July 7, 2015
By Alex Keown, BioSpace.com Breaking News Staff
FOSTER CITY, Calif. – California-based Gilead Sciences, Inc. used a $125 million voucher to accelerate potential approval of a new HIV-1 drug submitted to the U.S. Food and Drug Administration (FDA) last week.
Gilead acquired the voucher which speeds up the FDA’s review process for New Drug Applications from Montreal-based Knight Therapeutics Inc. The voucher was given to Knight be the federal regulatory agency for developing a treatment for leishmaniasis, a tropical eye disease. Knight had the opportunity to use the voucher for another of the drugs in its pipeline, or to sell it on the open market, the San Francisco Business Journal reported this morning.
The FDA developed the voucher program in 2007 to push drug makers to develop treatments for neglected tropical diseases and rare childhood diseases.
While Gilead is hoping the new drug hits the streets sooner than initially planned, the company’s stock was not responding positively this morning. Shares were trading at $114. 39, down from a high of $116.42 per share. The stock has not yet hit the numbers that some analysts were speculating. Earlier this year RBC Capital speculated the company’s stock could go as high as $118, while analysts at Citigroup Inc. set a $120 target on the stock.
Gilead snapped up the voucher in November for $125 million with hopes of shaving approximately four months off the FDA’s approval time. The FDA can take up to 10 months to approve a new drug, but the voucher would trim that down by four months. Gilead is hoping to see approval for its once-daily tablet HIV-1 drug that combines Gilead’s emtricitabine and tenofovir alafenamide (TAF) with Janssen Pharmaceutical’s rilpivirine for the treatment of HIV-1 in Adults and pediatric patients in January 2016 rather than May 2016.
Norbert Bischofberger, Gilead’s chief science officer, said in a statement that the company is “looking forward to the potential to offer people living with HIV another effective treatment option with a favorable safety profile.”
Last week’s New Drug Application is the third for HIV over the past 12 months by Gilead Sciences. In April the company April the company submitted a New Drug Application to the FDA for two doses of an HIV-1 treatment in combination with other HIV drugs for pediatric patients age 12 years and older. 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.
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.”
Gilead is also working on another combination HIV treatment with Janssen, which contains F/TAF, cobicistat and Janssen’s darunavir.
While Gilead Sciences has been making moves with its HIV pipeline, the company has run into some issues with its hepatitis drugs. Last week two Yale University-affiliated public health organizations, the Treatment Action Group (TAG) and the Global Health Justice Partnership (GHJP) filed a federal lawsuit to obtain information that Gilead Sciences provided the U.S. Food and Drug Administration (FDA) concerning its hepatitis C drugs Sovaldi (sofosbuvir) and Harvoni (sofosvubir/ledipasvir).
The public health agencies said although the drugs had a high price tag and were widely approved for use, the company did not publicize the clinical trial data. In their lawsuit, the plaintiffs argue that public access to the raw data is important because it will allow health officials to make informed and cost-based decisions on treatments. The pricing for Sovaldi is about $84,000 for course of treatment and about $94,500 for Harvoni, or about $1,000 per pill.
Additionally, China rejected a patent application for Sovaldi. Patents have also been challenged in India, Europe and the United States.
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That’s lead BioSpace to ask, what do you think about the drug approval process in this country? Let us know your ideas.
