Monday, October 21, 2013

Gilead's sofosbuvir and Johnson & Johnson's simeprevir Face the FDA this week

Related: PDF Downloads
Download FDA
review package for simeprevir ahead of October 24th meeting and Johnson & Johnson document both released today.

FDA: J&J Hepatitis C Drug Cures 80% of Patients

(WASHINGTON) — An experimental hepatitis C drug from Johnson & Johnson appears to be slightly more effective at eliminating the virus than currently available treatments, though federal safety reviewers say it also causes rash and sunburn in some patients.

The Food and Drug Administration posted its review of simeprevir online ahead of a public meeting Thursday where experts will vote on whether to recommend the drug’s approval.

More than 3 million people in the United States have hepatitis C, a blood-borne disease linked to 15,000 deaths a year. The disease slowly eats away at the liver over 20 to 30 years and most people don’t even realize they have the virus until after liver damage occurs.

Drugmakers see hepatitis treatments as potentially lucrative because the disease is expected to grow into a major public health problem as the U.S. baby boom generation ages.

For most of the last 20 years, the standard treatment for hepatitis C involved a grueling one-year regimen of pills and injections that caused flu-like symptoms and cured less than half of patients. Then in 2011, the FDA approved two new drugs from Merck and Vertex Pharmaceuticals that raised the cure rate to about 65 and 75 percent, respectively, when combined with the older treatments.
J&J’s new drug appears to raise the level of effectiveness again: simeprevir cured 80 percent of patients who had not previously been treated for the disease, according to the FDA. The New Brunswick, N.J., company is seeking approval to combine the drug with the standard treatment regimen for patients with the most common form of the virus.

But the agency’s review is not all positive. FDA scientists note that 25 percent of patients taking the drug developed a rash during the first 12 weeks of treatment. About 5 percent of patients also developed sunburn as a side effect of the drug.

On Thursday the FDA will ask a panel of outside experts whether the drug should carry warnings about rashes and sunburn on its label. The agency also wants to know whether “sun-protection measures should be recommended for all patients.”

The FDA is not required to follow the advice of its panelists, though it often does.

The same panel of experts will review another proposed hepatitis C drug from Gilead Sciences Inc. on Friday. Some analysts expect that drug, known as sofosbuvir, to become the leading drug for the disease, based on research showing it cured 90 percent of patients in 12 weeks.

Investment Commentary @ The Motley Fool

The Most Important Week of the Year Has Arrived for Gilead Sciences
by Sean Williams, The Motley Fool
Oct 22nd 2013 6:33PM

It's not time yet for biopharmaceutical juggernaut Gilead Sciences to report earnings -- that will come next week. But this is, nonetheless, the most important week of the year for the company.
On Wednesday, the Food and Drug Administration is set to release its briefing documents on Gilead's oral hepatitis C drug sofosbuvir, ahead of a Food and Drug Administration advisory panel meeting Friday. This, without question, is a meeting that could make or break Gilead for the remainder of the year.
Gilead and Johnson & Johnson Face the FDA

Gilead Sciences (NASDAQ:GILD) and Johnson & Johnson (NYSE:JNJ) will face Food and Drug Administration advisory committees this week when the panels review their respective hepatitis C drugs. Advisory committee meetings can be the start of a downfall for a drug's chances for approval, but Gilead and Johnson & Johnson don't appear to have much to worry about.

A means to an end
Gilead's sofosbuvir and Johnson & Johnson's simeprevir are just building blocks of eventual all-oral treatments for hepatitis C. For genotype 1 patients, the most common strain of hepatitis C in the U.S., the drugs will need to be used in combination with one of the injected drugs already on the market: Merck's (NYSE: MRK) Pegintron or Roche's Pegasys.

In addition to genotype 1, Gilead is also asking the FDA to approve sofosbuvir for the other five genotypes. Patients infected with genotypes 2 and 3 virus will get to skip Pegintron/Pegasys and take sofosbuvir with a generic drug called ribavirin. Like genotype 1 patients, those infected with genotype 4, 5, and 6 will still have to take PegIntron or Pegasys with sofosbuvir and ribavirin.

The ultimate goal for Gilead, Johnson & Johnson, and all the other hepatitis C drugmakers is to skip Merck's Pegintron and Roche's Pegasys because -- in addition to needing to be injected -- they often produce annoying flu-like symptoms over the months that patients have to take the drugs.

For now, the drugs will replace the first generation oral hepatitis C drugs -- Merck's Victrelis and Vertex Pharmaceuticals' Incivek -- but aren't likely to reach their full potential until other drugs in development are approved to create an all-oral cocktail.

Tuesday and Wednesday are key
Johnson & Johnson's advisory committee meeting is actually on Thursday and Gilead's is on Friday, but investors will get a first look at what the FDA thinks of the drugs two days before those meetings when the agency publicly releases its briefing documents for the panel members.

I doubt there are going to be any issues with efficacy. The drugs appear to be substantially better than Victrelis and Incivek with clean clinical endpoints. Patients are either rid of the virus or they're not. It's hard to see how the companies could get tripped up.

It's the places where the data are a little more obtrusive to the public that investors have to worry about. Sometimes, for instance, the FDA brings up results from preclinical animal studies, asking the panel of outside experts whether they think the findings are worrisome.

Not that I have any reason to think that'll happen to Gilead or Johnson & Johnson this week.

Neither does anyone else
And that's kind of the problem with the stocks. For both drugs, an approval is widely expected because there haven't been any red flags to think otherwise. There doesn't seem to be much upside to me.

In fact, I wouldn't be surprised to see Gilead go down after the documents are released. There's bound to be something negative in the briefing documents -- the FDA's job is to find every potential issue, no matter how small -- and considering that Gilead is up more than 80% this year, an overreaction wouldn't be surprising.

If you're an owner of Johnson & Johnson, simeprevir is just a small part of the pharma giant's long-term growth plan, so I doubt Johnson & Johnson's stock will react unless something really bad is revealed in the briefing documents.

1 comment:

  1. This is like finding a cure for polio. we need it now . please