Immunex Corp. Wednesday continued its string ofpositive news since the unsolicited buyout offer made byAmerican Home Products Corp. on Nov. 1, 1995.
The Seattle company was granted marketing clearance foranother indication for Leukine _ for use followingallogeneic bone marrow transplantation from HLA-matched related donors. The drug, a granulocytemacrophage-colony stimulating factor, shortened the timeto recovery of white blood cells and decreased theincidence of infection when used in that indication.
While the market for allogeneic bone marrowtransplantation consists of only a few thousand patients,the news gave additional support for the value of thecompany's pipeline. Since the $263 million bid byAmerican Home Products, which was soundly rejected,Immunex had Leukine recommended for approval for usein peripheral blood stem cell mobilization, presentedgood data on the drug in reducing infections in high-riskinfants, and had positive results of a Phase II trial of itstumor necrosis factor receptor in rheumatoid arthritis.
Immunex's stock has stayed near $16 per share sinceAmerican Home's $14.50-per-share offer for the 54.6percent of Immunex shares it doesn't already hold.Immunex (NASDAQ:IMNX) closed Wednesday at$16.63, up 13 cents, after hitting a high of $17.75 on theday.
"As you argue for value, every little piece of tangible databecomes more important," said Edmund Debler, ananalyst with New York-based Mehta & Isaly. "Thisapproval helps the argument. On any other day it wouldnot carry as much weight."
An FDA advisory panel last April recommended approvalof Leukine for allogeneic bone marrow transplantation, sothe news came as no surprise. The panel, however, didnot recommend the approval of Leukine in the largerbroad chemotherapy setting, an indication for whichImmunex said it is still in discussions with the FDA.
"The important thing," said Immunex spokeswomanRobin Shapiro, "is this is another indication for Leukine."In addition, she said, the drug showed statisticalsignificance against severe mucositis, a secondaryendpoint in the study but potentially a much larger marketthan allogeneic bone marrow transplantation.
In the 53-patient Leukine arm, 7.5 percent of patients hadmucositis, a painful condition characterized by mouthulcers that often afflicts chemotherapy patients. In theplacebo arm, 28.5 percent of 56 patients developedmucositis.
The randomized, double-blind study showed use ofLeukine decreased time to white blood cell recovery,decreased hospital time and reduced the incidence ofinfection _ 57 percent for the drug group compared to 75percent of placebos.
Allogeneic bone marrow transplantation involves apatient receiving healthy bone marrow harvested from amatched donor. After transplantation, patients havereduced levels of white blood cells, which puts them atrisk for infectious diseases such as pneumonia.
Immunex will present data on a preclinical compound,the FLT-3 ligand, at the American Society of Hematologymeeting that starts Friday in Seattle.
Matthew Geller, an analyst with New York-basedOppenheimer & Co., said Immunex has gainedmomentum with its run of positive news, and apresentation to analysts at the hematology meeting couldportend more positive news.
"People see the American Home offer as being a floor onthe stock," Geller said. "American Home plays hardball.They may not be able to force Immunex to sell out tothem, but they could stand in the way of anyone elsetrying to buy Immunex."
Neither Geller nor Debler has heard of others expressinginterested in acquiring Immunex. The ball clearly is backin American Home's court.
American Home, of Madison, N.J., has not commentedsince the Nov. 13, 1995, rejection of its offer by non-American Home board members at Immunex. All it saidin response was that it was disappointed and believed the$14.50 offer was fair to Immunex shareholders.
Debler originally said there would be no meaningfuldiscussion on the offer until it reached $18 per share."The only way you'd have a takeout by American Homeis a price of at least $20," he said. "The $14.50 shareprice was laughable.
"Immunex just has to wait until the next move," Deblersaid. "They don't have to move. The company can carryforward for at least another three years without anyfinancial difficulties." n
-- Jim Shrine
(c) 1997 American Health Consultants. All rights reserved.