A new and better version of
disappointing protease inhibitor could be on the market sooner and be more formidable than Wall Street expects.
The Swiss drug giant foresees an October launch, and the buzz is that the new version could come even sooner. Either way, that's earlier than the year-end launch most analysts anticipated for the drug. Protease inhibitors, or PIs, are the breakthrough therapies that have saved the lives of thousands of AIDS patients.
If the PI market
flattens by fall, as some investors fear, the new drug could cut into the share of Crixivan, the market leader made by
, and Viracept, the
version. Most analysts more or less overlook Roche in this $800-million-a-year market, as it has a small and shrinking share. Neither Roche's nor Merck's PI contributes heavily to their bottom lines, but Merck in particular is attempting to stake out sales dominance and scientific leadership in the emerging AIDS market. Viracept is Agouron's lone drug on the market.
To become an important player, Roche has to overcome the ill will generated by what some AIDS activists charge was a premature launch and misleading marketing campaign for its previous PI, Invirase. Toward a rehab effort, the company will launch its new gel cap version with a new, as-yet-unannounced brand name.
The absorption rate has been the chief problem with Invirase. The new gel cap formulation of the drug, which has the chemical name of saquinavir, is absorbed about eight to 10 times better than the hard cap version. At best, it is absorbed as much as the other PIs, though its range of absorption is still lower, according to
, a San Francisco AIDS publication. The new formulation can be taken with food, and though it has to be taken three times a day, doesn't have to be every eight hours religiously. That makes it more convenient than Crixivan.
Crixivan has the largest market share, about 43%, estimates David Crossen, an analyst for
, while Viracept has about a fifth of the PI market. Analysts estimate that Invirase might have about a tenth of the market, but it's been losing market share rapidly. In fact, in a new draft of
National Institutes of Health
guidelines for AIDS treatment, Invirase isn't mentioned.
What made Invirase alluring originally was its minimal side effects. And the new formulation "looks very similar to the current product," says Roche spokesman Jeff Winton, suggesting it could be the most benign PI.
AIDS activists, however, warily regard the company's claims because of what they say is Roche's mishandling of Invirase. With the new launch, Roche will attempt to salvage what advantages it may have had as the first company to market with a PI in late 1995.
"They screwed up because they wanted to be first on the market," says Spencer Cox, a spokesman for influential New York activist organization
Treatment Action Group
Treatment Action Group went so far as to call the launch of Invirase a public health hazard. If doctors used saquinavir in the way it was approved, "it actually became harmful to patients," increasing the possibility they would become resistance to other therapies, says Cox.
The group charged that Roche rushed the drug to market before the company had tested the right dose, didn't make its poor absorption clear and claimed that the drug didn't produce resistance to the other PIs on the market without the data to back it up. "No one faults them for not knowing at the time," says Cox. But "there is a lot of anger at them for having made the assertion."
Roche compounded that mistake by marketing the drug as the protease inhibitor patients could live with because of its minimal side effects, activists say.
"In good faith and conscience, we launched the drug," said the Roche spokesman. "By no means did we launch knowing the problems."
Aggressive doctors and cutting-edge patients could give Roche's saquinavir a surprising boost. Small studies and anecdotal evidence suggest that a combination of saquinavir and Norvir, the protease inhibitor from
, could be powerful. The two-drug regimen cuts out other drugs such as the commonly prescribed AZT, made by
). The group is largely made up of patients who have developed resistance to the other drugs available, a significant portion of those patients currently on therapy.