Schering AG's Mirena(R) approved in the USA
Berlin, Germany, December 7, 2000; Schering AG, Germany (NYSE: SHR), announces
that the U.S. Food and Drug Administration (FDA) yesterday approved Mirena(R)
for the U.S. market. Mirena(R) is an innovative intrauterine hormone delivery
system for fertility control with effectiveness in preventing pregnancy as well
as significant long-acting performance. Mirena(R), which is available today in
47 countries worldwide, will be launched by Berlex Laboratories, Inc., the U.S.
subsidiary of Schering AG, in the first quarter of 2001.
"We are proud to offer Mirena(R) to women in the U.S. who are looking for
reliable long-acting contraception," said Dr. Giuseppe Vita, Chairman of the
Board of Executive Directors of Schering AG. "Sterilization is the method used
by more than 20 million women in the USA. The market seems to be waiting for
Mirena(R), because it is an effective and reversible alternative." Mirena(R) is
well-tolerated and characterized by its long-acting efficacy (up to five years)
and the fast recovery of fertility after its removal.
Today, nearly 40 percent (26 million) of women in the U.S. between the ages of
18 and 49 currently use a method of long-term contraception and decide between
sterilization (80 percent), injectables, implants, and intrauterine devices.
Mirena(R), as a combination between a hormonal contraceptive and an intrauterine
system, gives these women an attractive new choice. Lutz Lingnau, President and
Chief Executive Officer of Schering Berlin, Inc., and Member elect of the Board
of Executive Directors of Schering AG, explained: "Schering AG is world leader
in oral contraceptives with a market share of about 30% and has been active in
this field for many years. Our special expertise will give Mirena(R) a strong
basis for a successful launch in the U.S. market"
"The introduction of Mirena(R) is an important milestone in the implementation
of our accelerated growth strategy. It will broaden our market share in the U.S.
contraceptive market, strengthening our growth in the world's largest
pharmaceutical market," Dr. Vita added. Mirena(R) is the first in a series of
new, innovative products that Schering AG will bring to market as part of its
strategy to become a major player in fertility control and hormone therapy in
the USA.
Mirena(R), which was developed in Finland by Schering AG's affiliate Leiras Oy,
has been used by approximately two million women worldwide. In addition to
preventing pregnancy, use of Mirena(R) can lead to shorter and lighter periods.
Mirena(R) delivers a low dose of the progestin levonorgestrel directly to the
lining of the uterus and, therefore, has minimal systemic effects. In 1999,
Mirena(R) sales amounted to EUR60m and figures for 2000 show a continued growth
of 15%.
Schering AG is a research-based pharmaceutical company. Its activities are
focused on four business areas: fertility control and hormone therapy,
diagnostics and radiopharmaceuticals, dermatology as well as therapeutics for
disabling diseases, e.g. multiple sclerosis, leukemia and solid tumors. As a
global player with innovative products Schering AG aims for leading positions in
specialized markets worldwide. With in-house R&D and supported by an excellent
global network with external partners, Schering AG is securing a promising
product pipeline. Using new ideas, Schering AG aims to make a recognized
contribution to medical progress and strives to improve the quality of life.
An electronic version of this news release - as well as additional information
about Schering AG - is available at www.schering.de.
Berlin, Germany, December 7, 2000
Schering AG Corporate Communication
For further information please contact:
Dr. Friedrich von Heyl
Business and Financial Communication
Phone: +49 - 30 - 468 152 96
Fax: +49 - 30 - 468 166 46
[email protected]
Frank Richtersmeier
Pharma Communication
Phone: +49 - 30 - 468 176 61
Fax: +49 - 30 - 468 167 10
[email protected]
Peter Vogt
Investor Relations
Phone: +49 - 30 - 468 128 38
Fax: +49 - 30 - 468 166 46
[email protected]
