Bio-Technology General Corp. announced Tuesday that itexpects to reacquire all U.S. rights to human growth hormone(hGH) from Du Pont-Merck Pharmaceuticals.
BTGC originally licensed the marketing rights to Du Pont inreturn for Du Pont taking hGH through clinicals and obtainingdrug approval, said Sim Fass, BTGC president.
To reacquire hGH, BTGC of New York will issue Du Pont ofWilmington, Del., $1 million of BTGC stock and pay Du Pont upto $5 million in royalties, the total exceeding Du Pont'sinvestment in the drug's development, said Fass. BTGC will alsorecover all data generated by Du Pont and become the assigneeof the new drug application before the Food and DrugAdministration for use of hGH to treat GH-deficient children.
Fass told BioWorld that BTGC (NASDAQ: BTGC) may sell hGHdirectly or seek another corporate partner. BTGC cannot sellhGH in the United States to treat GH-deficient children until EliLilly & Co.'s orphan drug status expires in 1994, said Fass. TheU.S. market for that indication is more than $200 million.
BTGC has begun clinical trials to test hGH to prevent wasting incancer patients and will begin trials by July to study thehormone's ability to prevent wasting in AIDS patients andmuscle loss in the elderly, said Fass.
BTGC has licensed hGH to SmithKline Beecham for Europeansales and to JCR Pharmaceutical Co. for Japanese sales.
BTGC initiated the reacquisition when Du Pont-Merck beganfocusing on "more near-term opportunities with very largeclinical and commercial potential," said Fass. Du Pont-Merck, ajoint venture begun in January to develop Du Pont'shypertensive, cardiovascular, Alzheimer's and immunologicalproducts, could not be reached for comment.
Fass also said BTGC hopes to close a $6 million round of privatefinancing within a week.
-- Carol Talkington Verser, Ph.D. Special to BioWorld
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