Replies to post #5024 on GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Artisan Pharma recruits director:

http://biz.yahoo.com/bw/071022/20071022006323.html?.v=1

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Gary Shearman, Ph.D. Joins Board of Artisan Pharma

Monday October 22, 2:28 pm ET

WALTHAM, Mass.--(BUSINESS WIRE)--Artisan Pharma, Inc. today announced that Gary Shearman, Ph.D. has joined the board of directors of Artisan Pharma, Inc., bringing with him more than 25 years of senior management and leadership experience in the pharmaceutical and venture capital industries.

Dr. Shearman is currently President and Chief Executive Officer of Neuro-Hitech, Inc. (www.neurohitech.com) (NASDAQ :NHPI ), a public biopharmaceutical company focused on developing innovative new drugs for the treatment of neurodegenerative diseases. He is also Chairman of the board of directors of Nereus Pharmaceuticals, Inc. (www.nereuspharm.com), a privately held biotechnology company. From 2001 – 2007, Dr. Shearman was Chairman and Managing Director of HBM Advisors USA, LLC, a provider of investment advisory services for HBM Partners (Cayman) Ltd. the investment manager for all HBM vehicles including HBM Bioventures and HBM Biocapital. Prior to his tenure at HBM, Dr. Shearman held a number of senior positions in the pharmaceutical industry, most recently as Senior Vice President of Pharmaceutical Drug Development and Deputy Head of Research and Development at Rhone Poulenc Rorer (now Sanofi-Aventis). While at Rhone Poulenc, he was intimately involved with the development of LOVENOX®, the low molecular weight heparin anticoagulant, experience which will be fully leveraged at Artisan.

Commenting on Dr. Shearman’s appointment, Jeffrey D. Wager, M.D., President and CEO of Artisan, said, “Dr. Shearman brings a unique combination of international drug development and venture capital experience which will be invaluable in guiding the development of our lead product ART-123, the building of our portfolio and the shaping our corporate strategy going forward. We are very pleased to have him join the Artisan board.”

Philippe Chambon, M.D., Ph.D., Managing Director of New Leaf Venture Partners, a key investor in Artisan, continued, “We are honored to have Dr. Shearman join our board. His tremendous clinical development expertise and management skills will be instrumental to the Company as it continues its development.”

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. Artisan licensed ART-123 from Asahi Kasei Pharma Corporation and holds all development and commercial rights for ART-123 outside of Japan, China, Taiwan and Korea.

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 Pharma, Inc.

Artisan Pharma is a biopharmaceutical company dedicated to bringing best-in-class acute care therapeutics to patients. Artisan’s strategy is to acquire clinical stage or marketed drugs and develop them for markets with clear unmet medical needs. www.artisanpharma.net
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[DewDiligence]

Artisan Pharma’s ART-123 Approved for DIC in Japan

[This is competition for ATryn obviously. There’s lots of prior discussion of ART-123 on this board, including analysis of the Japanese clinical data.]

http://biz.yahoo.com/bw/080222/20080222005073.html

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Friday February 22, 9:03 am ET

WALTHAM, Mass.--(BUSINESS WIRE)--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. Artisan licensed ART-123 from Asahi Kasei Pharma Corporation and holds all development and commercial rights for ART-123 outside of Japan, China, Taiwan and Korea.

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, Inc.

Artisan Pharma is a biopharmaceutical company dedicated to bringing best-in-class acute care therapeutics to patients.

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
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[DewDiligence]

Artisan Pharma’s Program in DIC/Sepsis

[Added item on Japanese approval.]

#msg-27043027 ART-123 approved in Japan
Paper on ART-123 Japanese study
#msg-22288440 Musings on the Japanese study

#msg-22260580 How big a threat is ART-123?

#msg-22257491 Phase-2b trial begins in US
#msg-21829339 clinicaltrials.gov listing of above trial

#msg-22972952 Production collaboration with A-Bio