Gilead's Sofosbuvir Gets New Name, Price, Headaches

The FDA didn't surprise anybody when it approved Gilead's (NASDAQ: GILD  ) high-profile hepatitis C drug sofosbuvir in early December. The drug has enjoyed fanfare as the most promising drug in Gilead's pipeline ever since the company picked it up in its $11 billion acquisition of Pharmasset back in 2011. Now, with the FDA's blessing and a market-friendly name in hand, Gilead has an opportunity to make back some of that investment -- but it will have to leapfrog price objections first.

Out with the old, in with the new

Drugs are well known for their clunky, inefficient and difficult-to-pronounce names. So once the FDA gives the go-ahead, marketing teams crunch the data and scour the lists to find names that pass muster with regulators and consumers.

Those names get vetted pretty thoroughly in an FDA black-box process that makes sure companies don't sneak in hints of efficacy or safety. Those names also have to resonate with consumers enough to build a brand around.

Gilead hopes it's found the right formula in christening sofosbuvir as Sovaldi, a geographically neutral name that could stick globally once the drug wins approval in Europe.

Pricing is sky-high, but not as lofty as feared

Gilead also announced pricing for Sovaldi, and payers are happy to see that Gilead settled on a cost south of the rumored $100,000 mark. Still, there's little joy at insurers, given that its $84,000 bill for a course of treatment dwarfs the $15,000 to $20,000 a year they were paying a few years ago for Peg-interferon and ribavirin.

Sovaldi's stiff price tag is also a big jump from the $50,000-a-year price commanded by Johnson & Johnson's (NYSE: JNJ  ) and Vertex's Incivek, and Merck's Victrelis.  Both of those drugs were recently approved in 2011, and Incivek was the fastest drug ever to reach $1 billion in sales. 

Balking at paying

The decision to price Sovaldi higher than Johnson & Johnson's recently approved Olysio, formerly known as simeprevir, was bound to result in push back.

The first shove came from Express Scripts (NASDAQ: ESRX  ) . The company suggests that it's willing to substitute lower priced competitors, even if those therapies come with a more unfriendly dosing schedule.

For now, that may prove an empty threat.

No other treatment, including Johnson's Olysio, is as effective across as large a patient pool as Sovaldi. Olysio, despite a solid showing in trials, struggled when treating patients with the Q80K polymorphism, which occurs in 50% of patients with hepatitis C, genotype 1a -- the most commonly occurring genotype in the United States.

That means Express Scripts has to hope AbbVie (NYSE: ABBV  ) , with an up-and-coming multi-drug oral cocktail, will be willing to deal. So far, AbbVie's cocktail has enjoyed impressive results, including a 96% cure rate after 12 weeks in its most recent phase 3 trial.

Alternately, insurers could look to Bristol-Myers's  (NYSE: BMY  ) daclatisvir, which is seeking approval in Japan as the first all-oral, interferon- and ribavirin-free treatment for the disease.

Foolishly creative math

The argument over pricing isn't a new debate for next-generation therapies. That means Express Scripts may be all bark and no bite. After all, hoping that AbbVie or Bristol-Myers will cut a deal to charge pharmacies less may prove a long shot, given that each has invested big money ushering its compound through clinical trials.

That's not to say there big buyers and big pharma can't strike deals behind closed doors. However, Gilead and Johnson's drugs, while more expensive, are also significantly better than predecessors. They cut the treatment time in half, with better outcomes. That suggests doctors and patients will embrace Sovaldi regardless of cost.


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Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

  • Report this Comment On December 11, 2013, at 8:15 PM, tolucajo wrote:

    What the article is not taking into consideration to the total cost of the regimens for the new HCV treatments and cure rates. Sofosbuvir is a 12 week treatment and that is it. Simeprevir is a total treatment regimen of 48 weeks for experienced patients. The cost is relatively neutral. Nevertheless, sofosbuvir has some of the highest cure rates for HCV Geno 1. If you were a doctor or a patient, you'd probably make the best decision possible for curing this disease.

  • Report this Comment On December 13, 2013, at 12:28 AM, pharmtrade wrote:

    The Express Scripts comment was totally taken out of context and the news of that appears to be just the shorts doing what they know best, creating fear in your investment. Shaking out the weak hands.

    As a Pharmacist, (Doctor of Pharmacy) I would agree with the statement above by tolucajo. A physician would very much opt for the shortened treatment length for their patient plus the very high cure rate.

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