Study Group: Physicians who Treat Insomnia (US)

GLG News^SM Analyses by this Study Group's Leading Experts(?)

Fampridine-SR -- anxiously awaited new MS therapeutic

June 2, 2009

Analysis by:Daniel Wynn, Director of Clinical Research,

Analysis of: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.     

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

June 2, 2009

Analysis by:Daniel Wynn, Director of Clinical Research,

Analysis of: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.

Sequenom's delay

May 4, 2009

Analysis by:Alan Patterson, Obstetrician and Gynecologist,

Analysis of:UPDATE 2-Sequenom delays Down Syndrome test; shares plunge | uk.reuters.com

This delay is not good for the company, especially since there are already tests in place that are effective to screen for Down's syndrome.  These tests now are the standard of care, so the longer it takes for Sequenon to launch it's test the worse, for the company.

Oral Treprostinil: An effective medicine hiding in a study with a challenging design?

November 18, 2008

Analysis by:Robert Aris, Associate Professor of Medicine,

Analysis of:Freedom-C Trial of Oral Treprostinil in Pulmonary Arterial Hypertension Fails to Meet Primary Endpoint | ir.unither.com

This phase III study was done without the benefit of conventional drug development with Phase I and Phase II studies (which would have provided more information about the effective dose) preceding it because pharmacokinetic date from IV and SC dosing studies were used to extrapolate for the oral dosing. While in hindsight, this may have not been ideal, the trial holds a lot of promise that treprostinil will be effective since there was a nice dose-response curve and the higher doses clearly appeared to be effective. Oral Treprostinil is probably very similar to subcutaneous and intravenous prostanoids (remodulin and flolan) that require a slow uptitration of dose to allow the patient to become tolerant to the side effects. Thus having smaller doses for titration, which were available later in the trial, probably would have allowed for greater success had these doses been available earlier in the study.

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

November 17, 2008

Analysis by:Daniel Wynn, Director of Clinical Research,

Analysis of: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.

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