›Glaxo AIDS Drug May Have Edge After Promising Data
• Once-daily integrase inhibitor tops Sustiva in study • New drug '572 a rival to Merck and Gilead medicines • Potency, resistance, side-effect profile may give it edge
VIENNA, July 22 (Reuters) - A new AIDS drug from GlaxoSmithKline (GSK) and its partner Shionogi works faster and has fewer side effects than Bristol-Myers Squibb's (BMY) older medicine Sustiva, researchers said on Thursday.
The promising results from mid-stage clinical tests suggest S/GSK1349572 may have an important role in fighting the disease and shows why the two drugmakers decided this week to move the experimental drug into final Phase III trials[#msg-52482079].
The new drug, which industry analysts believe could reach the market in 2013, belongs to a class of AIDS drugs known as integrase inhibitors, designed to block genetic information needed for the human immunodeficiency virus (HIV) to reproduce.
Merck & Co (MRK) already has an established integrase inhibitor drug called Insentress, which achieved sales of $752 million last year, and Gilead (GILD) has a rival product in Phase III testing called elvitegravir.
But Phase IIb data presented at the International AIDS Conference in Vienna indicate Glaxo's once-daily next-generation compound, which does not require a booster, may have an edge.
In one study involving 205 patients who had not previously received treatment, more than 90 percent of patients on '572 plus other older drugs[Truvada or Epzicom]had undetectable levels of virus after 16 weeks, compared with 60 percent of those receiving a combination containing Sustiva.
The effect of the new drug was also much faster, with 66 percent of patients achieving viral suppression after four weeks against 18 percent with Sustiva.
Importantly, '572 was better tolerated than Sustiva, with fewer moderate- or higher-intensity side effects, and there were no major signs of resistance problems in the study.
Dominique Limet, chief executive of ViiV Healthcare, the majority-owned Glaxo company that combines its HIV operations with those of Pfizer (PFE), said he was confident '572 would compete well against rival integrase inhibitors.
"It is very potent, we have less resistance problems, it's a once-a-day formulation, and this is a product that doesn't require a booster, which means that the potential side effects are also reduced," Limet told Reuters.
Success with '572 would signal the re-emergence of Glaxo as a significant player to rival Gilead (GILD) in the HIV market. For Gilead, '572 could represent a strong competitor for its new combination pills, including a four-in-one "Quad" tablet in Phase III development that contains elvitegravir.‹
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