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Many contenders for one big prize

March 3, 2008

Analysis of:PAION's anticoagulant Solulin successfully tested in first-in-man study | www.pipelinereview.com

The field of anticoagulant compounds to be used in the prevention and  treatment of venous and arterial thrombosis is getting more crowded by the day. The new compounds are set to replace coumadin and heparin, to widely used medicines that have some serious disadvantages (heparin has also made headlines recently, because of possible issues with the manufacturing process, which led to allergic reactions. The new compounds are generally either inhibitors of activated coagulation factor X (factor Xa) or direct inhibitors of thrombin (coagulation factor IIa). Two other compounds that act similarly to heparin, idraparinux and SSR 126517 also compete for market share. Solulin has a long half life and, if shown to have a better safety profile, may become clinically useful. However, odds are that by that time, one of the many other compounds will have already established itself.

Whoever wins the oral anticoagulant race gets the gold

February 11, 2008

Analysis of:Nuvelo Initiates Phase 1 Clinical Trial of Thrombin Inhibitor, NU172 | www.pipelinereview.com

The oral anticoagulant market is huge and expanding. It is currently dominated by warfarin, which is widely prescribed, but which needs monthly blood draws to monitor the treatment intensity. The parenteral (non-oral) anticoagulant market is dominated by two players: [unfractioned] heparin (which is generic) and the low molecular heparin Lovenox (Aventis). Several pharmaceutical companies are close to bringing a compound to the market that can potentially replace warfarin and/or heparin(s).  Whoever has the first compound approved will make great profits because both doctors and patients are eagerly waiting for alternatives to warfarin and heparins. No matter what the product will be approved for, it will likely be widely prescribed off label.

A Study With The Wrong Endpoints

January 21, 2008

Analysis of:First Head to Head Study Comparing CRESTOR(TM) and LIPITOR(R) Effects on the Treatment of Atherosclerosis | www.pipelinereview.com

Lipitor is the dominant statin on the market and has an indication for reducing the risk of heart attack and stroke. Crestor is more potent than Lipitor, but, because it was approved later, has less data to show for and no indication for lowering the risk of clinical events. Moreover, Zocor (Simvastatin) the third most potent statin is now available as a generic. Crestor is trying to accumulate data showing it is superior to Lipitor, but Astra Zeneca took a blow when Crestor did not reduce the rate of death and heart attacks in patients with heart failure caused by heart attacks.

Innovative technology of uncertain usefulness

November 27, 2007

Analysis of:Toshiba Introduces FaCTor64 Study To Improve Early Diagnosis And Treatment Of Coronary Artery Disease In Asymptomatic Diabetics | www.medicalnewstoday.com

The CorE 64 is the latest in coronary imaging technologies, but it is unclear what the provided results mean and what doctors need to do about them. The results of the initial study presented at the American Heart Association Scientific Sessions sparked an intense debate about the role of coronary computed tomographic angiography (CTA) in the care of patients with chest pain and coronary disease. Several other companies are pursuing similar approaches with the aim of offering a diagnostic test that replaces both stress tests and coronary angiograms (cardiac catheterization).

Moving Forward With Stem Cell Technology

October 8, 2007

Analysis of:Aastrom Announces Positive Interim Results From Phase I/II Study Involving Use of Vascular Repair Cells in Patients With Critical Limb Ischemia | www.pipelinereview.com

There will be an increased impetus to start clinical trials with stem cells in peripheral vascular disease in order to avoid amputations (the same is true for osteonecrosis of the hip). As the prevalence of diabetes increases in the Western world, the demand for this type of therapies will be increasing. Stem cells are viewed as powerful, low risk therapy options and getting the lead in stem cell therapy will provide a significant competitive advantage.

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