As Patent Expires, AHF Calls on Gilead for 90% Price Reduction on Tenofovir-based Drugs, Including Truvada

  As Patent Expires, AHF Calls on Gilead for 90% Price Reduction on
  Tenofovir-based Drugs, Including Truvada

  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

Business Wire

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^1(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 15^th. We urge you
to immediately cut the price of all tenofovir-based regimens by
ninety-percent," added Weinstein.

AIDS Healthcare Foundation (AHF), the largest global AIDS organization,
currently provides medical care and/or services to more than 810,000
individuals in 38 countries worldwide in the US, Africa, Latin
America/Caribbean, the Asia/Pacific Region and Eastern Europe. To learn more
about AHF, please visit our website: www.aidshealth.org, find us on Facebook:
www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare.

^1 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

View source version on businesswire.com:
http://www.businesswire.com/news/home/20171017006733/en/

./ContentItem/Format  

With the patent ending & generics looming, we call on Gilead for a 90% price
redux on all its tenofovir-based drugs

Contact:

AHF
Ged Kenslea, Senior Director, Communications
Telephone: (323) 308-1833
Mobile: (323) 791-5526
gedk@aidshealth.org
Press spacebar to pause and continue. Press esc to stop.