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July
2008
Dainippon S'tomo Eyes Bipolar
Indication For Schizophrenia Drug
Dainippon Sumitomo Pharma Co. has decided to conduct clinical trials on
the use of lurasidone to treat bipolar disorder. The firm is now
developing lurasidone as a promising treatment for schizophrenia. It plans
to apply to the U.S. Food and Drug Administration for marketing approval
in 2010 and to begin U.S. sales in 2012. The patents on lurasidone will
expire in 2018 -- just six years after the scheduled release date -- and
Dainippon Sumitomo Pharma would like to establish a market presence for
its product as quickly as possible. Since many schizophrenia drugs are
also prescribed for bipolar disorder, the company has decided to conduct
phase III trials on lurasidone for this treatment so that it can release
the drug for both indications from the start. Dainippon Sumitomo Pharma
will begin the phase III trials in the U.S. during or after October. (The
Nikkei Business Daily; Wednesday, July 2, 2008)
June
2008
Pharmaceutical Start-Up Wins
Fast-Track Status For Flu Vaccine
UMN Pharma Inc. on Tuesday announced that the Health Ministry granted
orphan drug status to its influenza vaccine. The pharmaceutical venture
will begin clinical trials of UMN-0501 on June 18 and expects to submit
the results in 2010 for evaluation by the ministry. It normally takes more
than a year for a drug to get through the evaluation, but the orphan drug
designation grants priority to UMN-0501 and will significantly speed up
the process. For example, the Kitasato Institute and the Research
Foundation for Microbial Diseases of Osaka University submitted an
influenza vaccine with orphan drug status in January of 2007 and received
approval in October of that year. The vaccine under development by UMN
Pharma is mass-produced in cultures of cells rather than the traditional
method of using chicken eggs. The procedure yields a vaccine in roughly
eight weeks, compared with the half year currently needed. (The Nikkei;
Wednesday, June 11, 2008)
Takiron Devises Hollow,
Biodegradable Bone-Set Screw
Takiron Co. has developed a hollow version of its biodegradable screws
used to fasten bones together when mending fractures and performing bone
transplants. The advantage of hollow screws is that they can be positioned
directly over the pin for exact placement, but until now strength has been
an issue. Takiron solved the problem and is able to make hollow screws
that are nearly as strong as the solid types by forging the starting
materials the same way a sword is forged. The new Super Fixsorb 30 line of
hollow screws is available in head diameters of 4.5 to 6.5mm and in
lengths of 30 to 90mm. Like the other Fixsorb products, the screws are
made from a 70:30 mixture of biodegradable polylactic acid and
hydroxyapatite, which promotes bone regeneration. The hollow screws are
around 80% as strong as the solid variety, so Takiron will market the
fasteners for use with bones of the ankle, pelvis and other places that do
not carry heavy loads. (The Nikkei; Thursday, June 5, 2008)
Researchers Eyeing Stem Cells
To Treat Brain Disease In Infants
Nagoya City University in June will begin research aimed at using nerve
stem cells and induced pluripotent stem, or iPS, cells to treat a type of
encephalopathy seen in some low-birth-weight infants. The study will
target periventricular leukomalacia (PVL), a malady seen in around 8% of
infants delivered at less than 33 weeks that causes cerebral palsy.
Research at the university to this point has shown that nerve cells die
when blood flow is obstructed around openings inside the brain known as
cerebral ventricles, causing motor impairments. Researchers will first
study mice and monkeys to understand the system by which the various nerve
cells in the brain are created from nerve stem cells, then work to specify
the drugs necessary for such differentiation. These drugs will be
administered to animals in which PVL is reproduced, the aim being to
regenerate the lost nerves. Plans also call for iPS cells to be
manufactured from mice and monkeys. Because patients will have nerves
derived from iPS cells for the long term, researchers will seek to develop
methods to prevent tumors from forming. (The Nikkei; Thursday, June 5,
2008)
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