GSK buoyed as another generic Advair blocked, HIV treatment meets goals

GlaxoSmithKline shares were given a double boost on Thursday as the drugmaker said its two-drug treatment for HIV had met main targets in late-stage studies, while news also emerged that one potential rival to its blockbuster Advair had been blocked by US regulators.

Overnight, rival Mylan said the US Food & Drug Administration will reject its generic version of Glaxo's blockbuster asthma drug Advair after finding "minor deficiencies". The company did not provide further details, leaving it unclear as to whether the company will be able to resolve them and get approval this year.

On Thursday morning, GSK's 76.5%-owned ViiV Healthcare arm revealed the positive headline results from its phase III Gemini study programme, which was evaluating the safety and efficacy for 'naïve' HIV-1 infected adults with baseline viral loads less than 500,000 copies per mlof to be treated by a combination of dolutegravir and lamivudine compared to a three-drug regimen of dolutegravir and two nucleoside reverse transcriptase inhibitors, tenofovir disoproxil fumarate/emtricitabine (TDF/FTC).

An HIV-positive person is considered naïve if they have never taken any antiretroviral therapy for their infection.

The studies, which are address long-term toxicity concerns of people living with HIV by reducing the number of medicines used in their treatment, met their primary endpoint for non-inferiority at week 48, with safety results consistent with the product labelling for the medicines. No patient who experienced virologic failure in either treatment arm developed treatment-emergent resistance.

ViiV's chief scientific and medical officer, John C. Pottage, Jr, said: "People with HIV are living longer and more productive lives. However, under current standard of care, many patients still take three or more medicines every day.

"The GEMINI studies demonstrate the potency, safety and tolerability of the dolutegravir plus lamivudine combination. They affirm our two-drug regimen strategy, and reinforce our belief that many patients can control their disease with two drugs instead of three or more.

"Importantly, the studies show that this two-drug regimen could be an option for treatment naïve patients and can support a broad range of patients living with HIV around the world."

The Gemini studies together include approximately 1,400 men and women living with HIV in Europe, Central and South America, North America, South Africa and Asia Pacific.

The FDA has declined to approve several Advair knock-offs in the past from drugmakers including Novartis AG, Hikma Pharmaceuticals and Mylan itself, whose generic was rejected last year.