Monday, November 6, 1995
In the new age of cost-managed health care, simply conducting a superlative set of pivotal trials will not guarantee a market for new products, and many biotech companies with late-stage products may find that regulatory approval is simply another milestone, rather than the end point of product development.
Genzyme Corp.'s Seprafilm anti-adhesion product is the latest product to cross this threshold, and GENZ's experience going forward should prove to be instructive to the industry.
GENZ ran a classically perfect clinical trial of Seprafilm, one that will set a new standard for trials in this area. Nor can one quibble with the data, which was highly statistically significant at every end point, and clearly demonstrated that the hyaluronic acid-based product reduces adhesions.
Now all the Cambridge, Mass., company has to do is persuade surgeons to use it. But conversations with physicians who perform major abdominal surgeries indicate that for many, it will be a lengthy sales job.
The product story
Seprafilm is designed to stop adhesions that result from direct trauma. It acts as a barrier for seven days and is applied at the end of surgery. In the trial it was placed between the bowel and the midline incision. But according to Bonnie Fendrock, vice president of surgical products, it can be placed anywhere the surgeon has made an incision, including, for example, at the site of an anastomosis, where the surgeon has taken out a piece of the bowel and sewn it back up. "Conceptually, there's no reason why you can't put Seprafilm on any organ," she said.
A companion HA product, Sepracoat, has a residence time of 24 hours and is applied at the start of surgery and every 30 minutes thereafter. It is designed to stop indirect trauma.
Adhesions cause a number of major medical problems, including small bowel obstruction, chronic abdominal pain and infertility in women. They can also add time and risk to second surgeries. Adhesion-related problems can appear as long as 20 years following surgery.