Glaxo Submits First Regulatory Application for Daprodustat

GlaxoSmithKline plc GSK announced that it has submitted a new drug application for its pipeline candidate, daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, to Japanese regulatory authorities. The company is looking to get the candidate approved for the treatment of renal anemia associated with chronic kidney disease (“CKD”).

This is the first regulatory application submission globally, seeking approval for daprodustat. The regulatory submission is based on data from three phase III studies conducted in Japan, which evaluated the candidate for the treatment of anemia in patients across the spectrum of CKD from stages 3-5. Data from these studies have shown that oral daprodustat met its primary endpoint of non-inferiority to darbepoetin alfa IV injection as measured by mean hemoglobin levels over weeks 40 to 52.

In April, Glaxo signed a marketing deal with Kyowa Hakko Kirin Co., Ltd for commercialization of daprodustat in Japan following a potential approval. The press release states that there are approximately 3.5 million patients with anemia associated with renal disease in Japan. Successful commercialization is likely to boost Glaxo’s future revenues.

Meanwhile, Glaxo is conducting a global clinical development program for daprodustat in a similar indication consisting of two late-stage studies – ASCEND-D and ASCEND-ND. The studies are evaluating the candidate in CKD patients on dialysis and those not on dialysis. While enrollment has been completed in ASCED-D study, it is currently ongoing in the other study.

Shares of Glaxo have increased 6.5% so far this year against the industry’s decline of 2.1%.

In a separate press release, ViiV Healthcare, Glaxo’s HIV subsidiary, announced headline data from phase III ATLAS-2M study of its long-acting, injectable two-drug regimen of cabotegravir plus rilpivirine as a treatment for HIV patients. The study evaluated administration of the combo regimen every eight weeks (two months) compared to every four weeks (one month). Data from the study showed that administration of the combo every two months was non-inferior to administration once every month.

Please note that rilpivirine has been developed by Janssen, a subsidiary of J&J JNJ, and is marketed under the tradename of Edurant for HIV-1 infection. ViiV Healthcare is a joint venture between Glaxo, Pfizer PFE and Shionogi Limited.

ViiV Healthcare has submitted regulatory applications in the United States and in Europe for once a month administration of cabotegravir plus rilpivirine regimen for the treatment of HIV-1 infection. In July, the FDA accepted the application under priority review with a decision expected in December 2019.

Meanwhile, ViiV Healthcare also announced the start of the first-ever study — CUSTOMIZE — to identify and evaluate approaches to implementing its once-monthly injectable HIV treatment in the real world.

HIV is a key therapeutic area for Glaxo with successful dolutegravir-based regimens, namely Tivicay, Triumeq and Juluca, in its portfolio. The company remains committed to bringing new treatment regimens for HIV patients.

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Zacks Rank & Stock to Consider

Glaxo currently carries a Zacks Rank #3 (Hold). Merck & Co., Inc. MRK is a better-ranked stock in the large-cap pharma sector, carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Merck’s earnings estimates have been revised 3.2% upward for 2019 and 1.1% for 2020 in the past 30 days. The stock has rallied 13.7% so far this year.

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