With billions of dollars in sales projected for the recentlyapproved AIDS therapy 3TC, a small Connecticutbiotechnology company is trying to cash in on theexcitement and some of the anticipated wealth through itsU.S. patent application for use of the drug for hepatitis B.
OncoRx Inc., of New Haven, Conn., is hoping its 1991use patent application will be granted forcingpharmaceutical giant Glaxo Wellcome plc to negotiate fora licensing agreement and to part with a portion of whatanalysts predict will be "monster" revenues.
Glaxo Wellcome, of London, licensed 3TC (lamivudine)from BioChem Pharma Inc., of Laval, Canada, andreceived FDA approval of the drug in November 1995 foruse in combination with AZT (zidovudine) to treat AIDS.
Clinical trial data indicated 3TC and AZT performedbetter than AZT alone, which was the first drug approvedfor AIDS in 1987. Glaxo Wellcome also markets AZT. Inaddition it has rights to 3TC for hepatitis B and iscollaborating with BioChem Pharma on clinicaldevelopment for that disease.
Hepatitis B is not considered a major problem in the U.S.The largest market is in Asia. But OncoRx president andCEO, John Spears, said the disease often is associatedwith AIDS, raising the issue of whether 3TC would treatboth diseases and enhance royalty claims for holders of ahepatitis B use patent.
In 1994, OncoRx, of New Haven, licensed technologyfrom Yale University, of New Haven, that included a1991 U.S. patent application for use of 3TC for hepatitisB.
"Yale filed patents on several nucleoside analogs,including 3TC, and a use claim for hepatitis B for 3TC,"said Spears. "OncoRx licensed the patent application in apackage deal that included anti-cancer compounds."
BioChem Pharma and Glaxo Wellcome, whose U.S.headquarters are in Research Triangle Park, N.C., have acomposition of matter patent for 3TC and a use patent forHIV. BioChem Pharma officials have said their usepatent application for hepatitis B was filed earlier thanOncoRx's.
Spears has been alerting the investment community to hiscompany's potential good fortune should it be granted apatent.
"OncoRx is a fairly new company," Spears said. "We justdid an initial public offering this summer and this is anopportunity to tell our story."
OncoRx, which raised $10 million in its August stockoffering, is focusing primarily on anti-cancer compounds.The company has no intention of trying to develop 3TCfor hepatitis B. If its use patent were granted, OncoRxcould not sell the drug unless it negotiated for a license tothe composition of matter patent from BioChem Pharmaand Glaxo. Such an agreement, Spears acknowledged,would be unlikely.
On the other hand, if OncoRx were issued its patent,BioChem Pharma and Glaxo Wellcome would have topay OncoRx for a license to sell 3TC for hepatitis B.
Spears said he has been contacted by "a number ofcompanies" already interested in buying OncoRx's rightsto the hepatitis B use patent.
Wall Street analysts have projected more than $1 billionin U.S. sales for 3TC by the end of this decade, in part,because the FDA expanded the market for the 3TC-AZTcombination therapy, allowing it to be used earlier in theprogression of HIV than AZT alone. n
-- Charles Craig
(c) 1997 American Health Consultants. All rights reserved.