HIV research programs
In 3Q15, Gilead Sciences (GILD) had three tenofovir alafenamide (or TAF) based investigational HIV medicines under review by the Food and Drug Administration (or FDA) in the US and European Medicines Agency (or EMA) in Europe. The company expects that these three new products will be approved by the first half of 2016.
According to the Prescription Drug User Fee Act (or PDUFA), the FDA has to approve a new drug before a predetermined deadline. The deadline for Gilead Sciences’ first TAF-based regimen, Genvoya (E/C/F/TAF) is November 5, 2015. On September 24, 2015, the European Committee for Medicinal Products for Human Use (or CHMP) adopted a positive opinion about this regimen. The European Commission is expected to give its final ruling by the end of 2015. The PDUFA deadline for Gilead Sciences’ second TAF-based drug, F/TAF, is April 7, 2016. The deadline for the third drug, R/F/TAF, is March 1, 2016.
The existing HIV portfolio of Gilead Sciences is based on a compound called tenofovir disoproxil fumarate (or TDF). Clinical trials have proven that TAF-based drugs aren’t inferior to TDF-based drugs in efficacy. Besides, TAF-based drugs don’t cause as many side effects related to the bones and kidneys as TDF-based drugs do. The better safety profile makes the TAF-based drugs an important innovation for newly diagnosed HIV patients, who will receive these treatments for decades. These new drugs are expected to give a strong advantage to Gilead Sciences in the face of tough competition from other players in the HIV space such as Pfizer (PFE), GlaxoSmithKline (GSK), and Johnson and Johnson (JNJ).
Single tablet regimens
Gilead Sciences’ has adopted the strategy of developing single tablet regimens (or STRs) in the HIV space. This results in higher conformance, which is vital for HIV treatment. Gilead Sciences is exploring two additional TAF-based single tablet regimens (or STRs), TAF emtricitabine and GS-9883, which are currently in phase three clinical trials. GS-9883 is expected to be launched by the middle of 2018.
Instead of directly investing in Gilead Sciences and being exposed to excessive company-specific risks, you can invest in the company through the iShares Core S&P 500 ETF (IVV). Gilead Sciences accounts for about 0.9% of IVV’s total holdings.