Archive for the ‘Merck’ Category

Merck recalled Pedvaxhib and Comvax

Friday, December 14th, 2007

Merck recalls Comvax and PedvaxhibMerck & Co., Inc. said it voluntarily recalled 13 lots of its Hib vaccine given to ankle-biters to prevent meningitis and pneumonia as quality control found production equipment may not have been properly sterilised.

Merck recalled 11 lots of Pedvaxhib [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)], and two lots of its combination Haemophilus influenzae type B/ hepatitis B vaccine, Comvax [Haemophilus b Conjugate (Meningococcal Protein Conjugate)]. The recall is specific to these 13 lots and does not affect any other vaccines manufactured by Merck. The affected doses of Pedvaxhib and Comvax were distributed starting in April 2007.

The company said the recall is because it can not assure sterility of these specific vaccine lots. The potential contamination of these specific lots was identified as part of the company’s standard evaluation of its manufacturing processes. Sterility tests of the vaccine lots that are the subject of this recall have not found any contamination in the vaccine.

The potential for contamination of any individual vaccine is low, and, if present, the level of contamination would be low. However, because the company cannot assure the sterility of these specific lots of vaccine, it is conducting this recall.

Merck is working closely with the US Food and Drug Administration (FDA) and the US Centres for Disease Control and Prevention (CDC) to inform affected healthcare providers of this recall. The company is also communicating with public health authorities and healthcare providers in the US and in other countries where these lots were distributed, as appropriate.

“We are taking this action because we are committed to ensuring the quality of our vaccines,” said Mark Feinberg, MD, Ph.D., vice president, medical and policy affairs, Merck vaccines and infectious diseases. “We know that our vaccines can play an important role in the nation’s public health system, and we are committed to resolving this issue as quickly as possible to ensure that our vaccines are readily available.”

Physicians are advised not to administer any vaccine from the vaccine lots being recalled. Individuals who received vaccine from these lots should complete their immunization series with a Haemophilus b conjugate-containing vaccine not affected by this recall, but do not need to be revaccinated to replace a dose they received from a recalled lot. The efficacy of the vaccine was not affected, the company officials said in a press statement.

Pedvaxhib is indicated for routine vaccination against invasive disease caused by Haemophilius influenzae type b in infants and children two to 71 months of age. As with any vaccine, the use of Pedvaxhib may not result in a protective antibody response in all vaccines; Pedvaxhib may not induce protective antibody levels immediately following vaccination.

Comvax [Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine] is indicated for vaccination against invasive disease caused by Haemophilus influenzae type b and against infection caused by all known subtypes of hepatitis B virus in infants six weeks to 15 months of age born to HBsAg-negative mothers.

Comvax is contraindicated in patients with hypersensitivity to yeast or any component of the vaccine. Comvax included injection-site reactions, somnolence, irritability, crying, and fever.

As with other vaccines, Comvax may not induce protective antibody levels immediately following vaccination and may not result in a protective antibody response in all individuals given the vaccine.

General information about Haemophilus b Conjugate Vaccine

Some commonly used brand names in the U.S. and Canada are:

  • Act-Hib
  • Hibtiter
  • Pedvaxhib
  • Prohibit

Category: Immunizing agent, active

Description

(more…)

Posted in Drugs and Medications, Merck, Vaccines | 1 Comment »

Vioxx - a $4.85 billion cost painkiller

Friday, November 9th, 2007

VioxxMerck & Co. said it will pay $4.85 billion to end thousands of lawsuits over its painkiller Vioxx in what is believed to be the largest drug settlement ever.

Merck faced personal injury lawsuits representing 47,000 plaintiffs, and about 265 potential class action cases, filed by people or family members who claimed the drug proved fatal or injured its users. The agreement covers cases filed in both federal and state courts.

Negotiating teams met more than 50 times in eight states and spoke hundreds of times over the telephone to hammer out the deal, according to attorneys.

“I’m very happy with it,” Chris Seeger, one of the six plaintiff lawyers who helped negotiate the settlement, said Friday. “It’s a tremendous way to resolve this litigation.”

Merck pulled Vioxx from the market Sept. 30, 2004 after its researchers determined the then-blockbuster painkiller doubled risk of heart attacks and strokes.

To qualify for a settlement, plaintiffs must have filed claims by Thursday and meet several criteria, including medical proof that they suffered a heart attack or stroke, that they received at least 30 Vioxx pills and that they received enough pills to support a presumption that they were ingested within two weeks before injury.

That is a big concession by Merck, which has long claimed that Vioxx caused harm only after 18 months of use.

Those claims were dismissed by independent scientists and plaintiffs lawyers.

Merck stressed that the agreement is not a class action settlement and that it is not admitting fault.

Company executives and attorneys said as recently as last month that every case would be fought individually.

Analyst Steve Brozak of WBB Securities called Merck’s’ handling of the litigation “a Harvard casebook study of how to deal with a problematic product.”

Investors seemed to agree, as Merck shares jumped 4.6 percent, or $12.50, to $57.27 Friday.

Analysts predicted early on that liability could reach $50 billion, but after losing its first case in a $253 million verdict, Merck has won a string of civil cases.

Merck may now have put the uncertainty of millions of dollars in legal costs behind it, though it has been fairly successful fighting cases individually, winning 10 of 15 court verdicts to date.

The company said last month it had added $70 million to its reserves for defending lawsuits. As of Sept. 30, Merck had reserved a total of $1.92 billion for legal expenses and spent a total of $1.2 billion.

The deal becomes binding only if 85 percent of the plaintiffs in about 26,600 lawsuits agree to drop their cases. It was finalized in the early morning hours after attorneys for Merck and the plaintiffs met with three of the four judges overseeing nearly all Vioxx claims.

Seeger said the deal was put in motion last December when three key judges pushed the parties to open out-of-court talks.

“Every claimant is going to be compensated” once their claim is validated, he said.

Seeger believes it is the largest settlement ever in the industry and said he will recommend that his 2,000 clients accept the deal.

Payments would vary, depending on severity of injuries and the length of time that Vioxx was used.

“The agreement is structured to provide a significant degree of certainty toward resolving the majority of the outstanding VIOXX product liability claims in the United States for a fixed amount,” Richard T. Clark, chairman, president and chief executive officer of Merck, said in a statement.

Attorneys for both sides were to present the deal Friday morning to U.S. District Judge Eldon E. Fallon in New Orleans.

“In light of significant costs and delay that would result in protracted litigation, the settlement program will ensure that those who suffered injuries as a result of Vioxx are compensated fairly and efficiently,” according to a statement from one of the lead plaintiffs law firms in the case, Beasley, Allen, Crow, Methvin, Portis & Miles of Montgomery, Ala.

Merck agrees to pay $4.85 bln in Vioxx settlement

Merck & Co has agreed to pay $4.85 billion to settle claims that its painkiller Vioxx caused heart attacks and strokes in thousands of users, the drugmaker said on Friday.

The agreement covers lawsuits filed against the company in U.S. courts, resolving a major legal battle that has dogged the drugmaker since it pulled Vioxx off the market three years ago.

Merck recalled the popular painkiller, which had $2.5 billion in annual sales, in September 2004 after a study showed it doubled the risk of heart attack and stroke in patients taking it for more than 18 months.

In the settlement, reached with representatives of plaintiffs in federal and state courts, Merck did not admit Vioxx caused patient injury and did not admit fault.

The drugmaker, whose shares rose nearly 2 percent in pre-market trade on news of the deal, said it would take a charge of $4.85 billion to cover costs of the agreement.

The settlement marks a shift in strategy for Merck, which previously said it intended to fight Vioxx litigation on a case-by-base basis rather than consider a broad settlement.

“The agreement is structured to provide a significant degree of certainty toward resolving the majority of the outstanding Vioxx product-liability claims in the United States for a fixed amount,” said Richard Clark, chairman, president and chief executive officer of Merck.

The drugmaker said it would still defend all claims not included in the settlement. Since the withdrawal of Vioxx, Merck has won 11 court cases over the drug and lost five.

While it is appealing those cases that it lost, analysts said the settlement will solidify Merck’s future.

“They’re trying to reduce the uncertainty surrounding the costs related to Vioxx,” said Damien Conover, an analyst at Morningstar. “While it will probably bring a little more clarity, I think there are still going to be a lot of cases that won’t settle within this agreement.”

Conover said the cases included in the settlement are likely the weakest cases.

“What you’re going to be left with is a significant number of plaintiffs who will want to address Merck on an individual basis, which means they will likely seek higher compensation,” he said.

Conover said that while it is difficult to gauge how many people will try to fight Merck alone, he estimates the company could be facing 1,000 to 2,000 outstanding claims and could face more than $1 billion in additional costs.

Mike Ward of Nomura Securities in London said a settlement value of less than $5 billion likely would be taken positively by the market, noting that litigation over Wyeth’s Phen-Fen diet drug was only now coming slowly to a close after 10 years in the courts and over $21 billion in settlement costs.

Merck shares tumbled on news of the withdrawal of Vioxx in 2004, losing more than a third of their market value. But with Merck’s Vioxx victories in court, and a string of successful new medicines, the shares have recouped those losses.

The stock, even with the major litigation drag, has outperformed its peers on the American Stock Exchange pharmaceutical index this year, rising 25 percent, compared with little change in the index.

Merck shares rose to $55.70 in pre-market trade from a Thursday close at $54.77 on the New York Stock Exchange. The stock is trading just below a four-year high of $58.36, reached earlier this month.

!Vioxx was withdrawn from the U.S. market in 2004!

The manufacturer of Vioxx has announced a voluntary withdrawal of the drug from the U.S. and worldwide market. This withdrawal is due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients taking Vioxx.

Notify your doctor immediately if you develop abdominal pain, tenderness, or discomfort; nausea; blood in your vomit; bloody, black, or tarry stools; unexplained weight gain; swelling or water retention; fatigue or lethargy; a skin rash; itching; yellowing of your skin or eyes;”flu-like” symptoms; or unusual bruising or bleeding. These symptoms could be early signs of dangerous side effects.

What is Vioxx?

!Vioxx was withdrawn from the U.S. market in 2004!

Vioxx is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Vioxx works by reducing substances that cause inflammation, pain, and fever in the body.

Vioxx is used to reduce pain, inflammation, and stiffness caused by osteoarthritis, rheumatoid arthritis and certain forms of juvenile rheumatoid arthritis; to manage acute pain in adults; to treat migraines; and to treat menstrual pain.

Posted in Drugs and Medications, Merck, Painkillers | No Comments »

Cordaptive to replace Zokor?

Wednesday, November 7th, 2007

CordaptiveMerck announced that the extended-release niacin/laropiprant (cordaptive) co administered with simvastatin had significant additive effects on reducing LDL-cholesterol (LDL-C), increasing HDL-cholesterol (HDL-C) and reducing triglyceride levels in a phase III study with patients with primary hypercholesterolemia or mixed dyslipidemia. The results were presented by Merck & Co, Inc. at the American Heart Association 2007 Scientific Sessions in Orlando, Fla.

In the study, 2 g (two 1-gram tablets) of Cordaptive co administered with simvastatin (pooled across 20 mg or 40 mg doses) reduced LDL-C by 48 per cent, increased HDL-C by 28 per cent, and reduced triglyceride levels by 33 per cent following 12 weeks of treatment. The primary study endpoint was LDL-C reduction; secondary endpoints included increased HDL-C, triglyceride reduction and effects on other lipoproteins. A 1 g tablet of cordaptive contains 1 g of Merck-developed extended-release niacin and 20 mg of laropiprant - a novel flushing pathway inhibitor that is designed to reduce the flushing associated with niacin. All of the comparative lipid efficacy results were measured as mean per cent change from baseline and were statistically significant, p < 0.001.

“The results in this study suggest that, if approved, cordaptive used with a statin could offer another approach to treat patients with dyslipidemia,” said Christie M. Ballantyne, associate chief and professor of medicine, Baylor College of Medicine, and co-author of the study.

The double-blind, parallel, 12-week study with seven treatment arms in almost 1400 patients evaluated 1 g of cordaptive (1 g extended-release niacin/20 mg laropiprant) coadministered with simvastatin 10 mg to 40 mg in weeks one through four and 2 g of cordaptive (two 1-gram tablets each containing 1 g extended-release niacin/20 mg of laropiprant) co administered with simvastatin 20 mg to 40 mg in weeks five through 12 (n = 590). Tolerability and the safety profile of Cordaptive co administered with simvastatin were also evaluated.

Reported lipid results in other treatment arms included a 17 per cent decrease in LDL-C, 23 per cent increase in HDL-C, and 22 per cent decrease in triglycerides with Cordaptive alone (n = 192); and a 37 per cent reduction in LDL-C, six per cent increase in HDL-C and 15 per cent reduction in triglycerides with simvastatin alone (pooled) (n = 585).

Reported side effects of interest included: liver enzyme elevations >3x ULN in ALT and/or AST (0.3 per cent with cordaptive co administered with simvastatin, 0.5 per cent with Cordaptive alone, and 1.0 per cent with simvastatin alone), and increased median fasting plasma glucose values (4.0 mg/dL with Cordaptive plus simvastatin, 4.0 mg/dL with Cordaptive alone, and 1.0 mg/dL with simvastatin alone). There were no cases of creatine kinase (CK) levels >10x ULN in the group treated with Cordaptive coadministered with simvastatin, which was not significantly different than that of the group treated with Cordaptive or simvastatin alone (0.5 per cent and 0.3 per cent, respectively). All elevations were asymptomatic and resolved with discontinuation of treatment. There were no cases of myopathy, rhabdomyolysis or drug-related hepatitis.

Discontinuations due to flushing were 4.8 per cent in the group treated with cordaptive co administered with simvastatin, 8.7 per cent with Cordaptive alone and 0.3 per cent with simvastatin alone.

Niacin-induced flushing is primarily caused by a prostaglandin, PGD2, a chemical that causes vasodilatation in the skin and flushing symptoms, acting through the DP1 flushing pathway. Laropiprant selectively blocks the binding of PGD2 to its receptor, DP1. Research has shown blocking DP1 reduces flushing associated with niacin.

“It has been shown that niacin-based therapies reduce the risk of cardiovascular events. But even though niacin has broad lipid effects, the flushing side effect has been a barrier to many patients reaching the maximum 2 g dose,” said John Paolini, MD, Clinical Research, Cardiovascular Disease, Merck Research Laboratories.

Cordaptive is in development by Merck for the treatment of elevated LDL-C, low HDL-C and elevated triglycerides. Merck has previously announced that the NDA for cordaptive has been accepted by the US FDA and the regulatory action is anticipated in the second quarter of 2008. Merck is also on track to file an NDA in 2008 for the company’s investigational compound MK 0524B.

Dyslipidemia is the elevation of LDL-C and/or triglycerides or a low HDL-C level that contributes to the development of atherosclerosis, the number one cause of death among men and women and the primary reason for loss of quality of life in Western countries. Major modifiable risk factors for atherosclerotic disease include hypertension, diabetes, obesity, smoking and high levels of total cholesterol or LDL-C. Low levels of HDL-C also increase a person’s chances of developing atherosclerosis. In fact, epidemiologic studies have shown that for every 1 mg/dL rise in HDL-C, the risk of developing cardiovascular disease decreases by two per cent to three per cent.

Simvastatin, a cholesterol-modifying medicine from Merck, and marketed under the brand name Zocor, is used in addition to diet to modify cholesterol levels after diet and other non-drug measures have failed to achieve target levels.

Researchers have said that patients were able to safely use Merck & Co.’s experimental Cordaptive drug to raise good HDL cholesterol alongside the company’s older Zocor cholesterol medicine.

Results of the Phase III trial involved about 1,400 patients and lasted 12 weeks. Cordaptive is a combination of an extended release form of niacin, a nutrient that raises heart-protective HDL, and an experimental drug called laropiprant that reduces the uncomfortable facial flushing which is a side effect of niacin.

Merck aims to seek approval next year for a separate product called MK-524B. It would combine Cordaptive in the same tablet with simvastatin, the active ingredient of Zocor which works by cutting the body’s production of LDL.

In the trial, levels of LDL fell 48 percent among patients receiving simvastatin as well as Cordaptive containing the full recommended two gram dose of niacin. That effectiveness against LDL, the primary goal of the trial, was deemed highly statistically significant.

Patients taking Cordaptive by itself in the trial experienced favorable, but less-impressive results: a 17 percent decrease in LDL, a 23 percent boost in HDL and a 22 percent drop in triglycerides.

Cordaptive is now awaiting U.S. marketing approval.

Posted in Cholesterol-modifying medicines, Drugs and Medications, Merck, New drugs, Research | No Comments »