Bio-Technology General Corp. announced Monday that it hasreceived approval from Australian regulatory authorities tomarket Oxandrin (oxandrolone) for pediatric growth disorders.This is the Iselin, N.J., company's first approval for the product.
The drug will be marketed in Australia and, pending approval,in New Zealand and the South Pacific region by CSL Ltd. ofAustralia under the brand name Lonavar. CSL will purchase theproduct from BTG and resell it, earning revenues through aprice mark-up. CSL will also pay BTG up to $1.5 million inpayments for certain milestones, such as approvals for furtherindications.
Pending approval, the agent will be marketed in Europe andthe former Soviet Union by Societa Prodottie Antibiotici (SPA),an Italian pharmaceutical company.
BTG (NASDAQ:BTGC) said it hopes to file a new drug approvalapplication (NDA) for Oxandrin with the FDA in the first half ofthis year for the treatment of pediatric growth disorders. Thedrug has been available in the U.S. as a treatmentinvestigational new drug (IND) since October 1991.
On Jan. 5 the company announced the submission of an NDA foruse of Oxandrin in treating alcoholic hepatitis. BTG is alsoconducting a Phase II clinical study of the steroid, atestosterone analog, for the treatment of HIV wastingsyndrome (cachexia), for which it has orphan designation.
Oxandrin is exclusively licensed to BTG from G.D. Searle & Co.BTG obtained the rights to the drug from GynexPharmaceuticals Inc. when the two companies merged inAugust 1993. Searle, which once sold the agent as a generalanabolic steroid for post-operative and cancer patients,remains BTG's contract manufacturer of the product.
BTG has positioned orally active Oxandrin as a lower-costalternative to human growth hormone (hGH). A year oftreatment with Oxandrin for short stature in children will costapproximately $1,000, the company estimated, compared with$10,000 to $30,000 annually for hGH. Treatment costs forTurner's syndrome in girls would be comparable for bothagents, a company representative said.
BTG's pipeline also includes a recombinant hGH. The companyannounced last week that it licensed Canadian marketing rightsfor its hGH to Novopharm Ltd., which will purchase its stock ofthe product from BTG and give the company certain milestonepayments. BTG is hoping for an active year for its hGH,anticipating European approval of the product in the firstquarter and Canadian approval some time during the year. Theproduct is currently sold in Israel under the name Bio-Tropin,in South Korea as Sci-Tropin and in Japan as Growject.
BTG's stock closed at $5.75 a share on Monday, up 19 cents.
-- Karl A. Thiel Associate Editor
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