Zocor is a so-called ‘statin’ lipid lowering agent that exerts its action by inhibiting an enzyme known as HMG-CoA., which plays a critical role in cholesterol synthesis. The clinical benefit of Zocor in reducing death due to CHD, MI, and decreasing the need for invasive coronary procedures in patients with elevated cholesterol levels is well established. Unlike Zocor, Zetia works by inhibiting the absorption of dietary cholesterol from the small intestine. Data demonstrating Zetia’s ability to significantly decrease morbidity and mortality from coronary artery disease has not been produced.

According to the American Heart Association, in excess of 100 million Americans presently have total blood cholesterol levels above 200 mg/dl. In addition, fewer than 50% of patients who would benefit from cholesterol lowering treatments are actually receiving them. Some analysts expect Vytorin to eventually attain annual sales of up to $8 billion.

Given that Vytorin is comprised of two already approved drugs, a positive FDA decision is anticipated. Combination therapies are almost always less expensive than the cost of their constituents purchased separately, so potentially Vytorin would not drive up cost of per patient treatment. However, Vytorin will most certainly be more costly than the individual statin drugs that in some cases it is likely to replace. Clinicians might choose Vytorin when they are striving for more aggressive lipid control or when patients are inadequately controlled on a statin alone. Both of these scenarios would see the cost of treatment significantly increase on a per patient basis and forms the underlying rationale for our recommendation that clients should begin preliminary assessment activities for Vytorin in anticipation of FDA approval.

Technology Details
Target Disease / Indication: Hyperlipidemia
Technology Classification: Drug
Body System: Cardiovascular System
Program Area: Medicine/Cardiology
Regulatory Status: Phase III
BioHorizon Impact Score: 81/100 – High

Torecetrapib is a cholesterol ester transfer protein (CETP) inhibitor. CETPs play a role in the conversion of HDL cholesterol into LDL cholesterol. It is thought that interfering with the activity of CETP increases HDL levels. There are a number of chemical CETP inhibitors in the pre-clinical stage of development. At least one other CETP inhibitor, JTT-705, has been tested in human clinical trials.

There are many large-scale clinical trials that demonstrate that the lowering of low-density lipoproteins (LDL cholesterol) with statins has significant effects on a variety of clinical outcomes. While it is generally accepted in the medical literature that low levels of HDL cholesterol increase the risk of coronary artery disease, the data supporting the beneficial effects of elevating HDL cholesterol is epidemiologic in nature. Pfizer will have to demonstrate the safety and efficacy of torcetrapib with respect to some hard cardiovascular endpoints, similar to what has been done with the statins, before this innovative therapy can have a substantial impact on the estimated 100 million Americans with abnormal cholesterol levels.

It appears as though Pfizer continues to devote considerable resources to the development of torcetrapib. Pfizer reportedly paid $1.3 billion to acquire the company that developed torcetrapib and has earmarked $800 million for ongoing clinical trials. Combining Lipitor and torcetrapib in a single treatment for dyslipidemia could significantly increase per patient cost. Biohorizon currently designates torcetrapib a Moderate Impact Technology and recommends no assessment activities at this time.

Technology Details
Target Disease / Indication
Low HDL/Coronary Artery Disease

Technology Classification
Drug

Body System
Cardiovascular System

Program Area
Medicine/Cardiology

Regulatory Status
Phase I

BioHorizon Impact Score
64/100 – Moderate

Unlike traditional or ‘bare metal’ stents, the Taxus stent is coated with a substance named paclitaxel and a unique polymer. The stent props the blocked coronary artery open while the polymer gradually releases the paclitaxel into the vessel wall to stop the growth of scar tissue which causes restenosis. The pivotal Boston Scientific sponsored Taxus IV clinical trial reported an in-segment (stented vessel segment plus 5 mm beyond each end of the stent) binary restenosis (50% or greater vessel re-occlusion) rate of 7.9% in the Taxus group compared with 26.6% in the control group (P=<0.0001). The study also reported a target lesion revascularization (TLR) rate of 3.0% in the Taxus group compared with 11.3% in the control group (P=<0.0001). TLR (or retreatment) rate is one of the most accurate indicators of the performance of drug-eluting stent technology.

In excess of five million Americans are treated for coronary artery disease each year. Most of these patients (about 80%) are treated medically, however, in excess of 1million patients will require more invasive procedures like Coronary Artery Bypass Grafting (CABG) or angioplasty. Among those patients receiving stents, 15-20% will require repeat treatment for restenosis. Industry analysts value the drug-eluting stent market in the 3-4 billion dollar per annum range with some predicting a 5 billion dollar market within the next 2 years. The actual direct cost increase associated with Taxus compared to a bare metal stent is significant. Each Taxus stent will likely cost between $2500 and $3000. This represents an increase of 200-300% over the per unit cost of a bare metal stent. It is duly noted that the significant decrease in restenosis rates and therefore revascularization procedures may ultimately reduce the cost per patient treated by a given health services organization.

The Taxus Express stent is currently in our High Impact Technology category. All clients with significant cath-lab operations should commence or continue assessment activities as soon as possible.

Technology Details
Target Disease / Indication: Coronary Artery Disease
Technology Classification: Combination Drug/Device
Body System: Cardiovascular System
Program Area: Cardiology
Regulatory Status: Approved

BioHorizon Impact Score: 84/100 – High

In excess of five million Americans are treated for coronary artery disease each year. Most of these patients (about 80%) are treated medically, however, in excess of 1million patients will require more invasive procedures like Coronary Artery Bypass Grafting (CABG) or angioplasty. Among those patients receiving stents, 15-20% will require repeat treatment for restenosis. The CYPHER stent, approved for U.S. marketing in April 2003, has been used to treat approximately 500,000 patients in more than 80 countries worldwide. Industry analysts value the drug-eluting stent market in the 3-4 billion dollar per annum range. The actual direct cost increase associated with CYPHER compared to a bare metal stent is significant. Each CYPHER stent costs in the $2500 to $3000 range. This represents an increase of 200-300% over the per unit costs of a bare metal stent. It is duly noted that the significant decrease in restenosis rates and therefore revascularization procedures may ultimately reduce the cost per patient treated by a given health services organization.

The CYPHER stent is currently in our High Impact Technology category. All clients with significant cath-lab operations should commence or continue assessment activities as soon as possible.

Technology Details
Target Disease / Indication: Coronary Artery Disease
Technology Classification: Combination Drug/Device
Body System: Cardiovascular System
Program Area: Medicine/Cardiology
Regulatory Status: Approved
BioHorizon Impact Score: 86/100 – High