Gilead Sciences, Inc. (NASDAQ:GILD) has announced that the company has submitted a new drug application, to Pharmaceutical and Medical Devices Agency of Japan. The application concerns the company’s new drug tenofovir alafenamide (TAF), a treatment for adults suffering from hepatitis-B infection. The drug is similar to Viread, another tenofovir drug from Gilead, but offers better efficacy, with a dose that is 1/10th of Viread. However, in Japan Viread is marketed as Tenozet by GlaxoSmithKline.
Norbert Bischofberger, the Executive Vice President of R&D at Gilead, clarified that more than a million patients in Japan, suffer from chronic HBV, which creates the need for a new treatment option, with a favorable safety profile. He referred to the results from a phase-3 study of the drug, which suggested that the drug can be used to improve the conditions of patients, who usually require lifelong treatments, to manage HBV.
Gilead Sciences has used data from two phase-3 studies of TAF, conducted over a 48-week period, as the basis for filing the NDA. The primary objective of the studies was to determine non-inferiority of the drug, in terms of efficacy, which was successfully achieved. The studies were conducted at various test centers across Japan, while adhering to the criteria set by the American Association for the Study of Liver Disease. The positive outcome from the trials included a significantly smaller decline in hip and spine mineral bone density, for TAF patients, as compared to its counterpart. However, it is important to note here that the drug is still an investigational therapy, whose efficacy and safety is yet to be determined.
It is also important to remember that the hepatitis-B market is already saturated and new small players, like ContraVir, are entering the market. As such Gilead’s share of the market is shrinking. ContraVir’s new drug has already shown improved potency, amongst patients, as compared to TAF.
Gilead Sciences, Inc. (NASDAQ:GILD) had a trade volume of 13.66 million and lost 0.12% during the March 31 session, to reach a close at $91.86.