Gilead Sciences already faces mounting investor unease and plummeting hep C sales, and now it's looking at another Sovaldi patent challenge. Patient access groups that have targeted Gilead's Sovaldi IP all over the world are back on the attack in Europe.
Global charities Médecins Sans Frontières and Médecins du Monde, plus groups from the U.K., Greece, Spain, France and Ireland are lodging a protest on Sovaldi, claiming that the med’s patents keep millions of patients from getting needed treatment. Aliénor Devalière, EU policy advisor for MSF’s Access Campaign, added in statement the “science behind” the drug “isn’t new.”
In all, 30 groups from 17 countries are joining together to target Sovaldi's exclusive hold on its market in Europe.
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Médecins du Monde prevailed in a previous patent challenge, according to the group, though Gilead disputed its claims that the win essentially removed Sovaldi's shield against competition. The latest action continues that effort, and MdM says it should "incentivize" countries to issue compulsory licenses, which would force Gilead to allow generics makers to start selling cheap knockoff versions.
A Gilead spokesperson said the company is "committed to delivering our innovative medicines in a way that is economically sustainable and respects healthcare budgets while also respecting our patents, which is central to ensuring ongoing innovation in biomedical research."
The new challenge "has no immediate impact on Gilead's patents or on our exclusive right to make and sell Sovaldi, Harvoni, and Epclusa" in Europe, he added. The patent in question has been granted in 19 other countries, "reflecting the innovation involved in the development of this medicine and its unprecedented value to patients."
Despite MSF’s claim that Sovaldi doesn’t utilize new science, the med was the first in a class of antivirals that have “caused cure rates to skyrocket,” according to MSF’s release.
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For the California-based Big Biotech, losing protection on Sovaldi throughout Europe—however remote the possibility—would be a big deal. After an overwhelmingly successful launch, Gilead is already ceding sales ground in hep C because it's now competing with multiple meds and paying big rebates to payers in return for favorable coverage.Sovaldi accounted for $891 million in European sales last year, while Harvoni, a combo that includes Sovaldi, posted $1.8 billion in European sales for 2016.
According to the European Public Health Alliance, the patent challenge seeks to combat high price tags for Sovaldi and Harvoni, which force governments to deny or ration access. Gilead has charged €55,000 for a treatment course in Europe, according to the group, though several countries have said they negotiated much more favorable deals.
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Worldwide, Gilead’s hep C franchise quickly achieved record sales levels after launch, but the drugs have more recently lost their momentum because of competition from AbbVie’s Viekira Pak and Merck’s Zepatier. Bristol-Myers Squibb’s Daklinza has also played a role.
Last year, Harvoni revenues slipped 34% compared with 2015, while Sovaldi fell by 24%. Together, the two meds lost $6 billion in sales versus the prior year. Gilead expects that trend to continue, too. For 2017, the drugmaker forecasts total hep C sales of $7.5 to $9 billion, representing a steep falloff after the products reeled in $14.8 billion last year.
In light of that trend, analysts and investors have been pushing Gilead to make an acquisition for quite a while, but the company still hasn’t pulled the trigger. Just this month, Barclays analysts wrote to Gilead’s management encouraging the company to shake up its strategy.