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Glaxo's Dovato Wins EU Nod, RA Candidate Enters Phase III

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GlaxoSmithKline plc’s GSK HIV subsidiary, ViiV Healthcare, announced that the European Commission has granted a marketing authorization to Dovato, its once-daily, single-tablet two-drug HIV regimen. The approval in the EU is for the treatment of HIV-1 infection in adults/adolescent patients, aged above 12 years and weighing minimum 40 kg with no known resistance to integrase inhibitors or lamivudine.

ViiV Healthcare is majorly owned by Glaxo and Pfizer PFE.

Dovato is a fixed-dose combination of Tivicay (dolutegravir - 50 mg) and lamivudine (300 mg) and was approved by the FDA in this April.

The EU approval was based on data from the GEMINI 1&2 studies, which evaluated more than 1,400 patients with HIV-1 infection. Data from the studies showed that after 48 weeks, treatment with the two-drug regimen of Dovato demonstrated non-inferior efficacy as compared to a three-drug regimen for treatment-naïve, HIV-1 patients. This means, a two-drug HIV regimen can control the intensity of HIV in treatment naïve patients as effectively as a three-drug regimen, thereby exposing the newly diagnosed patients to fewer drugs at the start of their treatment for the first time.

Following this nod, patients can begin treatment with Dovato as the first once-daily two-drug regimen knowing that efficacy is non-inferior to the standard three-drug regimen for the given patient population.

Shares of Glaxo have rallied 8.1% so far this year, outperforming the industry’s rise of 3.7%.

HIV is a key therapeutic area for Glaxo with successful dolutegravir-based regimens, namely Tivicay, Triumeq and Juluca in its portfolio. HIV sales totaled £1.1 billion in the first quarter of 2019. The metric increased 4% at CER on the back of 7% growth in dolutegravir franchise (Triumeq and Tivicay and Juluca), which partly offset lower sales of the established HIV products.

In a separate press release, Glaxo announced that it has started the phase III program on its anti GM-CSF antibody, otilimab,for the treatment of patients with moderate-to-severe rheumatoid arthritis (RA), who do not respond to disease modifying antirheumatic drugs (DMARD) or any such targeted therapies.

The phase III ContRAst study will also include head-to-head comparison of otilimab with Pfizer's Xeljanz (tofacitinib) and Regeneron Pharmaceuticals REGN/ Sanofi's SNY Kevzara (sarilumab) across all pivotal studies.

The primary endpoint of these analyses will assess the proportion of patients achieving the American College of Rheumatology criteria (ACR20) at 12-week treatment compared with placebo.

The study will be conducted across a broad range of difficult-to-treat patients. The initiation of the phase III program was based on encouraging data from the phase II BAROQUE study, which showed striking clinical improvements in patients treated with otilimab.

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Glaxo currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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