June 15, 2013

In $15 billion hepatitis race, drugs move quickly from revolutionary to outdated

By Simeon Bennett, Published: June 13

GENEVA — Jean-Michel Pawlotsky has deja vu.

The doctor in the town of Creteil, just outside Paris, is telling hepatitis C patients to delay treatment until later this year, when two new drugs that may boost their chances of defeating the lethal liver infection hit the market.

It’s the same advice he offered two years ago, when earlier medicines developed by Vertex Pharmaceuticals and Merck & Co. were poised for approval. Now he says those drugs, hailed as breakthroughs in 2011, will soon be superseded by products from Gilead Sciences and Johnson & Johnson.

The pace of innovation, spurred by drugmakers jostling for a slice of a market that may reach $15 billion by 2018, has turned hepatitis C research into one of the fastest-developing areas of medicine. That boosted Gilead’s shares to a record last month, and left others like Vertex facing dwindling sales as their products quickly go from revolutionary to outdated.

“Things are moving very fast,” Pawlotsky, who teaches medicine at the University of Paris-Est, said by phone. “People are frustrated; they want more, better.”

Hepatitis C, an infectious disease that can scar the liver and afflicts about 170 million people worldwide, is still treated largely with injections that can take six months to clear the virus, sometimes don’t work and cause side effects ranging from flulike symptoms to depression. If untreated for longer periods, hepatitis C can cause cancer.

The current market

Gilead, a newcomer to the field, in April applied for regulatory clearance of a drug known as sofosbuvir. The pill may become the Foster City, Calif.-based company’s top-selling product by 2015 and reach sales of $6.3 billion by 2016, according to the average of nine analyst estimates compiled by Bloomberg. The stock has more than doubled in the past year on optimism about the pill.

Until 2011, there was only one standard treatment: the generic antiviral ribavirin, together with a weekly injection called pegylated interferon, sold by Roche Holding and Merck.

Two years ago, doctors and patients embraced the new drugs from Vertex and Merck because they boosted cure rates to about 80 percent from 50 percent. But they came with more side effects, including skin rashes and the risk of birth defects.

In clinical studies, newer formulations from Gilead and Johnson & Johnson show similar or better results in ridding patients of the disease, and fewer risks. Both may win regulatory approval this year. Johnson & Johnson’s Janssen unit applied in March for clearance of its product, simeprevir, which was developed by Medivir AB. Other drugs from AbbVie and Bristol-Myers Squibb are in late-stage trials.

“It’s not often you’re in a field that moves so fast and offers so much promise,” said Graham Cooke, a clinician at Imperial College London. “We’ve had very difficult treatments for so long, and we’re now in this era of incredible throughput from the pipeline.”

Vertex, of Cambridge, Mass., gets 76 percent of its revenue from Incivek, the hepatitis drug it developed with Janssen, which markets the treatment as Incivo in Europe. The drug won U.S. regulatory approval in May 2011, and prescriptions and sales reached a peak in the fourth quarter of that year but have declined since. The drug may garner sales of only $669 million this year, the average of 12 analyst estimates compiled by Bloomberg.

“We recognize that fewer patients are starting treatment for hepatitis C, however there are still patients who want or need to be treated now,” Erin Emlock, a spokeswoman for Vertex, said by e-mail. “Three of four people who start treatment today get Incivek, a number that’s unchanged since launch.”

To stoke demand, Incivo’s booth at a meeting of the European Association for the Study of the Liver in Amsterdam in April featured a video with the message, “Treat now to take your patient’s life off hold.”

Some doctors agree. The practice of delaying treatment to wait for better drugs, known as warehousing, is “irrational and almost unethical,” said Mitchell Shiffman, a clinician who sees about 1,000 new hepatitis C patients a year at the Liver Institute of Virginia. “If a patient can be cured now, why do you want to tell them to wait?”

French doctor Pawlotsky says people with mild disease aren’t harmed by a short delay. Most of his patients want to try the new drugs by participating in clinical trials, he says.

“Obviously, if we thought that the new treatments would come in something like five or six years, we would not warehouse,” he said. “But it’s a matter of months.”

More upcoming options

Mark Thursz, the secretary general of the European Association for the Study of the Liver, says many people he has put on experimental drugs are faring better than those using treatments now on the market.

“Our patients are struggling with the current regimes,” Thursz said. “The sooner we can get the new drugs licensed and in the clinic for our patients, the better.”

Gilead may charge up to $100,000 per patient for a course of sofosbuvir, according to ISI Group in New York. The drugmaker says it doesn’t comment on drug prices before they’re approved, but says the medicine can shorten treatment times to as little as 12 weeks, from as long as a year now.

Even as doctors disagree on whether to delay treatment, they have one eye on the next wave of drugs. At least three are in the final stage of clinical trials and may become available within two years.

Gilead is testing a combination of sofosbuvir with an experimental drug called ledipasvir in a cocktail that cured 100 percent of patients in a mid-stage trial presented in Amsterdam in April. AbbVie’s three-in-one combo won designation as a “breakthrough therapy” from the U.S. Food and Drug Administration on May 6, meaning it may be reviewed more quickly, after a study showed it cured 96 percent of patients after 24 weeks. Bristol-Myers Squibb’s three-in-one experimental combo won the same accelerated status just weeks earlier.

That means yet more difficult decisions about whether to treat or wait, said Dominique Larrey, a doctor at Saint-Eloi Hospital in Montpellier, France.

“I tell my students it’s like we’re in a therapeutic jacuzzi,” he said. “Each bubble is a new drug.”

— Bloomberg News


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