HIV drug giant Gilead Sciences Inc. failed to pay royalties on sales of a drug that is the linchpin of the company's multibillion-dollar AIDS-fighting franchise, according to a recent lawsuit that seeks $125 million in damages.
In the suit, filed Dec. 17 in San Mateo County Superior Court and moved last week to U.S. District Court in San Francisco, Royalty Pharma plc (NASDAQ: RPRX) claims Foster City-based Gilead (NASDAQ: GILD) failed to pay royalties on sales of drugs that use the antiviral therapy emtricitabine. That drug is sold as Emtriva but is now more often used as an ingredient in the HIV drugs Truvada, Atripla, Complera, Stribild, Eviplera, Genvoya, Odefsey, Descovy, Biktarvy and Symtuza.
The lawsuit was filed by Royalty Pharma Collection Trust, a Wilmington, Delaware-based unit of the New York company, the largest buyer of drug royalties.
With one-time cash payments to developers of drugs or technologies, companies such as Royalty Pharma provide capital in the present in exchange for a portion of a drug's sales in the future. The arrangement allows cash-strapped smaller companies or academic institutions, in particular, to monetize their work immediately instead of waiting for a drug to clear regulatory, sales or insurance reimbursement hurdles; for royalty buyers, it provides a potentially steady source of revenue for years to come.
In the case of emtricitabine, Gilead and Royalty Pharma in 2005agreed to pay $525 millionto Emory University to eliminate Emtriva royalties due to the Atlanta school. Gilead covered 65% of the payment with Royalty Pharma picking up the remainder.
Gilead also agreed to make a one-time payment of $15 million to Emory for amending its original license agreement with the university.
But in a heavily redacted copy of the suit — 6-1/2 pages of the 12-page document, including the bulk of Royalty Pharma's claims, are blacked out — Royalty Pharma said Gilead has breached the agreement by failing to make royalty payouts as they were due.
Royalty Pharma seeks recovery of what it claims is $125 million in damages, plus interest, attorneys' fees and costs and any other award from the court, and a declaration that Gilead must continue to pay royalties.
In a statement to the San Francisco Business Times, Gilead said it is aware of the lawsuit and "believes Royalty Pharma's claims are without merit and (Gilead) intends to vigorously defend itself against them."
Emtriva was discovered by Emory researchers Dr.Dennis Liotta, Dr.Raymond Schinaziand Dr.Woo-Baeg Choiand licensed in 1996 to Triangle Pharmaceuticals by Emory. Triangle was bought by Gilead in January 2003 and Emtriva was approved by the Food and Drug Administration six months later.
Emtricitabine, which acts with other drugs to slow the progress of the AIDS virus, has gone on to become a keystone in multiple HIV drugs developed and marketed by Gilead. That portfolio includes the once-daily, two-drug combo Truvada, which is approved as an HIV treatment but also was the first drug greenlighted to prevent HIV infection, and Symtuza, a drug approved in 2018 for Johnson & Johnson's (NYSE: JNJ) Janssen Pharmaceuticals unit.
HIV drug sales remain Gilead's top category, accounting for nearly $11.8 billion of the company's $19.8 billion in revenue in the nine months of this year ended Sept. 30.
Gilead registered a profit of $5.8 billion through the first three quarters.
Despite Gilead's successful expansion into hepatitis C, hepatitis B, cancer and cell therapy, those drugs either delivered a short pop in revenue or are too early in their product lifecycles to account for much revenue compared to the company's HIV franchise. The current exception is the Covid-19 drug remdesivir, branded as Veklury, that had 2021 sales through the third quarter of $4.2 billion.
Royalty Pharma has had several agreements involving Bay Area drug makers, including royalties on the cancer drugs Cabometyx and Cometriq that were developed by Alameda's Exelixis Inc. (NASDAQ: EXEL) and Novato-based Ultragenyx Pharmaceuticals Inc.'s (NASDAQ: RARE) rare disease drug Crysvita.