ROBERT F' SERVICE

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ROBERT F. SERVICE Surviving the Blockbuster
Syndrome. Science 3031796, 2004 New
technologies have sent drug company RD costs
soaring, but with no corresponding rise as yet
in the number of new drugs. Executives are
talking about mergers, reorganization, and other
ways to kick-start their production engines
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Merck Announces Voluntary Worldwide Withdrawal of
VIOXXR WHITEHOUSE STATION, N.J., Sept. 30,
2004 Merck Co., Inc. today announced a
voluntary worldwide withdrawal of VIOXXR
(rofecoxib), its arthritis and acute pain
medication. The companys decision, which is
effective immediately, is based on new,
three-year data from a prospective, randomized,
placebo-controlled clinical trial, the APPROVe
(Adenomatous Polyp Prevention on VIOXX) trial.
The trial, which is being stopped, was designed
to evaluate the efficacy of VIOXX 25 mg in
preventing recurrence of colorectal polyps in
patients with a history of colorectal adenomas.
In this study, there was an increased relative
risk for confirmed cardiovascular events, such
as heart attack and stroke, beginning after 18
months of treatment in the patients taking VIOXX
compared to those taking placebo. The results
for the first 18 months of the APPROVe study did
not show any increased risk of confirmed
cardiovascular events on VIOXX, and in this
respect, are similar to the results of two
placebo-controlled studies described in the
current U.S. labeling for VIOXX. VIOXX was
launched in the United States in 1999 and has
been marketed in more than 80 countries. In some
countries, the product is marketed under the
trademark CEOXX. Worldwide sales of VIOXX in
2003 were 2.5 billion.
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Simon Frantz Pharma companies becoming more
aggressive towards generics firms Mercks
tactics with statin shows how brand companies are
upping the ante to retain market share Nature
Reviews Drug Discovery 5619,2006.
The battle between brand and generic drug
companies is becoming more fevered, reflecting
just how much revenue is at stake. Over the
next few years, more than US50
billion dollars-worth of drugs will face generic
competition in the US alone. Merck, the latest
company to face patent expiration on one of
its top-selling drugs, has taken the
most aggressive action so far by targeting the
heart of the strategy that generic companies
depend on for much of their profits.
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Figure 3. Deal distributions. Optimal deal timing
for a. pharma and b. biotech.
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FDA Investigational New Drug (IND) PH3
RESEARCH NUMBER PH-CP011 SPONSOR
PhytoHealth Corporation
(??????) RELEASE DATE 09/07/2007
Approved 14/10/2007
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Our pharmaceuticals business started its
operation in 1946 with the production of
penicillin, and has contributed to the
realization of today's long-lived society by
providing various types of anti-infectious
drugs. Over the last few years, we have expanded
our product line with medicines for the central
nervous system, winning Meiji Seika a respected
presence in the neurology and infectious disease
sectors. In these ways and more, Meiji Seika is
steadily growing as a specialty pharmaceutical
company.
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The Pharmaceutical Division's RD
activities are focused on kidney diseases, cancer
(including hematopoietic diseases), and
immune-system/allergy-related diseases. In the
field of kidney diseases, the division is
committed to the development of KRN321, which is
positioned as the second generation of the
previously commercialized "ESPO" product. Using
data supplied by Amgen, a U.S. company, the
division aims to develop KRN321 as quickly as
possible. Development is also underway of
KRN1493, a drug for the treatment of secondary
hyperparathyroidism. In the field of cancer, the
division is committed to the development of TPO,
an agent that increases the number of platelets
and that has been successfully cloned by our
company. In addition, development is underway of
drugs such as KRN7000, which is expected to
activate the immune system. In the field of
immune-system/allergy-related diseases, the
division's efforts include a joint study with the
LIAI (La Jolla Institute for Allergy and
Immunology) located in California, U.S.A.
Recently, the division has focused on studies of
human antibodies and cell-based therapeutic
vaccine. Relying on its proprietary technology,
the division successfully developed a mouse (the
TC mouse) that carries human antibody genes.
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