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Glaxo Seeks EU Approval for Two-Drug Regimen in First-Line HIV

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GlaxoSmithKline (GSK - Free Report) announced that its HIV-focused company, ViiV Healthcare submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for a single-tablet, two-drug regimen of dolutegravir (Tivicay) and lamivudine (Epivir) for the treatment of HIV-1 infection.

ViiV Healthcare was established by Glaxo and Pfizer (PFE - Free Report) in 2009. After certain amendments in Oct 2012, Shionogi joined as a shareholder.

Shares of Glaxo have outperformed the industry so far this year. The stock has gained 10.0% comparing favorably with the industry’s 6.0% growth.

The submission is based on data from the global GEMINI 1 & 2 studies that included more than 1400 HIV-1 infected adults. The two phase III studies — GEMINI-1 and GEMINI-2 — evaluated the two-drug regimen in treatment naïve who have not received prior antiviral therapy, HIV-1 infected adults compared to a three-drug regimen of dolutegravir plus tenofovir alafenamide fumarate and emtricitabine.

The studies demonstrated that the dolutegravir and lamivudine regimen was non-inferior to the standard three-drug regimen in HIV control. This means a two-drug HIV regimen can control HIV in treatment-naïve patients as effectively as a three-drug regimen.

The company expects to file a new drug application (NDA) for this single-tablet regimen in October, using a priority review voucher.

We remind that Glaxo’s HIV portfolio includes Juluca, which is the first two-drug regimen that reduces the number of medicines HIV patients take without compromising on the efficacy of a conventional three-drug regimen. Juluca is developed and marketed by Glaxo in partnership with Johnson and Johnson (JNJ - Free Report) . Juluca received the FDA approval in November last year.

Last month, ViiV Healthcare and partner Johnson and Johnson announced positive headline results from phase III ATLAS study, evaluating another two-drug HIV regimen (2DR). The ATLAS study results showed that the combination of long-acting Edurant (rilpivirine) marketed by Johnson and Johnson and cabotegravir being developed by ViiV Healthcare injected once a month  had similar efficacy to a standard of care, daily, oral three-drug regimen at Week 48. The study met its primary endpoint of non-inferiority.

Zacks Rank & Stock to Consider

Glaxo is a Zacks Rank #3 (Hold) stock.

A better-ranked stock in the same space is Eli Lilly and Company (LLY - Free Report) carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Lilly’s earnings per share estimates have increased from $5.16 to $5.47 for 2018 and from $5.56 to $5.73 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters with an average beat of 10.15%. The stock has rallied 25.3% year to date.

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