AIDS foundation asks Congress, FDA to investigate Gilead over HIV patent

Gilead’s new HIV meds containing tenofovir alafenamide fumarate, or TAF, can work at a fraction of the dose of last-gen product Viread, significantly cutting down on side effects. But critics claim the TAF meds shouldn’t be so new--and they’re calling on Congress to back them up.

The Los Angeles-based AIDS Healthcare Foundation intends to ask lawmakers and the FDA to investigate Gilead for potential patent manipulation and antitrust violations, it said Tuesday, citing “bald-faced greed” and “disregard for patient safety” by the California company.

The foundation has a problem with the timeline of TAF’s development, considering that Gilead’s investigators had the compound on their hands--and clinical evidence that it could cut toxicity levels--more than a decade ago, The Los Angeles Times reports. But it halted research on the candidate in 2004, and in the meantime, Viread went on to live out most of its patent life, building up to $1.1 billion in 2015 sales--and some patients suffered serious damage to their kidneys and bones, the Times says.

And the AIDS Healthcare Foundation doesn’t like that outcome--especially considering that Gilead restarted its TAF research in 2010 and ultimately launched Genvoya last November, a move that could save Gilead's HIV franchise from blockbuster sales losses when Viread’s IP shield expires in 2018. Earlier this year, the foundation slapped the drugmaker with a lawsuit claiming it delayed TAF in “a calculated, anticompetitive manner” to keep prices on its star high and prevent generics-makers from snapping up market share.

It’s not uncommon for companies to roll out a new-and-improved med toward the end of a key product’s patent life to preserve its market share. Just look at Teva, which managed to switch most of its Copaxone patients over to a long-acting newcomer before Novartis’ Sandoz launched copy Glatopa. Or Roche, whose new med Gazyva was meant to protect billions in Rituxan revenue in a competitive chronic lymphocytic leukemia market.

The difference with TAF is the delay on doing so--but that’s a “simplistic” view, Gilead’s executives say. As Chief Scientific Officer Norbert Bischofberger told the Times, Gilead put the brakes on the TAF project to shift funds toward the search for another type of HIV med. Years later, it saw a need for a less toxic drug for aging patients--who are more susceptible to kidney and bone problems--and that prompted it to pick up TAF development again.

That susceptibility in aging patients--and the fact that HIV itself can cause kidney in bone problems--also make it hard to point a finger at Viread, Bischofberger figures. “Just because you observe kidney toxicity while a patient is taking the drug doesn’t prove causality,” he told the newspaper.

Either way, the Big Biotech denies the lawsuit’s claims; in a recent court filing seen by the Times, the company’s lawyers said Gilead “had no duty to develop, test, seek approval of, or launch its new product on any particular timetable.”

But the outcry still doesn’t look good for the company, which has been slammed for “unethical” behavior before. In the hep C arena, payers and patient advocacy groups have been up in arms since late 2013, when it priced breakthrough hep C cure Sovaldi at $84,000 per 12-week treatment course.

- read the LA Times story

- see the lawsuit

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