New Caution Urged Over Sole Oral MS Drug On the Market

The FDA says the only oral multiple-sclerosis drug on the market, Novartis’s Gilenya, shouldn’t be used in patients with a recent history of stroke or some heart problems. The WSJ reported that a safety review of the treatment was prompted by a report in November of a 59-year-old patient dying in the United States. He passed less than a day after taking the first dose of the medication. Although the agency said an exact cause of the patient’s death couldn’t be identified, it continues to recommend that doctors closely monitor the hearts of patients after they have been given the first dose of the drug because the treatment can lower a person’s heart rate temporarily. Patients who have had a stroke or heart trouble within the past six months shouldn’t take the drug, the FDA says. It also shouldn’t be used in patients taking some kinds of medicines to treat heart arrhythmias. The FDA warning comes after Europe’s drug regulator last month and requested stronger safety warnings. The U.S. agency is currently reviewing another oral Multiple Sclerosis drug from Biogen Idec designed to work through a different mechanism than Gilenya. Contact HCC Healthcare Consultants - Pharmacy Business Solutions for help with pharmacy startup, help with pharmacy performance and efficiency or pharmacy business management service.

Pfizer Parts With Lipitor

Pfizer on May 9, 2012 released their exclusive rights to distribute Lipitor, but the company is still working aggressively to squeeze revenue from the brand. Lipitor is the best selling drug in the pharmaceutical industry's history. Pfizer is continuing to market Lipitor, a cholesterol drug that accounts for about 20 per cent of its US sales, and is cutting prices to compete with competition from generic manufacturers. It will sell the drug through pharmacies or directly to customers and it is making deals with benefits managers and insurers to offer deep discounts. During a company briefing, David Simmons, president and general manager of emerging markets and established products, said that Pfizer will compete with generics over the next six months by offering Lipitor to patients for $4 for a one-month supply. “More than a third of the current patients who are on Lipitor would like to stay on Lipitor,” Mr Simmons said. Pfizer is hoping patients will continue to use its branded drug out of lack of knowledge about generics. That strategy has been successful in emerging markets, where patients often choose more expensive branded drugs over generics out of concern for quality and safety. “In the current system when I go into pharmacy and if I am going to be dispensed a generic, I have no idea where it’s coming from,” Mr Simmons said. Although generic drugs have the identical chemical components as branded drugs, Pfizer warns on its “Lipitor for you” website that the generics might not yield the same results. “Your body could respond differently to a different medication,” the company wrote. “The cholesterol level you’ve achieved could change.” Ranbaxy Laboratories, an Indian drug company, and Watson Pharmaceuticals are the only companies with rights to sell generic Lipitor for the next six months, at which point other companies can enter the market. Lipitor has been valued at $12 BILLION a year in sales to Pfizer and analysts expect the company to be able to maintain about 40 per cent market share over the next six months. Wow. “The moves they are making surrounding Lipitor will provide some very substantial cash flows,” said Michael Meyers, chief investment officer Arcoda Capital Management. Randall Stanicky, analyst at Canaccord Genuity, said that Pfizer’s aggressive tactics with Lipitor will help support the brand and will benefit them in international markets where they continue to have exclusive rights to sell the drug. Pfizer said earlier this month that it would eventually try to in troduce an over-the-counter version of Lipitor. Although Pfizer anticipates that Lipitor prices will erode sharply in the US and plans to eventually pull back its advertising efforts, strong demand for cholesterol drugs in Asia offer hope. Pfizer executives insist that the company’s future remains bright even without its biggest blockbuster thanks to an improving pipeline of new drugs and greater potential in emerging markets. “In a market where there are questions on quality, there are not questions on quality on the Lipitor brand,” Mr Simmons said. “It will continue to have a lifespan.” Contact HCC Healthcare Consultants - Pharmacy Business Solutions for help with pharmacy startup, help with pharmacy performance and efficiency or pharmacy business management service.

J.&J.’s New Chief Confronts Critical Challenges

Johnson & Johnson needs to rethink the way it brings drugs to market, expand its reach into global markets and rebuild consumer confidence by returning recalled brands to pharmacy shelves, the incoming chief executive, Alex Gorsky, said in an interview last Wednesday. Mr. Gorsky, who is scheduled to take over formally during Johnson & Johnson’s annual meeting last Thursday, did not lay out plans for major changes at the company, which has been troubled in recent years by a succession of product recalls, manufacturing problems and government inquiries. He said he intended to build on the company’s long legacy of success. Still, he said, “I think we’re going to need to be bold, disciplined and decisive about how we go forward.” Essential to the company’s future, he said, was a rethinking how it develops new drugs. “I think the markets are going to demand a higher bar around innovation and really making a difference for patients,” he said. Les Funtleyder, a portfolio manager at Miller Tabak & Company

, agreed that Johnson & Johnson’s research and development operation has been sluggish recently, failing to turn out as many profitable drugs and devices as it once did. “It’s more of a question of steering it back to where it was,” said Mr. Funtleyder, whose fund owns the stock. “I’m not sure you need a total redo. You need a course correction.” Mr. Gorsky also sees major opportunities in global markets. Already, 55 percent of Johnson’s sales come from overseas, but the company can do better, Mr. Gorsky said. Developing markets, he said, are growing at three to five times the rate of markets like the United States and Europe. “And as more people move into the middle class, they represent even more of an opportunity,” Mr. Gorsky said. There is no question that Mr. Gorsky, who is replacing William C. Weldon, has his work cut out for him. Consumer confidence in Johnson & Johnson, once one of the most trusted brands, has dipped in recent years as the company recalled dozens of products, including millions of bottles of children’s Tylenol and other medications, as well as artificial hips and other products. Last week, company officials told analysts that efforts to fix the manufacturing problems that had caused the recalls of over-the-counter brands were taking longer than expected, and that some brands might not return to shelves until 2013. Mr. Gorsky said that the company has made changes to its supply chain and quality control procedures and that working with a third-party firm as well as the Food and Drug Administration was taking a long time. “We’re learning as we go through this process,” he said. “We believe we’re starting to see the benefits of some of that, but we still realize that there’s work that we have to do.” When the products return to shelves, Mr. Gorsky said he was confident that customers would continue to buy them. He said this has already happened with some returning brands. “The events over the last couple of years have had a negative impact, but we’ve been, I think, encouraged by how resilient our brands and our company reputation has been,” he said. Mr. Gorsky, who is 51, joined Johnson & Johnson as a sales representative in 1988. He ran the company’s pharmaceutical businesses in Europe, Africa and the Middle East, then left in 2004 to head the North American pharmaceuticals business at Novartis. He returned to Johnson & Johnson four years later. Mr. Gorsky won the chief executive job over Sherilyn S. McCoy, who had led the pharmaceuticals and consumer groups, but resigned to become chief executive of Avon this week. Mr. Weldon will remain as chairman. Manufacturing problems are not the only troubles that the company faces. A judge in Alabama fined the company $1.2 billion over accusations that it had hidden and diminished the risks of Risperdal, an antipsychotic drug, and the company is facing similar lawsuits by state attorneys general across the country. The Alabama case is being appealed, and Mr. Gorsky declined to comment on the matter, citing the litigation. He also declined to comment for similar reasons on his role in an artificial hip implant that has failed in thousands of patients, crippling some of them. Mr. Gorsky was head of the device and diagnostics group at the time that critical decisions were being made about the implants. Although some have criticized Johnson & Johnson for hiring an insider to lead the company during a difficult time, Mr. Gorsky said he has a track record of taking decisive, sometimes counterintuitive, action. He described himself as a “realistic optimist” and cited as an example the company’s decision last year to stop making drug-coated heart stents. Recent research has shown that stents were overused and that drugs might be a better alternative to avoiding heart attacks or strokes. At the same time, he said, he chose to expand the company’s orthopedics business by negotiating the deal to acquire Synthes, a medical device maker. Of the decision on the heart stents, “I think that represents the kind of decisiveness that we’re going to need again, even in an area where I think that few would have felt that Johnson & Johnson would do that,” he said. “That’s the realist in me.” Contact HCC Healthcare Consultants - Pharmacy Business Solutions for help with pharmacy startup, help with pharmacy performance and efficiency or pharmacy business management service.

Insurance Coverage Gaps for Million of Americans in 2011

In 2011, a quarter of working adults had a gap in their health-insurance coverage. This was mainly due to lost or changed jobs, a new think-tank study says.

One in four people between the ages of 19 and 64 were uninsured or had only recently regained coverage when they were interviewed in the summer of 2011, a survey for the non-partisan Commonwealth Fund found. That translates to about 48.2 million people, analysts of the data said.

The survey also showed how hard it can be for consumers to buy insurance on the individual market in its current form, said Commonwealth Fund researchers . Close to two-thirds of the respondents said they couldn’t find policies they could afford, and others said they had problems because of their medical history.

“The individual market has proven to be a weak stop-gap option for families who lose employer insurance,” the researchers wrote.

And an early provision of the health-overhaul law passed in March 2010 — “high-risk pools” for sick people to buy insurance — hadn’t helped many people, they added.

Even though most of respondents in the survey said they knew about it, only about 6% of them had tried to get coverage through the program, which, as WSJ reported last month, has tricky eligibility requirements.

The survey’s tally of people with coverage gaps came in higher than previous ones: Census data show about 41.2 million 19-64 year old adults in 2010 were uninsured. Those numbers, however, were based on whether people lacked coverage at the specific time they were interviewed.

Including children and some elderly people not covered by Medicare, the Census found there were 50 million people uninsured at the time they were interviewed in 2010.

In the Commonwealth Fund survey, the most people said they didn’t have insurance because they had always previously received it have an employer, but lost it after being laid off, changing jobs, or bybecoming part-time. Only a few respondents said they had lost coverage because their employer had stopped offering benefits.

Some respondents said they had previously had government-funded coverage through the Medicaid program for low-income Americans, but lost it because their income changed or they grew too old to qualify.

Researchers said a provision of the 2010 overhaul law that lets parents include children on their plans until their 26th birthday had closed coverage gaps for some people.

Overall…researchers said that the health-overhaul law would make it easier for people to replace lost coverage, either by shopping for policies through new insurance exchanges after 2014 (with government subsidies towards the premiums), or, for some poor adults, through Medicaid.

Contact HCC Healthcare Consultants - Pharmacy Business Solutions for help with pharmacy startup, help with pharmacy performance and efficiency or pharmacy business management service.

Lipitor goes off patent and Ranbaxy becomes the leading seller

ATTENTION Lipitor patients!!

Per the WSJ…there are good odds that your pills were sold by generic drug maker Ranbaxy Laboratories, not the cholesterol fighting drug’s longtime maker, Pfizer.

Ranbaxy is now selling more pills than Pfizer, according to Wolters Kluwer Pharma Solutions. That makes Ranbaxy the leading seller of the top-selling drug of all time.

The FDA says generics are identical to brand-name drugs, so whoever makes your Lipitor shouldn’t make a clinical difference for patients. But many patients believe the brand and generics are different, and they have tried to keep getting Pfizer’s Lipitor. Pfizer has tried to oblige by selling by mail, among other steps.

Pfizer lost its exclusive rights to sell Lipitor in the U.S. on Nov. 30, but since then, has sought to keep sales. Watson Laboratories also sells a generic version of the drug, often called its chemical name atorvastatin.

Ranbaxy took the lead spot dispensing atorvastatin pills during the last week of March, according to Wolters Kluwer. That week, Ranbaxy sold 17.5 million pills, some 300,000 more than Pfizer; Watson sold 10.8 million tablets.

Contact HCC Healthcare Consultants - Pharmacy Business Solutions for help with pharmacy startup, help with pharmacy performance and efficiency or pharmacy business management service.