MediGene's First Drug Eligard(R) Is Launched
May 04 2004 - 11:30AM
PR Newswire (US)
MediGene's First Drug Eligard(R) Is Launched * Marketing partner
Yamanouchi launched cancer drug Eligard(R) in Germany today.
MARTINSRIED, Germany and SAN DIEGO, May 4 /PRNewswire-FirstCall/ --
Eligard(R), the first drug of the German-American biotechnology
company MediGene AG (Frankfurt, Prime Standard: MDG), is available
in German pharmacies today. With the launch of the prescription
drug to treat advanced prostate cancer, MediGene becomes the first
German biotech company with a drug on the market. The Japanese
pharmaceuticals group Yamanouchi takes over the commercialization
of Eligard(R) (see press release dated January 14, 2004).
Yamanouchi is the second largest pharmaceuticals company in Europe
in the field of urology, and the market leader in the field of
benign hyperplasia. In Germany, more than 120 medical
representatives nationwide will promote Eligard(R) with urologists,
the specialists in diseases of the prostate gland. Upon launch,
MediGene receives a milestone payment from Yamanouchi. In addition,
MediGene will receive royalties on sales of Eligard(R). Dr. Peter
Heinrich, MediGene's Chief Executive Officer, comments: "Today
MediGene has reached the market with its first drug -- this is a
landmark for our company on our way to becoming a fully integrated
biopharmaceutical company. MediGene is no longer a mere research
and development company, as we are now generating recurring
revenues with Eligard(R). We are confident that Yamanouchi will tap
the full potential of this promising drug. They possess years of
experience, proven expertise and an excellent reputation in the
commercialization of urological products. Eligard(R) offers
physicians and patients another innovative therapy for advanced
prostate cancer." Eligard(R) (previously known as Leuprogel(R)) was
approved for commercialization in Germany in December 2003 (7.5 mg
one-month sustained release product) and January 2004 (22.5 mg
three-months sustained release product). By the end of this year,
marketing authorization applications shall be submitted for both
products in other European countries. The approval for the German
market will serve as a reference in the European "Mutual
Recognition Procedure". MediGene acquired the license for
pan-European commercialization of Eligard(R) from the US Company
Atrix Laboratories, Inc. in April 2001, and has successfully taken
both the one-month and the three- months products through the
approval procedure. For this purpose, MediGene adapted the US
marketing dossier to the requirements of the German regulatory
authorities and supplemented the clinical data with additional
preclinical studies. MediGene and Yamanouchi also hold the licenses
for the four-months and six-months products of Eligard(R). About
Eligard(R): Eligard(R) is an LH-RH agonist (LH-RH = luteinizing
hormone-releasing hormone) which significantly and consistently
reduces the testosterone level in the body, thus suppressing tumor
growth in patients suffering from advanced, hormone-dependent
prostate cancer (palliative therapy). Eligard(R) (active substance:
leuprolide acetate) combines standard hormone therapy with a novel,
patient-friendly and efficient drug delivery system, the Atrigel(R)
depot technology. Liquid Eligard(R) is injected subcutaneously into
the patient where it forms a solid depot, slowly and steadily
releasing the drug, while the biodegradable depot disintegrates.
The clinical trials have shown that Eligard(R) is safe, well
tolerated and efficient. 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) is a 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 a drug on the market. With the Polyphenon E Ointment,
MediGene has a further oncological late-stage product in the
clinical phase 3, the last stage of clinical development.
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: Financial press and
investors - Julia Hofmann, Public Relations, +49-89-85-65-3324, or
Dr. Michael Nettersheim, Investor Relations, +49-89-85-65-2946,
both for MediGene AG, fax, +49-89-85-65-2920, Email, ; Medical
press - John Bolodeoku, Director Medical Affairs, +44-1784-274-300,
for Yamanouchi; Patients and physicians - Dr. Hans- Ulrich Bressel
or Dr. Carsten Mueller, +49-6221-34340, both for Yamanouchi
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