029 Group SE

Environmental & Social Information • Jan 9, 2002

News Details

Ad-hoc | 9 January 2002 08:30

Rhein Biotech N.V. english

Preliminary phase III results Ad-hoc-announcement transmitted by DGAP. The issuer is solely responsible for the content of this announcement. ——————————————————————————– RHEIN BIOTECH REPORTS POSITIVE PRELIMINARY PHASE III RESULTS FOR ITS NOVEL 2-DOSE HEPATITIS B VACCINE Maastricht, Jan. 9, 2002 — Rhein Biotech N.V., specialized in the development, production and marketing of vaccines, and Corixa Corporation (Nasdaq: CRXA), a developer of immunotherapeutics, today announced positive preliminary efficacy results of a phase III clinical trial with a novel 2-dose hepatitis B vaccine. The new vaccine is based on Rhein Biotech’s Hansenula polymorpha yeast based recombinant Hepatitis B antigen (HBsAg), the active ingredient of commercially approved Hepatitis B vaccines (Hepavax-Gene, AgB, Biovac B), and Corixa’s RC-529 synthetic adjuvant. The hepatitis B vaccines currently on the market generally need 3 injections for full protection. The results of the primary efficacy analyses showed that there were significantly more individuals seroprotected after two immunizations with Rhein Biotech’s hepatitis B vaccine plus RC-529 than with 2 immunizations of the 3-dose Rhein Biotech vaccine alone (95.5 percent vs. 82.1 percent, p=0.001). This shows that the Rhein Biotech vaccine with RC-529 allows a reduction from the standard 3 to 2 doses. Preliminary efficacy results were presented yesterday by Corixa and Rhein Biotech at the World Health Organization’s “Third Meeting on Novel Adjuvants Currently in/close to Human Clinical Testing” in Annecy, France. Note: The results of the study are preliminary results. Final data will be announced as soon as they are available. end of ad-hoc-announcement (c)DGAP 09.01.2002 Issuer’s information/explanatory remarks concerning this ad-hoc-announcement: “The results of the study confirm our expectations of being able to reduce the amount of injections needed for full protection against Hepatitis B infection from 3 to 2 doses,” stated Dr. Zbigniew Janowicz, Vice President Research & Development of Rhein Biotech. “This improved vaccine will be very important for vaccination of travelers, health care professionals, patients undergoing surgery, and other people who need fast protection against Hepatitis B. The 2- dose Hepatitis B vaccine is also interesting for alternative vaccination programs of children and adolescents, as currently evaluated by various national vaccination authorities. Furthermore, we are pleased about the successful scientific cooperation with our partner Corixa and are looking forward to continuing the collaboration.” “We are extremely pleased with the results of this trial,” stated Steven Gillis, Ph.D., Chairman and Chief Executive Officer of Corixa. “We hope the data obtained will prove useful for further commercial development of RC-529 with Rhein Biotech and other vaccine partners and provide further evidence of the potential value of our proprietary adjuvant portfolio. RC-529 is one of several immunostimulatory aminoalkyl glucosaminide phosphate derivatives currently being tested in clinical settings. We are encouraged by these initial results particularly as they are derived from a randomized, blinded and controlled clinical trial.” For more information: Rhein Biotech N.V. Company Contact: Marcel Jacobs Communication Manager T: +31 (0)43 / 35 67 894 F: +31 (0)43 / 35 67 899 E: m.jacobs@rheinbiotech.com Media Contact Claudia Hagedorn, IR-Consultant vom Hoff Kommunikation GmbH, T: +49 (0)211 / 515 805 16 F: +49 (0)211 / 515 805 55 E: c.hagedorn@vomhoff.de ——————————————————————————– WKN: 919544; ISIN: NL0000230324; Index: NEMAX 50 Listed: Neuer Markt in Frankfurt; Freiverkehr in Berlin, Bremen, Düsseldorf, Hamburg, München, Stuttgart, Hannover 090830 Jän 02