Gilead: Strategic Research and Development

Gilead has recently been on the radar in the specialty pharmacy world for a key business move in the industry—the acquisition of Pharmasset. Pharmasset became a wholly-owned subsidiary of Gilead Sciences, Inc on January 17, 2012.

The recent news focuses on the drugs and compounds that Gilead gained the rights to when they purchased Pharmasset for $11.1 billion, most notably, the drugs that are being tested in clinical trials for the treatment of the hepatitis C virus (HCV).

Despite promising results in the first few trials, Gilead announced in February 2012 in a press release that the majority of hepatitis C genotype 1 patients with a prior ‘null’ response to an interferon (IFN)-containing regimen enrolled in the ongoing ELECTRON study experienced viral relapse within four weeks of completing 12 weeks of treatment."

Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer noted that all is not lost with their research progress. He said, “These data answer an important question about the use of GS-7977 and ribavirin for the treatment of genotype 1 null responder patients, suggesting that additional direct acting antivirals may be necessary to effectively treat this patient population. We will continue to explore a number of therapeutic approaches to address this significant unmet medical need, including combinations with other oral antivirals.”

In addition to actively searching for a treatment for hepatitis C, Gilead’s primary areas focus on HIV, liver diseases, and serious cardiovascular, metabolic and respiratory conditions.  According to their corporate overview, the company’s R&D program “identifies and evaluates compounds that show potential to advance the treatment of life-threatening diseases in areas of unmet medical need.” The current investigational specialty drugs that are in clinical trials, or have been submitted to the FDA for review, are as follows:

  • The Quad is a once-daily, single-tablet regimen being evaluated for the treatment of HIV. It combines 4 medicines into a single pill: elvitegravir (an investigational integrase inhibitor), cobicistat (an investigational pharmacoenhancing or “boosting” agent) and the 2 component drugs of Truvada. An application for marketing approval of the Quad was accepted for review by the FDA in December 2011 and is currently under review in the United States and Europe.
  • Elvitegravir is one of the first candidates in a new class of HIV drugs known as integrase inhibitors. Unlike other classes of antiretroviral agents, integrase inhibitors interfere with HIV replication by blocking the ability of the virus to integrate into the genetic material of human cells (Phase 3).
  • Cobicistat is an investigational compound being developed as a pharmacoenhancing or “boosting” agent to increase blood levels and allow once-daily dosing for certain HIV medicines, including elvitegravir. It is also being studied as a boosting agent for other antiretrovirals, in particular, protease inhibitors (Phase 3).
  • GS-7340 is a novel prodrug of tenofovir, the active agent in Viread, that has the potential to provide greater antiviral efficacy at a dose 10 times lower than Viread. It is being studied as a treatment for HIV infection (Phase 3).
Hepatitis C/Liver Disease
  • GS-7977 is an oral nucleotide NS5B inhibitor being studied for the treatment of hepatitis C (HCV) infection (Phase 3).
  • Tegobuvir/GS-9190 is an oral non-nucleoside NS5B inhibitor being studied for the treatment of HCV infection (Phase 2).
  • GS-9256 is an oral NS3 protease inhibitor being studied for the treatment of HCV infection (Phase 2).
  • GS-9451 is an oral NS3 protease inhibitor being studied for the treatment of HCV infection (Phase 2).
  • GS-5885 is an oral NS5A inhibitor being studied for the treatment of HCV infection (Phase 2).
  • GS-9620 is an oral TLR-7 agonist being studied for the treatment of HBV and HCV infection (Phase 1).
  • GS-9669 is an oral non-nucleoside NS5B site 2 inhibitor being studied for the treatment of HCV infection (Phase 1).
Inflammation (Rheumatology)/Oncology
  • GS-1101 is a PI3K delta-specific inhibitor that is being studied as a treatment for chronic lymphocytic leukemia (Phase 3) and refractory indolent non-Hodgkin’s lymphoma (Phase 2).
  • GS-6624 is also being studied as a treatment for colorectal cancer (Phase 2), myelofibrosis (Phase 2) and pancreatic cancer (Phase 2).
  • GS-9973 is an oral spleen tyrosine kinase (Syk) inhibitor being studied as a treatment for rheumatoid arthritis (Phase 1).
Gilead’s Access to Specialty Medications

The research and development of a drug is only half of the battle in the fight against disease. Gilead believes it is their duty to help all patients—regardless of income or location—gain access to the drugs they need to improve their treatment outcomes. Gilead participates in the following programs:
  • Gilead Access Program
The Gilead Access Program was designed to provide HIV medications in 132 low and lower middle-income countries. This program provides approximately 2.1 million patients with HIV therapies.
  • Partnerships with Generic Manufacturers and Medicines Patent Pool
Gilead is the first pharmaceutical company to sign an agreement with the Medicines Patent Pool Foundation, which seeks to improve access to affordable, appropriate HIV medicines in developing countries through voluntary licensing. They have non-exclusive agreements with generic manufacturers in India and South Africa to produce Viread and Truvada. It was recently announced that Emcure will be able to manufacture several products licensed to the Medicines Patent Pool by Gilead Sciences, including: emtricitabine (FTC), cobicistat (COBI), elvitegravir (EVG), and the fixed-dose combination of these medicines known as the Quad (a combination of FTC, COBI, EVG and tenofovir).
  • Gilead’s US Advancing Access program
Through this program, Gilead offers assistance for people who cannot afford to pay for the following specialty pharmaceuticals: Viread, Complera, Truvada, Emtriva, Hepsera, and Vistide.
  • The Cayston Access Program
This program is tailored specifically to cystic fibrosis patients, and helps them with insurance verification, referrals to participating specialty pharmacies, claims support and copay assistance. In some instances, Gilead also helps patients pay for Cayston as well.
  • The Atripla Patient Assistance Program
The Atripla Patient Assistance Program assists eligible HIV patients in the United States who do not have insurance, are underinsured or who otherwise need financial assistance gain coverage for or access to Atripla.
Gilead’s work in drug research and development, coupled with their commitment to expand access to their therapies across the globe, helps solidify them as a leader in the specialty pharmaceutical market. For more information about the treatments for HIV, read our article HIV Drugs: What’s New?

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