Exubera

On Thursday March 4, Aventis SA and Pfizer Inc. stated that the European Medicines Evaluation Agency has accepted the filing of a marketing authorization application for Exubera (human insulin powder). The companies are seeking approval to market Exubera for adult patients with Type 1 and Type 2 diabetes. Pfizer and Aventis have been working with the US FDA to determine the appropriate timing for submission of the new drug application for Exubera in the US.

Pfizer and Aventis are collaboratively developing Exubera, a dry powder form of insulin, for patients with Type 1 and Type 2 diabetes. They have entered into a global agreement to co-develop, co-promote (where permitted by local law) and co-manufacture inhaled insulin. Pfizer is also in collaboration with Nektar Therapeutics, developers of the inhalation device and formulation. We believe that if equivalent safety and efficacy with injectable insulin is demonstrated, diabetic patients and their physicians will find the inhaled route of insulin delivery highly desirable. There has been some speculation that delays in FDA filing for Exubera have centered around concerns pertaining to adverse effects on lung function in clinical trials comparing the inhaled insulin vs. standard injected insulin. The financial media has recently carried stories estimating the potential value of Exubera’s sales to be in the 1 to 2 billion dollars per year range. There are currently no FDA approved forms of inhaled insulin.

Data from the National Health Interview Survey suggest that in the year 2000, 1, 104, 000 Americans were diagnosed as having diabetes. Complications commonly associated with uncontrolled or poorly controlled diabetes include heart disease, stroke, kidney failure and blindness. Diabetes and its complications may account for more than $100 billion annually in healthcare costs in the United States.

Due to the sheer size of the diabetic population in the United States and the potential for transformation of insulin delivery from the injected to inhaled routes, we have designated this innovative technology as High Impact. However, due to the unknowns surrounding price and a FDA submission, we recommend no preliminary assessment activities at this time.

Technology Details
Target Disease / Indication
Diabetes

Technology Classification
Drug

Body System
Endocrine System

Program Area
Medicine/Endocrinology

Regulatory Status
Phase III

BioHorizon Impact Score
71/100 – High