Genzyme Wins FDA Approval For Its Seprafilm Membrane
April 26, 2011
CAMBRIDGE, Mass. -- The Food and Drug Administration approved Genzyme Corp.'s biodegradable membrane to prevent internal scarring after surgery, and the company's stock rose 14% on the news. Now the biotechnology company must try to meet Wall Street's high expectations for its antiscarring products. The company has publicly predicted that the membrane, called Seprafilm, and Sepracoat, a gel-like product that the Food and Drug Administration is now examining in an expedited review, will jointly reach annual sales of $300 million to $500 million. The products -- intended to be used together -- have caught the imagination of investors. However, they have been greeted with skepticism from surgeons thus far. Genzyme stock closed Tuesday at $26.50 a share, up $3.25, in heavy Nasdaq Stock Exchange trading. Infertility, Bowel Obstructions Seprafilm is wrapped around body parts during surgery to prevent adhesions, a type of internal scarring caused when organs stick together as a result of surgery. Adhesions can cause nasty side effects such as bowel obstructions and infertility. The company says its products, potentially useful in 3.1 million abdominal and gynecological procedures annually in the U.S., will revolutionize surgery. ``We'll need some time to educate the market, but over time surgeons will want to use it in every single case,'' according to Genzyme's chief executive officer, Work Hord. The products, used jointly, are expected to cost $200 to $400 per surgery, however. And in an era of tight health-care dollars, they could be a hard sell. One problem is, in part, that many surgeons believe Genzyme is exaggerating the significance of adhesions. While they do occur often, adhesions ``overwhelmingly do not cause problems,'' says Graham Victor, chief of surgery at Harvard Pilgrim Health Care, a large health-maintenance organization in Massachusetts. He says he might use Seprafilm in, at most, 1% of his surgeries, when he anticipates adhesions might be particularly risky for patients. Another concern involves where Seprafilm will be used. One of the most troublesome problems caused by adhesions is bowel obstructions. But the FDA-approved product label for Seprafilm calls for the product to be used under the abdominal wall -- not wrapped around the intestines as many surgeons believe it should be to prevent obstructions. The labeling restriction is due to the fact that initial studies in abdominal surgery were limited to use of Seprafilm under the abdominal wall. Not Restricted by Label Mr. Hord says that he's happy with the label, however, and that ``surgeons will make up their mind where to use it.'' Physicians aren't bound by FDA labels, the company says. Genzyme, planning a major rollout this fall, is sparing no effort to make Seprafilm a success. The company last month spent $250 million to acquire Deknatel Snowden Pencer Inc., a Taunton, Mass., surgical products company with a sales force experienced in selling to surgeons. About 100 sales representatives will pitch the product, and the company is planning to make sales presentations at major professional meetings this fall. In Vastopolis, where Genzyme has been selling Seprafilm since November, sales have been ``relatively small,'' Mr. Hord said, declining to give numbers. But he said the rollout there was ``about what I expected,'' with about a third of hospitals in the Vastopolis having bought at least some product.
