In June, the U.S. Food and Drug Administration (FDA) approved Gilead Sciences, Inc.'s (NASDAQ:GILD) Yeztugo (lenacapavir) as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg, making it the first and only twice-yearly option available in the U.S. for people who need or want PrEP.
Data show that ≥99.9% of participants who received Yeztugo in the Phase 3 PURPOSE 1 and PURPOSE 2 trials remained HIV negative.
The first PrEP medication, which was also developed by Gilead, was approved in the U.S. in 2012.
On Friday, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion under accelerated review recommending lenacapavir—the company's injectable HIV-1 capsid inhibitor—for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents with increased HIV-1 acquisition risk.
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The final European Commission (EC) decision is expected later this year. If approved, lenacapavir will be marketed in the European Union (EU) under the trade name Yeytuo.
If approved, lenacapavir will be granted one additional year of market exclusivity in the EU due to the new indication.
Data from Gilead's Phase 3 PURPOSE 1 and PURPOSE 2 trials supported the positive opinions.
In the PURPOSE 1 trial, data at the primary analysis showed that administration of twice-yearly subcutaneous lenacapavir led to zero HIV infections among 2,134 participants, 100% reduction in HIV infections and superiority of prevention of HIV infections when compared with once-daily oral Truvada (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF) in cisgender women in sub-Saharan Africa.
In the PURPOSE 2 trial, there were two HIV infections among 2,179 participants in the twice-yearly subcutaneous lenacapavir group, demonstrating 99.9% of participants did not acquire HIV infection and superiority of prevention of HIV infections when compared with once-daily oral Truvada among a broad and geographically diverse range of cisgender men and gender-diverse people.
In both trials, lenacapavir demonstrated superiority in preventing HIV infections when compared with background HIV incidence.
Needham upgraded Gilead after positive feedback from a recent physician survey on Yeztugo.
Analyst Joseph Stringer says the physician survey has increased confidence in Yeztugo and could be a multi-billion dollar contributor to the top line over the next several years.
Needham models that the HIV PrEP TAM (actual people on therapy) could grow from approximately 500K to around 900K by 2035.
The analyst upgraded Gilead from Hold to a Buy rating with a price forecast of $133.
Doctors predict the HIV prevention (PrEP) market will grow by about 49% by 2030, and Yeztugo could take about 38% of that growth. They favor Yeztugo because it's easier to take than the current treatments.
With around 70% of Gilead's revenue coming from its HIV drugs, Yeztugo could become a key driver of the company's future growth.
Needham says Yeztugo could generate $4.1 billion in sales by 2030—about 10% more than current expectations—and $6.4 billion by 2035, about 20% above consensus.
Price Action: GILD stock is up 2.75% at $116.31 at the last check on Friday.
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