Peroxinorm, a drug developed by DDI Pharmaceuticals(NASDAQ:DDIX) of Mountain View, Calif., and distributed inGermany through a German licensee, has been temporarily withdrawnfrom sale there following two deaths that may have been attributable tothe product.The Italian government has followed suit in banning the sale of theproduct in Italy, where it is sold as Orgotein and distributed bySmithKline Beecham, according to Betsy Truax, DDI's spokeswoman.Peroxinorm, or bovine superoxide dismutase (bSOD), is an enzymemade from bovine liver extract and marketed as a treatment forosteoarthritis of the knee. It has not been approved for sale in the U.S.,but has been marketed in Germany since 1981 through DDI's licensee,Gr-nenthal GmbH. According to DDI, more than 11 million vials ofthe product have been sold since then.Truax said DDI's president, Ray Rogers, is now in Europe and willwork with Gr-nenthal and the German health ministry to investigatewhether Peroxinorm had anything to do with the deaths. She saidroyalties from Gr-nenthal amounted to $164,000 in 1993. bSOD is alsosold in Spain, Portugal, Hungary, Luxembourg, and Poland, as well asin some Latin American and Middle Eastern countries. Royalties fromworldwide sales of the product totaled $729,000 in 1993. Truax alsonoted that DDI's total revenues in 1993 amounted to some $3 million.Peroxinorm will be withdrawn from the German market through Oct.1. During this period, individuals using the drug will not be able to getreimbursement for purchase of the product. In addition, anyonewishing to obtain the drug will have to go through Gr-nenthal;Gr-nenthal will then have to seek permission from German healthauthorities to supply the product to that person, she said.bSOD has had a troubled history in recent years. In 1990, the Frenchgovernment refused to approve sales of the drug in France.In addition, Phase III trials of the product in the U.S. in 1992 failed toprove that bSOD was significantly better than a placebo in alleviatingpatients' knee pain enough to allow reduction of their non-steroidalanti-inflammatory drug dose. In August 1993, DDI announced that itwould begin human trials to establish the efficacy of bSOD inmanaging osteoarthritis pain, and would also initiate dosage andtoxicity studies in animals with polyethylene glycol (PEG) recombinanthuman SOD. DDI's spokesman said PEG rhSOD extends the half-lifeof proteins and other molecules and would make the drug 300 timesmore effective.The company has also been troubled with a shareholder revolt thatforced the resignation of three members of the board of directors inMay 1993.040794Ddi
-- Philippa Maister
(c) 1997 American Health Consultants. All rights reserved.