Gilead Sciences Inc. (GILD:US) won the backing of U.S. advisers for its hepatitis C pill, helping solidify the company’s drive to lead the growing market for drugs to defeat the disease.
Gilead’s drug, known as sofosbuvir, should be approved, a panel of outside advisers to the Food and Drug Administration voted unanimously today in Silver Spring, Maryland. The FDA is expected to decide whether to clear sofosbuvir for sale by Dec. 8. The agency doesn’t have to follow the panel’s advice.
Gilead, Johnson & Johnson, AbbVie Inc. (ABBV:US) and Bristol Myers Squibb Co. are among companies working on new hepatitis C drugs that alleviate the burden of current treatments that include interferon injections, which can cause flu-like symptoms. The market for hepatitis C medicines may reach more than $100 billion over a decade, according to Bloomberg Industries.
“This is a historic vote,” said Daniel Raymond, the consumer representative on the panel and policy director at the Harm Reduction Coalition in New York. “This is the first vote for a interferon-free regimen to treat hepatitis C. This is going to be a very important move forward.”
About 4 million Americans have hepatitis C, which can cause liver cirrhosis, according to the National Institutes of Health. The disease, which is classified into six genotypes, can be passed through infected blood or body fluids, most commonly through needle-sharing by drug users.
Gilead is seeking approval of once-daily sofosbuvir for patients with the genotype 1 form of the infection, the most common type, in combination with pegylated interferon and another pill called ribavirin. The Foster City, California-based company, the world’s biggest maker of AIDS drugs, hopes to gain approval for an all-oral combination that omits interferon for those patients within about a year. Gilead also is seeking sofosbuvir approval in other genotypes with and without interferon.
Sofosbuvir may generate (GILD:US) $1.82 billion in sales next year, according to the average of nine analysts’ estimates compiled by Bloomberg. The drug can shrink the current treatment time to 12 weeks from about a year for most patients.
The panel voted 15-0 that sofosbuvir should be approved in combination with pegylated interferon and ribavirin for genotype 1 and genotype 4 patients who haven’t previously been treated. About 70 percent of patients in the U.S. have genotype 1.
The panel also voted 15-0 that the treatment in combination with only ribavirin should be cleared for genotype 2 and genotype 3 patients, which include as much as 25 percent of those with hepatitis C in the U.S. The combination for these patients would be the first all-oral regimen.
Gilead shares fell less than 1 percent to $69.68 at the close in New York.
“There were already high expectations going into the panel and the stock was at its all-time high yesterday already,” said Michael Yee, an analyst at RBC Capital Markets.
The panel today offered glowing reviews of sofosbuvir and discussed a question asked by the FDA about whether patients with genotype 1 hepatitis C who tried other treatments should have access to the drug as well, Yee said in an e-mail. Gilead only studied the treatment in genotype 1 patients who had never been treated before.
“As we reviewed this application we realized how important a drug this was and we also realized that not every patient population was represented,” Debra Birnkrant, director of FDA’s Division of Antiviral Products, said during the meeting.
FDA modeled data to hypothesize whether the drug could be used in treatment-experienced patients.
Advisers voted 19-0 yesterday that a Johnson & Johnson (JNJ:US) and Medivir AB (MVIRB) hepatitis C medicine known as simeprevir should be approved for genotype 1 patients in combination with pegylated interferon and ribavirin. The drug can reduce current treatment time in half to 24 weeks. Potential simeprevir users need screening for a genetic mutation that renders the drug ineffective.
Analysts assumed treatment-experienced patients would use J&J and Medivir’s drug though Gilead now may be available for those patients, Yee said. He estimates sales of Gilead’s sofosbuvir will total $300 million in the first quarter of next year versus a consensus estimate of $223 million.
For the majority of current patients interferon and ribavirin are combined with Merck & Co.’s Victrelis or Vertex Pharmaceuticals Inc. (VRTX:US)’s Incivek. Victrelis, Incivek and J&J’s simeprevir are protease inhibitors that battle genotype 1 hepatitis C. Sofosbuvir, if approved, will be the first in a new class of drugs called nucleotide polymerase inhibitors.
Treatment-experienced patients made up 40 percent of first-year sales (MRK:US) of Victrelis and Incivek, Yee said. Sales of the two drugs totaled $1 billion in 2011, the year they came on the market, and $1.7 billion last year, according to data compiled by Bloomberg.
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