Photogen Technologies Licenses Imagent(R) In Japan to Kyosei Pharmaceutical Co.
2003年12月17日 - 10:00PM
PRニュース・ワイアー (英語)
Photogen Technologies Licenses Imagent(R) In Japan to Kyosei
Pharmaceutical Co. SAN DIEGO, Dec 17 /PRNewswire-FirstCall/ --
Photogen Technologies, Inc. announced today that it has entered
into an agreement with Kyosei Pharmaceutical Co., Ltd., a unit of
Sakai Group, for Kyosei to develop and market Imagent(R)
(perflexane lipid microspheres) for all indications in Japan.
Imagent is Photogen's ultrasound imaging agent that has previously
received FDA approval. Terms of the agreement call for the payment
to Photogen of up to $10 million in fees and development milestone
payments plus royalties on commercial sales. Kyosei will also pay
Photogen to manufacture Imagent for Kyosei's clinical and
commercial requirements. "We are very pleased to complete this
agreement with Kyosei, a highly respected company both developing
and marketing imaging pharmaceuticals in Japan," said Taffy J.
Williams, Ph.D., President and Chief Executive Officer of Photogen.
Dr. Williams continued, "The Japanese market has significant
potential, and Kyosei has the development and marketing
capabilities to rapidly capitalize on this opportunity." "We are
very pleased that we can introduce IMCOR's excellent product into
Japan," said Shigeharu Higuchi, President of Kyosei Pharmaceutical.
"The field of ultrasound imaging in Japan is expected to rapidly
increase with the use of new diagnostic imaging agents. We believe
that this will benefit the marketing efforts of Kyosei and IMCOR in
the future as well as medical practice in Japan." Imagent will be
developed in Japan for radiology and cardiology indications. The
product has been approved for marketing in the US for use in
patients with suboptimal echocardiograms to opacify the left
ventricle and thereby improve visualization of the main pumping
chamber of the heart, and to improve delineation of the endocardial
borders of the heart. About Photogen Photogen Technologies, Inc.
markets a platform of innovative imaging products led by Imagent(R)
(perflexane lipid microspheres), an FDA approved ultrasound imaging
product. Photogen's development programs use a versatile iodinated
nanoparticulate formulation that shows promise as a subcutaneous,
intravenous or intra-arterial agent for both cardiovascular imaging
and lymphography (the diagnosis of cancer metastasizing to lymph
nodes). PH-50, which is entering Phase 1 clinical studies, has
potential benefits when used with conventional or computed
tomography (CT) angiography to address the need for early detection
of coronary artery disease, cancer and other diseases affecting the
body's arteries and organs. N1177, which is entering Phase 2
clinical studies, has potential applications for the diagnosis and
staging of cancers such as breast, prostate, lung, melanoma,
uterine, cervical, and head and neck cancer. About Imagent
Imagent(R) (perflexane lipid microspheres), has been approved for
marketing by FDA for use in patients with suboptimal
echocardiograms to opacify the left ventricle and thereby improve
visualization of the main pumping chamber of the heart, and to
improve delineation of the endocardial borders of the heart. As a
result, ultrasound with Imagent may better distinguish normal and
abnormal heart structure and function - two critical indicators of
cardiac health. Echocardiography is the most widely used imaging
modality for the diagnosis of heart disease, the leading cause of
death in the U.S. The incidence of heart disease is increasing due
to shifts in demographics toward an older population and an
increase in obesity. An estimated 17.5 million echocardiograms were
performed last year in the U.S., of which up to 20% produced
suboptimal images, primarily due to the patient's size or body
structure. Imagent is manufactured from synthetic materials, and
packaged as a dry powder in a ready-to-use kit that is stored at
room temperature. The powder is reconstituted with water to form an
osmotically stabilized suspension of microscopic spheres, or
"microspheres", containing a perfluorochemical (perflexane) vapor
and physiologic gases. Imagent is then injected intravenously into
a patient undergoing a cardiac ultrasound exam. Imagent has no
known contraindications; however, the product should be
administered with caution to patients with cardiac shunts or severe
pulmonary vascular disease. The overall incidence of adverse events
is similar to that of placebo (saline), and adverse events
occurring with a low frequency included headache, hypertension, and
nausea. Imagent is manufactured using a proprietary technology. A
series of patents has been issued covering methods of forming
stable microsphere formulations, spray-drying processes to make a
powder that facilitates product shipping and storage, methods of
using contrast agents in conjunction with conventional and harmonic
ultrasound, and related technologies. Additional patent
applications are pending in the U.S. and elsewhere. Statements in
this release that are not strictly historical are "forward-
looking" statements made pursuant to the safe harbor provision of
the Private Securities Litigation Reform Act of 1995.
Forward-looking statements involve known and unknown risks that may
cause Photogen's actual results in the future to differ materially
from expected results. These risks and uncertainties include the
ability of the company to: obtain necessary financing to support
its development and commercialization programs, maintain and defend
intellectual property protection for its proprietary products,
avoid infringing intellectual property rights of third parties,
successfully market its approved product, develop additional
products and obtain regulatory approval for their use, and
manufacture or obtain supplies of drug product. These and other
risks are described and qualified in their entirety by cautionary
language and risk factors set forth in the company's filings from
time to time with the Securities and Exchange Commission. Brooks
Boveroux, CFO Photogen Technologies, Inc. (858) 410-5601 Brian
Ritchie EURO RSCG Life NRP (212) 845-4269 DATASOURCE: Photogen
Technologies, Inc. CONTACT: Brooks Boveroux, CFO of Photogen
Technologies, Inc., +1-858-410-5601; or Brian Ritchie of EURO RSCG
Life NRP, +1-212-845-4269, for Photogen Technologies, Inc.
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