Eli Lilly and Sankyo’s CS-747 / Prasugrel for Acute Coronary Syndrome

admin — Mon, 25 Oct 2004 18:42:10 +0000

On October 25, 2004 Eli Lilly and Company and Sankyo Company announced that a Phase 3 clinical trial comparing the antiplatelet agents prasugrel and Plavix™ is scheduled to begin later this year. The study, known as TRITON-TIMI 38, will include a reported 13,000 patients who are suffering acute coronary syndromes (heart attacks or unstable angina) and undergoing a percutaneous coronary intervention (PCI) like angioplasty or coronary artery stenting. The company has indicated that the main focus of the study is to compare the efficacy of prasugrel with that of Plavix in the prevention of heart attack, stroke and death in patients who undergo PCI. The outcomes of post procedure bleeding, recurrent heart-related chest pain (ischemia) and the need for additional procedures to restore blood flow (urgent target revascularization) will also be examined. BioHorizon has assigned prasugrel an efficacy score of 75/100 for its Phase 3 stage of development and a 42/100 value for the burden of illness associated with the approximately 560, 000 PCI’s performed in the United States each year.

Prasugrel is an oral antiplatelet drug that may prevent platelet activation by blocking adenosine diphosphate receptors on the platelet surface. When activated, these receptors allow for a protein in the blood known as fibrin to link platelets together, creating a ‘plug’ or ‘clump’ of platelets that can produce a critical vessel blockage and cause a heart attack. Other anti-platelet treatments currently available include ASA, the thienopyridines-clopidogrel (Plavix), and ticlopidine as well as the glycoprotein IIb/IIIa inhibitors abciximab and tirafibrin. We have assigned prasugrel 50/100 for innovation as a new drug in an existing class of oral antiplatelet drugs.

BioHorizon believes that demand/diffusion parameters for oral anti-platelet drugs are increasing. Bristol Myers Squibb, the manufacturers of Plavix™, recently reported a 23% increase in U.S. prescriptions and a nine month total sales figure of in excess of 900 million dollars. Depending on the forthcoming efficacy and adverse event data, prasugrel could compete in this market. We have assigned this technology a demand/diffusion score of 20/100.

The overall BioHorizon Emerging Health Technology Impact Score is 47/100, currently placing prasugrel in our Moderate Impact Technology category. No preliminary assessment activities are recommended for health services clients at this time.

Technology Details
Target Disease / Indication: Acute Coronary Syndrome
Technology Classification: Drug
Body System: Cardiovascular System
Program Area: Medicine/Cardiology
Regulatory Status: Phase 3
BioHorizon Impact Score: 47/100 – Moderate Impact

Preos osteoporosis drug

admin — Fri, 02 Apr 2004 15:47:02 +0000

On March 30, 2004 NPS Pharmaceuticals Inc. said that its Phase III osteoporosis drug, Preos, significantly reduced spinal fractures or worsening of fractures in a study of 2, 600 postmenopausal women. The 18-month study on Preos involved postmenopausal women with mild to moderate osteoporosis. 81% of participants had no previous history of vertebral fracture. The trial consisted of a treatment arm (patients received daily injections of Preos and supplements of calcium and vitamin D) and a control arm (patients received placebos along with the same supplements). NPS said its drug met the main goal of a statistically significant reduction in the incidence of new or worsened vertebral fractures. It reported a 59% reduction in new or worsened fractures in the treatment versus control arms of the study. That is, 1.4% of women taking Preos had new or worsened fractures by the end of the trial compared to the fracture rate of 3.4% among those taking placebos. Patients taking Preos who had not had a fracture prior to entering the trial experienced a relative reduction of 68%. NPS indicated that it would seek U.S. approval this year for Preos. Preos would compete with Eli Lilly and Co.’s Forteo, a similar injectable drug.

Preos is an injectable, bioengineered version of human parathyroid hormone. Parathyroid hormone is secreted by the thyroid gland and regulates the level of calcium in various body tissues. A similar drug, Eli Lilly’s Forteo, was approved in November 2002 for the treatment of osteoporosis in the United States. Forteo, an injectable bioengineered human parathyroid hormone fragment, is reported to have had sales of $65 million last year. Estimated future annual sales of both injectable drugs has been gauged at about $400 million by several Wall Street analysts.

According to the National Osteoporosis Foundation (NOF), osteoporosis is responsible for more than 1.5 million fractures annually in the United States. The most common fractures are vertebral (700, 000), hip (300, 000), and wrist (250, 000).

Biohorizon has maintained its Moderate Impact Technology designation for Preos. Available treatment options for clinicians treating osteoporosis are considerable with bisphosphonates (Fosamax®, Actonel®), calcitonin (Miacalcin®), estrogen/hormone therapies, parathyroid hormone (Forteo®), and selective estrogen receptor modulators (Evista®). No assessment activities are currently recommended for Preos.

Technology Details
Target Disease / Indication
Osteoporosis

Technology Classification
Drug

Body System
Musculoskeletal System

Program Area
Medicine/Rheumatology

Regulatory Status
Phase III

BioHorizon Impact Score
56/100 – Moderate

BioHorizon » Eli Lilly

Eli Lilly and Sankyo’s CS-747 / Prasugrel for Acute Coronary Syndrome

Preos osteoporosis drug