Clinical trials and tribulations overshadowed more positiveannouncements coming from the biotech community for a goodpart of 1993's first quarter.
The year got off on a resoundingly sour note in mid-January,when Centocor Inc. (NASDAQ:CNTO) announced that it hadhalted the second Phase III trials on its flagship drug, Centoxin(HA-1A), for treating septic shock because it was killing peoplein one arm of the study. As a result, the Malvern, Pa.,company's stock dropped 63 percent, or $11.13 per share, onJan. 18, closing at $6.63 a share, about where it has been stuckever since.
Even more devastating was what happened to Synergen Inc. OnFeb. 22, exactly five weeks after the Centocor announcement,Synergen (NASDAQ:SYGN) of Boulder Colo., announced thatPhase III results on its own flagship product for treating septicshock, Antril, indicated that the drug was only slightly betterthan the placebo in preventing septic shock-associated death.The news sent Synergen's stock tumbling about 68 percent, or$28.63, to $13.50 a share.
After those announcements -- and the resounding shock wavesthey sent through the financial community -- any positiveproduct-related event should have had a warm reception. Butwhen FDA approved its first biotech drug of 1993 -- Kogenate-- on Feb. 25, the Street heralded the event with a yawn.
Nonetheless, March proved full of positive or provocativepronouncements. Centocor was so confident of the Phase IIItrial results on its heart drug, CentoRx, that on March 16 thecompany declared it would file a product license application(PLA) by the end of this year. And Gensia Pharmaceutical Inc.(NASDAQ:GNSA) of San Diego reported on March 16 that PhaseIII trials on its flagship heart drug, Arasine, were statisticallyin favor of the drug's efficacy.
Trials have been completed on some other high-profile biotechdrugs. Genentech Inc. (NYSE:GNE) of South San Francisco, Calif.,filed a PLA on March 30 for Pulmozyme, its recombinant DNasefor treating cystic fibrosis. Vestar Inc. (NASDAQ:VSTR) of SanDimas, Calif., filed the first NDA in the U.S. on a liposomal drug(DaunoXome for treating AIDS-related Kaposi's sarcoma) inFebruary. And Immunex Corp. (NASDAQ:IMNX) of Seattle,which is already marketing its GM-CSF (granulocytemacrophage-colony stimulating factor) drug Leukine forhastening bone marrow transplants in cancer patients, justfiled a product license amendment to expand the labelapplications for this drug to treat chemotherapy-inducedneutropenia.
FDA is even moving on approvals for some first-ever products.Its Peripheral and Central Nervous System Drugs advisorycommittee voted to recommend approval of a drug for treatingAlzheimer's -- Warner-Lambert Co.'s Cognex (a non-biotechproduct that potentiates the activity of a neurotransmitter) --and one for treating multiple sclerosis -- Betaseron, a betainterferon analog created by Chiron Corp. (NASDAQ:CHIR) ofEmeryville, Calif., and partner Berlex Laboratories Inc. Therehave been no treatments for these two diseases.
None of these developments, however, have been able to shakebiotechnology stocks out of their doldrums.
Of all the high-profile biotech products that have capturedpeoples' attention this quarter, the one that's likely to get themost play in the media is bovine growth hormone (BGH). OnWednesday, FDA's Veterinary Medicine advisory committeerecommended approval of Monsanto Co.'s genetically alteredBGH (also called bovine somatotropin, BST) to boost milkproduction in dairy cattle despite the misgivings ofenvironmentalists, who have promised to fight the product inthe marketplace.
-- Jennifer Van Brunt Senior Editor
(c) 1997 American Health Consultants. All rights reserved.