TOKYO and KENILWORTH, N.J., March 31 /PRNewswire-FirstCall/ -- Toyama
Chemical Co. Ltd. and Schering Corporation, a unit of Schering-Plough
Corporation (NYSE: SGP), announced today that they have entered into a letter
of intent regarding garenoxacin (Code No. T-3811), Toyama's proprietary
quinolone antibacterial agent. Under the proposed transaction, Toyama will
grant to Schering-Plough exclusive rights to develop, use and sell garenoxacin
worldwide, excluding Japan, Korea and China. The parties hope to negotiate
and execute definitive agreements regarding the transaction within the next
few months.
"Schering-Plough looks forward to working with Toyama to conclude this
agreement and making this new antibiotic available to medical practitioners in
many major world markets," said Fred Hassan, Schering-Plough chairman and
chief executive officer. "The addition of this therapy would serve to broaden
the anti-infective portfolio we are developing, which includes NOXAFIL(R)
(posaconazole), an antifungal agent in development for serious fungal
infections. This planned agreement is in line with our strategy to build
strength in our global franchises through internal development and fiscally
sound licensing, key elements in our five-stage Action Agenda to transform
Schering-Plough."
Katsuhiko Nakano, president and CEO of Toyama Chemical, stated, "Toyama's
original compound, T-3811, is a potent drug, having shown favorable efficacy
and safety properties compared to other antibiotic agents in its Phase III
clinical trials. Garenoxacin is one of the main pillars that will support the
future of Toyama, and we are very pleased to enter into this letter of intent
with Schering-Plough. Toyama has research efforts in the antifungal and
antiviral fields, and we wish to continue our good relationship with
Schering-Plough hereafter. Through our collaboration with Schering-Plough we
feel that we are able to come closer to fulfilling our goal 'to support health
and contribute to an active life in good health for all.'"
Under the terms contemplated by the letter of intent, Toyama would receive
a payment from Schering-Plough of $80 million upon definitive agreements being
reached and becoming effective. Schering-Plough would expense this amount at
that time, which the company expects to occur in the second quarter of 2004.
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. The closing of the definitive agreements
will be subject to the satisfaction of certain conditions.
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 needed by 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 concluding
definitive agreements with Toyama Chemical. Forward-looking statements relate
to expectations or forecasts of future events. Please carefully consider any
forward-looking statement and understand that many factors could cause actual
results to differ from Schering-Plough's forward-looking statements. The
reader of this release should understand that there are no assurances that
garenoxacin will receive regulatory approval, which is subject to the
substantial risks and uncertainties inherent in the drug approval process for
new products and indications. The reader of this release should also
understand that the extent that garenoxacin will be prescribed, if approved,
will be determined by market forces, and the viability of the product is
subject to substantial risks and uncertainties. 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 2003 10-K.
Schering-Plough is a research-based company engaged in the discovery,
development, manufacturing and marketing of pharmaceutical products worldwide.
SOURCE Schering-Plough Corporation
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