Glaxo Wellcome Inc. submitted a new drug application for 3TC inthe expected time frame, and approval by the end of the year wouldcome as no surprise to analysts.

Data from surrogate-marker trials of the nucleoside analogue havebeen so strong that there appears to be little standing in the way ofapproval for the HIV drug, which, with AZT, has shown better resultsthan AZT taken alone.

The specific indication sought is as a first-line combination therapy inHIV patients with CD4 counts of 500 and less. BioChem PharmaInc., of Laval, Quebec, discovered the drug in 1989 and later licensedrights to Glaxo, the London-based pharmaceutical company thatbought out Wellcome plc earlier this year to give itself a leadingposition in the HIV market. Wellcome owned AZT, or Retrovir(zidovudine).

"I've always believed the main impetus in buying Wellcome was toget full control of the combination therapy," David Crossen, directorof health care services for UBS Securities, told BioWorld. "BecauseAZT sales were running about $300 million per year, one mightlegitimately expect to double those sales with the combination. Itabsolutely will be the combination of choice."

Further, Crossen said, the AZT-3TC combination likely will be thecore when three-drug regimens are used against HIV.

Tim Wilson, senior biotechnology analyst for Hambrecht & QuistInc., said Glaxo in the past year has gone from being a minor playerin antivirals to having the No. 1 position in the world.

"The message," Wilson said, "is the product works fantastically withAZT. While it's not a cure, it's by far the best treatment we've everhad for AIDS. I've loved this stock to death for years. Finally, they'regetting recognition."

Wilson pointed out BioChem Pharma's stock (NASDAQ:BCHXF)has doubled this year. It closed 1994 at $10.37 per share, and closedWednesday down 62 cents at $21.63. A different formulation of 3TCcalled lamivudine is producing good results in late-stage trials againsthepatitis B. That drug also is being developed with Glaxo.

BioChem Pharma has said all year that it expected to file for 3TCapproval in the first half of the year, and Glaxo met that goal withFriday's submission. Phase II and III studies consistently have shownthat the combination therapy increases CD4 counts, reduces viralload and prolongs AZT's antiviral activity. Both drugs are nucleosideanalogues that attack reverse transcriptase, an enzyme that makes itpossible for HIV to copy itself.

Crossen, who recommended the stock at $12, said BioChem Pharmawill get about 14 percent on worldwide sales of 3TC.

Glaxo has worldwide rights, excluding North America, to develop,manufacture and sell 3TC. An equally owned joint venture willcommercialize 3TC in Canada. And in the U.S., Glaxo will be theexclusive distributor for the joint venture. n

-- Jim Shrine

(c) 1997 American Health Consultants. All rights reserved.