Candidate inhibits cancer-treatment resistance and is being tested in multiple indications.
Teva Pharmaceutical agreed to pay OncoGenex Pharmaceuticals $110 million in the near term in exchange for global rights to the latter’s Phase III cancer therapy OGX-011. Oncogenex will receive up to $370 million if all goals including regulatory and sales milestones are met.
Under the terms of the global license, collaboration, and share purchase agreements, Teva will provide OncoGenex with a $60 million initial cash payment, which includes a $10 million equity investment in OncoGenex common stock at a price of $37.38 per share. Teva will also pay $20 million up front and $30 million as a prepayment for OncoGenex’ contribution to the development costs of OGX-011.
In addition, OncoGenex will receive tiered royalties on sales of the product. The royalty percentage will range from the mid-teens to the mid-twenties, depending upon the amount of net sales. Teva is responsible for all commercialization and development expenses. OncoGenex retains an option to co-promote OGX-011 in the U.S. and Canada.
OGX-011 is designed to inhibit the production of clusterin, a protein that is associated with cancer-treatment resistance. It is expected to be used as adjunct therapy to enhance the effectiveness of chemotherapy. Teva and OncoGenex will collaborate on a global Phase III program. Studies to evaluate its use along with first-line and second-line chemotherapy in men with metastatic castrate-resistant prostate cancer are expected to begin in 2010. Another Phase III investigation as a first-line treatment of advanced, unresectable non-small-cell lung cancer is intended to begin by early 2011.
OGX-011 has received fast-track designation from the FDA for the treatment of progressive metastatic prostate cancer in combination with docetaxel. Clusterin is a protein that is over-produced in several types of cancer and in response to many cancer treatments including hormone ablation therapy, chemotherapy, and radiation therapy. Preclinical and other data suggest that clusterin promotes cell survival, according to OncoGenex. Increased clusterin production has been linked to faster rates of cancer progression, treatment resistance, and shorter survival duration.
Teva has two additional clinical-stage oncology candidates. Phase III Stem Ex®, being developed under a joint venture with Gamida Cell, comprises cord blood-derived allogeneic stem cells. Gamida Cell’s technology enables preferential expansion of hematopoietic stem and early progenitor cells to be applied as an alternative for bone marrow transplants in patients with hematological malignancies undergoing myeloablative high-dose chemotherapy.
Teva is also studying Talampanel in a Phase II glioblastoma trial. It is believed that the compound’s ability to block AMPA receptors may act against malignant gliomas, both slowing their growth and reducing their ability to invade brain tissues.