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GLG News by Clinical Neurophysiologists (US)

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June 5, 2008
Novartis and Multiple Sclerosis: A Major Commitment
Analysis of: Extavia® approved in E.U for treatment of multiple sclerosis, first in planned portfolio of therapies from Novartis | www.asia-manufacturing.com
Author: Daniel Wynn, Director, Clinical Research, Consultants In Neurology Ltd.

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,...

June 2, 2008
Abbott's ABT-089 --Much More than a Treatment for ADHD
Analysis of: Abbott Scientists Present A New Approach for Treating Attention-Deficit Hyperactivity Disorder | biz.yahoo.com
Author: Daniel Wynn, Director, Clinical Research, Consultants In Neurology Ltd.

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.

May 29, 2008

Post laser prostate laparascopic TURP problems
Analysis of: Mixed Outcomes in Laparoscopy for Prostates | www.nytimes.com
Author: GLG Expert Contributor

Surgeons adn patiets need to know that although laser TURP is an attractive and simple technique, patients may still need an alpha blocker to easily initiate voiding afterwards. Further, later catheterization may be difficult due to pocket formation and thus blind-ending the catheter passage rather...

April 24, 2008
COPAXONE from the START of MS
Analysis of: 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
Author: Daniel Wynn, Director, Clinical Research, Consultants In Neurology Ltd.

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.

February 15, 2008

Gamunex in CIDP
Analysis of: Positive Results from Phase III Trial of Gamunex in Patients with CIDP | pharmalive.com
Author: GLG Expert Contributor

IVIg (intraveonus immunoglobulin) reduces disability and reduces risk of relapse in patients with CIDP (chronic inflammatory demyelinating polyradiculoneuropathy).

February 15, 2008
Win for Talecris' Gamunex IVIG in Inflammatory Polyneuropathy
Analysis of: Positive Results from Phase III Trial of Gamunex in Patients with CIDP | pharmalive.com
Author: Daniel Wynn, Director, Clinical Research, Consultants In Neurology Ltd.

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...

February 4, 2008
SILENOR -- A Sleeper among Hypnotics
Analysis of: Somaxon Pharmaceuticals Submits New Drug Application For SILENOR(TM) For The Treatment Of Insomnia | www.pipelinereview.com
Author: Daniel Wynn, Director, Clinical Research, Consultants In Neurology Ltd.

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...

January 25, 2008

Artificial Cervical Disc Looks Promising
Analysis of: Artificial Disc Versus Fusion: A Prospective, Randomized Study With 2-Year Follow-up on 99 Patients | www.medscape.com
Author: GLG Expert Contributor

Outcomes in patients implanted with the artificial disc compare favorably with single level ACDF after 2 years.

January 18, 2008
Major Win For Glaxo with Xenoport for Restless Legs syndrome -- Next Blockbuster?
Analysis of: GlaxoSmithKline and XenoPort report positive top-line results of second phase 3 restless legs syndrome trial for XP13512/GSK1838262 | www.pipelinereview.com
Author: Daniel Wynn, Director, Clinical Research, Consultants In Neurology Ltd.

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.

November 30, 2007

Lacosamide Should Solidify UCB as CNS Drug Leader
Analysis of: UCB Announces FDA Filing for lacosamide in the Treatment of Partial Onset Seizures | www.reuters.com
Author: GLG Expert Contributor

UCB has filed new drug application for regulatory approval for lacosamide through FDA and European Medicines Agency. Primary indication would be the treatment of partial onset seizures (epilepsy)

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