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Successful Collaboration Is Better Than Individual Failure

October 20, 2008

Analysis of:Health Firms to Study Clots in Stent Patients | online.wsj.com

This plan to start a large trial to determine the optimal antiplatelet therapy. after [drug-eluting] stent implantation makes sense both scientifically and economically for the involved stent companies (Johnson & Johnson, Boston Scientific, Medtronic and Abbott). Sanofi-Aventis and Bristol Myers Squibb, who market clopidogrel (Plavix) are likely also interested to have more precise data out there about the issue, before the rival compound, prasugrel, gets FDA approval. The optimal length and intensity of antiplatelet therapy after drug-eluting stent placement is not known and the trial will be specifically designed to answer this question.

Signs That the Is Party Over?

October 10, 2008

Analysis of:Pfizer shifts focus to cancer and biotech drugs | ap.google.com

The growth of the big pharma companies in the past 20-30 years has to do with the fact that the medical community was willing to accept large trials (some with surrogate endpoints) as proof that a new treatment is good and that it can replace the old one. Since the problems with Troglitazone, Cerivastatin, Rosiglitazone and Ezetimibe, safety is being emphasized by the medical community and by the political oversight. Showing safety is much more tough than showing efficacy and the trials are much more expensive and thus much more risky and this is probably why Pfizer is pulling out. The heart disease drug market is unlikely to see any new blockbusters like Atorvastatin and Amlodipine again and the new drugs will probably just bring small incremental improvements. The market is crowded and there is little chance for a big hit. Pfizer will continue to develop (anti)thrombosis drugs and that's a market where big hits are still possible, and in fact expected.

Not All That Shines is Gold

October 2, 2008

Analysis of:Anemia Drugs Linked to Stroke Study Deaths: FDA | health.usnews.com

The anemia drug erythropoietin and its congeners have been used extensively in patients with renal failure and in patients with cancer to boost the red cell count. However, erythropoietin also helps reduce programmed cellular death and is involved in the growth of new vessels. Because of these features it was always considered an attractive therapy for patients with heart attacks or strokes. Unfortunately, it can also increase the risk of thrombosis (blood clotting), which is how heart attacks and strokes occur in the first place. The usage in patients with renal failure has decreased after studies showed that increasing the red blood cell count too much in these patients can be detrimental. The results of this FDA warning are also going to lead to a reduction of usage as physicians become more cautious even though the population studied in the trial is different from the usual patients receiving erythropoietin.

The trial that is all about hype

August 28, 2008

Analysis of:Heart Stents No Better Than Drugs for Chest Pain Over Time | www.bloomberg.com

The general public hears the bullet that stents are no better than medications, but the reality that this trial (COURAGE trial) had major flaws, the main being that only 10% of the patients screened participated in the trial. 90% were excluded. Thus, the patients enrolled were not necessarily the typical patients. Also, very few of the new, drug-eluting stents were used. That being said, the initial study, published in 2007, showed that stents were no better than medications in terms of reducing deaths of myocardial infarctions. This second report suggests that in this particular group of patients, the stents are not better at reducing chest pain/improving quality of life.

Improved User Friendliness Is the Key

April 21, 2008

Analysis of:CV Therapeutics and Astellas Announce FDA Approval for Lexiscan(TM) (regadenoson) Injection | www.pipelinereview.com

Regadenoson is similar to the drug it's set to replace, adenosine, in terms of its ability to increase coronary flow and detect coronary artery disease. However, it's easier to use (it's given as a bolus as opposed to an infusion over 3-5 minutes) and seems to have less side effects. It also has a longer half life than adenosine, meaning that it's effects last longer. The main issue will be whether nuclear labs will switch from the older drug to the newer drug  for the convenience, or whether the (presumably) higher price will be an issue. Either way, the detection of coronary disease per se will probably not improve.

Troubled Times on the Lipid-Lowering Drugs Market

April 3, 2008

Analysis of:Discontinuation of Development of TAK-475, A Compound for Treatment of Hypercholesterolemia | www.pipelinereview.com

The decision by Takeda to halt development of TAK-475, is not surprising considering the problems faced now by companies trying to get regulatory approval for new lipid-lowering drugs. TAK-475 was not more potent, but was thought to have a better safety profile than statins. However, because the safety profile of the statins currently on the market is great, the improvement would not have made much difference. Moreover, the cost of bringing TAK-475 to the market would have been significant and the prospect of it getting a meaningful market share was not too good.

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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