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AstraZeneca and Targacept Initiate Phase 2b Clinical Trial of TC-5214 as a Switch Monotherapy Treatment for Major Depressive Disorder

In the Phase 2b study, patients with MDD who do not respond adequately, based on predefined criteria, to initial open label treatment with one of six commonly used SSRI or SNRI antidepressants will be switched to receive either one of two fixed doses of TC-5214, the active control duloxetine or placebo. Dosing in this double blind phase of the study is twice daily for eight weeks. The primary outcome measure for the study is change from double-blind baseline at the end of the dosing period for TC-5214 on the Montgomery-Asberg Depression Rating Scale (MADRS) as compared to placebo. The study is projected to enroll approximately 350 patients into the double blind phase from approximately 75 centers worldwide.

About TC-5214

Recent scientific evidence suggests that depressive symptoms are associated with an overstimulation of neuronal nicotinic receptors (NNRs) and other receptors in the brain that are activated by the neurotransmitter acetylcholine. This overstimulation is referred to as increased cholinergic tone. TC-5214 modulates the activity of certain NNRs, which is believed to help normalize cholinergic tone resulting in antidepressant effects.

In 2010, AstraZeneca and Targacept initiated the RENAISSANCE Program, a group of Phase 3 double blind, placebo controlled studies designed to assess the safety and efficacy of TC-5214 as an adjunct treatment in patients with MDD who did not respond adequately to initial therapy with either an SSRI or SNRI. The program also includes a long-term safety study in which patients receive TC-5214 or placebo for up to one year. Study design for the Phase 3 adjunctive program borrows heavily from the positive Phase 2b clinical trial for TC-5214 conducted by Targacept.

About the Collaboration Agreement between AstraZeneca and Targacept

In December 2009, AstraZeneca and Targacept signed a collaboration and license agreement for the global development and commercialization of TC-5214. The initial goal for the collaboration is to develop TC-5214 as an adjunct treatment for MDD in patients with an inadequate response to an SSRI or SNRI to regulatory approval.

About Major Depressive Disorder

Major Depressive Disorder (MDD) is a highly prevalent and debilitating disease with significant unmet need, affecting approximately 42 million people worldwide, and the global antidepressant market is estimated to be approximately $20 billion today. SSRIs and SNRIs are the most commonly prescribed classes of drugs for depression, but in many cases patients fail to respond adequately. In the NIMH's large-scale STAR*D study conducted between 2001 and 2006, approximately 63% of patients did not achieve remission with first-line treatment with the SSRI citalopram hydrobromide.

About Targacept

Targacept is developing a diverse pipeline of innovative NNR Therapeutics for difficult-to-treat diseases and disorders of the nervous system. NNR Therapeutics selectively modulate the activity of specific neuronal nicotinic receptors, a unique class of proteins that regulate vital biological functions that are impaired in various disease states. Targacept's lead program, TC-5214, is being co-developed with AstraZeneca and is in Phase 3 clinical trials as an adjunct treatment for major depressive disorder. Targacept leverages its scientific leadership and proprietary drug discovery platform Pentad to generate novel small molecule product candidates to fuel its pipeline and attract significant collaborations with global pharmaceutical companies. For more information, please visit www.targacept.com.

TARGACEPT
Building Health, Restoring Independence^SM

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com.

Forward-Looking Statements

This press release includes "forward-looking statements" made under the provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements, other than of historical fact, regarding, without limitation: the progress or scope of development of TC-5214, such as the size, design, population, conduct, objective or endpoints of any clinical trial as an adjunct treatment or as a monotherapy, the timing for initiation or completion of any clinical trial, for availability of results from any clinical trial or for submission or approval of a new drug application or marketing authorization application for TC-5214; the competitive position of TC-5214 or the commercial opportunity for treatments for major depressive disorder; or Targacept's plans, expectations or future operations, financial position, revenues, costs or expenses. Actual results may differ materially from those expressed or implied by forward-looking statements as a result of various important factors, including, without limitation, risks and uncertainties relating to: Targacept's dependence on the success of its collaboration with AstraZeneca for TC-5214; the significant influence that AstraZeneca has over the development of TC-5214; the conduct and results of clinical trials and non-clinical studies and assessments of TC-5214, including the performance of AstraZeneca or third parties engaged to execute such trials, studies and assessments, delays resulting from any changes to the applicable protocols and difficulties or delays in the completion of subject enrollment or data analysis; the timing of discussions with regulatory authorities and the timing and success of submission, acceptance and approval of regulatory filings. These and other risks and uncertainties are described in greater detail under the heading "Risk Factors" in Targacept's most recent Annual Report on Form 10-K and in other filings that it makes with the Securities and Exchange Commission. As a result of the risks and uncertainties, the results or events indicated by the forward-looking statements may not occur. Targacept cautions you not to place undue reliance on any forward-looking statement.

In addition, any forward-looking statement in this press release represents Targacept's views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Targacept disclaims any obligation to update any forward-looking statement, except as required by applicable law.

NNR Therapeutics , Pentad and Building Health, Restoring Independence^SM are trademarks or service marks of Targacept, Inc. Any other service marks, trademarks and trade names appearing in this press release are the properties of their respective owners.

Targacept, Inc.
Alan Musso, 336-480-2186
SVP and CFO
alan.musso@targacept.com
or
Linnden Communications
Michelle Linn, 508-362-3087
linnmich@comcast.net
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AstraZeneca
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