Targacept, AstraZeneca expand TC-5619 development program to include ADHD, Alzheimer's disease

Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics (TM), today announced an amendment to its 2005 collaboration agreement with AstraZeneca expanding the TC-5619 development program. In addition to the current development of TC-5619 in cognitive dysfunction in schizophrenia (CDS), the amended terms provide for parallel development in attention deficit/hyperactivity disorder (ADHD) and potentially Alzheimer's disease. AstraZeneca will make an $11.0 million payment to Targacept and maintain its future option to license TC-5619.

“Neuronal nicotinic receptor targeted therapeutics show great promise for addressing unmet medical need in these key disease areas”

Targacept is currently conducting a Phase 2 clinical proof of concept trial of TC-5619 in CDS. As part of the expanded TC-5619 program, Targacept expects to initiate a Phase 2 clinical proof of concept trial in adults with ADHD this month. In addition, Targacept has agreed to conduct specified clinical and non-clinical studies, and AstraZeneca has agreed to conduct other specified non-clinical studies, to support the potential advancement of TC-5619 into Phase 2 clinical development for Alzheimer's disease in the first half of 2011. A decision as to whether to conduct Phase 2 clinical development of TC-5619 for Alzheimer's disease would be made in the future. If TC-5619 has been licensed by AstraZeneca or remains subject to AstraZeneca's license option, any such development for Alzheimer's disease would be funded by AstraZeneca.

"Neuronal nicotinic receptor targeted therapeutics show great promise for addressing unmet medical need in these key disease areas," said Bob Holland, Vice President and Head of the Neuroscience Therapy Area, AstraZeneca. "Our continued collaboration with Targacept in cognitive disorders allows us to strengthen our clinical pipeline in therapeutic areas with inadequate treatment options where we remain committed to developing novel approaches."

"We expect that parallel development of TC-5619 will accelerate our ability to potentially improve the lives of countless patients," said J. Donald deBethizy, Ph.D., President and Chief Executive Officer of Targacept. "This expanded development program is a testament to the progress made to date with our longtime strategic collaborator AstraZeneca."

Under the amended terms of the agreement, AstraZeneca has an option for an exclusive license to TC-5619 for various cognitive disorders the first time that TC-5619 achieves clinical proof of concept, whether in CDS, ADHD or Alzheimer's disease. AstraZeneca may also exercise its option to license TC-5619 upon completion of the other clinical and non-clinical studies related to Alzheimer's disease if TC-5619 does not achieve clinical proof of concept in CDS or ADHD. If TC-5619 achieves clinical proof of concept and AstraZeneca does not exercise its resulting option, Targacept would retain all of its rights in the compound.

In connection with the expanded TC-5619 development program, the amendment restructures the financial terms for TC-5619 under the agreement. As restructured, AstraZeneca has agreed to make the $11.0 million current payment to Targacept described above and, if AstraZeneca exercises its license option, AstraZeneca would pay Targacept $30.0 million and assume responsibility for and fund all development and commercialization for TC-5619 beyond the currently agreed upon development program. In that event, Targacept would now be eligible to receive additional payments of up to $212.0 million, contingent upon the achievement of development, regulatory, first commercial sale and first detail milestones for TC-5619 in three indications, and would remain eligible for stepped double-digit royalties on any future TC-5619 product sales.

Targacept and AstraZeneca entered into their global collaboration agreement focused on cognitive disorders in December 2005. In addition to TC-5619, there are two other product candidates in clinical development under the agreement, AZD3480 and AZD1446, both of which target the alpha4beta2 NNR subtype. Targacept expects AstraZeneca to initiate a Phase 2b trial of AZD3480 in adults with ADHD in the second half of 2010. AstraZeneca is currently conducting a number of clinical trials of AZD1446, including, among others, a safety and tolerability study as an add-on treatment to donepezil in subjects with Alzheimer's disease and a Phase 2 study in adults with ADHD that are expected to be completed in the second half of 2010.

SOURCE Targacept and AstraZeneca