AstraZeneca and Targacept Announce First Top-Line Phase III Results for TC-5214 As An Adjunct Treatment in Patients With Major Depressive Disorder

LONDON, Nov. 8, 2011 - AstraZeneca and Targacept, Inc. today announced top-line results from the first of four RENAISSANCE Phase III studies investigating the efficacy and tolerability of TC-5214 as an adjunct therapy to an antidepressant in patients with major depressive disorder (MDD) who do not respond adequately to initial antidepressant treatment. The study did not meet its primary endpoint of change on the Montgomery-Asberg Depression Rating Scale (MADRS) after eight weeks of treatment with TC-5214 as compared to placebo.

TC-5214 was overall well tolerated in the study and showed an adverse event profile generally consistent with the earlier Phase IIb study. Analyses of the full data set from the RENAISSANCE 3 study remain ongoing.

The RENAISSANCE clinical trial programme consists of four randomised, double blind, placebo controlled Phase III efficacy and tolerability studies and a fifth long-term safety study. The results announced today are from the RENAISSANCE 3 study, a flexible dose trial conducted in Europe. All RENAISSANCE Phase III studies have now completed enrolment, and reporting of all results is expected by the first half of 2012.

TC-5214 has the potential to be a first-in-class nicotinic channel modulator to serve as an adjunct treatment for MDD in patients with an inadequate response to initial antidepressant therapies, for example, selective serotonin reuptake inhibitors (SSRIs) or serotonin/norephinephrine reuptake inhibitors (SNRIs).

An NDA filing in the US is planned for the second half of 2012, with an MAA filing in the EU targeted for 2015.

– ENDS –
NOTES TO EDITORS
Targacept and AstraZeneca Collaboration

In December 2009, AstraZeneca and Targacept signed a collaboration and license agreement for the global development and commercialisation 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.
About the Montgomery-Asberg Depression Rating Scale

The Montgomery-Asberg Depression Rating Scale (MADRS) is a commonly used 10-item questionnaire that psychiatrists employ to measure the severity of depressive episodes in patients with mood disorders.
About MDD

MDD is characterised by one or more major depressive episodes without a history of manic, mixed or hypomanic episodes. The essential feature of a major depressive episode is a period of at least two weeks during which there is depressed mood or the loss of interest or pleasure in nearly all activities. In the large-scale STAR*D study sponsored by the US National Institute of Mental Health between 2001 and 2006, approximately 63 per cent of patients with MDD did not achieve study-defined remission with first-line treatment with the SSRI citalopram hydrobromide.
RENAISSANCE Programme

The RENAISSANCE Programme consists of five studies. In this first study RENAISSANCE 3, there were 780 patients with MDD that were screened at 79 sites in Europe, of which 624 initially received one of seven SSRIs or SNRIs on an open label basis for eight weeks to determine the extent of therapeutic response. At the end of the eight weeks, 295 patients who did not respond adequately, based on predefined criteria, were randomized into the double blind phase of the study and received either a flexible dose of TC-5214 or placebo, twice daily, while continuing the SSRI or SNRI therapy for an additional eight weeks. The dosage of TC-5214 was initially 2 mg/day and could be increased at the discretion of the investigator to 4 mg/day and 8 mg/day based on tolerability and therapeutic response.

In addition to RENAISSANCE 3, there is one more flexible dose study (RENAISSANCE 2) and two fixed dose studies (RENAISSANCE 4 and RENAISSANCE 5) designed to evaluate the efficacy and tolerability of TC-5214 as an adjunct treatment to SSRI/SNRI therapy. RENAISSANCE 7 is a randomised, double blind, placebo controlled, long-term safety study in which patients receive TC-5214 or placebo, plus baseline SSRI/SNRI, for one year.
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 III 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.
About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation 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.
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Posted: November 2011

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