Dr. Mark Vandewalker MD

GLG News^SM Analyses by Mark Vandewalker

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Will Merck's New Asthma Drug Make the Big Time?

July 6, 2010

Analysis of:FDA Approves Merck's DULERA® Inhalation Aerosol | www.reuters.com

The FDA recently approved Merck's Dulera, inhaled corticosteroid/long-acting beta-agonist (ICS/LABA) combination, for moderate to severe asthma control. This agent is the third combo inhaler, after Advair and Symbicort; thus it starts with an immediate disadvantage in the market. Furthermore, timing seems most inauspicious in light of the FDA's current phobia with the entire class of LABA agents. Any potential profits may be negated by the expense of conducting mandatory long-term safety trials.

FDA Poised to Damage Asthma Pharmacotherapy Advances

December 10, 2008

Analysis of:FDA: Long-Acting Asthma Drugs Increase Asthma Risks | online.wsj.com

The use of long-acting beta-agonists (LABAs) in the treatment of persistent asthma has become one of the most controversial issues of respiratory disease management during this decade. Both salmeterol and formoterol have been shown in numerous clinical trials of asthma to dramatically improve pulmonary function, symptoms scores, and need for rescue medication. However, some long-term safety studies have demonstrated increased risk of severe asthma exacerbations when these LABAs are used as monotherapy without concomitant inhaled steroid therapy. Based on this data, the FDA is considering the withdrawal of LABAs from the US market. I anticipate the FDA will come to their senses and appreciate the significant benefit that combination LABA/ICS therapy has in the vast majority of moderate and severe asthmatics for whom they are appropriately prescribed. In my opinion, cessation of LABA therapy for asthma would return us to asthma mortality rates not seen since the 1990s.     

Will Xolair Become Obsolete in the Treatment of Allergies?

June 10, 2008

Analysis of:Investigational Anti-IgE Antibody Promising as Extracorporeal Allergy Therapy | www.medscape.com

This recent report characterizes a newly discovered anti-IgE monoclonal antibody (mAb12) which appears dramatically more potent than omalizumab (Xolair) in its ability to reduce systemic IgE levels. If further studies confirm this enhanced reduction of IgE and IgE-bearing cells, mAb12 has significant potential to replace omalizumab as effective anti-IgE therapy with just one dose, even in patients with very high initial levels of total IgE. The potential market share for such a treatment is enormous since at least 25% of the population suffers from Ige-mediated diseases such as allergic rhinitis, asthma, atopic eczema, and food allergy.

Impact of Symbicort on the U.S. Asthma Market

June 11, 2007

Analysis of:AstraZeneca Launches New Advance In Asthma Treatment - Symbicort Maintenance And Reliever Therapy (Symbicort SMART) | www.medicalnewstoday.com

Symbicort is AstraZeneca's answer to Advair, presently the number one combination ICS/LABA in the U.S. for treating moderate to severe asthma. Symbicort will not, however, have an indication for quick relief of bronchospasm as it does in many European countries. Nevertheless, Symbicort appears to be very well positioned to achieve significant market share, especially with the imminent release of the revised NIH guidelines which strongly emphasize long-term control of asthma.

Of Mice and Men: Revisiting the Hygiene Hypothesis

June 23, 2006

Analysis of:Wild Vs. Lab Rodent Comparison Supports Hygiene Hypothesis | medicalnewstoday.com

The "Hygiene Hypothesis" has gained recent favor to explain the dramatic increase in allergic conditions, as well as autoimmune disorders, especially in more industrialized countries that emphasize sanitation and stringent public health measures. The theory rests on lack of sufficient immunologic stimulation due to overly hygienic lifestyle thus encouraging allergic and possibly autoimmune processes to predominate. This hypothesis is supported by a recent study from Duke University comparing laboratory rodents living in an essentially "germ-free" environment to wild rodents naturally exposed to bacteria and parasites. The wild mice and rats have higher levels of certain antibodies which appear to afford protection from allergic and autoimmune disease. This putative mechanism may offer insight into the pathogenesis of allergy and autoimmunity in humans which could then be applied to developing preventive therapies to reduce the frequency of these chronic, debilitating disorders.

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