previously reported here on RedOrbit.com, one of those three drugs, Qnexa, received approval from a panel of FDA advisors on Thursday by a 20-2 margin. That verdict placed Qnexa, a combination of the appetite suppressant phentermine and the anti-seizure and migraine drug topiramate that is manufactured by Vivus, one step closer to reaching the market. According to the Associated Press (AP , "topiramate is believed to make patients feel more satiated." When the medication was rejected previously, the FDA asked Vivus for additional clinical data on the drug's potential impact on major cardiovascular events and birth defects. Studies have also shown that topiramate use during pregnancy can increase the risk of birth defects, including oral clefts. One question the advisory committee considered is whether or not Vivus should be required to conduct a large new clinical trial before the medicine receives final approval, in order to determine whether the drug can increase a person's risk of heart attack. Vivus is requesting permission to conduct the study after receiving approval, in the hopes of avoiding additional delays which could last several years. "Many experts view the combination pill as the most promising of the new weight loss drugs, due to studies showing most patients lost nearly 10 percent of their weight -- the highest reduction reported with any recent diet pill," the AP wrote. A second ruling on the drug is expected by April 17, the news agency added. The other two medications up for approval are Orexigen Therapeutics' Contrave, a combination of an antidepressant and an anti-smoking drug believed to curb appetite, and Arena Pharmaceutical's lorcaserin, which stimulates serotonin receptors in the brain in order to make people feel fuller. The AP describes Contrave's results as "lackluster." Approximately 40% of those taking the medication losing 5% of their body weight -- barely allowing the medication to qualify as an effective weight loss pill under the FDA's minimum requirements, according to the wire service. There are also cardiovascular concerns surrounding Contrave, leading the FDA to order a 10,000-patient heart health study scheduled to be completed in two years' time. "Lorcaserin has faced the most severe safety questions from FDA, which rejected the drug in 2010 after raising concerns about cancerous tumors seen in rats who received the drug," the AP said. "Early this year Arena submitted new information evaluating the link between its drug and cancer. The FDA is scheduled to make a new ruling on the drug by June 27." --- On the Net:
An interesting article in the Swiss
press this morning regarding the big Swiss drug companies, Roche and Novartis.
Apparently the PIGS are not paying their drug bills. The numbers are big. The bills have been unpaid for years. Some excerpts from the article:
Hospitals in Portugal, Italy, Greece and Spain are delaying paying for drugs by up to three years.
Three years??
According to the European Federation of Pharmaceutical Industries and Associations (EFPIA , European states owe ˆ12-15 billion (SFr14.4-18 billion to the pharma industry, which includes groups like Roche and Novartis.
$20 billion of unpaid drug bills??
A number of public hospitals and state insurance schemes are close to bankruptcy. But before being unable to pay staff salaries they stop paying suppliers,” Ignazio Cassis, vice-president of the Swiss Medical Association.
Hospitals and state managed health insurers are bankrupt??
This came as a bit of a shocker to me:
The number of unpaid bills from Spain, Portugal and Italy increased last year, while those from Greece fell as a
result of ‘zero coupon bonds’ issued by Athens
, Roche spokeswoman Claudia Schmitt said.
WHAT?? Greece is issuing zero coupon bonds? Bonds, not trade payable debt? To pay for drugs? How many zero coupon bonds has Greece issued? What are the terms for these bonds?
This whole story blows me away. I’m not surprised that the bankrupt PIGS are late payers. But three-years? That's ridiculous. If the PIGS are stiffing drug companies, who else are they stiffing? Are they paying for the oil they use? Food? How big are these trade IOUs?
.
Nearly every day we get some story about the progress being made to address the financial ills of the weak European countries. Last week it was the phony Greek restructuring deal (it won’t happen . This weekend the talk is for Trillions of dollars from the IMF. Complete rubbish. The USA has said it will not put up a dime, so there is no IMF option.
You have guys like Tim Geithner saying silly stuff like this over the weekend:
"I hope that we're going to see, and I expect we will see continued efforts by the Europeans ... to put in place a stronger, more credible firewall."
"Firewalls" indeed. Tim boy is worried about the sovereign bonds issued by the PIGS. He knows that if the Sov. bonds go tapioca, the lights will go off in the USA. But the reality is that the problem has extended far beyond bonds; the PIGS are not paying trade creditors. Timmy is just making noise about ring fencing debt.
Where does this go? Can the drug companies keep up the charade? If one of the big pharmas breaks, and says, “No more IOUs, we want cash”, then they all will. At that point, things come apart very quickly. From the article:
Swiss pharmaceutical giants Roche and Novartis are examining whether to limit supplies.
This is a very sensitive issue. If the drug companies cut supplies, there will be hell to pay. These companies do not want to take a public position on this issue, they could become a target by demonstrators in the PIGS. The Swiss druggies avoid the publicity problem by having their trade group SMA, do the talking for them. I thought there was a very blunt tone to these words:
Pharma companies are private. In a liberal, democratic society respect for private property is a fundamental value. Private firms are the only ones able to weigh the pros and cons of stopping the supply of certain medicines.
Really? The drug companies are the only ones with a vote? Wanna bet?
If the drug companies do limit supplies, there will be consequences. The question of whether or not the PIGS are, in fact, liberal democratic societies, will be put to the test. In the process, I wouldn’t be surprised if the issue of whether the drug makers are public or private is also tested.
Note
#1
I was part of the problem (and part of the solution for the Latin American debt crisis of the 80’s. I had a front row seat with each central bank as they went bust. Every effort was made to kick the financial can down the road. In the end, it all blew up.
For every country, the death march was the same. When big trade creditors finally balked, and said, “
No mas IOU
”, debt default followed within weeks.
Note
#2
Novartis and Roche have the PIG “trade receivables” and those Greek “Zeros” on the books at 100% of par. The other global drug companies who are sitting on the rest of the $20b of IOUs have it booked the same. These debts are not worth par. One day these drug companies will have to write them off. I do wonder what other big EU companies are sitting on chunky IOU’s from PIGS. None of this is “money good”. Novartis had this to say:
Deteriorating credit and economic conditions and other factors in these countries
may require us to re-evaluate the collectability of these receivables in future periods.
.
The head of Britain biggest drugs company has accused the Government of systematically delaying the introduction of new cancer drugs in order to save money.
GLaxoSmithKline chief executive Sir Andrew Witty warned that ministers were making false economies as they tried to grapple with the deficit in the public finances.
In an interview with the BBC, he said that governments across Europe had already cut drug prices by 5% a year - costing GSK around ?300 million per annum.
However, he said governments were now seeking to go further in an effort to achieve even bigger savings - and he highlighted Britain's decision to delay new cancer treatments.
"The bit I'm much more frightened about is that what's now beginning to become clear is that, in addition to price reductions, governments are delaying the approval of innovative new drugs," he said.
"So a second way they can save money, they think, is 'Let's just not buy the next round of innovation'.
"Cancer in the UK is a good example where we're seeing oncology drugs being systematically delayed from introduction and reimbursement.
"We are seeing a variety of the more innovative and more expensive medicines being delayed in a whole series of different diseases across Europe."
Sir Andrew accused governments of treating the pharmaceuticals industry as a "simple procurement business" without understanding the wider implications of their decisions.
"As governments have got more and more anxious about their debt positions and austerity agendas, what happened is quite predictable," he said.
"If you are a minister and you need to cut costs, it is a lot easier to cut drug prices than it is to close a hospital or reduce the size of the Civil Service. I understand that.
"The issue here is, of course, if you don't buy the new drug it is going to save you money in the drug bill. But the drug bill is only 8% to 10% of the total healthcare bill and what is being lost in this stampede for cost cut is any kind of strategic thoughtfulness."
"The transition to new management will hopefully help J&J focus on rectifying its manufacturing problems," said George Sillup, professor of pharmaceutical marketing at St. Joseph's University and a former J&J executive. But, Sillup notes, J&J is a huge operation with $65 billion in revenue, and reputations - good or bad - don't change quickly. "The concern with that is, once you start going wrong, you can't turn the battleship. That is very difficult to recoup."
The challenge is not only in the more well-known consumer divisions. J&J has issues in pharmaceuticals and medical devices.
One example is the antipsychotic drug Risperdal, J&J's third-best-selling prescription medication, which had sales of $1.6 billion in fiscal 2011.
J&J's subsidiary Janssen makes Risperdal. Gorsky, who started as a Janssen sales rep, was leading the company in the early 2000s when problems with the drug first came to light.
In January, the company paid $158 million to settle allegations - first made in Pennsylvania by whistle-blower Allen Jones - that the company illegally promoted Risperdal for unapproved use in children and adolescents, in part by paying Texas Medicaid officials to give it preferential treatment.
Such episodes would run counter to J&J's official credo that says the company's "first responsibility is to the doctors, nurses, and patients, to mothers and fathers and all others who use our products and services." After mentioning employees and communities, "our final responsibility" is to shareholders.
"After settlement was announced in the Austin courtroom, I had a brief, congenial conversation with J&J's corporate representative," Jones said last week when asked about the CEO change. "I asked him to please go back to his company and fix things - to try to make the J&J Credo mean something again. I sincerely hope that J&J has the same desire and that this is a step in that direction."
The litigation is not over, not by a long shot. J&J said last week in a filing with the Securities and Exchange Commission that the company started 2012 with 10,415 lawsuits pending, including 420 involving Risperdal. Besides other state battles, J&J said in the SEC filing, it is negotiating with the federal government to settle civil and criminal allegations of improper marketing. That bill might run beyond $1 billion. Then there are individual suits, 63 of which are being argued by Philadelphia lawyer Stephen Sheller's firm.
In court filings, Sheller has argued - unsuccessfully so far - that evidence of negative clinical data provided by J&J in discovery should be forwarded to the FDA with the idea that Risperdal would be pulled from the market because of negative side effects.
"I hope they've had an epiphany and will do the right thing," Sheller said of paying the plaintiffs, some of whom rely on taxpayer-funded Medicaid to provide health care, including for diabetes and gynecomastia (enlarged breasts in boys , which are some of the possible side effects of Risperdal.
Gorsky got the job in part because he was in charge of J&J's DePuy medical-device unit and was intimately involved in J&J's pending $21.3 billion acquisition of Synthes Inc., another device-maker, with several facilities in Chester County. Before J&J made the largest purchase in its history, Gorsky met several times with Synthes chairman Hansjorg Wyss in 2010 when Wyss was looking to sell his company. At the same time, Synthes was preparing to settle criminal and civil charges involving illegal human testing of one of its products, a bone cement.
DePuy is facing lawsuits over recalled replacement hips. Now, integrating Synthes with DePuy will not be easy, and the device market has been hurt by the recession in the United States and Europe.
J&J's challenges were the subject of a recent article in the online periodical
Knowledge@Wharton from the Wharton School of the University of Pennsylvania. The article's title: "Patients Versus Profits at Johnson & Johnson: Has the Company Lost Its Way?"
Gorsky holds an M.B.A. from Wharton.
In the article, a Wharton professor of legal studies and business ethics, Thomas Donaldson, gave J&J credit for taking steps to fix manufacturing plants, but said J&J managers were having to juggle a lot of balls.
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