Gilead Sciences, Inc. (NASDAQ:GILD) kick-started the new quarter reporting a big development. The company published a press note, stating that it has tendered a New Drug Application (NDA) before Japan’s Pharmaceutical and Medical Devices Agency for its drug, tenofovir alafenamide (TAF).
Alternative to Viread
Reportedly, TAF has been found out as an effective treatment for chronic hepatitis B virus (HBV) among adults as compared to another drug, Viread, which is also developed by Gilead. However, GlaxoSmithKline (NYSE:GSK) currently reserves the right to market Viread in the Japanese market, under the brand name Tenozet.
Gilead has submitted reports indicating that TAF’s one-tenth of the dose is equivalent to the regular dose of Viread while the impact on bones and kidneys is far less as against Viread. If the NDA gets approved by the Japanese authorities, then it will position Gilead to tap immense market opportunities in Japan. The sales potential of TAF can be gauged from the $1.1 billion sales of Viread in the region, representing an increase of 4.7%.
Robust line of approvals
Further, Gilead has already highlighted the need for an HBV drug in Japan, given the fact that roughly one million people in the country are affected by the disease. It is noteworthy that TAF is already under review in both the European Union and the U.S. for the treatment of HBV.
Gilead has already secured approval for Genvoya, a first TAF-based drug for the treatment of HIV-1, in the U.S in November 2015. This followed approval of second-TAF based regimen, Odefsey, by the FDA for the treatment of HIV-1 disease late last month. After winning the approval for Genvoya, the company reported sales worth $45 million in the fourth-quarter.
Based on the company’s record of recent approvals, it has been assigned a rating of buy by Zacks research firm. The stock of Gilead rose 2.46% to $94.12 during the previous trade session.
