Abbott Labs ABT-874 for Treatment of Crohn’s Disease

admin — Thu, 11 Nov 2004 19:04:27 +0000

On November 11, 2004 the results of an Abbott Labs Phase 2 Crohn’s disease clinical trial examining the safety and efficacy of ABT-874 were published in the New England Journal of Medicine. , ABT-874 is a monoclonal antibody designed to target interleukin-12 (IL-12). The authors concluded that treatment with ABT-874 may have caused clinical responses and remissions in patients with active Crohn’s disease; however, at no time were the remission rates in the ABT-874 groups significantly different from those in the placebo group. Other significant findings of note include a decrease in Th1-mediated inflammatory cytokines at the site of disease. 79 eligible patients were enrolled in this study and these participants received either ABT-874 by injection or placebo across a range of dosages and frequencies. Emerging technologies entering Phase 2 are awarded a baseline 50 efficacy points; we have are adjusted this to 40 based on our analysis of the published results.

ABT–874 is a fully human, monoclonal antibody directed against an inflammatory cytokine known as IL-12. IL-12 is a known mediator of inflammation and may be important in Crohn’s disease. Given the inflammatory nature of Crohn’s, many targets related to immune system function are being pursued. Already, approved infliximab targets the tumor necrosis factor, another member of the class of inflammatory cytokines. We have assigned ABT-874 a score of 60 for innovation status.

Crohn’s disease is a chronic, inflammatory disease of the gastrointestinal tract that affects between 500,000 and 1 million Americans. Usually diagnosed before age 30, symptoms include diarrhea, cramping, abdominal pain, weight loss, fever, and in some cases rectal bleeding. There is no cure for Crohn’s disease. Incidence estimates for this disease vary greatly, ranging from 1/100, 000 cases per year to 70/100, 000. Published studies seem to cluster around the 5-10/100, 000 range resulting in a burden of illness score of 10.

We have scored the demand/diffusion variable at 10 resulting in an overall BioHorizon Emerging Health Technology Impact Score of 30, placing ABT-874 in our Low Impact Technology category. No preliminary assessment activities are required at present.

Technology Details
Target Disease / Indication: Crohn’s Disease
Technology Classification: Drug
Body System: Gastrointestinal
Program Area: Medicine/Gastroenterology
Regulatory Status: Phase 2
BioHorizon Impact Score: 30/100 – Low

Elan/Biogen Idec’s Antegren (Natalizumab) for Treatment of Multiple Sclerosis

admin — Mon, 26 Jul 2004 18:33:40 +0000

On July 26, 2004 Elan Corp.’s application for approval of its multiple sclerosis (MS) drug Antegren was accepted for review by the FDA. Elan has developed Antegren with U.S. partner Biogen Idec. The company has stated that this therapy represents a new approach in the treatment of MS and is expected to eventually generate annual sales of more than $1 billion. This estimate merits a 50/100 BioHorizon demand/diffusion variable score. The FDA, which granted Antegren ‘priority status’ in June 2004, will now review the New Drug Application and make its decision within 6 months as opposed to the standard 10 months. Completion of Phase III trials for the MS indication results in a BioHorizon efficacy variable score of 75/100.

Antegren is a humanized monoclonal antibody designed to inhibit the migration of immune cells into tissues where they may play a role in causing or propogating an inflammatory response. The company states that it is the first alpha-4 antagonist in the new selective adhesion molecule (SAM) inhibitor class. Approximately 2,800 patients have received natalizumab in clinical trials for both Crohn’s disease and MS; headache, fatigue, and nasopharyngitis were the most commonly reported side effects. BioHorizon has currently assigned Antegren a first in class 75/100 innovation status variable score.

Multiple sclerosis is a chronic, debilitating autoimmune disease that affects the brain and spinal cord. MS causes the body to direct antibodies and white blood cells against proteins in the myelin sheath that surrounds the nerves in the brain and spinal cord. This may cause inflammation and areas of scarring on nerves resulting in loss or decrease in function. An estimated 400,000 Americans have MS. BioHorizon utilizes an incident case number of 10, 400 new cases of MS in the U.S. per annum and assigns an 11/100 value to the burden of illness variable.

BioHorizon is currently monitoring 23 emerging technologies for the treatment of Multiple Sclerosis. Of these 23 drugs, Avonex®, Betaseron®, Rebif®, and Copaxone® are already approved for this indication while Antegren is the only Phase III technology currently in the BioHorizon database. Although currently designated as Moderate Impact technology, we feel that the high degree of innovation exhibited by this treatment and the large unmet medical need surrounding MS will result in significant technology impact. Health Services clients should commence preliminary assessment activities within the next quarter and watch for news regarding approval.

Technology Details
Target Disease / Indication: Multiple Sclerosis
Technology Classification: Drug
Body System: Nervous System
Program Area: Medicine/Neurology
Regulatory Status: Phase III
BioHorizon Impact Score: 53/100 – Moderate Impact

BioHorizon » Crohn’s disease

Abbott Labs ABT-874 for Treatment of Crohn’s Disease

Elan/Biogen Idec’s Antegren (Natalizumab) for Treatment of Multiple Sclerosis