Targacept, Inc. Provides Update on TC-6499 and Pain Program in GlaxoSmithKline Alliance - Data Does Not Support Further Development

Published: Mar 11, 2009

WINSTON-SALEM, N.C.--(BUSINESS WIRE)--Targacept, Inc. (NASDAQ: TRGT - News), a clinical-stage biopharmaceutical company developing a new class of drugs known as NNR Therapeutics (TM), today announced that it has completed analysis of data from a Phase 1 multiple rising dose trial of TC-6499, a product candidate included in the GlaxoSmithKline alliance, and concluded that the results do not project a therapeutic margin sufficient to support further development of TC-6499 for neuropathic pain.

“While we are disappointed not to be moving TC-6499 forward, we have learned a great deal about the NNR targets involved in perception of pain,” said J. Donald deBethizy, Ph.D., Targacept’s President and Chief Executive Officer. “Importantly, our alliance with GlaxoSmithKline continues to make progress as we remain focused on advancing programs in smoking cessation, obesity, Parkinson’s disease, addiction and pain. We are fortunate to have a pipeline of NNR Therapeutics representing multiple opportunities for future success.”

Targacept’s first-generation product candidates for pain, which include TC-6499, have acted primarily at a specific form of the alpha4beta2 NNR subtype. Emerging developments in the NNR field suggest that a compound with concurrent activity at multiple NNR subtypes may have increased potency1. Targacept is leveraging this learning to guide its research in the discovery of next generation product candidates for pain in its alliance with GlaxoSmithKline.

About Targacept

Targacept is a clinical-stage biopharmaceutical company that discovers and develops NNR Therapeutics (TM), a new class of drugs for the treatment of central nervous system diseases and disorders. Targacept’s product candidates selectively modulate neuronal nicotinic receptors that serve as key regulators of the nervous system to promote therapeutic effects and limit adverse side effects. Targacept has clinical-stage product candidates in development for major depressive disorder, Alzheimer’s disease, attention deficit/hyperactivity disorder and cognitive dysfunction in schizophrenia, as well as multiple preclinical programs. Targacept also has a cognition-focused collaboration with AstraZeneca and a strategic alliance with GlaxoSmithKline. Targacept’s news releases are available on its website at www.targacept.com.

Forward-Looking Statements

Statements in this press release that are not purely historical in nature constitute “forward-looking statements” made under the provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, without limitation, statements regarding the potential benefits of compounds that have concurrent activity at multiple NNR subtypes, the discovery and development by Targacept of new product candidates for pain, progress of Targacept’s research programs in the therapeutic focus areas of its alliance with GlaxoSmithKline, 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 ability to successfully discover and develop new product candidates for pain; the limited scientific understanding of the relationship between the underlying causes of pain and the effects of modulating particular NNR subtypes; and the conduct and outcomes from Targacept’s research programs in the therapeutic focus areas of its alliance with GlaxoSmithKline, including the performance of third parties engaged to execute non-clinical studies and assessments and clinical trials, delays resulting from any changes to the applicable protocols and difficulties or delays in the completion of subject enrollment or data analysis. 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 (TM) is a trademark of Targacept, Inc. Any other service marks, trademarks and trade names appearing in this press release are the properties of their respective owners.

1 Young et al., “Peripheral nerve injury alters spinal nicotinic acetylcholine receptor pharmacology.” Eur J Pharmacol. 2008, 20;590(1-3):163-9.; Vincler and McIntosh, “Targeting the alpha9alpha10 nicotinic acetylcholine receptor to treat severe pain.” Expert Opin Ther Targets. 2007, 11: 891-7; Vincler and Eisenach, “Knock down of the alpha 5 nicotinic acetylcholine receptor in spinal nerve-ligated rats alleviates mechanical allodynia.” Pharmacol Biochem Behav. 2005; 80(1):135-43.


Targacept, Inc. Alan Musso, 336-480-2186 VP and CFO alan.musso@targacept.com or Linnden Communications Michelle Linn, 774-696-3803 linnmich@comcast.net

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