AEGiS-GMHC: Treatment Briefs: Upjohn to Sell Out?

Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.

Treatment Briefs: Upjohn to Sell Out?

Treatment Issues, Volume 12, Number 5 - May 1998
Dave Gilden

Rumors, partially confirmed by company officials, indicate that Pharmacia & Upjohn is considering selling its HIV drugs or at least finding a partner for their further development. The product line includes first of all the FDA-approved NNRTI delavirdine (Rescriptor). Sales of delavirdine, which went on the market a year ago, have been disappointing. Delavirdine has suffered in the market mostly because of the lack of trial data demonstrating a solid anti-HIV effect and an inconvenient dosing schedule consisting of four tablets three times a day (see Treatment Issues, April/May 1997, pages 1-3). Its skin rash problems are less serious than those of the competing NNRTI nevirapine, however.

Upjohn has continued to research the drug, especially after a trial of AZT/3TC/delavirdine in a treatment-na ve cohort did find HIV suppression comparable at least to nevirapine, if not efavirenz. Ongoing delavirdine trials test various three and four drug delavirdine-containing regimens, a pediatric formulation, and delavirdine's contribution to salvage therapy regimens.

Upjohn also is developing an NNRTI designed to be effective against delavirdine-resistant HIV. The new NNRTI could be combined with delavirdine to form a potent one-two antiretroviral knockout, but this delavirdine backup agent has not yet undergone human testing.

P&U's most intriguing anti-HIV drug right now is its experimental protease inhibitor, which because of its unique structure, should have activity against HIV resistant to the currently available protease inhibitors. Initial dose-escalation studies of this compound, designated PNU140,690, have been completed and a dose of 1,500 mg three times a day selected for further study. This dose requires taking a total of 30 tablets. Upjohn is developing a 300 mg pill in an attempt to reduce the pill burden -- if patients can swallow tablets that large -- and also is exploring formulations that increase the drug's absorption by the intestines.

A salvage therapy trial is about to commence, too, covering individuals with viral loads over 5,000 after taking indinavir or ritonavir plus two other anti-HIV medications for at least six months. Volunteers will replace their previous protease inhibitor with PNU140,690 for four weeks before being allowed to switch the other two drugs too. This approach, which is virtual monotherapy, may favor the development of drug resistance. P&U will have to show that it believes in this drug to get volunteers to swallow a risk like that along with all the tablets. Putting it up for sale is not a sign of faith, though.

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