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Artisan Pharma's Lead Product, ART-123,
Approved in Japan
(Waltham, MA, February 22, 2008) - Artisan Pharma, Inc. today
announced that the Japanese Pharmaceutical and Medical Device
Agency approved Artisan's lead drug, ART-123 (human, soluble,
recombinant thrombomodulin), on January 25, 2008 for the
treatment of disseminated intravascular coagulation ("DIC") in
Japan.
The approval of ART-123, which was received by Artisan's partner
and licensor of ART-123, Asahi Kasei Pharma Corporation ("AKP"),
further establishes AKP as a leader in biologic pharmaceutical
product development.
Commenting on the Japanese approval of ART-123, Jeffrey D.
Wager, M.D., President and CEO of Artisan, said, "We heartily
congratulate our partner AKP on this significant achievement.
This approval comes at an excellent time for Artisan, as we
continue our multinational, 800-patient Phase 2b trial in DIC,
and have also just initiated an effort for seeking corporate
partners in select markets for ART-123. The Japanese approval of
ART-123 should provide partnering candidates with added
confidence on the commercial viability of ART-123 in additional
worldwide markets."
Kei Oe, President of Asahi Kasei Pharma Corporation ("AKP"),
continued, "AKP is a pharmaceutical company researching and
developing new drugs for unmet needs by employing novel drug
discovery technology. Through its strengths in drug discovery
and drug development, AKP is pleased to have successfully
developed the world's first human recombinant thrombomodulin.
AKP has provided Artisan with technology and information, and it
is confident that Artisan, too, will meet with success in its
development of ART-123 focused in the US and the EU."
Hironori Hozoji, Investment Officer for JAFCO Life Science
Investment which is a wholly owned subsidiary of JAFCO Co.,
Ltd., Japan's largest venture capital investor and a key
shareholder in Artisan, had these comments, "We congratulate AKP
on a successful development and regulatory submission program
involving ART-123 in Japan. We are expecting that this approval
will further accelerate interest on the part of Western
physicians to participate in Artisan's Phase 2b trial and also
fuel interest on the part of potential corporate partners."
Artisan Pharma was formed as result of a partnership between
Asahi Kasei Pharma Corporation and NGN Capital as the lead
investor in a syndicate with JAFCO, New Leaf Venture Partners,
Bio*One Capital and Novaquest (Quintiles). Artisan's strategy is
to acquire clinical stage or marketed drugs and develop them for
markets with clear unmet medical needs.
www.artisanpharma.net
About ART-123
ART-123 is a novel, recombinant, soluble thrombomodulin for the
treatment of DIC (disseminated intravascular coagulation) in
sepsis. ART-123 uniquely targets both anti-coagulant and
systemic anti-inflammatory pathways, and holds great promise as
a self-regulating treatment of DIC inWaltham, MA, February 22,
2008) - Artisan Pharma, Inc. today announced that the Japanese
Pharmaceutical and Medical Device Agency approved Artisan's lead
drug, ART-123 (human, soluble, recombinant thrombomodulin), on
January 25, 2008 for the treatment of disseminated intravascular
coagulation ("DIC") in Japan.
The approval of ART-123, which was received by Artisan's partner
and licensor of ART-123, Asahi Kasei Pharma Corporation ("AKP"),
further establishes AKP as a leader in biologic pharmaceutical
product development.
Commenting on the Japanese approval of ART-123, Jeffrey D.
Wager, M.D., President and CEO of Artisan, said, "We heartily
congratulate our partner AKP on this significant achievement.
This approval comes at an excellent time for Artisan, as we
continue our multinational, 800-patient Phase 2b trial in DIC,
and have also just initiated an effort for seeking corporate
partners in select markets for ART-123. The Japanese approval of
ART-123 should provide partnering candidates with added
confidence on the commercial viability of ART-123 in additional
worldwide markets."
Kei Oe, President of Asahi Kasei Pharma Corporation ("AKP"),
continued, "AKP is a pharmaceutical company researching and
developing new drugs for unmet needs by employing novel drug
discovery technology. Through its strengths in drug discovery
and drug development, AKP is pleased to have successfully
developed the world's first human recombinant thrombomodulin.
AKP has provided Artisan with technology and information, and it
is confident that Artisan, too, will meet with success in its
development of ART-123 focused in the US and the EU."
Hironori Hozoji, Investment Officer for JAFCO Life Science
Investment which is a wholly owned subsidiary of JAFCO Co.,
Ltd., Japan's largest venture capital investor and a key
shareholder in Artisan, had these comments, "We congratulate AKP
on a successful development and regulatory submission program
involving ART-123 in Japan. We are expecting that this approval
will further accelerate interest on the part of Western
physicians to participate in Artisan's Phase 2b trial and also
fuel interest on the part of potential corporate partners."
Artisan Pharma was formed as result of a partnership between
Asahi Kasei Pharma Corporation and NGN Capital as the lead
investor in a syndicate with JAFCO, New Leaf Venture Partners,
Bio*One Capital and Novaquest (Quintiles). Artisan's strategy is
to acquire clinical stage or marketed drugs and develop them for
markets with clear unmet medical needs. www.artisanpharma.net
About ART-123
ART-123 is a novel, recombinant, soluble thrombomodulin for the
treatment of DIC (disseminated intravascular coagulation) in
sepsis. ART-123 uniquely targets both anti-coagulant and
systemic anti-inflammatory pathways, and holds great promise as
a self-regulating treatment of DIC in sepsis. A regulatory
submission for approval of ART-123 in the treatment of DIC has
been filed in Japan. Artisan holds all development and
commercial rights for ART-123 outside Japan, China, Taiwan and
Korea, and has initiated an 800 patient, multinational, Phase 2b
trial in DIC in sepsis.
About DIC in Sepsis
Almost 2 million patients in the United States and Europe suffer
from sepsis annually, with up to 30% of them developing or being
at high risk of developing DIC. For those that do, prognosis is
poor. DIC is a severe condition in which widespread microthrombi
formation ultimately contributes to organ dysfunction and death.
This market is estimated at over $2 billion and is increasing
due to the growing incidence of sepsis in the industrialized
world.
About Artisan's ART-123 Phase 2b Trial in DIC in Sepsis
The phase 2b study entitled "A Randomized, Double-Blind,
Placebo-Controlled, Phase-2b Study to Assess the Safety and
Efficacy Effects of ART-123 on Subjects with Sepsis and
Disseminated Intravascular Coagulation" will enroll 800 subjects
in over 140 sites worldwide. For further information please
refer to http://clinicaltrials.gov/
About Artisan Pharma
Artisan Pharma is a biopharmaceutical company dedicated to
bringing best-in-class acute care therapeutics to patients.
http://www.artisanpharma.net
About Asahi Kasei Pharma Corporation
Asahi Kasei Pharma, headquartered in Tokyo, Japan, is a
research-based healthcare innovator that discovers, develops,
manufactures, and markets products for the pharmaceutical,
pharmaceutical intermediate, diagnostics,
biopharmaceutical/biological filtration, medical device, medical
nutrition, and contact lens markets. Asahi Kasei Pharma is a
wholly owned business unit of Asahi Kasei Corporation, a US$13
billion technology company that provides innovative,
science-based solutions to a diverse range of markets including
chemicals and plastics, apparel, housing and construction,
healthcare, and electronics. For additional information, visit
www.asahi-kasei.co.jp.
About JAFCO
Founded in 1973, JAFCO is managing approximately $5 billion in
46 investment funds globally through its offices in Japan, North
America, China, South Korea, Singapore, Taiwan and other parts
of the world. The charter of JAFCO is to invest in U.S. based
early and later stage biopharmaceutical and medical device
companies and create significant values of investee companies
through partnerships with Japanese companies. www.jafco.co.jp.
Media Contact
Jennifer Greenleaf, MacDougall Biomedical Communications, (508)
647-0209
For Artisan Pharma: Jeffrey D. Wager, M.D., (781) 419-1920
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