GlaxoSmithKline plc (GSK - Free Report) announced that it has signed a strategic collaboration deal with Japanese company Kyowa Hakko Kirin Co., Ltd for the future commercialization of its late-stage candidate, daprodustat, in Japan. Daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, is currently being evaluated in phase III studies for the treatment of anaemia associated with chronic kidney disease (CKD).
Per agreement, Glaxo will be responsible for completing the ongoing phase III studies on daprodustat and the subsequent regulatory submissions for its marketing authorization in Japan. While Kyowa Hakko Kirin will take care of the product’s distribution/marketing in Japan. On approval, both companies will jointly look after the commercialization and launch activities of the same. Financial details of the contract have been kept under the wraps though.
Glaxo expects to submit a regulatory application to the Japanese Ministry of Health, Labour and Welfare for daprodustat in 2019. The company believes that this will be a new oral treatment option for Japanese patients suffering anaemia associated with CKD.
Last month, Glaxo announced data from the second analysis of the three phase III studies evaluating daprodustat on Japanese patients afflicted with anaemia associated with CKD. The outcomes showed that oral daprodustat met its primary endpoint of non-inferiority to darbepoetin alfa IV injection as measured by mean haemoglobin levels over weeks 40 to 52. Findings from the first phase III study were presented at the American Society of Nephrology’s Kidney Week in the same month.
Results from the third phase III study on non-dialysis dependent Japanese patients are awaited in the first half of 2019.
Shares of Glaxo have rallied 14.6% year to date compared with the industry’s increase of 6.7%.
Zacks Rank & Other Stocks to Consider
Glaxo currently carries a Zacks Rank #2 (Buy). Other top-ranked stocks in the large cap pharma sector include Bristol-Myers Squibb Company (BMY - Free Report) , Johnson & Johnson (JNJ - Free Report) and Merck & Co., Inc. (MRK - Free Report) . While Bristol-Myers sports a Zacks Rank #1 (Strong Buy), J&J and Merck carry a Zacks Rank of 2. 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.
J&J’s earnings estimates have moved 0.2% north for 2018 and 0.6% for 2019 over the past 60 days. The stock has inched up 1.8% so far this year.
Merck’s earnings estimates have been raised 1.6% for 2018 and 1.7% for 2019 over the past 60 days. The stock has surged 32.7% year to date.
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