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.

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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.

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Drug Resales Get Investigated

Per the WSJ, there are several drug distributors are setting up fake pharmacies that allow them to obtain and artificially raise the prices for cancer drugs and other medicines that are in short supply, according to letters written by lawmakers .

Lawmakers are looking into what they claim is a "gray market" for scarce prescription drugs that has emerged in recent months. The U.S. is grappling with a shortage of some cancer and other critical-care drugs used in hospital emergency rooms and intensive-care units, the result of manufacturing glitches and shifts in supply.

On Wednesday three Democrats sent letters to pharmacies that have sold drugs in short supply to drug wholesalers which sold them at a sharp markup instead of dispensing the drugs to patients. The lawmakers asked the companies for more information about who sold them the drugs and to whom they later sold or transferred the drugs.

In many three cases, the pharmacies were owned by the same people who also owned small drug-wholesale companies, according to lawmakers. The letters came from Rep. Elijah Cummings of Maryland and Sens. Jay Rockefeller of West Virginia and Tom Harkin of Iowa.

"It appears that some of these individuals essentially established fake pharmacies to obtain drugs that are in critically short supply and are desperately needed to treat patients with cancer and others diseases," said Mr. Cummings, the top Democrat on the House Oversight and Government Reform Committee. "What remains unclear is exactly how much they profited from this activity.

The reselling in question violates laws in certain states in which these pharmacies operate, though in some instances there is little to stop distributors and pharmacies from using such a chain to boost prices. Some of the transactions could violate certain provisions of the federal prescription drug marketing act, lawmakers said.

The drug shortages have caused many hospitals to ration certain drugs and delay some treatments, according to doctors and hospital pharmacists. Many hospitals report they have received offers from companies saying they have products in short supply available for sale. Hospital pharmacists say they are curious how these companies can get drugs they can't through their normal drug distributor.

The drug-distribution system is dominated by three drug wholesalers—AmerisourceBergen Corp., ABC +1.75% Cardinal Health Inc. CAH +1.57% and McKesson Corp. MCK +0.23% —which obtain products from drug manufacturers and sell them to hospitals and pharmacies at prices usually negotiated by a group purchasing organization. None of those three have been accused of wrongdoing.

A document reviewed by The Wall Street Journal shows in one case, Cardinal Health sold the cancer drug fluorouracil to LTC Pharmacy of Durham, N.C., then licensed by the state to provide medications to long-term care facilities. LTC transferred the drug to International Pharmaceuticals Inc., a North Carolina distributor, the document said. The latter two are owned by the same person, Jessica Hoppe. Ms. Hoppe declined to talk about the companies but said they have been shut down.

The drug later was obtained by PRN Pharmaceuticals, a Rockville, Md., distributor, which had offered it to hospitals for $350 a vial, according to a prior letter to PRN released by Mr. Cummings last year. It normally sells for $15 a vial. PRN didn't return a request for comment, but said last year that it plays "an important role in helping health-care providers locate needed products during manufacturing shortages."

A Maryland-based pharmacy, Priority Healthcare, bought fluorouracil for $6.77 a vial and then sold it to Tri-Med America, a New Jersey distributor, according to information obtained by House investigators. The same husband-and-wife team owned the two companies, the investigators said. Tri-Med America sold the drug to another company for $69 a vial.

Priority Healthcare didn't return a request for comment; Tri-Med couldn't be reached.

In the North Carolina case, the state Department of Agriculture, which conducts annual inspections of drug wholesalers in the state, discovered that the small distributor and the pharmacy shared the same building, according to a state investigator. The state refused to renew International Pharmaceuticals' license, and it expired in December. LTC Pharmacy, which was originally licensed by the state to provide medications to long-term care facilities, surrendered its pharmacy license last year.

"There is more and more of these outfits popping up," said Daniel Ragan, director of North Carolina's Food & Drug Protection division.

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