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SANTEN BEGINS CLINICAL TRIALS WITH OAKWOOD-MANUFACTURED PRODUCT
CLEVELAND, OHIO – November 20, 2007 –Santen Pharmaceutical Co., Ltd., of Osaka,
Japan has commenced Phase 1/2a human trials of its steroidal treatment for
macular edema (development code named “DE-102”) using Oakwood Laboratories’
CHRONIJECT™ sustained release delivery technology, Oakwood announced today. The
product’s microsphere formulation as well as sterile filling was accomplished at
Oakwood’s Cleveland manufacturing facility.
Among patients with diabetes, macular edema is the most common cause of visual
impairment.
"Oakwood is very pleased to have been able to solve some difficult technical
issues in order to bring this product to commercial manufacturing scale, and to
the point of clinical use," said Mark Smith, Oakwood's President. “We look
forward to the continued development of this product.”
Retinal disease is an important area of research and development for Santen. The
company expects DE-102 will improve patients’ quality of life, as well as
enhance its pipeline of products in this area.
Oakwood Laboratories’ proprietary CHRONIJECT™ technology has been shown to offer
an adaptable and easily scaleable system for the development and manufacture of
injectable sustained release dosage forms of multiple drug classes. A distinct
benefit of the technology is its ability to offer customizable release profiles
as well as control of the duration of delivery. It can also be used to target
therapy to specific areas of the body.
Santen Pharmaceutical Co., Ltd., founded in Osaka, Japan in 1890, specializes in
the research, development, production and marketing of ophthalmic and
anti-rheumatic pharmaceuticals and surgical devices. Among prescription
ophthalmic pharmaceuticals, Santen holds the top share within the Japanese
market and is one of the leading ophthalmic companies worldwide. Santen has
subsidiaries in the U.S., Europe and Asia, including its wholly-owned Napa,
California-based Santen Inc.
Oakwood Laboratories, L.L.C., is an emerging specialty pharmaceutical company
focused on advanced injectable drug delivery. Its first technology platform,
CHRONIJECT™, is a sustained release microsphere formulation that enables a
single injection to deliver drug for periods ranging from one week up to one
year. Oakwood is currently using this patented technology to develop a portfolio
of proprietary products in a variety of therapeutic areas, including oncology,
endocrinology, CNS, dermatology and ophthalmology. Oakwood also partners with
pharmaceutical and biotechnology companies to apply its drug delivery technology
to new chemical entities or to extend the patent life of existing products. The
company has recently completed an aseptic manufacturing facility for the
production of clinical and commercial supplies of products employing CHRONIJECT™
technology, as well as other liquid and lyophilized parenteral pharmaceuticals
for contract customers.
Oakwood Laboratories, L.L.C. is located at:
7670 First Place, Oakwood Village, Ohio 44146
Telephone: (440) 359-0000 Fax: (440) 359-0001
Web: www.oakwoodlabs.com
Contact at Oakwood Laboratories
Mark T. Smith
(440) 359-0000
msmith@oakwoodlabs.com
PR Contact at R.H. Blake, Inc.
Bruce Blake
(216) 595-2400
brb@rhblake.com
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