GLG News by Psychiatrists (US)

David RosenbergChief of Psychiatry and PsychologyCHILDREN'S HOSPITAL OF MICHIGAN

Neuronal nicotinic receptor agonists potential breakthrough for ADHD research

May 12, 2008

Analysis of:Abbott Scientists Present A New Approach for Treating Attention-Deficit Hyperactivity Disorder | biz.yahoo.com

1. Effective treatment for ADHD 2. Well tolerated with few side effects 3. Help with smoking, a big problem in ADHD patients important 4. Advantage in not being Schedule II may be helpful

David RosenbergChief of Psychiatry and PsychologyCHILDREN'S HOSPITAL OF MICHIGAN

Important New Data for Children and Adolescents

May 12, 2008

Analysis of:FDA Approves Strattera® for Maintenance of ADHD in Children and Adolescents | newsroom.lilly.com

1. Important new finding given safety concerns raised about this and other treatmetns 2. Nice to have data back up what has long been done clinically 3. Stimulants still first line and lack of active comparator trial

David RosenbergChief of Psychiatry and PsychologyCHILDREN'S HOSPITAL OF MICHIGAN

Exciting new treatment for OCD and Social Anxiety Disorder

March 7, 2008

Analysis of:FDA Approves Luvox CR (Fluvoxamine Maleate) Extended-Release Capsules for the Treatment of Social Anxiety Disorder and Obsessive Compulsive Disorder | pharmalive.com

1. Controlled release preparations are often better tolerated with fewer side effects than immediate release preparations 2. OCD and SAD are severe, highly prevalent and chronically disabling conditions 3. Despite presence of SSRIs and other treatment, e.g, cognitive behavioral therapy, up to 1/3 of patients with OCD or SAD do not respond to currently available treatments and among responders many do so only partially

David RosenbergChief of Psychiatry and PsychologyCHILDREN'S HOSPITAL OF MICHIGAN

FDA Approval of Abilify for Pediatric Bipolar disorder is a Major Advance

March 7, 2008

Analysis of:U.S. Food and Drug Administration Approves Abilify (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age) | pharmalive.com

1. Despite common use of multiple psychotropic medications for bipolar disorder in youth, there are few FDA-approved treatments 2. Abilify is one of the safest and best tolerated of the atypical antipsychotics with fewer side effects than some of the other atypical antipsychotic medications 3. This treatment offers new hope to many children and their families

David RosenbergChief of Psychiatry and PsychologyCHILDREN'S HOSPITAL OF MICHIGAN

More questions raised than answers

February 5, 2008

Analysis of:Chantix And Suicide: The Latest Numbers | www.pharmalot.com

No good data that Chantix is associated with suicide Need more controlled research to answer questions Scary adverse events are not the same as side effects directly linked to medication

Lawrence GinsbergPresidentRED OAK PSYCHIATRY ASSOCIATES, P. A.

Vanda"s Iloperidone: Lemonade or Lemon

October 11, 2007

Analysis of:Vanda Pharmaceuticals Submits Iloperidone New Drug Application | www.pipelinereview.com

1. Iloperidone has demonstrated efficacy in treating positive and negative symptoms of schizophrenia and also has a favorable safety profile. 2. Vanda has utilized pharmacogenetic studies to identify a group of schizophrenic patients that will benefit from this agent that binds to a number of serotonin and dopamine receptors. 3. Two out of three previous Novartis Iloperidone trials were failed trials but they utilized low to medium doses of Iloperidone.

Lawrence GinsbergPresidentRED OAK PSYCHIATRY ASSOCIATES, P. A.

DOV 21,947: A Triple Reuptake Inhibitor With a Favorable Metabolic Profile

October 8, 2007

Analysis of:DOV 21,947 Demonstrates Significant Body Weight and BMI Reductions in Drug Compliant Subjects in Phase Ib Clinical Study | www.medicalnewstoday.com

1. DOV 21,947 in a phase Ib study produced a statistically significant reduction in plasma triglyceride levels, body weight, and Body Mass Index (BMI). 2. This compound is believed to not only manage depression but also impact weight gain. 3. A phase II study of DOV 21,947 is being delayed until the first quarter of 2008 to allow for sufficient capital to conduct the study and to further evaluate the protocol design. 4. Phase I studies of DOV 21,947 have shown that the compound was safe and well tolerated with a low incidence of adverse events.

Amit VijapuraOwnerAMIT VIJAPURA MD

Lilly has great product pipe line for Schizophrenia and other Psychiatric Disorders

September 24, 2007

Analysis of:Investigational Agent Targeting Metabotropic Glutamate 2/3 Receptors Demonstrates Antipsychotic Activity in Humans, Study in Nature Medicine Finds | www.pipelinereview.com

Lilly is currently leader in Psychiatry with 4 active medications with great marketing for Psychiatry and Primary care physician. New compound that has a unique mechanism on Metabotropic Glutamate 2/3 Receptors, can work on Schizophrenia and other Psychiatric diagnosis. This is great opportunity for Lilly to continue with its leaders ship position in Psychiatry market, which is a fasted growing sector in medical research. LY2140023 is still going thru Phase II trials and its results are not yet released.

Lawrence GinsbergPresidentRED OAK PSYCHIATRY ASSOCIATES, P. A.

Shire Takes Proactive Stance Regarding Daytrana Skin Patches

September 18, 2007

Analysis of:Shire withdraws some ADHD skin patches | www.reuters.com

1. Shire has withdrawn patches that had defective patch liners. 2. This defect is not related to safety or efficacy issues. 3. The cost to Shire is less than $10 million.

Lawrence GinsbergPresidentRED OAK PSYCHIATRY ASSOCIATES, P. A.

New Potentially Effective Antidepressants to be Marketed by a Potentially Effective Alliance

September 12, 2007

Analysis of:Lundbeck and Takeda form Alliance to Develop and Commercialize a Portfolio of Novel Compounds in the US and Japan for the Treatment of Mood and Anxiety Disorders | www.pipelinereview.com

1. Lu AA21004 and Lu AA24530 are two compounds with a great deal of potential and will be co-marketed jointly by Takeda and Lundbeck. 2. Lu AA21004 is the more advanced of the compounds and is currently in phase II development for the treatment of major depression. 3. The compounds potentially address some unmet needs as they have fast onset of effect and increased efficacy.

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