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Second Drug Wins Approval For Treatment of Hepatitis C

May 24, 2011 by Leave a Comment

Incivek, as the drug will be called, is expected to be the first big product for Vertex, and the first it will sell on its own. It is expected to allow the company to finally become profitable after 22 years in business and an expenditure of $4 billion.

Merck’s drug, Victrelis, was approved by the Food and Drug Administration on May 13.

The drugs “represent a new direction in the treatment of hepatitis C and a significant improvement over the current standard of care,” Dr. Margaret A. Hamburg, the commissioner of the F.D.A., said in a conference call on Monday.

Both products borrow from the strategy used by H.I.V. drugs of inhibiting the action of a viral enzyme — in this case, the hepatitis C protease enzyme.

In a clinical trial, 79 percent of people treated with Incivek combined with the existing treatment achieved what is effectively considered a cure, compared with 46 percent for those getting the existing drugs alone.

About half the patients treated with Incivek were able to finish treatment in 24 weeks instead of the usual 48 weeks. That is considered important because treatment, which involves the existing drugs alpha interferon and ribavirin, is arduous. Side effects can include flulike symptoms, anemia and depression.

Incivek has its own side effects, particularly a severe rash. It can also worsen anemia and cause nausea, fatigue and hemorrhoids.

Most analysts expect Vertex’s drug to reach annual sales of $2 billion within three years and to outsell Merck’s drug because it appears to be somewhat more effective in clinical trials, though the two drugs were never compared head to head. Also, the treatment using Vertex’s drug is less complex and requires six pills a day, half as many as required for Merck’s drug.

Vertex set the wholesale price of Incivek, also known as telaprevir, at $49,200 for the entire course of treatment. Merck’s Victrelis, also known as boceprevir, costs $26,400 to $48,400 depending on the duration of treatment. Both drugs would be used in addition to the standard therapy, which costs about $15,000 to $30,000 depending on duration.

Vertex executives defended the price, saying that cures can prevent the problems that can be caused by hepatitis C, like liver cirrhosis, liver cancer and the need for a liver transplant.

“Cure is rare in medicine and that makes the economics very compelling,” said Joshua Boger, who founded Vertex. He stepped down as chief executive two years ago, but is still a director.

The new drugs could appeal to some people who were not cured by the existing treatments and might want to try again. One of those is Michael Desroches, 44, of Methuen, Mass., who said he already had cirrhosis. “It’s not going to get any better by itself, obviously,” he said.

Dr. Boger, who had been a chemist at Merck, started Vertex in 1989 with the aim of revolutionizing drug discovery. But it has been a costly and slow revolution and Vertex now finds itself competing with Dr. Boger’s former company. Vertex did develop two H.I.V. drugs that were sold by GlaxoSmithKline, and it has a couple of promising drugs for cystic fibrosis in development.

Vertex, based in Cambridge, Mass., started on the hepatitis C project in 1993, a few years after the virus was first identified. In 1996, it published the three-dimensional structure of the virus’s protease enzyme. Then it set about finding a chemical that could block the enzyme’s activity.

With the prospects for curing hepatitis C increased, efforts might shift to identifying more of the 3.2 million Americans said to be infected with hepatitis C.

Health authorities say most of those infected, primarily baby boomers who might have been infected decades ago by injecting drugs, or through sex or blood transfusions, do not know it. That is because it can take decades for liver problems to show up, and many times they never do.

Vertex is expected to start a public awareness campaign, with New York City being an initial focus. The company commissioned a study that made the case for screening all people 40 to 64 years old, not just those deemed to have risk factors.

Article source: http://feeds.nytimes.com/click.phdo?i=2b05e63f205702333730a5e492673351

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F.D.A. Clears First New Hepatitis C Drug in 20 Years

May 13, 2011 by Leave a Comment

WASHINGTON (AP) — The Food and Drug Administration on Friday approved a highly anticipated hepatitis C drug from Merck that is the first new treatment for the virus in 20 years.

The first-of-its-kind pill, Victrelis, has been shown to cure more patients in less time than the older drugs now used.

About 3.2 million people in the U.S. have Hepatitis C, a blood-borne disease linked to 12,000 deaths a year.

The current two-drug treatment for the virus cures only about 40 percent of people and causes side effects like nausea, fatigue and vomiting.

The FDA said it approved the new drug based on two trials in which more than 65 percent of patients were cured when combining Victrelis with the two older drugs.

Some patients were also able to eliminate the virus in six months on the drug, half the time needed with the current treatments alone.

Boceprevir works by blocking the enzyme protease that helps hepatitis reproduce. It differs from the older medications that boost the immune system.

“This new medication provides an effective treatment for a serious disease, and offers a greater chance of cure for some patients’ hepatitis C infection compared to currently available therapy,” said Dr. Edward Cox, director of the FDA’s office of antimicrobial products.

The drug, known generically as boceprevir, is designed to be taken three times a day with meals. Side effects include fatigue, nausea, headache and low blood cell count.

Analysts expect boceprevir to reach annual sales between $800 million and $1 billion. The drug is one of two new hepatitis treatments expected to gain approval this month. Vertex Pharmaceuticals is scheduled to receive a decision on its drug, telaprevir, by May 23. That drug is could garner even higher sales of up to $3 billion due to higher efficacy data, according to analyst estimates.

Hepatitis C is the primary cause of liver transplants in the U.S. and is expected to become a much larger public health problem as aging baby boomers succumb to the disease.

People can get the disease by sharing needles or having sex with an infected person. The disease could also be picked up from blood transfusions before 1992, when testing of the blood supply for the virus began.

Most people with hepatitis C don’t even know they have the virus until after liver damage has occurred, which can cause abdominal pain, fatigue, itching and dark urine.

Current treatment for hepatitis C runs about $30,000. A spokeswoman for the Whitehouse Station, N.J.-based Merck could not immediately discuss the drug’s price. The company will begin shipping the drug immediately.

“We look forward to building on our legacy in the fight against infectious diseases, and to being a part of this exciting new era in the treatment of hepatitis C,” said Merck CEO Kenneth Frazier, in a statement.

Merck Co. Inc. was the first company to market a drug for hepatitis C in 1991 when it launched interferon-alpha.

Article source: http://www.nytimes.com/aponline/2011/05/13/business/AP-US-Hepatitis-Drug-FDA-Approval.html?partner=rss&emc=rss

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Screening the Day’s Catch for Radiation

April 6, 2011 by Leave a Comment

“I just want to make sure whatever we use is safe,” said Mr. Ripert, whose staff is using the device to screen every item of food that enters the restaurant, regardless of its origin. He has also stopped buying fish from Japan, which means no high-quality, farm-raised hamachi and kampachi for raw seafood dishes.

“Nobody knows how the currents will carry the contaminated water,” he said.

Despite assurances by health officials that radiation from the stricken Fukushima Daiichi nuclear power plant in Japan is unlikely to show up in the food supply, worries about contaminated foods are growing among consumers, businesses and governments across the globe.

On Tuesday, the Japanese government announced new radiation standards for fish after high levels of radioactive iodine and cesium were found in fish caught halfway between the reactor site and Tokyo. In response, the European Union said it would tighten its own radiation limits for Japanese food imports. India said it would ban all food from Japan for at least three months.

In the United States, where about 4 percent of food imports come from Japan, the Food and Drug Administration has restricted some foods from the country. And the agency is working with customs officials to screen incoming fish and other food for traces of radiation.

So far, that screening has identified seven items that required further testing to see if the radiation detected exceeded normal background levels, according to Siobhan Delancey, an F.D.A. spokeswoman. Those items included tea and flavoring compounds. She said three of the items had been cleared for delivery and four were awaiting test results.

Patricia A. Hansen, a senior scientist at the F.D.A., acknowledged that the radiation detection methods used to screen food imports were not sensitive enough to detect a single contaminated fish in a large shipment. But she said that small amounts of contamination did not represent a public health hazard. A person would have to consume large amounts of fish in excess of what are known as an “intervention level,” or threshold level, of radiation for an extended period of time before it would be considered dangerous, she said.

“One fish that might be at an intervention level in a huge cargo container, we’re not going to pick that up,” she said. “But the important context is, is that one fish at the intervention level a public health concern? No, it is not.”

Nicholas Fisher, a professor of marine sciences at the State University of New York at Stony Brook, said that, according to some radiation safety guidelines, people could safely eat 35 pounds of fish each year containing the level of cesium 137 detected in the Japanese fish.

“You’re not going to die from eating it right away,” he said, “but we’re getting to levels where I would think twice about eating it.” All the talk about radioactive food in Japan, which earlier banned milk and other farm products from areas near the crippled plant, has made some people uneasy, even thousands of miles away.

“When radioactive material started going into the ocean, that raised my concern greatly,” Karen Werner, 68, said on Tuesday as she shopped for fish at 99 Ranch Market in Richmond, Calif. “Right now, I’m not too worried about it showing up in fish, but I’m keeping my eye on it.”

Lee Nakamura, a partner who manages the fish counter at Tokyo Fish Market in Berkeley, Calif., estimated that one in five customers asked about possible radiation, but he had not yet seen an impact on sales. He said his Japanese suppliers had assured him that fish were being tested for possible radiation.

“Everything is under a microscope right now,” Mr. Nakamura said. “I feel confident the fish is safe. Everyone in Japan and here is looking at it and double-checking it before it gets to us.”

Several restaurant owners and fish importers said that while they continued to buy some fish from Japan, it came from areas far from the reactor site.

Still, Scott Rosenberg, an owner of Sushi Yasuda, a highly regarded sushi restaurant in Manhattan, said he planned to buy a radiation detector and would post a notice on the restaurant’s Web site to let customers know about the testing. “We want to make sure there is no exposure,” he said.

Elisabeth Rosenthal and Malia Wollan contributed reporting.

Article source: http://www.nytimes.com/2011/04/06/business/06food.html?partner=rss&emc=rss

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DealBook: S.E.C. Said to Weigh Inquiry of Sokol’s Lubrizol Trades

April 1, 2011 by Leave a Comment

David L. SokolMario Anzuoni/ReutersDavid L. Sokol and Warren E. Buffett say he has done nothing wrong.

David L. Sokol said he thought he did nothing illegal when, as a top lieutenant of Warren E. Buffett, he bought shares of a company while orchestrating Berkshire Hathaway’s acquisition of it.

Mr. Buffett agrees.

But neither is the ultimate arbiter.

The Securities and Exchange Commission is weighing whether to formally investigate Mr. Sokol’s purchases of stock in the company, Lubrizol, according to a person briefed on the matter who was not authorized to speak publicly.

Securities lawyers say rules surrounding insider trading are murky, making it difficult to handicap whether Mr. Sokol could face legal liability.

“The decision whether to bring a case against Sokol will turn on a close analysis of the facts,” said Richard L. Scheff, a lawyer at Montgomery, McCracken, Walker Rhoads. “It will also turn on his state of mind as to why he was trading in Lubrizol when he was.”

A spokesman for the S.E.C. declined to comment. Mr. Sokol did not return requests for comment.

Mr. Buffett disclosed the trading in a press release on Wednesday announcing Mr. Sokol’s resignation from Berkshire. Mr. Sokol accumulated about $10 million shares of Lubrizol, a chemical maker, in January, just days before he suggested an acquisition of the company.

Two months later, Berkshire agreed to buy Lubrizol for $9 billion. The announcement of the deal increased the value of Mr. Sokol’s stock by $3 million.

The news of Mr. Sokol’s trading in Lubrizol comes at time when federal authorities have cracked down on insider trading. The hedge fund manager Raj Rajaratnam is on trial in Federal District Court in Manhattan in the biggest insider trading case in a generation. Earlier this week, the Justice Department brought criminal charges against a longtime Food and Drug Administration employee, accusing him of trading on confidential drug information.

Central to the regulators’ decision to bring a case is whether Mr. Sokol traded stock on material nonpublic information in violation of a duty of trust or confidence owed to the company or its shareholders — the legal definition of insider trading.

Did Mr. Sokol trade on information that was nonpublic?

In December, Mr. Sokol asked bankers at Citigroup to reach out to Lubrizol about a possible acquisition by Berkshire. Citigroup relayed his interest to the Lubrizol chief executive, who “indicated that he would inform his board of Berkshire’s possible interest,” according to a Lubrizol securities filing.

A few weeks later, Mr. Sokol bought about $10 million worth of Lubrizol stock.

Securities lawyers say regulators could take the view that such information — that is, investment bankers approaching Lubrizol about a potential deal with Berkshire — was confidential, or nonpublic.

Did Mr. Sokol trade on nonpublic information that was material?

This is a close call, say legal experts.

The Supreme Court recently said that information was material if it would have “significantly altered the total mix of information made available” to a “reasonable investor.”

An average investor would probably have viewed the news that Berkshire had approached Lubrizol as relevant in a decision to buy shares in the company. News of potential acquisitions — particularly those by Mr. Buffett — move stocks.

But Mr. Sokol, securities lawyers say, has a defense on this point. Even though he bought Lubrizol stock after initiating a potential transaction, the possibility of a deal actually happening was remote.

“Dave’s purchases were made before he had discussed Lubrizol with me and with no knowledge of how I might react to his idea,” Mr. Buffett said in his release. “In addition, of course, he did not know what Lubrizol’s reaction would be if I developed an interest.”

Mr. Buffett added: “Furthermore, he knew he would have no voice in Berkshire’s decision once he suggested the idea; it would be up to me and Charlie Munger, subject to ratification by the Berkshire board, of which Dave is not a member.”

Did Mr. Sokol violate a duty to Berkshire or its shareholders?

Mr. Buffett said in his release that he felt that Mr. Sokol’s purchases were in no way unlawful. When Mr. Sokol approached Mr. Buffett about Lubrizol, he said that he owned stock in the company.

“It was a passing remark and I did not ask him about the date of his purchase or the extent of his holdings,” Mr. Buffett said in his letter.

But a regulator could argue that Mr. Sokol had violated his duty to Berkshire by breaching the company’s insider trading policy, said Steven M. Davidoff, a securities law professor and a columnist for The New York Times.

Berkshire’s insider trading policy states that executives “who have access to confidential information are not permitted to use or share that information for stock trading purposes or for any other purpose except the conduct of the company’s business. All nonpublic information about the company should be considered confidential information.”

Did Mr. Sokol know that his actions were unlawful, or that there was a high likelihood they were unlawful?

The legal term scienter — or having knowledge of wrongdoing — is a critical element of any insider trading case.

A crucial question is whether Mr. Sokol bought Lubrizol knowing he was going to suggest the deal to Mr. Buffett.

“I don’t believe that I did anything wrong,” Mr. Sokol told CNBC in an interview on Thursday. “I can understand the appearance issue, and that’s why we made it public.”

Article source: http://feeds.nytimes.com/click.phdo?i=83a4cd60f94755a9fae6078906fbd315

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Prescriptions: Medicare Will Pay for Prostate Drug

March 31, 2011 by Leave a Comment

Updated: Medicare announced on Wednesday that it would pay for Dendreon’s prostate cancer drug Provenge, whose $93,000 price tag had ignited debate about the cost and effectiveness of cancer drugs.

The Centers for Medicare and Medicaid Services said in a memo posted on its Web site that Provenge was a “reasonable and necessary” treatment for Medicare patients who had the stage of prostate cancer for which the drug was approved by the Food and Drug Administration last April.

However, it said the evidence was “virtually nil” that Provenge was effective for men who had other stages of the disease and therefore it did not believe those so-called off-label uses should be reimbursed.

The proposed coverage plan was generally expected since it was line with the findings of a Medicare advisory committee last November. The proposed decision will be open for public comment, with a final decision expected in June.

Medicare generally pays for drugs that receive F.D.A. approval. So the decision of the agency to even undertake a formal “national coverage determination” aroused some controversy.

Some securities analysts, investors in Dendreon and patient advocates said Medicare’s move represented the start of a crackdown on high-price drugs, or even the beginning of the “health care rationing” that critics of the new federal health care legislation assert would accompany it.

Medicare officials denied this, saying they merely wanted a uniform payment policy, rather than leaving the decision to regional Medicare contractors. The officials also said that Provenge raised some novel questions because it resembled a treatment process more than a mass-produced drug.

Some health care experts have been arguing that society cannot continue to pay for cancer drugs that extend lives by only a few months, if that much. In the main clinical trial testing of Provenge, men with advanced prostate cancer who received the drug lived a median of about 26 months, about four months longer than those who got a placebo.

In November, an advisory committee to Medicare expressed a fairly high level of confidence in the evidence demonstrating that Provenge prolonged lives, at least for the type of patients included in the clinical trials.

But the committee, which did not consider the cost of the drug, said the evidence was not convincing that Provenge would help men who had earlier-stage or later-stage prostate cancer than the men in the trials.

In the memo on Wednesday, Medicare officials said they would not put in place a blanket national ban on reimbursement for off-label uses of Provenge, leaving it instead to local Medicare contractors to develop policies. But the memo said Medicare officials hoped all such off-label uses would be only in clinical trials.

“We may, if this turns out to be an overly optimistic viewpoint, reconsider this N.C.D. to ensure that Medicare coverage is restricted to uses that are supported by robust evidence,” the memo said.

Provenge is approved for men whose cancer has spread beyond the prostate gland and who are no longer responding to androgen-deprivation therapy, yet still have minimal or no symptoms.

Medicare said it received 657 public comments during its deliberations over Provenge, of which 620, or 94.4 percent, were in favor of it paying for the drug.

Provenge is sometimes called a cancer vaccine because it harnesses the body’s own immune system to fight the cancer. Immune system blood cells are removed from a patient and incubated by Dendreon with a genetically engineered protein that, in a sense, trains the immune cells to recognize and attack prostate tumors. The immune system cells are then infused back into the patient.

Dr. J. Leonard Lichtenfeld, deputy medical director of the American Cancer Society, said Wednesday’s decision was one “that they had to come to” given Medicare statutes. He said he was surprised that the decision left open the door for off-label use by delegating those decisions to local Medicare carriers.

“If they were going to pick a battle, they elected not to pick it at this particular point in time,” Dr. Lichtenfeld said, referring to the cost of the cancer drugs. But he added, “I think inevitably we’re going to have that discussion in one way, shape or form,” he said.

Just last week, Bristol-Myers Squibb set a price of $120,000 for a full course of treatment with its newly approved drug for the skin cancer melanoma.

As with Provenge, that drug, Yervoy, prolonged survival by about four months. In a clinical trial, those who got the drug lived a median of 10 months, compared with 6.4 months for those in a control group.

Article source: http://feeds.nytimes.com/click.phdo?i=2bc26b64290f366e0e2d8c051c80fc3f

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