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Reuters Health Information (2011-09-29): Vertex takes early rounds of hep C bout with Merck

Drug & Device Development

Vertex takes early rounds of hep C bout with Merck

Last Updated: 2011-09-29 17:22:18 -0400 (Reuters Health)

(Reuters) - In the bout between a pair of breakthrough hepatitis C treatments, Incivek from upstart biotech Vertex Pharmaceuticals appears to have taken the first round from pharmaceutical heavyweight Merck & Co and its Victrelis by a wide margin.

The companies next month will report sales from the first full quarter on the U.S. market for their new medicines, and weekly prescription data indicates that Merck has some serious catching up to do.

About 1,100 new patients are likely to begin Incivek treatment each week in the fourth quarter compared with about 300 new patients for Victrelis, according to Wolters Kluwer, a provider of analytical data to the healthcare industry.

It estimates U.S. Incivek sales reaching $752 million in 2011 -- a trajectory that would see the drug surpass $1 billion in its first year on the market -- making for one of the most successful drug launches in history.

Genentech's blockbuster cancer drug Avastin, which was approved in February 2004, racked up its first billion dollars in sales in about a year and a half.

In contrast, Wolters Kluwer's inThought unit is forecasting $146 million in 2011 U.S. Victrelis sales.

"It's absolutely impressive," Julie Hoggatt, an analyst for inThought, said of Incivek's performance out of the gate. "It does seem that Vertex, being that this was its first launch, did a very good job."

The two drugs, which promise far higher cure rates for the serious liver disease than prior standard treatments, as well as the potential for shorter treatment durations, were approved within days of each other in May.

Analysts said that Merck has made some savvy moves, including a co-promotion deal with rival Roche -- the biggest seller of one of the older drugs that must be used in combination with the new medicines.

But it has so far been unable to alter the perception that Vertex has the better drug, even though the two have never been tested against each other.

In the final round of clinical trials, Incivek, known chemically as telaprevir, cured between 75% and 80% of patients. Victrelis, known chemically as boceprevir, cured 66%. Both results easily topped the cure rate of only about 40% for the previous standard treatments that had to be taken for nearly a year and which often caused miserable flu-like symptoms.


While many industry observers believed the Roche co-promotion would help bring the market share split much closer to 50-50, Incivek has so far been dominating.

"There was a feeling that maybe Merck could do a little bit better because they've done some unique things in the marketplace," said Deutsche Bank analyst Barbara Ryan.

"The reality is that the Vertex drug is more potent, has a more straightforward, simple dosing regimen, and for that reason they've got the lion's share of the market," she added.

"We still think that in some markets, like the Asian markets, that Merck will do better than its share here just because the company's presence in those markets is so strong," Ryan said.

Both drugs were recently approved in Europe, where Johnson & Johnson will sell the Vertex drug.

Hoggatt agreed that simplicity and a larger percentage of patients who qualify for shorter treatment time with Incivek were working in Vertex's favor.

"One negative for boceprevir is how confusing its label is," Hoggatt said. "I think maybe you're seeing some hesitation from physicians because of the complexity."

Under the Victrelis regimen the two older drugs -- interferon and ribavirin -- are taken for four weeks before the Merck drug is added to the mix. There are several treatment duration variables depending on a patient's response to the drugs at certain points along the way.

With Incivek, all three drugs are taken from the beginning and there are fewer pills and fewer duration variables.

"Patients are asking for telaprevir," confirmed Dr. Douglas Dieterich, a liver disease specialist and professor of medicine at Mt. Sinai School of Medicine in New York.

"It's probably going to become less telaprevir-dominated as the side effects roll in," Dr. Dieterich predicted. Incivek has been associated with serious rash in clinical trials.

But asked if patients have also been asking for the new Merck drug, Dr. Dieterich said, "No. Not at all."

Both companies have so far limited consumer marketing to campaigns aimed at raising awareness of hepatitis C.

"While it's still early, we are off to a good start with the launch of Victrelis and are encouraged by the positive responses we've received on our product from physicians, patients and payers," Merck spokeswoman Pamela Eisele said.

Merck has won a contract for Victrelis to be the preferred treatment option by the U.S. Department of Veterans Affairs that serves thousands of patients, which should provide a boost for its drug.

But Merck may need to alter course and begin to promote its brand with consumers to get patients to start asking doctors for Victrelis if it is to close the gap.

"We thought it would be little better on the Merck side as a percent, less than 50 but certainly better than 25%," said Barclays Capital analyst Tony Butler.

But Butler said it was too early to declare a winner.

"In the past I've been surprised at how things have changed over time," he said.

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