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Acologix and Toray Partner on Phase III Therapeutic
for Dialysis Patients
Hayward, CA June 16, 2005 Acologix, Inc.,
a privately held biopharmaceutical company, and Toray Industries,
Inc. of Tokyo, Japan, announced that the companies have entered
into a collaboration and license agreement for Torays TRK-820
in North America and Europe. Under this agreement, Acologix is granted
an exclusive license to develop and commercialize TRK-820 in North
America. In Europe, Acologix and Toray will co-develop the compound
and Acologix retains a commercialization option. The financial terms
were not disclosed. TRK-820 is a highly selective kappa opioid receptor
agonist that has completed multiple Phase II studies for the treatment
of uremic pruritus, a severe itching condition in dialysis patients.
A pivotal Phase III study is planned to begin in Europe later this
year.
Uremic pruritus is a systemic itching condition in dialysis patients
for which there are no approved drugs and conventional anti-itch
therapies, such as antihistamines, are ineffective. Serious consequences
of uremic itch include loss of sleep, depression, skin
lesions, infections, hospitalization, and an overall reduction in
health and quality of life. As many as 50% of dialysis patients
may suffer from uremic pruritus with approximately 20% developing
severe and long-lasting effects.
Our agreement with Acologix on TRK-820 supports Torays
development effort in Europe as well as facilitates clinical studies
in North America. The problem of uremic pruritus exists on a worldwide
basis and the Toray-Acologix partnership expands the TRK-820 development
program to meet this need, stated Kozo Nagai, Director of
Pharmaceutical and Medical Products Division at Toray Industries,
Inc. Mr. Nagai further stated, We were very pleased to find
Acologix familiar with the unmet needs in the renal disease area.
Our confidence in their ability to develop TRK-820 in this field
was a strong motivator in choosing to partner with Acologix.
Developing novel therapeutics for unmet medical needs of
renal failure patients is an important component of Acologixs
corporate objectives. Our agreement with Toray strengthens Acologixs
pipeline while taking advantage of our expanding product development
expertise, stated Yoshi Kumagai, President and CEO of Acologix,
Inc. Mr. Kumagai added, Acologix is honored to work with Toray,
a company committed to innovation with significant expertise in
chemistry, pharmaceutical development and manufacturing, particularly
in kidney dialysis.
Acologix and Toray plan to submit a Marketing Authorization Application
in Europe following the completion of the planned pivotal study.
In North America, Acologix will begin discussions with regulatory
agencies to determine the appropriate development plan for product
approval. In Japan, Toray is co-developing TRK-820 with Japan Tobacco,
Inc. and Torii Pharmaceutical Co., Ltd. for uremic pruritus and
Maruho Co., Ltd. for atopic dermatitis.
About Toray Industries, Inc.
Toray, www.toray.co.jp, founded in 1926, is a diversified
chemical manufacturer with operations in 18 countries and regions.
Throughout its history, Toray has kept itself focused on research
and technological development, seeking to contribute to society
by creating new value. Underlying Torays operations is technological
expertise in the three core fields of organic synthetic chemistry,
polymer chemistry, and biochemistry. Torays operation also
diversifies into such business fields as Information and Telecommunications
Related (IT-Related) Products, Housing and Engineering, Pharmaceuticals
and Medical Products, and Advanced Composite Materials. Toray positions
its Life Sciences business, including pharmaceuticals and medical
products, as one of its strategic businesses destined for future
expansion and likely to become a nuclear business in the 21st century.
Notably, Toray was the first company to obtain approval for a human
natural interferon-ß product (Feron) and an orally active
prostacyclin (PGI2) derivative (Dorner). Feron is primarily used
to treat chronic hepatitis C, and Dorner is used to treat chronic
arterial occlusion. Toray has also established its preeminence as
a global leader in medical device products such as Filtryzer and
Toraysulfone artificial kidneys, and Toraymyxin an extra-corporeal
blood purification column for the treatment of septicemia.
About Acologix, Inc.
Acologix strives to improve patients lives by developing
and commercializing innovative biopharmaceuticals targeting osteo-renal
(bone and kidney) diseases. Acologixs substantial expertise
in identifying and developing therapeutics with unique mechanisms
of action (such as mineral metabolism sciences) is key to solving
major kidney and bone health problems. Chronic kidney failure, renal
osteodystrophy, orthopedics, periodontal disease, general dentistry
and oral care represent significant underserved medical needs. Acologix
is unique in its focus on these rapidly growing health care problems.
Acologix has recently announced the start of enrollment in two Phase
II studies in Europe and the United States for the repair of periodontal
defects and in dental restorations, respectively, using AC-100 (Dentonin®).
Acologix is also developing Phosphatonin to treat hyperphosphatemia
and its subsequent clinical problems in chronic kidney disease.
This press release contains forward-looking statements.
These statements involve risks and uncertainties, which may cause
results to differ materially from those set forth in the statements.
The forward-looking statements include statements regarding product
development and cannot be guaranteed. Acologix undertakes no obligation
to publicly update any forward-looking statement, whether as a result
of new information, future events, or otherwise. Forward-looking
statements in this press release should be evaluated together with
the many uncertainties that affect Acologixs business.
Company Contact
Yoshi Kumagai
President and CEO
Phone: 510.512.7200
Fax: 510.786.1116
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