Boston, MA 04/23/2014 (wallstreetpr) – The U.S. Food and Drug Administration (FDA) have accepted the refiling of Gilead Sciences, Inc. (NASDAQ:GILD)’s two new drug applications (NDA) for cobicistat and elvitegravir to treat HIV. In 2012, Gilead submitted the NDA for these molecules, but the application was rejected by the FDA due to lack of sufficient information. Now, the FDA will review the applications of Gilead by October, 2014.
Both Cobicistat and elvitegravir are yet to establish their efficacy and safety profile as both consider as investigational products in the U.S. These molecules are active components of Gilead’s Stribild that was approved to treat HIV-1 infection in adults in August 2012. Moreover, these products are already approved in Europe, Canada and Australia and available in different trade name such as Tybost (Cobicistat) and Vitekta (elvitegravir).
Why NDA
HIV/AIDS continues to become a serious challenge worldwide as more than 25 million people died since 1981, and about 33.4 million people are currently living with the disease. Africa, Asia and Latin America among the developing countries are more prone to the disease due to lack of care and treatment. So, the growing unmet needs will create demand for treatment measures especially cheaper generics.
Even, GBI Research estimated that the treatment market valued at $13.5 billion in 2011, including sales across the top seven markets. It also expects to grow at a CAGR of 7% in next seven years (2011–2018) to reach $21.8 billion by 2018 due to increasing use of branded products such as Atripla, Complera and Stribild. The market value may further increase with growing demand for generic drugs from the developing countries. Therefore, drugmakers are expanding their sales by availing generic version of their popular products to treat HIV/AIDS.
Gilead’s strength
Gilead Sciences, Inc. (NASDAQ:GILD), a leader in HIV treatment, drives the market with three leading products – Atripla, Complera and Stribild. These medicines have posted significant growth in FY2013 due to high demand for HIV therapies and expect to increase further in coming years with additional use. Stribild reported sales of $539 million in FY2013 and the NDA approval of its components will further increase demand. Generic products though generate lower sales by value, but it will improve the margin due to high growth.
