Artisan Pharma and Singapore-based A-Bio Pharma have established a relationship under which the Asian firm will provide process development, scale-up and manufacturing support for Artisan's investigational recombinant protein ART-123, the firms announced Sept. 17.

Under the agreement, A-Bio will "undertake the various development and validation activities necessary to ensure further clinical development and commercial supply of ART-123 for Artisan," the Waltham, Mass.-based firm said. In return, Artisan entered into a preferential and long-term supply agreement with A-Bio. Other terms of the relationship were not disclosed.

Artisan Pharma was spun off by Tokyo-based Asahi Kasei Pharma in September 2006 as a U.S. start-up with a critical care/hospital focus. It was capitalized by Series A financing of $39 million from a syndicate of venture capital firms that includes Singapore-based Bio*One Capital, which also has an interest in A-Bio.

[Editor's note: In an exclusive interview that appeared in "The Pink Sheet" DAILY, Singapore's Biomedical Sciences Group Director Yeoh Keat Chuan discussed private funding of Singapore biotechs ( ¹ Also see "Singapore Biomedical Sciences Group Director Yeoh Keat Chuan: An Interview With “The Pink Sheet” DAILY (Part 1 of 2)" - Pink Sheet, 24 January, 2007. ).]

As part of the start-up's financing, AKP licensed ART-123 to Artisan with development and commercialization rights to all pharmaceutical applications outside of Japan, China, Taiwan and Korea, where AKP retained those rights.

The mix of Western and Asian support in a Series A round is unique, Artisan CEO Jeffrey D. Wager said in an interview with "The Pink Sheet" DAILY. But, "the overwhelming differentiating feature" of the deal is that it is a top-priority product "in the pipeline of AKP that is the basis of Artisan, and that's unique, that's the first of a kind. You've never seen a top-priority compound ... being the basis for a new company that is venture capital-backed."

Artisan announced Aug. 21 that it had launched a global Phase IIb trial of ART-123 for treatment of disseminated intravascular coagulation in patients with sepsis. The multi-center, double-blind, placebo-controlled trial aims to enroll 800 sepsis patients who are at high risk of having concurrent DIC, which doubles their risk of death, Artisan said.

The primary endpoint of the study is 28-day mortality outcome compared to placebo, Wager added, noting the firm anticipates completing enrollment by the end of 2008.

AKP filed a Japanese NDA for the DIC therapy in the third quarter of 2006. The application was supported by results from a Phase III non-inferiority study that compared the effectiveness of ART-123 to heparin. The primary endpoint was resolution of DIC, which occurred in 66.1 percent of patients in the ART-123 group versus 49.9 percent in the heparin group. On the secondary endpoint of bleeding symptoms at seven days, 43.1 percent of the ART-123 group experienced bleeding, compared with 56.5 percent of the heparin group.

ART-123 is a novel, recombinant human soluble fragment of thrombomodulin that "targets both anti-coagulant and systemic anti-inflammatory pathways and holds great promise as a self-regulating treatment of DIC in sepsis," according to Artisan.

AKP and Artisan are positioning ART-123 as a first-in-class, next generation competitor to Lilly's Xigris (drotrecogin alfa), which according to Artisan had over $200 million in sales for the DIC indication in 2006. ART-123 also is being studied as a therapy for deep vein thrombosis.

Another Japanese pharma, Eisai, announced during its July 17 R&D day in Tokyo that it intends to file simultaneous U.S. and Japanese NDAs for its Xigris contender eritoran, a Toll-like receptor 4 antagonist, in 2009, seeking a claim for treatment of severe sepsis.

-Shirley Haley (s.haley@elsevier.com)

[Editor's note: Additional coverage of Asian markets is provided at ² PharmAsia News, F-D-C Reports' new beta site for Asian biotech and pharmaceutical news. To register for complimentary e-mail updates, visit ³ www.pharmasianews.com.]

Artisan, Singapore’s A-Bio Join Forces On Recombinant Sepsis Candidate

More from Archive

More from Pink Sheet