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GLG News by Neurologists

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.

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.

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.

Win for Talecris' Gamunex IVIG in Inflammatory Polyneuropathy

February 15, 2008

Positive Results from Phase III Trial of Gamunex in Patients with CIDP | pharmalive.com

Talecris' form of IVIG, Gamunex was studied in the largest trial of IVIG in chronic inflammatory polyradiculoneuropathy (CIDP), with more than twice as many patients moving into remission.  CIDP is a common acquired autoimmune peripheral neuropathy, which if not treated, may lead to a peripheral quadriparesis.  Gamunex showed not only a very strong treatment effect, but with a very low 0.8% incidence of serious adverse event.  This places it above other future putative B-cell therapies for CIDP in terms of tolerability.

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.

SILENOR -- A Sleeper among Hypnotics

February 4, 2008

Somaxon Pharmaceuticals Submits New Drug Application For SILENOR(TM) For The Treatment Of Insomnia | www.pipelinereview.com

Somaxon Pharmaceuticals has submitted a NDA for Silenor for the treatment of insomnia.  The active ingredient is doxepin, which has been available for years.The effect of the drug can be expected to be very modest, side effects unfavorable when compared to Ambien or Lunesta, and with both significant potential side effects and drug interactions. The introduction of this sleeper puts me to sleep.  I doubt that I would ever prescribe it.  given its disadvantages, I do not see Somaxon's goal.          

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.

Major Win For Glaxo with Xenoport for Restless Legs syndrome -- Next Blockbuster?

January 18, 2008

GlaxoSmithKline and XenoPort report positive top-line results of second phase 3 restless legs syndrome trial for XP13512/GSK1838262 | www.pipelinereview.com

Xenoport's trial for XP13512 in restless legs syndrome (RLS) shows strongly positive 9 month data in second phase 3  trial, should be a major win in the marketplace.  RLS represent a major unmet need, for drugs with sustained efficacy and high tolerability.

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.

ZOSTAVAX: New Vaccine Dramatically Reduces Risk of Shingles

May 30, 2006

FDA Licenses New Vaccine to Reduce Older Americans’ Risk of Shingles | www.fda.gov

Shingles, an illness caused by reactivation of the chicken pox virus varicella zoster, affects 20% of Americans and can lead to the dreaded, severely painful condition post-herpetic neuralgia.

Zostavax is the first FDA approved vaccine to prevent shingles.

Up until now, no effective therapy has been available to decrease the chance of contracting shingles.  Zostavax (Merck), a live virus vaccine was shown in a trial of 38,546 patients over age 60 to increase immunity against varicella zoster virus and decreased the chance of developing shingles by 50% and the risk of post-herpetic neuralgia by two-thirds.  Routine use of Zostavax in individuals over age 60 would translate to 250,000 fewer cases of shingles per year.

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