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AZD3480 (TC-1734) ADHD


AZD3480 (TC-1734) 


AZD3480 (TC-1734) is a novel small molecule that acts selectively on the alpha4beta2 (
α4ß2) NNR subtype.  In December 2005, we entered into a collaborative research and license agreement with AstraZeneca AB for the development and worldwide commercialization of AZD3480 as a treatment for various conditions marked by cognitive impairment.  As of May 2009, we or AstraZeneca has evaluated AZD3480 in six Phase 2 clinical trials in disorders representing a range of cognitive impairment, including attention deficit/hyperactivity disorder (ADHD), Alzheimer’s disease, mild cognitive impairment (MCI), age associated memory impairment (AAMI) and cognitive dysfunction in schizophrenia (CDS).

In May 2009, we announced preliminary results showing that AZD3480 met the primary outcome measure in a Phase 2 clinical trial in adults with ADHD. In the study, adult subjects received in random order daily doses of 5mg of AZD3480, 50mg of AZD3480 and placebo, each for two weeks with the dosing periods separated by a three-week washout period.  At 50mg AZD3480, subjects showed statistically significant (p < .01) improvement in symptoms of ADHD as measured by the study’s primary outcome measure, total symptom score on the Conners Adult ADHD Rating Scale – Investigator Rating (CAARS-INV).  In July 2009, we announced that AstraZeneca plans to conduct a robust development program for AZD3480 in ADHD.

As of May 2009, AZD3480 has been evaluated in approximately 1,350 subjects in Phase 1 and Phase 2 clinical trials and has consistently exhibited a favorable tolerability profile.


AZD1446 (TC-6683) 

AZD1446 (TC-6683) is a novel small molecule that, like AZD3480, acts selectively on the α4ß2 NNR subtype.  AZD1446 is the most advanced product candidate arising out of our preclinical research collaboration with AstraZeneca and is planned for development in Alzheimer’s disease.  AstraZeneca has an exclusive global license to AZD1446 under the terms of our 2005 collaborative research and license agreement and is responsible for executing and funding its development and commercialization.  AstraZeneca initiated Phase 1 development of AZD1446 in December 2008.


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About ADHD


Attention deficit/hyperactivity disorder is one of the most common neurobehavioral disorders.  The principal characteristics of ADHD are inattention, hyperactivity and impulsivity.  ADHD is a chronic disorder that develops during childhood, often persists into adulthood and can negatively impair many aspects of daily life, including home, school, work and interpersonal relationships.  The market research firm Business Insights estimated that there were approximately 25 million adults and 12.7 million children with ADHD in 2008 in the world’s seven major pharmaceutical markets (United States, France, Germany, Italy, Spain, United Kingdom and Japan).

Stimulants (e.g., amphetamine, methylphenidate) are the most commonly used treatments for ADHD.  Because these drugs have potential for abuse, they are scheduled and and can therefore be burdensome for patients.  Atomoxetine is a non-stimulant, non-scheduled treatment for ADHD, but it is not adequate for many patients.  All of the currently available treatments for ADHD have side effects, such as increased heart rate and blood pressure, loss of appetite, insomnia and behavioral changes like irritability.  A well tolerated, non-stimulant treatment for ADHD that is not scheduled would represent a significant advance for patients.

About Alzheimer's disease 


The treatment of Alzheimer’s disease is currently dominated by a class of drugs called acetylcholinesterase inhibitors. Acetylcholinesterase inhibitors have limitations in that only about half of Alzheimer’s disease patients who take them show symptomatic improvement, and the drugs do not substantially delay the progressive deterioration and death of cells in the brain that can lead to more severe impairment and debilitation.

 

A 2007 study conducted by researchers at Johns Hopkins University estimated that over 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 is projected to increase by more than 50 percent to 7.7 million by 2030.

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