Genzyme Corp. added its potentially biggest-selling product to itsportfolio Tuesday when the FDA granted marketing clearance to itslead anti-adhesion product, Seprafilm.
Genzyme gained a broad labeling for the product, alleviating fearssome had after an FDA advisory meeting that the product might beindicated for use in conjunction with a narrow range of surgeries.Genzyme plans a broad launch of Seprafilm in October.
The approved labeling allows the hyaluronic acid-based membrane tobe used in any open abdominal or pelvic surgery. Genzyme said thereare about 3.1 million such surgeries performed each year in the U.S.Adhesions, or scar tissue, can form after these surgeries and lead toserious complications.
"The label is as broad as anyone could have expected," said DavidStone, a managing director of Cowen & Co. in Boston. "It's not acomplete surprise because the company had indicated publicly it washaving some success in negotiating with the FDA on a relativelybroad label.
"It gives them what they need to market the product," Stone said.
Stone estimated Genzyme will sell about $20 million worth ofSeprafilm this year with sales reaching $100 million in 1997 and$200 million in 1998. "At full penetration they will get about 30percent penetration of the $1 billion to $1.5 billion market, as big aseverything they sell," said Stone, estimating Genzyme's total salesthis year at $450 million.
"It's good news," Stone said. "It's a reminder there are a lot ofproducts coming out of the biotech sector."
Genzyme's stock, falling in recent months along with the sector anduncertainty about Seprafilm, gained $3.25 Tuesday, or 14 percent, toclose at $26.50 in trading of more than seven million shares.Genzyme split its stock last month, increasing the outstanding sharesto about 74 million.
Seprafilm is used as a temporary barrier to separate tissues aftersurgery, giving time for the normal tissue repair process. One to twodays after being placed the membrane becomes a hydrated gel that isslowly resorbed within a week. Components are excreted within amonth.
Seprafilm is expected to cost between $200 and $400 per surgicalprocedure.
Specifically, the label says Seprafilm "is indicated for use in patientsundergoing abdominal or pelvic laparotomy [open surgery] as anadjunct intended to reduce the incidence, extent and severity ofpostoperative adhesions between the abdominal wall and theunderlying viscera such as omentum, small bowel, bladder andstomach, and between the uterus and surrounding structures such astubes and ovaries, large bowel and bladder."
Genzyme said some investors thought the product would be approvedfor use only with colectomy and myomectomy, the surgeries studiedin pivotal trials.
"They are ready in that they have a sales force that calls onsurgeons," Stone said. "They will have had ample time to train thesales force. The launch is planned for October, which coincides withmajor surgical meetings."
Genzyme got its sales force through the purchase of DeknatelSnowden Pencer Inc., of Fall River, Mass., for $250 million. Thepurchase was completed last month. (See BioWorld Today, May 29,1996, p. 1.)
When announcing the purchase, Genzyme said it would keep all 585Deknatel Snowden employees, including the 70-person sales force inthe U.S. and Europe. The company, which was privately held, had netsales last year of nearly $100 million. Its biggest-selling products arechest drainage devices, and it sells a variety of products tocardiovascular, gynecological and general surgeons.
Genzyme already is selling Seprafilm in Denmark, France, Germany,Italy, the Netherlands, Sweden and the U.K. Clearance also has beengained in 11 other European countries, and in Canada, Israel,Singapore and Hong Kong.
Genzyme, of Cambridge, Mass., will market Seprafilm under a jointventure with a limited partnership, Genzyme Development Partners,that was established in 1989 when 770 investors purchased a total of738 units at $50,000 each, raising $36.8 million. That fundeddevelopment of Seprafilm and related products into 1994, whenGenzyme began paying development costs. Genzyme in January1996 offered $93 million in stock for the rights held by thepartnership but that deal never went through.
Now Genzyme and the partnership will share profits for two years,after which Genzyme will pay $26 million to the partners plusroyalties of 10 percent on North American sales for 10 years.Partners also could receive lesser royalties on European sales.
Genzyme has run trials showing Seprafilm effectively prevented orreduced adhesions in abdominal and gynecological surgeries.
One study involved 183 abdominal surgeries in which half thepatients received Seprafilm sheets between the incision and internaltissues and organs. Fifty-one percent of Seprafilm-treated patients didnot develop adhesions compared to only 6 percent in the controlgroup. Of the 49 percent of Seprafilm patients who did experienceadhesions, nearly two-thirds developed less extensive scarring thanuntreated patients. Only 15 percent of Seprafilm patients experienceddense adhesions compared to 58 percent of non-Seprafilm patients.
A study in patients undergoing gynecological surgery showed 37percent fewer adhesions to the uterus in the Seprafilm groupcompared to untreated controls. Also, Seprafilm patients had 50percent fewer adhesions on the anterior surface of the uterus and 21percent fewer adhesions on the posterior surface. n
-- Jim Shrine
(c) 1997 American Health Consultants. All rights reserved.