Gilead nearing deal to sell Sovaldi in developing countries for much less than US price: report

Gilead Sciences' shares fell as much as nearly 5 percent Friday after Bloomberg reported that the company is close to reaching an agreement with generic drugmakers to introduce its hepatitis C drug Sovaldi (sofosbuvir) in about 80 developing countries. The report cited Gilead executive vice president Gregg Alton as saying a broad licensing deal could be signed as soon as the middle of the month and would allow generic manufacturers to produce Sovaldi, as well as an experimental treatment combining Sovaldi with another Gilead hepatitis drug.

"We are talking to five or six companies right now and we will see whether all six sign a licence with us," Alton said. Last month, Cipla chairman Yusuf Hamied confirmed that the company is in talks with Gilead, while a person with knowledge of the matter said Hetero Drugs and Mylan have also had discussions with Gilead regarding the production of generic Sovaldi.

According to the report, Gilead plans to market Sovaldi itself in certain lower-income countries, including India, at $900 for 12 weeks of therapy. In April, Gilead forged an agreement allowing Doctors Without Borders to obtain Sovaldi at the same price for a 12-week course of treatment, while a similar accord was reached with Egypt in March.

Sovaldi was approved last December in the US, where a 12-week course is $84 000, prompting some lawmakers there to ask that Gilead justify the cost. Previously, Gilead was asked by members of the US House Energy & Commerce Committee for a briefing on the therapy's "extraordinarily high cost." Alton remarked that the total cost of Sovaldi-based regimens in the US is similar to older regimens that required patients to stay on interferon for longer periods of time, adding that people who want explanations on how the company determined the price "are looking for something that is really not there."

The US pharmacy benefit manager Express Scripts has also argued that Sovaldi's price was not sustainable, adding that it would ask its members to use alternative treatments when they become available. In addition, France announced plans to collaborate with 13 other countries in Europe, where the drug was cleared in January, to negotiate a lower price.

Commenting on the Bloomberg report, FBR Capital Markets analyst Andrew Berens suggested investors are concerned that Gilead's plan to provide the drug at a discount to some countries could invite additional pricing scrutiny in the US. "[Investors] are worried that the US government is going to say, 'Why are you going to give it away in India while we're paying [much more] per patient," he remarked, adding "it makes it more of a foil...for what they're charging in the US." Conversely, RBC Capital Markets analyst Michael Yee noted that drug companies making their products available to lower-income countries at reduced cost is "nothing new," adding "[this] is something they already do with HIV pills and [is] already expected."

Sovaldi generated $3.5 billion in revenue for the quarter ended June 30. Meanwhile, Gilead revealed in a regulatory filing last month that an arbitration panel concluded that Roche failed to establish any of its claims to the therapy (for related analysis, see ViewPoints: Sigh of relief for Gilead as a small but real risk of disaster is averted in Sovaldi arbitration).

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