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August 8, 2012 9:39 pm

Gilead’s Quad pill likely to gain FDA nod given its inclusion in latest HIV therapy guidelines

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This article is provided to FT.com readers by BioPharm Insight—a news service focused on providing insight into the most price sensitive issues in the global pharmaceutical market. www.biopharminsight.com

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Gilead Sciences’ (NASDAQ:GILD) Quad pill for the treatment of HIV is likely to be approved as a new option for patients, experts told BioPharm Insight. They pointed to its inclusion, ahead of approval, in the recent International AIDS Society-USA (IAS-USA) guidelines as a sign of the drug’s importance to the HIV therapy landscape.

The drug has a US Food and Drug Administration review date of 27 August 2012.

The Quad pill is the first four-drug cocktail, co-formulated into a single-tablet regiment (STR). It contains the already-approved drug Truvada, itself a two-drug combination of emtricitabine and tenofovir, along with two novel drugs – elvitegravir and cobicistat.

The guidelines were released in conjunction with the AIDS 2012 medical meeting held 22-27 July in Washington, DC. The guidelines are updated every two years and provide information on when to start treatment and what drugs can be used.

The inclusion of Quad in the guidelines shows IAS-USA is being proactive, as it is “hard not to see” the Quad as a treatment option soon, said Dr David Margolis, professor of Medicine, Microbiology and Immunology, and Epidemiology at the University of North Carolina.

If approved, Quad could make USD 3.47bn in annual sales by 2017, according to BioPharm Insight data.

The guidelines list the Quad as an “alternative” rather than “recommended” regimen among drug combinations containing integrase inhibitors. Elvitegravir is an integrase inhibitor. Integrase inhibitors stop the action of a viral enzyme called integrase, which inserts the viral genome into the DNA of the host cell. This integration step is a key step in the retroviral replication process, such that blocking it can prevent spread of the virus.

Novelty of Drug Cocktail

The inclusion of the Quad in the updated guidelines is likely due to the fact it represents an innovation in care, said Dr Frank Palella, professor of medicine, Northwestern Feinberg School of Medicine, Illinois.

Quad will be the third STR, behind Gilead’s flagship STR, Atripla, and its follow-on, Complera. Both STRs contain Truvada in combination with Sustiva (efavirenz) or Edurant (rilpivirine), respectively. Truvada combines a nucleotide analogue reverse transcriptase inhibitor and a nucleoside reverse transcriptase inhibitor. Both Sustiva and Edurant are nonnucleoside reverse transcriptase inhibitors.

The drug cocktails incorporate drugs from multiple classes to combat the virus at different steps of its replication process. Reverse transcriptase inhibitors work by preventing the conversion of viral RNA to DNA, the first step. Without the DNA, the virus is unable to make functional copies of itself. Integrase inhibitors target the next step, or the incorporation of viral DNA into the host genome. Protease inhibitors arrest the maturation of the virus, or the last step.

Protease inhibitors have no effect on cells already harboring the virus. There are currently no approved STRs containing protease inhibitors.

In fact, Palella noted, Quad is the first STR to include an integrase inhibitor, which as a class is very well tolerated and quickly reduces viral load. Elvitegravir study results presented at the AIDS medical meeting showed elvitegravir dosed once-daily was similar to raltegravir twice-daily. Raltegravir is the only currently available integrase inhibitor. It is not available in any STR.

Palella also noted the Quad’s use of cobicistat as a boosting agent. Dr Joel Gallant, associate director, Johns Hopkins AIDS Service, Baltimore, Maryland, presented cobicistat data at the meeting that showed it to have fairly similar resistance and toxicity profiles to the other boosting agent, ritonavir.

Cobicistat’s advantage, however, is that it lends itself to co-formulation into a single pill, Gallant said. This includes cobicistat with Johnson & Johnson’s (NYSE: JNJ) protease inhibitor Prezista (darunavir) and the Phase II-stage combination pill of cobicistat, darunavir, emtricitabine and GS-7340, he noted; GS-7340 is an investigational pro-drug formulation of tenofovir.

Reasons for Inclusion

It was a “little bit of a surprise” to see Quad in the guidelines, said Dr Michael Horberg, director of HIV/AIDS, Kaiser Permanente. It is not unreasonable to anticipate a formal FDA approval for Quad, he added.

Dr Rebecca Colon, medical director for managed care, AIDS Healthcare Foundation, Fort Lauderdale, Florida, said she could not recall when a drug not FDA-approved has made it into a treatment guideline.

The inclusion was at least in part for the guidelines to stay current, in addition to the Quad being in the works for at least the past three years, noted Colon. “My assumption” is the thought leaders in the field and the guideline panel members viewed the Quad as having plenty of supporting data for inclusion in the guidelines, Colon added. Waiting two years for the next guideline would be a long time, she said.

Similarly, Gallant, noted the guidelines would be in an awkward position with no mention of Quad for the next two years. The Department of Health and Human Services (DHHS) guidelines, the other major guideline in the US, can be revised at any interval. “We all expect approval [for the Quad],” he added.

Gilead has a current market cap of USD 41.2bn.

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