Company: Gilead Sciences
Diseases: Hepatitis B and HIV
2016 U.S. sales: $591 million
U.S. patent expiration date: December 15
Viread was Gilead's first drug in a new generation of meds known as nucleotide analogue reverse transcriptase inhibitors. The med won its first approval in 2001, and Gilead then followed up with several combination drugs centered on the drug (tenofovir disoproxil fumarate, or TDF), including the blockbuster drug Truvada.
Now, under a previous patent settlement with Gilead, Teva Pharmaceutical Industries will be able to launch a generic version of hep B and HIV antiviral Viread late this year. The loss of Viread exclusivity will take a significant bite out of Gilead's sales at a time when the company is suffering steep declines in its hepatitis C sales.
Viread turned in U.S. sales of $591 million last year, according to Gilead's annual report. The EP analysts predict a steep sales dropoff for the med after this year and a descent all the way down to $15 million in 2022.
But Gilead does have a new generation of drugs designed to improve on the TDF crowd. The company tweaked its tenofovir compound to reduce side effects, and the resulting drug, tenofovir alafenamide (TAF), is now the basis for several new cocktails. The company raised its prices on the previous generation last year, leading analysts to conclude that Gilead was trying to switch patients over to the newer formulas.
“We suspect that these increases were taken on the TDF-based regimens to help accelerate the switch from TDF to TAF in advance of TDF patent expirations,” Cowen & Co. analysts said in an investor note at the time.
But the TDF meds aren't Gilead's only follow-ups. The company is also developing bictegravir, a competitor to GlaxoSmithKline's first-in-class Tivicay. Combos based on that compound—including one three-drug cocktail that delivered positive phase 2 data in mid-February—would compete with the Tivicay combos now sold by Glaxo's ViiV Healthcare.
Aside from Teva, which has an approved copycat to Viread, generics companies Mylan, Lupin, Strides Arcolab and Aurobindo have tentative approvals, according to Drugs@FDA.
Gilead and Teva inked their settlement to wrap up litigation not only over patents on Viread, but on Truvada and Atripla, according to Gilead’s latest 10-K filing with securities regulators. Teva can launch its Viread copycat on Dec. 15 as a result of that settlement; launch dates for the combo drugs remain under wraps.
“We believe strongly in the validity of our intellectual property,” then-COO John Milligan said in a statement on the agreement. “This settlement, however, removes some uncertainty and minimizes further distraction and investment of human and financial resources associated with this litigation.”
Milligan now serves as CEO at Gilead.