GLG News by Distributors of Durable Medical Equipments

Warren BotnickPresidentPSS Clinical Research

Exciting Prospect for Alternative Treatment of COPD and asthma

September 19, 2007

Analysis of:Newly Discovered Fatty Acids May Lead To Novel Treatments For COPD And Asthma | www.medicalnewstoday.com

Eicosanoids appear promising in the treatment of such airways diseases as COPD and asthma, which affect millions worldwide.  Any alternative to current anti-inflammatory therapy, which consists almost entirely of forms of corticosteroids, would almost certainly be welcomed and adopted in widespread fashion.

Warren BotnickPresidentPSS Clinical Research

Ceftobiprole for Community-Acquired Pneumonia is Breakthrough in Therapy

September 19, 2007

Analysis of:Basilea Announces Positive Top-line Data from Phase III Study of Ceftobiprole in Community-acquired Pneumonia Requiring Hospitalization | www.pipelinereview.com

Cephalosporins have been standard therapy for pneumonia for many years, but to date this class of drug has been ineffective against MRSA.  Ceftobiprole appears to represent a breakthrough in this regard.  I would expect the drug to be well tolerated and, for the most part, to cause few major adverse effects.  However, the use of ceftriaxone as a comparator is odd, as this would not be used as monotherapy by most physicians in the USA for patients with CAP who are sick enough to warrant hospital admission.

Warren BotnickPresidentPSS Clinical Research

Worldwide Market for Lunivia (eszopiclone) Uncertain

September 19, 2007

Analysis of:GlaxoSmithKline and Sepracor Inc. announce international alliance for commercilisation of Lunivia | www.pipelinereview.com

Though the potential international market for eszopiclone is large, interest in the product among sleep specialists in the US has leveled off.  Its success internationally may well depend more on distancing the product from other agents such as the Ambien "family," a decidedly difficult task, and on continuing to downplay the major side effect of bad taste, and less on the size of the potential patient population.  For many prescribers, it has become apparent that Lunesta is new but not necessarily improved.

Warren BotnickPresidentPSS Clinical Research

Emergence of Dabigatran for Prevention and Treatment of Blood Clots

September 17, 2007

Analysis of:Dabigatran Etexilate As Effective As Enoxaparin In Lowering Blood Clot Risk After Hip Replacement | www.medicalnewstoday.com

These data help strengthen the growing perception that oral agents in general, direct thrombin inhibitors in particular, and perhaps specifically dabigatran, represent the future of anticoagulation therapy.  Safety data are of paramount importance, given the prior failure of ximelagatran in this respect, and thus far dabigatran indeed has avoided causing similar liver toxicity.  Ongoing studies of dabigatran, and of other oral agents such as the factor Xa inhibitors, in treatment of venous thrombosis and pulmonary embolism will add critical information in this area.

Warren BotnickPresidentPSS Clinical Research

Anticoagulant TB-402 Data Raise Hopes but Raise Safety Concerns

September 12, 2007

Analysis of:ThromboGenics and BioInvent Announce Successful Completion of Phase I Clinical Trial of the Anticoagulant TB-402 | www.pipelinereview.com

Phase I data are promising for prevention on VTE, a major worldwide health problem.  However, inhibition of factor VIII raises grave safey concerns, despite safety profile in this study.  Long duration of action and cost also will be important considerations (current drug costs for this indication can be very low).

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