit.se/bitonline/1998/11/30/19990215BIT00400/bit0001.doc Entire report http://www.bit.se/bitonline/1998/11/30/19990215BIT00400/bit0002.pdf Entire report