Results tagged “merck” from Drugs & Medicaments

Worries are emerging about the safety of new diabetes medicines Januvia and Galvus, drugs expected to be big sellers for makers Merck and Novartis. But it is unclear if the concerns are justified or just the result of a hair-trigger tendency concerning drug safety on the part of doctors and regulators.

On Monday, Novartis said the U.S. Food and Drug Administration wants it to run a new safety study of Galvus. Analysts say that could take another year; the pill has already been delayed for three months.

That follows a Feb. 1 article in The New England Journal of Medicine that questioned the safety data available for these drugs. David M. Nathan, a Harvard Medical School endocrinologist, wrote that it is "surprising" that the FDA decided to clear Januvia at all, given the "paucity of published data from long-term clinical trials on its safety and efficacy." Nathan, who is a consultant for Novartis and other drug makers but not Merck , did not return requests for comment.

By Jerry Avorn

A FEW BLOCKS from the high-rise casinos of Atlantic City, Merck & Co. Inc. is in the middle of a multi billion-dollar bet. A jury is about to decide whether the pharmaceutical giant knew that its blockbuster Vioxx could cause heart attacks, but then minimized that risk in the information it gave to doctors and patients. The decision could have implications for the prevention of future drug disasters more profound than all the tepid plans being discussed by Congress and the FDA.

Faced with thousands of patients assigned to her jurisdiction suing the drugmaker for Vioxx-related heart damage, Superior Court Judge Carol Higbee decided to first resolve a few over-arching issues, before getting to the details of each individual case. She'll instruct the jury first to determine whether the pain reliever could ever increase the risk of heart attack. Most experts agree that it does, and Merck took the drug off the market in 2004 when its own clinical trial proved it, but the company still does not fully acknowledge this fact. Next, she'll ask the jury a kind of pharmacological Watergate question: What did the company know, and when did it know it? And finally, did Merck misrepresent this risk in its promotional materials?

Merck & Co., mired in multibillion litigation over its withdrawn painkiller Vioxx, has eliminated another legal headache, resolving several tax disputes with the Internal Revenue Service by agreeing to a $2.3 billion settlement.

In announcing the agreement Wednesday, the Whitehouse Station, N.J.-based company said the settlement resolves all outstanding tax disputes with the IRS, covering the years 1993 through 2006. Merck had faced potential taxes, interest and penalties totaling as much as $3.8 billion, but the agreement apparently reduced that amount.

Neither Merck nor the IRS would discuss the reduction.

A new arthritis drug causes fewer stomach disorders and complications than older painkillers, researchers said on Friday.

They analysed the results of three clinical trials to assess the safety of Merck & Co's drug etoricoxib - sold under the name Arcoxia - as compared with diclofenac.

Etoricoxib is a COX-2 inhibitor while diclofenac belongs to a class of therapies known as non-steroidal anti-inflammatory drugs or NSAIDs, which includes aspirin and ibuprofen.

TRENTON, N.J. (AP) - A New Jersey appellate court panel on Tuesday opened the door to a potential class action lawsuit against Merck & Co. on behalf of people who took its now-withdrawn painkiller Vioxx and want the company to pay for tests to detect possible heart ailments.

The ruling by the Appellate Division of the Superior Court of New Jersey came as jury selection began in Atlantic City for the next product liability trial over Merck's one-time blockbuster arthritis pill.

That trial, before Superior Court Judge Carol Higbee, is slated to begin with opening arguments Monday. It includes two plaintiffs: the son of a man who died of a heart attack after taking Vioxx and a retrial for a man who survived a heart attack, lost his first trial against Merck and was granted a new trial because of new evidence.

DARMSTADT, Germany (AFX) - Merck KGaA is considering selling its generics drugs business to focus on new medication, according to a report in Handelsblatt newspaper, citing sources.

Merck (nyse: MRK )'s generics unit could be worth around 4 bln eur, added the report.

The company's supervisory board has already given 'the green light' to look for a buyer, the report stated, citing sources.

Jan. 4 (Bloomberg) -- U.S. regulators approved 18 new drugs in 2006, close to an eight-year low, as drugmakers struggled to develop products for hard-to-treat disorders.

The number of medicines recommended for sale in 2006 and 2005 dropped from the annual average of 26 drugs recorded in the previous six years, according to U.S. data. Last year's approvals include Pfizer Inc.'s cancer treatment Sutent and Merck & Co.'s diabetes drug Januvia.

Drugmakers are spending more on research and developing fewer drugs, the U.S. reported last month. The failure rate of compounds in testing has increased as companies target intractable diseases, a government study said. London-based AstraZeneca Plc, for example, scuttled three experimental drugs last year, including treatments for diabetes and stroke.

U.S. regulators cleared six more companies to begin selling generic copies of Merck & Co.'s cholesterol drug Zocor, signaling steeper price reductions.

The approvals posted on the Food and Drug Administration's Web site Wednesday are in addition to those granted Teva Pharmaceutical Industries Ltd. and Ranbaxy Laboratories Ltd. in June when Merck's patents expired. The new versions of the world's second-best-selling cholesterol-lowering pill will drive prices down as much as 70 percent, analysts said. Teva has been selling copies for 8 percent less than Merck.

The price drop may hurt sales of Pfizer Inc.'s Lipitor, the world's top-selling drug, with revenue last year of $12.2 billion, and the source of almost half of the New York-based drugmaker's profits. Lipitor prescriptions declined 6 percent in the fourth quarter as health plans encouraged patients to switch to generic copies of Zocor, Bear Stearns analyst John Boris said in a Dec. 21 research report.

The drugmaker Merck & Co. is off to a strong start in its year-old program to cut costs, boost revenues and transform company operations, Chief Executive Officer Richard Clark said Tuesday.

The company this year launched five new vaccines and other medicines, all well received, without increasing its sales force, Clark told analysts at Merck's annual business briefing at headquarters in Whitehouse Station, N.J.

Merck is speeding up the time it takes to get experimental drugs through testing and onto the market, launching one of the five new products _ the diabetes drug Januvia _ about four years ahead of when it would have been approved under a traditional development schedule, he noted.

(Houston Chronicle (KRT) Via Thomson Dialog NewsEdge) Nov. 28--In September 2004, when pharmaceutical giant Merck withdrew its best-selling painkiller Vioxx amid concern over potentially fatal side effects, many of the nation's plaintiff lawyers were wide-eyed with anticipation.

Ominous headlines had circulated for years, prompted by studies that indicated Vioxx increased the risk of a heart attack or stroke. Merck's decision to withdraw the drug from the market, despite annual sales of $2.5 billion, was an invitation for lawsuits.

A trickle grew into a steady stream and eventually a torrent of litigation. The plaintiffs' prospects looked good, especially after the New England Journal of Medicine published an editorial accusing Merck of concealing heart attacks suffered by individuals who were part of a Vioxx study reported in the prestigious magazine in 2000.

NEW YORK (AFP) - A US federal judge refused to allow a class-action lawsuit to proceed against Merck for health problems linked to its Vioxx pain medication, in a major victory for the pharmaceutical giant.

Judge Eldon Fallon, asked by an interstate judicial panel to consider how to handle the thousands of lawsuits filed over Vioxx, said the cases did not meet the criteria for a national class action suit, where one court would hear the case for all plaintiffs.

"While the majority of plaintiffs in this case allegedly suffered either a heart attack or stroke as a result of ingesting Vioxx, the extent of each plaintiffs subsequent injuries varies widely," he said in a 25-page decision.

The German drugs giant Merck is seeking help from the world of traditional Chinese medicine to find a cure for cancer. The Chinese medicine company spun out of Hong Kong's Hutchison Whampoa, Chi-Med, will today unveil a potentially lucrative deal to research oncology on behalf of the German group.

Merck will pay Chi-Med to raid centuries of Chinese medical knowhow in search of a natural cancer-fighting product that it can turn into a marketable Western drug.

The financial terms of the deal were not disclosed, but Chi-Med stands to reap tens of millions of pounds from the partnership if it comes up with a drug that is suitable to be put into trial.

Unlike the Lipitor case where Ranbaxy Laboratories Ltd has been facing severe legal hurdles, a US Court of Appeal has upheld a district court's ruling granting Ranbaxy a 180-day exclusivity on the 80 mg strength of the anti-cholesterol drug, Simvastatin (the generic form of Merck's blockbuster drug, Zocor).

"We are pleased with this decision, for both Ranbaxy and the generic pharmaceutical industry, as it preserves the exclusivity of innovative generic pharmaceutical companies who expend significant effort and finances to introduce affordable generic medicines to the US healthcare system,'' said Jay Deshmukh, Senior Vice-President of Global Intellectual Property, Ranbaxy.

CHICAGO - The first published studies of Arcoxia, the drug that Merck & Co. hopes will take the place of its withdrawn painkiller Vioxx, are getting mixed reviews from doctors, some of whom say the results do not make a case for the medication's approval.

The critics cite not just Arcoxia's side effects but also that Merck tested it against diclofenac, an older painkiller known to raise heart risks. A fairer comparison would have been to a medicine that does not do that, such as naproxen, sold as Aleve, they say.

"The development program for Arcoxia is fatally flawed," said Dr. Steven Nissen, a Cleveland Clinic cardiologist who formerly headed the Food and Drug Administration's cardiac drug advisory panel. "My advice to the FDA is that they should not approve this drug."

NEW YORK -- Merck & Co. agreed to drop some of its objections to plaintiff lawyers' request for fees in a Vioxx case, but only if it doesn't have to disclose its own legal fees to a judge.

Plaintiff lawyer Ellen Relkin said Merck dropped some of its objections because it fears a N.J. judge may publicly disclose what it spent on a trial that ended earlier this year. Merck lawyer Ted Mayer said the drugmaker's legal fees have no relation to the plaintiff lawyers' request and that companies always want to be careful when asked to reveal such sensitive information.

Any disclosure of what Merck spent on a case would provide a window into how much the drugmaker's strategy of individually trying each of the roughly 24,000 cases it faces will ultimately cost. So far, Merck has set aside about $1.57 billion to cover legal expenses.

NEW YORK (CNNMoney.com) -- Novartis plans to bring a new arthritis painkiller to the U.S. market, but analysts say its similarity to the disgraced drug Vioxx could kill its chances of becoming a billion-dollar blockbuster.

The Swiss drug giant Novartis AG (up $0.32 to $61.55) said Tuesday that its painkiller Prexige was given a green light in the European Union for the treatment of arthritis. Novartis plans to "resubmit" the drug to the Food and Drug Administration in 2007, following the agency's request for more information in 2003.

Compared to Vioxx from Merck & Co., Inc., (up $0.33 to $46.14, Charts) Prexige has a better profile with regard to heart attack and stroke risks. Nonetheless, the drug is a member of the Cox-2 inhibitor class of drugs -- the same as Vioxx -- and could have a hard time winning the approval of American doctors and patients, not to mention the FDA.

"Doctors will be afraid to use this drug and ultimately that's what limits its potential," said Gbola Amusa, analyst for Sanford C. Bernstein. "Even when it's approved, doctors will see a safety issue with the drug and not use it as much."

 

Merck & Co. has disclosed four separate tax disputes in the U.S. and Canada with potential liabilities totaling $5.58 billion, as the drug maker faces tens of thousands of lawsuits over its withdrawn painkiller Vioxx, The Wall Street Journal reported on its Web site Tuesday.

Whitehouse Station, N.J.-based Merck says it is fighting the assessments disclosed in a filing with the Securities and Exchange Commission, the Journal said.

Merck isn't the only drugmaker hit with steep tax bills. In September, GlaxoSmithKline PLC agreed to pay the U.S. government $3.4 billion to settle a dispute over how to tax deals between the London-based company and its American subsidiary.

DARMSTADT, Germany: Merck KGaA, a German drug and chemical maker, said Monday that test results of its bowel cancer drug Erbitux did not meet its hopes for patient survival rate.

Results from a trial of 1,300 patient did not show a significant difference in prolonging life when comparing Erbitux taken in combination with standard treatment irinotecan and irinotecan alone.

Merck studied the efficacy of Erbitux in combination with irinotecan, a chemotherapy treatment, and found that patients did not survive without progression of the disease as the company hoped.

Still, Erbitux did show positive results in delaying the progress of the disease, the company said in a statement.