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Eisai Invests in Development of Personalized Cancer Rx via Stake in Biotech Startup

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By Turna Ray

With a $200 million investment, Japanese drug developer Eisai last week launched a US-based personalized medicine subsidiary called H3 Biomedicine that will apply genetics and novel chemistry to develop tailored cancer treatments.

Based in Cambridge, Mass., H3 Biomedicine "will undertake a comprehensive approach to breakthrough oncology treatments based on two primary principles: 1) the genetics of patients’ cancers can reveal drug targets tailored to their cancers; and 2) the advances in modern chemistry enable the discovery of new classes of safe and effective drugs against these targets," Eisai said in a statement.

In addition to the $200 million to kickstart H3 Biomedicine's research efforts, Eisai said it will also support the clinical development of H3 Biomedicine programs. According to a spokesperson from Eisai, H3 Biomedicine will have the freedom to pursue its own research efforts. However, it will also have access to Eisai’s resources and product portfolio as a starting point for advancing its R&D activities into personalized cancer drugs.

Kentaro Yoshimatsu, chief scientific officer of Eisai Product Creation Systems, will serve as the president of H3 Biomedicine. Clinical efforts at the startup will be guided by Stuart Schreiber and Todd Golub, who are both founding members of the Broad Institute.

Schreiber also serves as Morris Loeb Professor of Chemistry and Chemical Biology at Harvard University and is an investigator at the Howard Hughes Medical Institute. Golub, who is also an investigator at the Dana-Farber Cancer Institute, "has pioneered the use of genomic approaches to cancer biology and cancer drug discovery," Eisai noted.

"Eisai will not direct the science at H3 Biomedicine. H3 Biomedicine is an independent entity that will have the scientific freedom to choose and follow targets it identifies using genomic insights and modern chemistry, coupled with a disciplined approach to drug discovery and development," Suzanne Grogan, Eisai's associate director of US communications, told PGx Reporter.

In its goal of advancing personalized cancer drugs, H3 Biomedicine will use genomics, bioinformatics, and advances in small-molecule science to map the unique features of different types of cancer and develop treatments targeting these characteristics. Eisai is hoping that a biomarker-driven drug development paradigm will shorten clinical development timelines and reduce costs.

"H3 Biomedicine will possess its own resources and capabilities to operate as an independent company, while also being able to collaborate with Eisai on clinical-stage programs, should both companies desire to do so," Grogan said. She added that if H3 Biomedicine identifies "interesting targets that could be investigated by using or repurposing molecules existing within Eisai, then H3 will have the opportunity to investigate and develop these molecules further."

However, "the commercialization of companion tests is currently out of scope of H3 Biomedicine," Grogan said.

According to Eisai, its affiliation will enable H3 Biomedicine to take "a longer-term view of its drug discovery activities than is typical of many venture-backed startup companies," and will draw on the strengths of both biotech and pharma.

"H3 Biomedicine will draw on the experience and expertise of its scientific founders/advisors and its staff to take a disciplined approach to analyze and utilize cancer genomics and bioinformatics, and then apply modern chemistry to create small molecules and eventual medicines," Grogan said. "In addition, H3 Biomedicine will collaborate with the Biomarker and Personalized Medicine Core Function Unit of Eisai Product Creation Systems. The BPM-CFU has proteome, transcriptome, metabolome and imaging technologies."

Eisai is a drug developer focused on advancing treatments for unmet medical needs. The firm noted that H3 Biomedicine will strengthen this existing commitment.

Formed in 1995, Eisai launched its first product in the US in 1997. For the fiscal year ended March 31, 2010, Eisai netted sales of $3.9 billion. The Tokyo-based firm employs 11,000 people worldwide and has R&D facilities in Maryland, Massachusetts, New Jersey, North Carolina, and Pennsylvania, as well as manufacturing facilities in Maryland and North Carolina.

The company already has a strong focus in oncology. In terms of its collaboration with H3 Biomedicine, the cancer areas pursued by the startup "will only be limited by the availability of scientific knowledge," Grogan said.

Among Eisai's marketed oncology products are: Dacogen, an injection to treat myelodysplastic syndromes; Gliadel for newly-diagnosed high-grade malignant glioma patients as an adjunct to surgery and radiation; Halaven for metastatic breast cancer patients who have received at least two other anticancer agents; Ontak for persistent or recurrent cutaneous T-cell lymphoma expressing CD25 in IL-2 receptors; and Targretin to treat skin problems associated with cutaneous T-cell lymphoma.

Last year, Eisai reported at the American Society of Clinical Oncology's annual meeting Phase III results involving the metastatic breast cancer treatment eribulin mesylate compared to any treatment of the physician's choice. In that trial, eribulin mesylate improved median overall survival compared to alternatives, 13.12 months versus 10.65 months.

Also last year, Eisai announced preliminary results from a Phase III study comparing Dacogen to low-dose chemotherapy or supportive care in elderly patients with acute myeloid leukemia. Based on preliminary analysis, Dacogen injection did not reach statistically significant superiority over the control arm.

Last September, Eisai subsidiary Morphotek announced that it had selected a monoclonal antibody to advance with Human Genome Sciences. Under the terms of the deal, which is focused on the areas of oncology and immunology, Morphotek and HGS will discover and commercialize antibodies that target antigens discovered by HGS.

Outside of this collaboration with HGS, Morphotek is also studying MORAb-028, an IgM-type monoclonal antibody in advanced melanoma, among other investigational oncologics.

Beyond oncology, Eisai also has a strong R&D focus in the area of neuroscience, vascular, inflammatory and immunological reactions, as well as antibody-based programs. The firm's marketed products include Aricept, a drug for treating all stages of dementia due to Alzheimer's disease; Aciphex, a proton pump inhibitor for reducing stomach acidity; Banzel, an adjunctive treatment for seizures due to Lennox-Gastaut syndrome in adults, kids four years of age, or older; the heparin Fragmin for treating complications due to angina, deep vein thrombosis, and symptomatic venous thromboembolism; and other treatments.


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