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GLG News by Physicians who Treat Depression (US)

Daniel Wynn, Director of Clinical Research

Daniel WynnDirector of Clinical ResearchCONSULTANTS IN NEUROLOGY LTD What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Fampridine-SR -- anxiously awaited new MS therapeutic

June 2, 2009

Acorda’s Fampridine-SR Gets Priority Review | phoenix.corporate-ir.net

A major unmet need in the treatment of Multiple Sclerosis is a medication to increase walking ability.  Since disease modifying therapies have only been available for 16 years, MS starts at a mean age of 29, and the disease has only a minimal effect at shortening lifespan, the majority of MS patients presently have progressive forms of MS.  Ten percent have primary progressive disease, progressive from the onset, and others, start with relapsing remitting MS, and progress after approximately 15 years to progressive illness.  In the early years of progressive MS, patients loose the ability to walk, hence the prior motto of the National MS Society, "MS, the great crippler of young adults."  FAMPRIDINE SR IS THE FIRST MEDICATION FOUND TO IMPROVE MS PATIENTS ABILITY TO WALK.  Standard disease modifying agents, the interferons (Avonex, Betaseron, Rebif), Copaxone and Tysabri, decrease relapse rate and may slow progression, however do not improve one's ability to walk.     

Daniel Wynn, Director of Clinical Research

Daniel WynnDirector of Clinical ResearchCONSULTANTS IN NEUROLOGY LTD What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

NUVIGIL for Jet Lag -- An Important Broad New Indication for Cephalon

June 2, 2009

Cephalon to apply for FDA approval for Nuvigil for jet lag | www.reuters.com

NUVIGIL, Cephalon's single isomer longer effective half-life follow-up product to Provigil is coming to market only after careful strategic planning.  While extremely successful, Provigil, a unique wake promoting agent, suffered in many ways.  When introduced, it had only FDA approval for narcolepsy, a relatively uncommon, yet severe sleep disorder.  Sales increased markedly when Provigil became approved for other common conditions associated with excessive daytime sleepiness (EDS), treated obstructive sleep apnea with residual EDS and sleep wake shift disturbance (SWSD). If approved for Jet Lag, there is the promise that Nuvigil will become available for an increasing enlarging marketplace.

Daniel Wynn, Director of Clinical Research

Daniel WynnDirector of Clinical ResearchCONSULTANTS IN NEUROLOGY LTD What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

"Tamper-Proof" -- A Significant Gain to Whom??

November 17, 2008

FDA Asks if Pain Pill Is Tamper-Proof | online.wsj.com

Abuse resistant long acting narcotics offer benefit as they are less desirable to those who might wish a quick high via snorting, injecting crushed time-release narcotic. Unfortunately, given the higher cost than long acting generics and increased pressure on physicians to prescribe generics, expect pick up in the marketplace (assuming approval) to be slow.

Daniel Wynn, Director of Clinical Research

Daniel WynnDirector of Clinical ResearchCONSULTANTS IN NEUROLOGY LTD What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Novartis and Multiple Sclerosis: A Major Commitment

June 5, 2008

Extavia® approved in E.U for treatment of multiple sclerosis, first in planned portfolio of therapies from Novartis | www.asia-manufacturing.com

Extavia, Novartis' brand of  interferon beta 1b, has been approved for the  treatment of multiple sclerosis by the European Union.  With FTY72, Fingolimod, Novartis has the eye on filing NDA by the end of 2009.  While essentially identical to Bayer's Betaferon interferon beta 1b, and similar to EMD Serono's Rebif and Biogen's Avonex, Extavia does not offer a new therapy to MS patients, simply a new face.  With this launch, Novartis presumably hopes to work closer to key opinion leaders in multiple sclerosis, allowing an accelerated launch of Fingolimod.     

Daniel Wynn, Director of Clinical Research

Daniel WynnDirector of Clinical ResearchCONSULTANTS IN NEUROLOGY LTD What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Abbott's ABT-089 --Much More than a Treatment for ADHD

June 2, 2008

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

The data on ABT-089 in adults has been released with positive results, whereas the adolescent/childhood trial is on-going for this novel compound for ADHD.  The key difference is the potential to improve learning, not simply regain attention and lessen hyperactivity.

David RosenbergChief of Psychiatry and PsychologyCHILDREN'S HOSPITAL OF MICHIGAN What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Neuronal nicotinic receptor agonists potential breakthrough for ADHD research

May 12, 2008

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 What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Important New Data for Children and Adolescents

May 12, 2008

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

Daniel Wynn, Director of Clinical Research

Daniel WynnDirector of Clinical ResearchCONSULTANTS IN NEUROLOGY LTD What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

COPAXONE from the START of MS

April 24, 2008

Teva Seeks Approval for the Extension of its Indication to Include the Treatment of Patients with a First Clinical Event Suggestive of MS | www.pipelinereview.com

Copaxone has become the leading treatment for relapsing remitting MS in the US.  The results of the PRECISE trial will likely add to TEVA's sales momentum and boost sales further.

David RosenbergChief of Psychiatry and PsychologyCHILDREN'S HOSPITAL OF MICHIGAN What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Exciting new treatment for OCD and Social Anxiety Disorder

March 7, 2008

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 What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

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

March 7, 2008

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

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