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Glaxo (GSK) and J&J's HIV Drug Juluca Gets Approval in Japan

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GlaxoSmithKline plc (GSK - Free Report) and partner Johnson & Johnson (JNJ - Free Report) announced that the Ministry of Health, Labour and Welfare (MHLW) granted a marketing approval to Juluca for the maintenance treatment of HIV -1 infection in Japan.

Juluca combines two approved HIV drugs — Tivicay (50 mg) and Edurant (25 mg) — into a single, once-daily pill for the treatment of virologically suppressed HIV-1 infection.

Tivicay, a novel investigational integrase strand transfer inhibitor (INSTI), is marketed by ViiV Healthcare, an HIV company majorly owned by Glaxo and Pfizer (PFE - Free Report) . Edurant is a non-nucleoside reverse transcriptase inhibitor (NNRTI) marketed by Janssen, J&J’s pharma arm. Juluca has been developed under a partnership between ViiV Healthcare and Janssen.

Shares of Glaxo have rallied 14.4% so far this year compared with the industry’s increase of 6.7%.

Juluca was approved in the United States in November 2017 and in Europe during May 2018. It is the first two-drug regimen, once-daily, single pill approved for the treatment of HIV. The drug has been performing steadily since its approval. Juluca recorded sales of £71 million for the first nine months of 2018.

Juluca, the first two-drug regimen to get a nod, reduces the number of medicines that HIV patients take without compromising on the efficacy of a conventional three-drug regimen.

Juluca’s approval was based on data from two phase III SWORD studies. Findings from these studies showed that the combination of Tivicay and Edurant antiretroviral was as effective as a three- or four-drug antiretroviral regimen as a maintenance therapy in HIV patients, who have already achieved viral suppression.

Glaxo’s HIV portfolio has been growing steadily over the years. HIV sales rose 12% year over year at constant exchange rate (CER) in the nine months of 2018.

HIV is expected to be an important growth driver for Glaxo’s business going forward. The company witnessed some positive developments in its HIV pipeline recently. It is progressing well on its two drug regimens in HIV, making regulatory filings in the United States and Europe to get its HIV drug, Tivicay, approved as a two-drug regimen (2DR) in combination with lamivudine on the back of successful GEMINI study data. Glaxo anticipates the US approval by the second quarter of 2019.

Glaxo also announced positive data from both the FLAIR and ATLAS studies this year, evaluating cabotegravir plus rilpivirine in a long-acting, once-monthly HIV formulation. Glaxo believes that this long-acting injectable HIV therapy will provide a highly differentiated treatment option for those seeking a long-lasting therapy regarding HIV, thus freeing them of the burden of a daily oral therapy. It ascertains that the favorable data from these evaluations will allow it to file for an approval in the first half of 2019.

Zacks Rank & Stock to Consider

Glaxo currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the large cap pharma sector is Bristol-Myers Squibb Company (BMY - Free Report) , sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Bristol-Myers’ earnings estimates have been revised 6.9% upward for 2018 and 6.8% for 2019 over the past 60 days.

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