Provided by FiercePharma
December 9, 2013 | By Tracy Staton
Doctors and patients have been waiting impatiently for the big FDA approval on Friday: Gilead Sciences' ($GILD) breakthrough hepatitis C treatment sofosbuvir, now dubbed Sovaldi. But so have some of Gilead's fiercest critics, and those groups came out swinging.
No one questions the promise of Sovaldi, the first drug approved to treat hep C patients without the difficult-to-tolerate interferon. The once-a-day pill offers many patients not only a shorter course of treatment but better results, too. That's why doctors have been "warehousing" some hep C patients--in essence, waiting to treat them until Gilead's new drug hit the market.
What's the catch? It's priced at $84,000 per 12-week treatment course. That's $1,000 a day.
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The pent-up demand for Sovaldi, coupled with its steep price, is expected to push sales to $2 billion--not at peak, not even at 5 years out, but next year, its first on the market. As TheStreet points out, that's an unprecedented feat. And one analyst thinks Sovaldi could actually hit $4.5 billion next year, or more than $1 billion per quarter, on average. Try to get your head around that.
But that sort of price tag really riles people like Dr. Jennifer Cohn, medical director of the Doctors Without Borders access-to-medicines campaign. The international healthcare organization is already pushing Gilead to sell Sovaldi on the cheap--$500, including diagnostics--when it's launched in developing countries. Already, the legal activist group Initiative for Medicines, Access & Knowledge has filed an opposition to patent protection for Sovaldi in India, aiming to pre-empt Gilead's pricing power.
"We are very worried that Gilead will charge exorbitant prices in countries that are classified as 'middle-income,' even though they are home to around 75% of the world's poor," Cohn said in a statement. "Using patents to block affordable versions of sofosbuvir and pricing this drug out of reach of the most vulnerable groups who need it most is simply putting profits before people's lives."
Gilead has come under frequent fire for its pricing policies on AIDS treatments. Most recently, Doctors Without Borders and the AIDS Healthcare Foundation--along with a group of Democratic members of Congress--balked at the $28,000-a-year price on Gilead's four-in-one HIV pill Stribild. And that's after years of lobbying from activists looking for price breaks on the drugs.
Gilead has made some moves to open up access to its HIV treatments, including contributing some patents to the Medicines Patent Pool and licensing some drugs to generics makers for sale in India.
Those moves were a long time coming, however, and public health advocates are keen on winning concessions earlier on the hep C side. That's partly because so many patients in the developing world are coinfected with hep C and HIV--and, of course, because Sovaldi is such a big step forward for hep C treatment.
Gilead and plenty of others would argue that the company has spent billions developing the drug and has the right to make money on that investment. The pharma business is a business, after all. Stribild, for instance, has already made impressive progress toward its expected 2018 sales of $3.54 billion. Can Gilead's business interests and patients' interests find balance? That's the ultimate question.