MediGene Achieves Excellent Clinical Results With Polyphenon(R) E Ointment in European Phase 3 Trial
March 31 2004 - 12:18PM
PR Newswire (US)
MediGene Achieves Excellent Clinical Results With Polyphenon(R) E
Ointment in European Phase 3 Trial * Data indicate high and lasting
efficacy as well as excellent safety in treatment of genital warts.
MARTINSRIED, Germany and SAN DIEGO, March 31 /PRNewswire-FirstCall/
-- The German-American biotech company MediGene AG (Frankfurt,
Prime Standard: MDG) has achieved excellent results in a European
phase 3 trial of the Polyphenon(R) E Ointment for the treatment of
genital warts. The statistically significant trial with more than
500 patients showed a high and lasting efficacy of the drug with
extremely low systemic adverse reactions. The results of this
trial, along with the data from the still ongoing American phase 3
trial willbe prerequisites for the marketing authorization
application for Polyphenon(R) E Ointment. The pooled results of
both trials are expected at the end of 2004. In these two phase 3
trials, efficacy and safety of Polyphenon(R) E Ointment for the
treatment of external genital warts are being investigated in three
groups of patients each (10 % and 15 % ointment compared to
placebo). The European trial has achieved all objectives of the
trial. Approximately 53 % of the patient treated with the 15 %
Polyphenon(R) E Ointment showed complete clearance of all external
genital warts (clear statistical significance p = 0.01 compared to
placebo). In about 78 % of all patients treated with Polyphenon(R)
E Ointment, most or all of the genital warts disappeared.
Recurrence of genital warts during the twelve weeks of follow-up
occurred only in a very small number of patients (less than 5 %).
Local skin reactions (e.g. itching, burning) were mostly mild or
moderate. The trial is based on discussions with European
regulatory authorities, had been agreed with the US FDA and
complies with international quality standards. Dr. Peter Heinrich,
Chief Executive Officer of MediGene AG, comments: "I am very happy
about the convincing and competitive phase 3 results. Thedistinctly
positive data from the European trial represent an important
milestone on our way to marketing authorization. The results
indicate that this drug candidate which is close to the market has
a tremendous potential." Polyphenon(R) E Ointment: The active
substance in Polyphenon(R) E Ointment is a defined extract from
green tea leaves. MediGene estimates the sales potential of this
drug for the treatment of genital warts to be more than 100 million
Euro annually. Pre-clinical findings indicate that Polyphenon(R) E
Ointment may also be suited for the treatment of other skin
diseases. Genital warts: Genital warts are disfiguring and
contagious but benign skin tumors in the genital and anal area
which are mostly difficult to treat. Genital warts are one of the
most common and fastest spreading venereal diseases worldwide.
Approximately 14 million people in North America and 15 million
people in Europe are infected by human papilloma viruses (HPV 6 or
11), that cause genital warts. Additional details on the trial: The
phase 3 trial was carried out in a total of 48 hospitals in 7
European countries and South Africa. The study was randomized
(random assignment of treatment) and double-blind (no disclosure to
physician or patient during the trial). The ointment was applied to
the affected areas three times a day over a maximum period of 16
weeks. The primary objective of the trial was achieved:
approximately 53 % of the patients treated with the 15 %
Polyphenon(R) E Ointment completely recovered from all existing as
well as newly appearing warts (10 % Polyphenon(R) E Ointment: 51 %,
placebo: 37 %). The other primary objective was to prove the safety
of the drug. The majority of local skin reactions were mild to
moderate, and only in afew cases severe local reactions occurred.
The secondary objectives of the trial were also achieved: complete
recovery from warts that already existed at the beginning of the
treatment (baseline warts) of 55 % of the patients with 15 %
ointment, of 53 % of the patients with 10 % ointment and of 36 % of
the patients treated with placebo (clear statistical significance
compared to placebo: p = 0.01 for 15 % ointment, p = 0.03 for 10 %
ointment). This press release contains forward-looking statements
that involve risks and uncertainties. The forward-looking
statements contained herein represent the judgement of MediGene as
of the date of this release. These forward-looking statements are
no guarantees for future performance, and the forward-looking
events discussed in this press release may not occur. MediGene
disclaims any intent or obligation to update any of these
forward-looking statements. MediGene(TM) is a trademark of MediGene
AG, Polyphenon(R) E is a trademark of Mitsui Norin, Eligard(R) isa
trademark of Atrix. About MediGene: MediGene AG is a publicly
quoted (Frankfurt: Prime Standard), German- American biotechnology
company located in Martinsried, Germany and San Diego, USA.
MediGene has the most mature drug development pipeline in the
German biotech industry and possesses innovative platform
technologies. With Eligard(R) for the treatment of prostate cancer,
MediGene is the first German biotech company with an approved drug
on the verge of market launch. MediGene's core competence lies in
research and development of novel approaches for the treatment of
various tumor diseases. Thus MediGene focuses on indications of
high medical need and economic opportunities. DATASOURCE: MediGene
AG CONTACT: Julia Hofmann, Public Relations, +49-89-85-65-3324, or
Dr. Michael Nettersheim, Investor Relations, +49-89-85-65-2946,
both of MediGene AG, , Fax, +49-89-85-65-2920
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