U.S. Bioscience Inc. said Monday it received an"approvable" letter from the FDA for its cytoprotectiveagent Ethyol, and said it would be unconditional _meaning no post-marketing trials would be required.
An approvable letter is sent when certain issues still needto be resolved. Company officials said the remainingquestions will be addressed easily. Analysts said productapproval in the U.S. is expected by the end of the year.
"Had there been some material impediment to the processwe would have felt obliged to respond to it," RobertKriebel, senior vice president, finance and administrationfor U.S. Bioscience, said of the remaining questions. "Bytheir omission [from a company news release], that saysthey're not material."
The FDA letter said Ethyol is approvable to reduce thekidney toxicities of cisplatin in patients undergoingtreatment for advanced ovarian cancer. The company inthe past three and a half years was twice denied approvalof Ethyol for wider indications.
One issue still to be addressed for the WestConshohocken, Pa., company is its plans for marketingEthyol in the U.S. The company could go at it alone,Kriebel said, or enter some sort of marketing alliance.U.S. Bioscience has had several offers from potentialpartners, and has discussions ongoing, he said.
The letter was not unexpected following an FDA advisorycommittee's 8-0 recommendation for approval last June,but was good news nevertheless. U.S. Bioscience's stock(AMEX:UBS) gained 38 cents Monday to close at $5.13.
Alex Zisson, an analyst with New York-based Hambrecht& Quist Inc., said he is expecting approval this year andproduct launch early in 1996. Sales are projected at $5million in 1996, $27 million in 1997 and $80 million in1998, Zisson said. Those figures reflect off-label usage in1997 for chemotherapy, and usage in 1998 involvingradiation therapy.
Richard Vietor, a first vice president of Merrill Lynch &Co., estimated the market in a few years at $95 million to$125 million, assuming a good partner is found and 30percent of all patients using cisplatin also use Ethyol.
Ethyol is administered prior to chemotherapy and isdesigned to protect healthy cells, but not tumor cells,from toxicities through a selective uptake into non-malignant cells. The agent first was looked at as part of aU.S. Army research project to identify a drug that protectsagainst radiation. It was selected as the most activecompound from more than 4,400 that were screened.
U.S. Bioscience has ongoing Phase III trials of Ethyol innon-small cell lung cancer, and is testing its ability toreduce the effects of radiation in head and neck cancerpatients.
The product has been approved in Europe for a separateindication: the reduction of neutropenia-related infectionin advanced ovarian cancer patients. Kriebel said U.S.Bioscience intends to go back to regulatory authorities inEurope to add the renal toxicity attributes there.
Launch of Ethyol in Europe is under way throughmarketing partner Schering-Plough Corp., of Madison,N.J., which also has rights in a number of areas of LatinAmerica and the Far East. Eli Lilly and Co. Inc., ofIndianapolis, has rights in Canada, where Ethyol is underreview.
Both Zisson and Vietor said it would be difficult for U.S.Bioscience to launch the product itself given thecompany's current cash position, estimated at or under$15 million.
"To go from 15 to 50 sales representatives and spending$10 million on the launch of the drug would really strainthe resources of the company," Zisson said. "The launchperiod is critical in creating an impression in thephysicians' minds."
Vietor said that U.S. Bioscience needs money, througheither financing or a marketing partner. He pointed to arecent oncology meeting in Monte Carlo, Monaco,sponsored by Schering-Plough to introduce Ethyol, thatattracted 700 oncologists. U.S. Bioscience wouldn't beable to organize that itself, he said.
Kriebel would not comment further about marketingstrategies in the U.S., nor about the company's financingplans. n
-- Jim Shrine
(c) 1997 American Health Consultants. All rights reserved.