6:02AM Oncothyreon and Array (ARRY) announce collaboration to develop and commercialize anti-HER2 compound ARRY-380 (ONTY) 1.90 : Co and Array BioPharma (ARRY) announced that they will collaborate to develop and commercialize ARRY-380, an orally active, reversible and selective small-molecule HER2 inhibitor. HER2, also known as ErbB2, is a receptor tyrosine kinase that is over-expressed in breast cancer and other cancers such as gastric and ovarian cancer. Oncothyreon has agreed to pay Array an upfront fee of $10 mln upon initiation of the collaboration.Oncothyreon will fund and conduct the clinical development of ARRY-380 through a defined set of combination proof-of-concept trials in patients with metastatic breast cancer, including patients with brain metastases. ARRY-380 has demonstrated superior activity, based on overall survival, compared to Tykerb (lapatinib) and to the investigational drug, neratinib, in an intracranial HER2+ breast cancer xenograft model. This provides a strong rationale to explore whether ARRY-380 can provide benefit to patients with brain metastases, which occur in ~ one-third of women with metastatic HER2+ breast cancer.
The cos intend to jointly conduct Phase 3 development supported by the proof-of-concept studies, with each party retaining the right to opt out of further development and commercialization in exchange for a significant royalty. Array is responsible for worldwide commercialization of the product. Oncothyreon has a co-promotion right in the U.S., and the two cos will share the cost of U.S. commercialization, including any profit, equally. Outside of the U.S., Oncothyreon will receive a double-digit royalty on net sales intended to ~ a 50% profit share, and the two cos will share equally the proceeds from any sublicense of marketing rights.
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