TOKYO and KENILWORTH, N.J., June 22 /PRNewswire-FirstCall/ -- Toyama
Chemical Co. Ltd. and Schering-Plough Corporation (NYSE: SGP) announced today
that they have entered into a definitive license agreement for garenoxacin
(Code No. T-3811), Toyama's proprietary quinolone antibacterial agent. Under
the terms of the agreement, Toyama has granted to Schering-Plough exclusive
rights to develop, use and sell garenoxacin worldwide, excluding Japan, Korea
and China. Toyama and Schering-Plough had previously announced on March 31,
2004, that the companies had entered into a letter of intent regarding
garenoxacin.
As Schering-Plough indicated when the letter of intent was announced, the
company expects the addition of garenoxacin to broaden the anti-infective
portfolio it is developing. Schering-Plough said this is in line with its
strategy to build strength in its global franchises through internal research
and external licensing opportunities.
Katsuhiko Nakano, president and CEO of Toyama Chemical, stated, "We are
very glad to conclude the license agreement on garenoxacin with Schering-
Plough. Through our collaboration with Schering-Plough, we look forward to
bringing garenoxacin, the novel antibacterial compound, to the market and
contributing to the advance of anti-infective therapy worldwide." He added,
"With this collaboration, we would like to establish a good relationship with
Schering-Plough. We see this as being important as we gain experience to
undertake other similar collaborations in the future."
In connection with the execution of the license agreement, Toyama will
receive an up-front payment of $80 million. Schering-Plough will expense this
amount in the current fiscal quarter, as indicated in the March announcement.
Under the terms of the agreement, Toyama could also receive additional
milestone payments totaling up to $245 million based on the approval, further
development and commercialization of garenoxacin. The substantial majority of
such milestones will be based on the achievement of certain sales levels for
garenoxacin. In addition, Toyama would also receive royalty payments on net
sales of garenoxacin by Schering-Plough in its territories.
Schering-Plough noted that it will be responsible for compiling and filing
regulatory applications in its territories and for designing and implementing
any further clinical development programs it feels may be necessary to expand
the clinical uses of garenoxacin. The company said it is proceeding with its
review of the product dossier and implementation of technology transfer steps,
and expects to be in a position to file a U.S. New Drug Application by late
2005.
Originally discovered by Toyama, garenoxacin is a novel quinolone
antibacterial agent that has completed Phase III development. It has shown
potent activity against a wide range of Gram-positive and Gram-negative
bacterial pathogens, including anaerobic organisms, and resistant strains such
as penicillin-resistant Streptococcus pneumoniae. Garenoxacin may offer a
significant advance in its treatment category, with the potential to address
bacterial strains resistant to other antibiotics with a favorable side effect
profile. Toyama had previously licensed garenoxacin on a worldwide basis,
excluding Japan, to Bristol-Myers Squibb. On October 16, 2003, Toyama
reacquired all rights pertaining to garenoxacin from Bristol-Myers Squibb.
Toyama Chemical, having its priority in adopting new drug discovery
technologies, specializes in research and development. Toyama Chemical aims
to become a pharmaceutical company serving people all around the world, by
concentrating its efforts in creating novel drugs.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release
includes certain "forward-looking" statements concerning, among other things,
the market potential for garenoxacin and the prospects for regulatory
approvals in various markets. Forward-looking statements relate to
expectations or forecasts of future events. Many factors could cause actual
results to differ from Schering-Plough's forward-looking statements. These
factors include the regulatory process for approvals of new products and new
indications; product availability; the extent of market acceptance of new
indications for products; current and future branded, generic or over-the-
counter competition; governmental regulations and legislation; manufacturing
issues; trade buying patterns; and patent positions. Schering-Plough does not
assume the obligation to update any forward-looking statement. For further
details and a discussion of other risks and uncertainties that may affect
forward-looking statements, see the company's Securities and Exchange
Commission filings, including the company's first quarter 2004 10-Q.
Schering-Plough is a global science-based health care company with leading
prescription, consumer and animal health products. Through internal research
and collaborations with partners, Schering-Plough discovers, develops,
manufactures and markets advanced drug therapies to meet important medical
needs. Schering-Plough's vision is to earn the trust of the physicians,
patients and customers served by its more than 30,000 people around the world.
SOURCE Schering-Plough Corporation
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