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Agreements

Date: 2011-02-25

Type of information: R&D agreement

Compound: companion diagnostic tests in the prevention and treatment of prostateand breast cancers, neuro-endocrine tumors (NETs) and pituitary tumors

Company: Ipsen (France) bioMérieux (France)

Therapeutic area: Cancer - Oncology

Type agreement:

R&D

Action mechanism:

Disease: prostate cancer, breast cancer, neuro-endocrine tumors, pituitary tumors

Details:

Ipsen and bioMérieux have entered into a partnership to create a global collaboration in theranostics, with a focus on hormone-dependent cancers. The two companies have signed a framework agreement to leverage their expertise and resources to develop a personalized approach to medicine based on Ipsen’s broad portfolio of innovative compounds and bioMérieux’s diagnostic tests. Both companies will jointly identify programs that would benefit from the co-development of a therapeutic and a companion diagnostic test, notably in the prevention and treatment of prostate and breast cancers, neuro-endocrine tumors (NETs) and pituitary tumors. The two companies are already partners since September 2007 to develop a companion diagnostic for the breast cancer therapy BN 83495. This molecule is a selective inhibitor of he steroid sulfatase enzyme (STS) involved in the biosynthesis of estrogen. Ipsen indicates that an initial phase I clinical trial among patients has been completed and the results demonstrate that the enzyme sulfatase is inhibited in tumor biopsies at the tested doses. A second phase I study has determined the optimal dose of BN 83495 in postmenopausal patients with advanced breast cancer expressing hormone receptors. During this second phase I trial, close to complete inhibition (95%) of the target enzyme in peripheral blood mononuclear cells was obtained at a dose of 40 mg. A phase II program is currently underway in advanced endometrial cancer. A first study is exploring the safety and efficacy of BN 83495 compared to megestrol acetate on progression free survival in post menopausal patients with endometrial cancer. A second study aims to determine the effect of BN83495 on the progression of endometrial cancer with estrogen receptor in post menopausal women who had previously received chemotherapy. The third one is a biomarker study to assess the intratumoral pharmacological activity of BN83495 by changes in intratumoral levels of sex hormones and associated inhibition of steroid sulphatase (STS) activity. A pilot program in advanced prostate cancer is also underway.

Financial terms:

Financial details were not disclosed.

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