CuraGen and TopoTarget A/S Announce License and Collaboration Agreement for Novel Phase I HDAC Inhibitor for Oncology

04-Jun-2004

New Haven. and Copenhagen - CuraGen Corporation and TopoTarget A/S, announced a license and collaboration agreement to develop and commercialize PXD101, a novel histone deacetylase (HDAC) inhibitor for the treatment of solid and hematological cancers.

PXD101 is currently in a Phase I clinical trial in patients with advanced solid tumors and is one of the most advanced HDAC inhibitors in development. HDAC inhibitors are a new class of potential anti- cancer agents that have shown promise in preclinical and clinical studies. The two companies will also work together to identify additional candidates from TopoTarget's extensive HDAC inhibitor library for clinical development in the treatment of cancer and inflammatory diseases.

Under the terms of the agreement, CuraGen is acquiring exclusive rights to develop, and commercialize PXD101 in North America, Asia and all other markets excluding Europe. TopoTarget will retain commercialization rights in Europe. TopoTarget is expected to receive: a $5 million equity investment; $5 million in license fees; up to $10 million within the next 12 months in milestones and research support; $4 million over the subsequent 24 months in research support; and up to $27 million in additional milestone payments based on successful development, regulatory approval, and commercialization of PXD101. TopoTarget is expected to receive royalties from CuraGen based on sales of PXD101 outside of Europe, and CuraGen is expected to receive reciprocal royalties from TopoTarget based on sales of PXD101 in Europe. CuraGen will fund the global development of PXD101. In addition, CuraGen has an option to select additional HDAC compounds from TopoTarget for clinical development in oncology and other indications for a take-up fee not to exceed $1 million and up to $30 million in milestone payments based on successful development, regulatory approval, and commercialization of each additional product. TopoTarget has the option to fund a portion of the global development of PXD101 and additional products in exchange for higher royalties. Potential payments to TopoTarget from CuraGen based on the successful development and commercialization of PXD101 and 2 additional HDAC inhibitor products could exceed $100 million. As a result of CuraGen's collaboration with TopoTarget, CuraGen expects to increase its 2004 operating cash burn by $8 to $12 million from its previously provided guidance.

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"HDAC inhibitors are one of the most exciting new mechanistic approaches being developed for cancer today. PXD101 is a promising new compound that has the potential to play a role in several types of cancers," stated Vincent T. DeVita, Jr., MD, Director of CuraGen Corporation, Amy and Joseph Perella Professor of Medicine of Yale Cancer Center and Yale School of Medicine, and past Director of the National Cancer Institute (NCI).

"PXD101 is a good fit for CuraGen given our expertise, evolving pipeline in oncology, and the clinical development momentum we are building," stated Timothy Shannon, M.D., CuraGen's Executive Vice President and Chief Medical Officer. "We hope to further accelerate this program, as well as our other programs, through the application of genomics to identify biomarkers, select appropriate patients, measure response and further improve the efficiency of our clinical development process."

A growing body of research highlights the role of histone deacetylases (HDAC) in regulating gene expression, particularly the expression of cancer- related genes. HDAC inhibitors represent a new mechanistic class of anti- cancer therapeutics that target HDAC enzymes, and have been shown to: arrest growth of cancer cells (including drug resistant subtypes); induce apoptosis, or programmed cell death; promote differentiation; inhibit angiogenesis; and sensitize cancer cells to overcome drug resistance phenotype when used in combination with other anti-cancer agents. HDAC inhibitors are believed to play a role in a wide range of solid malignancies such as breast, colon, lung and ovarian cancers, and hematological malignancies, such as lymphomas, leukemias and myeloma. The current global oncology therapeutic market is estimated to be worth over $20 billion.

TopoTarget is a British/Danish biopharmaceutical company dedicated to the discovery, development and clinical progression of new and improved therapeutics for the cancer patient. The Company results from the merger of TopoTarget A/S, the Danish oncology company and Prolifix Ltd, the UK-based cell cycle company. TopoTarget has three products in its clinical pipeline including TopoTect(R) which is in Phase III clinical trials for the prevention of severe tissue damage following accidental chemotherapeutic extravasation. TopoTect(R)/etoposide co-therapy for treating brain metastasis and its proprietary HDAC inhibitor PXD101.

CuraGen Corporation is a genomics-based pharmaceutical company dedicated to improving the lives of patients by developing a pipeline of novel protein, antibody, and small molecule therapeutics in the areas of oncology, inflammation, obesity and diabetes, and central nervous system disorders.

http://www.topotarget.com.

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