Biotech Values

[DewDiligence]

NIH Trial Recommends Switching Some Epzicom Patients to Truvada

[Truvada (including use as part of Atripla) has almost cornered the US HIV market for first- and second-line patients (#msg-26915314). The development in this newswire might be the last straw for GSK’s Epzicom, a combination of two older HIV drugs that was already on the verge of irrelevancy in the US and has been rapidly losing share in Europe.]

http://www.reuters.com/article/marketsNews/idUKN2862935220080228

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Thu Feb 28, 2008 6:40pm EST
By Deena Beasley

LOS ANGELES (Reuters) - A safety board has recommended that certain AIDS patients taking part in a study of GlaxoSmithKline Plc's (GSK) Epzicom consider switching to Gilead Sciences Inc's (GILD) Truvada, sending Gilead's shares up about 4 percent on Thursday.

The National Institute of Allergy and Infectious Disease's AIDS Clinical Trials Group, a unit of the National Institutes of Health, is comparing the two drugs in a head-to-head trial involving 1,858 patients.

The unit said on Thursday that an independent Data and Safety Monitoring Board recently found that for patients with high levels of HIV virus, treatment regimens containing Epzicom were less effective at controlling the virus than regimens containing Truvada.

The board also found that patients with high levels of HIV virus treated with Epzicom developed side effects such as body aches and high cholesterol more quickly.

Glaxo said in a statement that the NIH study did not routinely exclude patients at risk for a known reaction with Epzicom, which might have accounted for some adverse events.

The trial recommendation applies to about half the patients being treated with the Glaxo drug and, if translated to real world usage, could mean a 20 percent market share gain for Gilead's Truvada and Atripla, Morgan Stanley analyst Sapna Srivastava said in a research note on Thursday.

Truvada is a pill combining Gilead's Viread and Emtriva, also known as tenofovir and emtricitabine. Atripla is a three-drug pill that also includes Bristol-Myers Squibb Co's Sustiva.

Glaxo's Epzicom combines AIDS drugs Ziagen, or abacavir, and Epivir, also known as lamivudine.

The board said it had no safety concerns regarding Epzicom and recommended that study participants who had lower levels of HIV virus continue their assigned treatment regimen.

"There are an estimated 100,000 patients on Epzicom in the U.S. and Europe, or $1 billion (502,000 pound) opportunity if all patients transition to Truvada," Thomas Weisel analyst Ian Somaiya said in a research note.

Even under a conservative scenario where 20 percent of those patients switched to Truvada by 2010, the analyst said his earnings estimate for Gilead would increase to $3.06 per share from $2.95 per share.

Baird analyst Thomas Russo said the NIH trial recommendation followed an update earlier this month from a Danish observational study that suggested a link between Glaxo's AIDS drugs and increased risk of heart attack.

"These issues could lead doctors to reconsider abacavir-based regimens in favor of regimens based on Gilead's market-leading tenofovir," he said in a research note.

Gilead declined to comment on market share impact. "We think this is an important result ... it reinforces the profile of Truvada," spokeswoman Amy Flood said.

The company's shares gained $1.67, or 3.8 percent, to close at $45.46 on Nasdaq. Shares of Glaxo fell about 1 percent to close at $45.05 on the New York Stock Exchange.
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