Ethically challenged drug company has made billions off the drug since its initial FDA approval while it simultaneously sought to ‘evergreen’ and manipulate patent extension process
LOS ANGELES (October 17, 2017) AIDS Healthcare Foundation (AHF), the largest global AIDS organization and a vocal critic of runaway drug pricing and drug profiteering today called on Gilead Sciences, Inc. to reduce the price of its tenofovir-based drug regimens—including Truvada—by as much as 90%.
The California drug company has made billions off of sales of its tenofovir-based drugs since the FDA first approved Gilead’s tenofovir disoproxil fumarate (TDF), branded as Viread, on October 26, 2001. The patent is set to expire on December 15, 2017, with the patent on a pediatric version of the drug set to expire in early 2018.
Since FDA approval of the drug in 2001, the TDF formulation of tenofovir has become a cornerstone of other big money Gilead combination HIV/AIDS treatment therapies beyond Viread including:
- Atripla (efavirenz + tenofovir disoproxil fumarate + emtricitabine—made in partnership with Bristol-Myers Squibb), Average Wholesale Price(AWP): $2,869.86 USD per patient-per month / $34,438.32 USD yearly
- Complera (rilpivirine + tenofovir disoproxil fumarate + emtricitabine—made in partnership with Janssen Theraputics), AWP: $2,815.04 USD per month / $33,780.48 USD yearly
- Stribild, the four-drug-in-one tablet (elvitegravir + cobicistat + tenofovir disoproxil fumarate + emtricitabine), AWP: $3,244.76 USD per month / $38,973.12 USD yearly
- Truvada (tenofovir disoproxil fumarate + emtricitabine), Gilead’s blockbuster HIV/AIDS treatment that is also the medication component used for pre-exposure prophylaxis (PrEP) to prevent HIV acquisition. AWP $1,759.73 USD per month / $21,116.76 USD yearly; and
- Viread (tenofovir disoproxil fumarate or ‘TDF’ – previously cited above), AWP: $1,197.32 USD per month / $14,367.84 USD yearly.
“Gilead has made untold billions off of tenofovir in its various treatment combinations since its introduction in 2001. More recently, it tried to extend its patent monopoly on tenofovir in order to maintain enormous profit margins on the drug. But the tenofovir patent expires in just a few short weeks, meaning the generic market for the drug will open widely,” said Michael Weinstein, President of AHF. “As a result, with the patent ending and generic versions on the horizon, we call on Gilead for an immediate ninety-percent reduction across the board on the price of all tenofovir-based drugs—including on Truvada, as well as combination therapies using tenofovir that Gilead makes in partnership with companies like BMS and Janssen.”
In February 2016, AHF filed a lawsuit against Gilead over its manipulation of the patent system in order to derail competition to its HIV medicines. As reported at the time by Ed Silverman on the health news service, STAT, “At issue is tenofovir, or TDF, which is a cornerstone of the combination HIV treatments that Gilead sells. The patent on the TDF compound expires in December 2017 and Gilead hopes to replace it with a modified version known as TAF. The patent on TAF doesn’t expire until May 2022, and the prospect of nearly five more years of sales without generic competition is extremely valuable.”
He also noted, “There is another important difference between the two compounds — TAF is more potent and causes fewer side effects, notably bone damage and kidney toxicity.”
In 2014 in anticipation of Viread’s upcoming patent expiration, Gilead pulled a much more efficacious 30mg lower dose version of Viread off its development shelf and instead began the evergreening process by filing its first New Drug Application (NDA) for the modified Viread molecule, tenofovir alafenamide, or TAF (later branded Vemlidy).
It should be noted that Teva, an Israeli multinational pharmaceutical company and generic drug manufacturer, is allowed to begin production of a generic version of Viread as of December 15, 2017, resulting from its litigation against Gilead. Truvada, which contains the older version of Viread combined with a second Gilead drug called Emtriva, can also go generic as of December 2017.
What is most telling about Gilead’s corporate conscience—or lack thereof—is that after many years of incredible successes, this newer TAF version of Viread, which has a significantly better adverse event profile (particularly regarding renal side effects that impact African Americans much more) was reportedly left on the shelf post-development by Gilead Sciences for years. The reason for doing so is obvious: to maximize profits via the evergreening process by waiting until just the right time to begin filing new drug applications for all previously approved combination therapies. This effectively extends patent life of Gilead’s drug portfolio and greatly enhances the profit margins for Gilead.
“Gilead shamelessly used every tactic in the pharma greed book to try and evergreen its HIV portfolio using a scientific tweak to the tenofovir molecule to try and reset the patent clock and add another 17 years to the patent cycle. Gilead also increases prices on its HIV/AIDS and hepatitis drug portfolio consistently—and well above the consumer price index. Well, tick-tock Gilead, the clock stops on tenofovir on December 15t”. We urge you to immediately cut the price of all tenofovir-based regimens by ninety-percent,” added Weinstein.
 The Average Wholesale Price (AWP) is the average price that retailers and others are reportedly paying for a particular drug. The AWP is reported by the manufacturers and compiled by independent publishers, the data of which is used by governments, insurance companies, and others to determine the reimbursement and retail prices of prescription drugs. Source: VeryWell.com April 24, 2017