(Cobicistat + elvitegravir + emtricitabine + tenofovir alafenamide fumarate) is a Small Molecule owned by Gilead Sciences, and is involved in 40 clinical trials, of which 32 were completed, and 8 are ongoing.
Elvitegravir is a dihydroquinoline carboxylic acid strand transfer inhibitor (integrase inhibitor) it is predominantly metabolized via cytochrome P450 (CYP)3A4 and P450 (CYP)3A5, along with minor pathways including glucuronidation via UGT1A1/3 and oxidative metabolism.
Cobicistat is a selective, mechanism-based inhibitor of cytochromes P450 of the CYP3A subfamily (primarily CYP3A4 and CYP3A5). Inhibition of CYP3A-mediated metabolism by cobicistat enhances the systemic exposure of CYP3A substrates, where bioavailability is limited and half-life is shortened by CYP3A-dependent metabolism.
Emtricitabine is phosphorylated by cellular enzymes to form emtricitabine 5'-triphosphate, which is responsible for the inhibition of HIV-1 reverse transcriptase. It competes with the natural substrate deoxycytidine 5'-triphosphate and incorporates into nascent viral DNA, resulting in early chain termination.
Tenofovir inhibits the activity of HIV-1 reverse trascriptase by competing with the natural substrate deoxyadenosine 5'-triphosphate and, after incorporation into DNA, by DNA chain termination.
The revenue for (Cobicistat + elvitegravir + emtricitabine + tenofovir alafenamide fumarate) is expected to reach a total of $14.8bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their (Cobicistat + elvitegravir + emtricitabine + tenofovir alafenamide fumarate) NPV Report.
(Cobicistat + elvitegravir + emtricitabine + tenofovir alafenamide fumarate) is currently owned by Gilead Sciences.
(Cobicistat + elvitegravir + emtricitabine + tenofovir alafenamide fumarate) Overview
Cobicistat, elvitegravir, emtricitabine and tenofovir alafenamide (Genvoya) is a fixed dose combination acts as an antiviral agent. It is formulated as tablets and film coated tablets for oral route of administration. Genvoya is indicated for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older, is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients 12 years of age and older and with no known mutations associated with resistance to the individual components of Genvoya.
Gilead Sciences Overview
Gilead Sciences (Gilead) is a research-based biopharmaceutical company. It is engaged in the discovery, development and commercialization of medicines for the treatment of cardiovascular, hematological and respiratory diseases, inflammation, liver diseases, cancer and human immunodeficiency virus (HIV) infection. The company sells its products through subsidiaries and distributors in Europe, the Americas, Asia-Pacific, the Middle East and Africa. It has manufacturing facilities in Edmonton, Alberta, Canada; Foster City, San Dimas, Oceanside, California; and Cork, Ireland among others. The company has partnerships with universities, medical research institutions and global pharmaceutical leaders to develop new drugs. Gilead is headquartered in Foster City, California, the US.
The company reported revenues of (US Dollars) US$27,305 million for the fiscal year ended December 2021 (FY2021), an increase of 10.6% over FY2020. In FY2021, the company’s operating margin was 36.3%, compared to an operating margin of 16.5% in FY2020. In FY2021, the company recorded a net margin of 22.8%, compared to a net margin of 0.5% in FY2020. The company reported revenues of US$7,042 million for the third quarter ended September 2022, an increase of 12.5% over the previous quarter.
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