Winston-Salem, NC Jul 23, 2007
Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing a new class of drugs known as NNR Therapeutics (TM), today announced that its strategic collaborator AstraZeneca has initiated a Phase IIb clinical trial of AZD3480 (TC-1734) in Alzheimer’s disease. AZD3480, Targacept’s lead product candidate, acts selectively on neuronal nicotinic receptors and has been evaluated in 12 clinical trials in approximately 540 subjects. In a previous Phase IIb clinical trial conducted by Targacept in age associated memory impairment, AZD3480 achieved statistically significant results on all of the primary endpoints, demonstrating cognitive enhancing effects in memory-impaired older adults.
The Alzheimer’s disease trial is a double blind, placebo controlled study being conducted at sites in Western Europe, Eastern Europe and Canada. The trial design provides for approximately 500 patients with mild to moderate Alzheimer’s disease to be randomly assigned to one of three dose groups of AZD3480, to an active comparator or to placebo and to be dosed over a 12-week period. The trial is expected to complete by the end of 2008. AstraZeneca is also scheduled to begin dosing in a Phase IIb trial of AZD3480 in cognitive deficits in schizophrenia in August 2007.
“We are very pleased with the planning and preparatory work conducted by our AstraZeneca colleagues to launch this important study,” said J. Donald deBethizy, Ph.D., President and Chief Executive Officer of Targacept. “The resources that are being invested in this program clearly demonstrate the commitment by AstraZeneca to the broad development of AZD3480 in areas where the medical need is evident.”
Bob Holland, Vice President and Head of the Neuroscience Therapy Area, AstraZeneca, added, “We are committed to developing innovative therapies for Alzheimer’s disease and other cognitive disorders and are enthusiastic about the profile and potential of AZD3480. We believe that the scientific rationale and clinical results to date bode well for the potential of AZD3480 (TC-1734) to make a real difference in the lives of those suffering from Alzheimer’s disease and their caregivers.”
Alzheimer's disease is a progressive, degenerative disorder that attacks the brain's nerve cells, or neurons, resulting in loss of memory, thinking and language skills, and behavioral changes. Approximately 26 million people worldwide suffer from Alzheimer’s disease. In the United States, Alzheimer’s disease is estimated to affect more than five million people and the number of people age 65 and over afflicted with the disease is projected to increase by more than 50 percent to 7.7 million by 2030. Current treatment options have limited efficacy and significant side effects in many patients.
About Targacept
Targacept is a clinical-stage biopharmaceutical company that discovers and develops NNR Therapeutics™, 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 product candidates in development for Alzheimer’s disease and cognitive deficits in schizophrenia, pain, and depression and anxiety disorders, as well as multiple preclinical programs. Targacept is located in Winston-Salem, North Carolina. For more information about Targacept, please visit www.targacept.com.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For more information about AstraZeneca, please visit www.astrazeneca.com.
In Neuroscience, AstraZeneca is dedicated to providing medicines that have the potential to change patients' lives. The company already markets several products including SEROQUEL (R) and ZOMIG (R). The AstraZeneca neuroscience pipeline includes leading approaches for the treatment of depression and anxiety, schizophrenia, dementia, pain control and anaesthesia.
Forward Looking Statements
Any statements in this press release about strategies, prospects, plans, expectations or objectives for Targacept, Inc., including, without limitation, statements regarding the progress, timing and scope of the research and development of our product candidates or related regulatory filings or clinical trials, our future operations, financial position, revenues or costs, and all other statements that are not purely historical in nature, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “promise,” “continue,” “ongoing” and similar expressions are intended to identify forward-looking statements. Actual results may differ materially from those expressed or implied by forward-looking statements as a result of various important factors, including our critical accounting policies and risks and uncertainties relating to: the amount and timing of resources that AstraZeneca devotes to the development of AZD3480 (TC-1734); AstraZeneca's right in the future to terminate the preclinical research collaboration that we and AstraZeneca are currently conducting prior to the end of the planned four-year term; the position of applicable regulatory authorities with regard to a treatment combination that includes mecamylamine hydrochloride, which is a racemate, as compared to one of its constituent enantiomers such as TC-5214; the results of clinical trials and non-clinical studies and assessments with respect to our current and future product candidates in development; the conduct of such trials, studies and assessments, including the performance of third parties that we engage to execute them and difficulties or delays in the completion of patient enrollment or data analysis; the timing and success of submission, acceptance and approval of regulatory filings; our ability to obtain substantial additional funding and our ability to establish additional strategic collaborations. These and other risks and uncertainties are described in greater detail under the heading “Risk Factors” in our most recent Annual Report on Form 10-K and in other filings that we make 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. We caution you not to place undue reliance on any forward-looking statement. In addition, any forward-looking statements in this release represent our views only as of the date of this release and should not be relied upon as representing our views as of any subsequent date. We anticipate that subsequent events and developments may cause our views to change. Although we may elect to update these forward-looking statements publicly at some point in the future, whether as a result of new information, future events or otherwise, we specifically disclaim any obligation to do so, except as required by applicable law. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make.
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Contacts:
Alan Musso, VP and CFO
Targacept, Inc.
Tel: (336) 480-2186
Email: alan.musso@targacept.com
Michelle Linn
Linnden Communications
Tel: (508) 419-1555
Email: linnmich@comcast.net