Gilead's Next-Gen HIV Drug Heads to the FDA, Stock Soars

Published: Apr 10, 2015

Gilead's Next-Gen HIV Drug Heads to the FDA, Stock Soars
April 8, 2015
By Alex Keown, Breaking News Staff

FOSTER CITY, Calif. -- Gilead Sciences, Inc. announced Wednesday it submitted a New Drug Application to federal regulators for two doses of an HIV-1 treatment in combination with other HIV drugs for pediatric patients age 12 years and older.

The announcement sparked an upsurge in the company’ stock, jumping to a morning high of $99.84 from its opening price of $98.70. RBC Capital speculates the company’s stock could go as high as $118, while analysts at Citigroup Inc. set a $120 target on the stock.

California-based Gilead, which has a history of developing HIV treatments, is seeking approval for an investigational fixed-dose combination of emtricitabine and tenofovir alafenamide, dubbed F/TAF. The new drug is a nucleotide reverse transcriptase inhibitor (NRTI) that has demonstrated high antiviral efficacy at a dose less than one-tenth that of Gilead’s Viread, which prevents human immunodeficiency virus (HIV) or hepatitis B virus cells from multiplying in your body. Viread has generated about $1.1 billion in revenue for Gilead in the last year. Another HIV treatment in Gilead’s pipeline has the potential to increase company growth.

Gilead plans to submit a regulatory application for F/TAF in the European Union in the second quarter of 2015. This is Gilead’s second F/TAF-based NDA submitted to the U.S. Food and Drug Administration (FDA) for review. In November Gilead filed an NDA for an investigational once-daily single tablet regimen containing elvitegravir, cobicistat, emtricitabine and TAF. The FDA is expected to respond to this application by Nov. 5.

Phase III clinical trials F/TAF data supported the effectiveness and safety of the drug for treatment of HIV in teens. TAF also demonstrated fewer side-effects on kidneys and bones in clinical trials, compared to Viread.

With the development of F/TAF, the company believes it has the potential to “optimize therapies for HIV patients who face a lifetime of antiretroviral treatment.”

“With its high antiviral efficacy and favorable safety profile, F/TAF may offer an improved backbone for a new generation of HIV regimens,” Norbert Bischofberger, Gilead’s chief science officer said in a statement.

Additional F/TAF-based regimens for HIV treatment are currently in development. In December Gilead announced the expansion of its existing agreements with Janssen Sciences Ireland UC for the development and commercialization of two new investigational once-daily single tablet regimens containing F/TAF. One combines F/TAF with Janssen’s rilpivirine. The other regimen contains F/TAF, cobicistat and Janssen’s darunavir

In February Gilead reported fourth quarter revenues were $7.3 billion, up 137 percent over the fourth quarter in 2013. Full year revenues for 2014 were $24.9 billion, more than double the $11.2 billion for 2013, primarily driven by sales of Solvadi and Harvoni, the company’s hepatitis C treatments.

BioSpace Temperature Poll
After last week's news that Gilead had issued a health advisory to doctors, concern is growing after nine patients taking Harvoni or Sovaldi along with another drug, amiodarone, were treated for abnormally slow heartbeats. One of the patients died of cardiac arrest. Three of the nine patients required a pacemaker. That has BioSpace asking, what next?

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