Gilead Touts New Products in Revamped Growth Strategy

Gilead Sciences outlined a growth plan this week at the J.P. Morgan Healthcare Conference in San Francisco, California, that calls for building on its existing portfolio of products, managing product expirations, and expanding further into the oncology space, particularly for immunotherapy agents.

The presentation Monday was an opportunity for new Chairman and Chief Executive Officer Dan O’Day to provide an update on the strategy he has developed since taking the helm 10 months ago.

Gilead’s clinical product pipeline includes multiple products for inflammatory diseases, fibrotic diseases, and oncology. “We’re focusing on the manipulation of the immune system to fight diseases,” he said.

One of the near-term drugs in this category is filgotinib (GLPG0634), a selective Janus kinase (JAK) inhibitor aimed at moderate-to-severe rheumatoid arthritis. Filgotinib was developed by Galapagos NV, which Gilead partnered with in July 2019. Gilead is seeking approvals for this agent in the United States, Europe, and Japan.

The drug is also being studied in ulcerative colitis and Crohn disease.

Gilead also has a robust pipeline in oncology products, with the furthest along being the CAR T-cell therapy KTE-X19 for relapsed refractory mantle cell lymphoma (MCL). The company is planning a biologics license application to the FDA.

Gilead has achieved impressive growth statistics in the HIV/AIDS drug market. The company has launched 15 antiviral products over the past decade, with a compound annual growth rate since 2011 for HIV products of 14%.

O’Day said he was optimistic about this year’s patent expiry of the emtricitabine-tenofovir combination Truvada, a pre-exposure prophylaxis (PrEP) for HIV/AIDS. Gilead aims to have 90% to 95% of patients under treatment with Truvada switched over to its newer F/TAF-based regimens, which include PrEP formulation emtricitabine/tenofovir disoproxil fumarate (Descovy), by the fourth quarter of this year.

Forty percent to 45% of individuals on PrEP for prevention are expected to be switched over to Descovy by the fourth quarter of 2020.

A source of confidence in these predictions, O’Day said, is that 8 of 10 individuals with HIV/AIDS are on Gilead agents currently, and the company has some leading products, such as Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide), an all-in-1 HIV-1 treatment that can be initiated in patients with little delay, has 0 cases of treatment-emergent resistance so far, and is the top-selling prescribed HIV regimen, he said. “It’s been growing 80% quarter on quarter since its launch.”

The drug, approved for use in the United States in 2018, passed the $1 billion sales mark 3 months ago.

Descovy was launched a few months ago and already, O’Day said, 20% of HIV at risk individuals are on PrEP today and 25% of PrEP scripts are for this product.

Gilead also has a capsid inhibitor moving into phase 2/3 trials that offers potential for less-frequent dosing for patients with HIV. “We’ve shown that we may be able to get up to twice-a-year infused doses and less-frequent oral doses for this,” O’Day said.