AHF Seeks Partners to Distribute Standalone Version of Tenofovir (TAF); Files Amended Federal Complaint Against Gilead Over Disputed AIDS Drug Patent

In Advocacy, News by AHF

In January, AHF filed a federal lawsuit against Gilead Sciences, Inc. and two other defendants alleging drug patent manipulation and anti-trust claims regarding slightly different formulations of tenofovir, a key HIV/AIDS drug that is found in Gilead’s all-in-one Fixed Dose Combination (FDC) HIV/AIDS treatments.

Last week, AHF filed an Amended Complaint bringing Odefsey and Descovy, two other drugs that each contain a form of tenofovir and are newly approved by the FDA, into the claim. The Amended Complaint also references efforts taken to obtain a standalone version of Gilead’s TAF (tenofovir alafenamide) which, despite having fewer negative side effects than TDF (tenofovir disoproxil fumarate), is only available as a part of Gilead’s FDCs and not as a standalone medication like TDF, branded as Viread.

AHF is putting out a call to potential partners—pharmacists, community health centers, etc.—who may also have an interest in distributing TAF as a standalone medication despite Gilead’s patent stranglehold.

LOS ANGELES (April 20, 2016) As part its federal lawsuit filed against Gilead Sciences Inc. alleging drug patent manipulation and anti-trust claims regarding slightly different formulations of tenofovir, a key HIV/AIDS drug, AIDS Healthcare Foundation (AHF) last week filed an Amended Complaint in U.S. District Court, Northern District of California, [Case # 3:16-cv-00443] bringing Odefsey and Descovy, two other Fixed Dose Combinations (FDC) of multiple drugs that each contain a form of tenofovir and that were recently approved by the FDA, into the claim. In addition, AHF’s Amended Complaint also references efforts taken to obtain a standalone version of Gilead’s TAF (tenofovir alafenamide), which has fewer negative side effects than TDF (tenofovir disoproxil fumarate), but unlike TDF, is only available as a part of Gilead’s FDCs and not as a standalone medication.

TDF, which may cause bone loss and kidney damage in patients, is a component of Gilead’s four-in-one combination HIV/AID treatment, Stribild, as well as its three-in-one combination treatment, Complera. It is also branded and marketed by Gilead as a standalone under the brand name, Viread.

Despite having fewer negative side effects, TAF is currently only available as a part of combination treatments like Gilead’s Genvoya, a Stribild equivalent, and Odefsey, a Complera equivalent (made by Gilead and Janssen Theraputics, now also named as a defendant in the complaint) as well as Gilead’s Descovy. However, Gilead makes no standalone version of TAF available to patients, such as with TDF branded and distributed as Viread. The availability of TAF, the less toxic form of tenofovir—and Gilead’s patent stranglehold on it—is at the heart of AHF’s patent manipulation case and anti-trust claims.

“We were stunned when lawyers for Gilead actually wrote in their motion to dismiss AHF’s lawsuit that Gilead, ‘… had no duty to develop …’ a less harmful HIV/AIDS drug,” said Arti Bhimani, Assistant General Counsel for AHF. “We believe and have asserted in our lawsuit that Gilead intentionally postponed clinical studies of TAF until its patent exclusivity period for TDF was about to expire, putting its market position ahead of patients who need the lifesaving, less toxic treatment afforded by TAF. AHF is also putting out a call for potential partners in the HIV/AIDS and pharmacy communities who may also have an interest in distributing TAF as a standalone medication despite Gilead’s patent stranglehold.”

AHF’s patent and anti-trust case centers on slightly different formulations of tenofovir, a key HIV/AIDS drug which was first synthesized over thirty years ago in the Czech Republic. One formulation of Tenofovir (tenofovir alafenamide or TAF) is a component in Genvoya, Gilead’s newest four-in-one Fixed Dose Combination (FDC) to treat HIV/AIDS patients, which was approved by the FDA in November 2015.

Gilead’s similar predecessor four-in-one Fixed Dose Combination, Stribild, includes the earlier formulation of tenofovir known as TD and commercially branded as Viread. TDF, the earlier formulation of tenofovir is also now nearing the end of its patent protection.

According to a New York Times article at the time of Genvoya’s approval by the FDA in November 2015, Genvoya “…contains the same four drugs as Stribild, but with the tenofovir disoproxil fumarate replaced by tenofovir alafenamide. The new form of the inhibitor, Gilead said, enters cells where H.I.V. replicates more efficiently, resulting in 91 percent less tenofovir in the bloodstream. That should make the pill less likely to cause kidney damage or loss of bone density…”

In response to FDA approval of Gilead’s Genvoya, the Indian online news site ‘The Hindu’ published a November 8, 2015 article titled, “Magic Pill, or Just an Old Cocktail?’ The article noted:

“There are two things one needs to know about this drug. First, it is not a new drug. It is a combination of four old drugs — elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (TAF). This is called a Fixed Dose Combination (FDC).

And while FDCs are good for improving adherence among patients, this is no magic pill. ‘Technically, this is simply not a breakthrough. No new drug has been discovered – older drugs have been brought together in the FDC form. This is important as it improves compliance, which is a great thing but to call it a breakthrough is a stretch,’ said Dr Manish Kakkar, a public health specialist in communicable diseases at the Public Health Foundation of India (PHFI).”

In January 2013, shortly after the FDA approved Stribild, the Fixed Dose Combination that Genvoya is now based on, Gilead filed a citizen’s petition with the FDA seeking an extension on its patent protection on Stribild from three years to five years.

In October 2014, the FDA denied Gilead’s petition for the patent extension.

AHF’s lawsuit, which demands a jury trial, seeks “Declaratory Judgment of Patent Invalidity and Violation of the Sherman Act,15 U.S.C. §§ 1 & 2.

If you represent a community health center, pharmacy, or a similar organization and are interested in joining AHF in distributing TAF as a standalone medication, please contact Arti L. Bhimani, Assistant General Counsel for AIDS Healthcare Foundation at (323) 860-5200 or [email protected].

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