Guilford Pharmaceuticals Inc has entered into an exclusive license agreement with Pfizer for a novel class of potential drugs called NAALADase inhibitors that have been shown in preclinical testing to ameliorate certain central and peripheral neurodegenerative diseases, such as diabetic peripheral neuropathy and neuropathic pain.
Under the terms of the agreement, Pfizer will have exclusive rights to develop Guilford's NAALADase inhibitors worldwide, and will conduct and pay for all costs associated with research, development, manufacturing, and commercialization of any products that may emerge from this agreement. Guilford retains the right to continue to conduct and pay for the development of NAALADase inhibitors not under development by Pfizer for prostate cancer, head and spinal cord injury, and drug addiction. Pfizer has the exclusive right in the future to acquire, for certain consideration, any products developed by Guilford for these indications. In exchange, Pfizer has agreed to pay Guilford $15 million in cash, including $5 million at signing, and $10 million by March 31, 2004 (or earlier depending on whether a lead compound has been selected for clinical development). If Pfizer does not pay the additional $10 million on or before March 31, 2004, rights revert to Guilford at its election, along with data and other information generated by Pfizer relating to Guilford's NAALADase inhibitors.
As part of the agreement, Guilford is eligible to receive royalties on future product sales and milestone payments related to the successful development and commercialization of a NAALADase inhibitor. The schedule of milestone payments outlines a total of $42 million to be paid for each compound developed through commercialization, as well as one additional set of milestone payments totaling $20 million for an additional indication for the same compound.
"We are very pleased to license our NAALADase inhibitor program to Pfizer, the world's leading pharmaceutical company. Pfizer has a major commitment to the fields of central and peripheral nervous system disorders," commented Craig R. Smith, Chairman, President and Chief Executive Officer of Guilford. "Our agreement with Pfizer is consistent with Guilford's objective of finding the highest-quality strategic partnerships for the programs we intend to license, while continuing to advance select product development efforts in the US independently."
Guilford has one marketed product, Gliadel Wafer, which recently received FDA approval for an expanded indication for use in patients with newly diagnosed high-grade malignant glioma as an adjunct to surgery and radiation, and a pipeline which includes two product candidates, GPI 1485 and Aquavan Injection, in Phase II clinical testing.