GlaxoSmithKline (GSK) and Targacept, Inc. announced a strategic alliance to discover, develop and market novel therapeutics that selectively target specified neuronal nicotinic receptors (NNRs).
The alliance includes Targacept's lead product candidates for pain: TC-2696, which is currently in a phase 2 trial for acute post-operative pain, and TC-6499, a preclinical product candidate that is currently planned for development for neuropathic pain. Targacept has retained an option to co-promote TC-2696 and TC-6499 for pain to specialists and hospital-based physicians in the United States.
Leveraging Targacept's more than 20 years of focused research in the NNR field, the alliance also provides GSK with access to other discovery programs across five therapeutic focus areas. In addition to pain, the other therapeutic focus areas of the alliance are smoking cessation, obesity, addiction, and Parkinson's disease.
Under the terms of the agreement, GSK will make an initial upfront payment of $35.0 million to Targacept, which includes an investment of $15.0 million for the purchase of 1,275,502 shares of Targacept common stock. In addition, Targacept is eligible to receive up to $1.5 billion in payments from GSK, contingent on the achievement of specified discovery, development, regulatory and commercial milestones across five therapeutic focus areas, as well as tiered double-digit royalties dependent on sales achieved.
In the alliance, Targacept will utilize its proprietary Pentad drug discovery technology to discover novel small molecule product candidates that target specified NNR subtypes and then would develop the most promising product candidate for each therapeutic focus area through a phase 2 proof of concept trial. Targacept is eligible to receive success-based progress milestones from GSK as product candidates are advanced. Upon Targacept's achievement of clinical proof of concept for a lead product candidate for a particular therapeutic focus area, GSK would have an exclusive option to license product candidates in development in the alliance from that program. GSK would then assume full responsibility for funding of further clinical development and commercialization on a worldwide basis.
"The breadth of this alliance validates the importance of NNRs in the potential treatment of a broad range of CNS-related disorders and diseases," said J. Donald deBethizy, Ph.D., president and chief executive officer of Targacept. "This uniquely structured deal enables us to accelerate the progression of our pipeline, capitalize on our discovery and development expertise and leverage the resources of a premier global pharmaceutical company while retaining considerable value. The alliance also aligns with our business strategy to progress our pipeline through human proof of concept and partner selectively for late-stage development and commercialization in primary care fields."
GSK will participate in the alliance through its Center of Excellence for External Drug Discovery (CEEDD). Hugh Cowley, M.D., senior vice president and head of the CEEDD said, "This alliance provides us access to innovative science and pioneering research and expertise in the promising NNR field. We believe there is tremendous potential for NNR therapeutics for a variety of CNS-related diseases and disorders, and look forward to working with Targacept to accelerate the development and delivery of new medicines to patients."
NNRs represent a new class of therapeutic targets with the potential to address significant unmet medical needs. NNRs are members of the super family of neurotransmitter-gated ion channel receptors and play a central role in modulating synaptic neurotransmission, fundamental intracellular signalling pathways, neuronal viability and synaptic architecture and function. Recent advances in NNR biology derive from an increased understanding of individual receptor subtypes, their genetic heterogeneity, and their diverse biological functions. Both preclinical and clinical evidence demonstrate the broad potential of NNRs as targets for novel therapies to treat dementia and neurodegenerative diseases, psychotic disorders such as schizophrenia, inflammatory diseases, acute nociceptive and neuropathic pain, and affective disorders such as major depression.
Targacept, a clinical-stage biopharmaceutical company, is a world leader in the discovery and development of NNR Therapeutics, a new class of drugs for the treatment of central nervous system diseases and disorders.