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Lipitor foreshadows approaching patent cliff for other leading drugs

BY Alaric DeArment

For the past several years, drug industry experts have spoken in terms of the “patent cliff,” the period when the patents covering several blockbuster drugs are set to expire, thus leaving their manufacturers with a big, gaping hole in their revenues as those drugs face competition from generics.

Of all the drugs on the patent cliff, Pfizer’s cholesterol medication Lipitor (atorvastatin calcium) is by far the best known, not to mention the drug with the highest revenues of any drug in history, with more than $7 billion in 2010 sales in the United States alone. When Lipitor’s patent expired on Nov. 30, 2011, thus opening the drug to competition from Ranbaxy Labs’ generic version, it provided some insight of where the market for cardiovascular drugs is heading.

According to a report released in December by market research firm Decision Resources, expiration of patents covering blockbuster drugs that treat dyslipidemia, and subsequent competition from generics, will decrease the size of the market by nearly $6 billion in the United States, the United Kingdom, Germany, France, Italy, Spain and Japan through 2020. Patent expirations, according to the report, will result in a decrease of nearly $19 billion in sales between 2010 and 2020; the market had sales of $29 billion in 2010. Other drugs facing patent expiration include Merck’s Zetia (ezetimibe) and Vytorin (ezetimibe and simvastatin), Abbott’s Niaspan (niacin extended-release), and AstraZeneca’s and Shionogi’s Crestor (rosuvastatin calcium), which had sales of $3.8 billion in 2010, according to IMS Health.

A similar phenomenon is occurring in the market for drugs to treat high blood pressure. According to a November Decision Resources report, the size of that market will decline from about $26 billion in 2010 to $20.5 billion in 2020 in the same seven countries named in the dyslipidemia report. The decline also is thanks to the loss of patent protection for drugs to treat the condition, particularly Novartis’ Diovan (valsartan/hydrochlorothiazide). According to IMS Health, Diovan will lose patent protection this year, and Decision Resources expected it to face a decline of more than $1 billion in major markets once generic versions enter the market. The drug had global sales of more than $6 billion in 2010, according to Novartis.

The increasing difficulty of achieving blockbuster sales on drugs targeted toward primary-care disease states, such as cholesterol and hypertension, is spurring many companies to pursue specialty drugs instead. “Emerging agents will find it difficult to penetrate the highly genericized hypertension market because of competition from inexpensive and efficacious generic anti-hypertension drugs,” Decision Resources analyst Taskin Ahmed said. But this doesn’t mean development hasn’t continued.

According to a report released last year by the Pharmaceutical Research and Manufacturers of America, 299 drugs are in clinical development or under review by the Food and Drug Administration for heart disease, including 43 for lipid disorders and 27 for hypertension. Of the drugs for hypertension, four were in, or had completed, phase-3 clinical trials, whereas 10 lipid disorder drugs were in, or had completed, the trials.

Of course, Pfizer isn’t letting go of Lipitor just yet. It’s hoping to get FDA approval to launch an OTC version of the drug — though the record of FDA approvals for OTC statins has so far been unsuccessful — and it has entered deals with PBMs and specialty pharmacy provider Diplomat Specialty Pharmacy to try and ensure that patients keep using the branded version of the drug.

Regardless, the market for heart health drugs has evolved considerably in recent years and is likely to continue evolving, especially as it becomes increasingly dominated by generics.

To view the charts listing the Top 20 hypertension and cholesterol-lowering drugs, click here.

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Fortunate drive that sparked an industry

BY Antoinette Alexander

Ever wonder how the convenient care industry blossomed into what it is today? One could say a fortune cookie.

“I love Chinese food, and my kids always get me Chinese food for dinner on Mother’s Day. My Chinese fortune cookie said, when I opened [it]: ‘You will be offered the opportunity of a lifetime, say yes,’” explained Sandy Ryan, Walgreens’ Take Care Health Systems chief nurse practitioner officer and clinical advocate.

On any other day, Ryan might have dismissed the fortune as trivial, but not that day. Earlier that very same day, she had been offered a position on the executive team at Take Care Health Systems, which would make her the first chief nurse practitioner officer in the convenient care industry.

That was in 2005, and the road since that time hasn’t always been easy. But anyone who knows Ryan knows that she thrives on overcoming adversity and doesn’t shy away from challenges. Perhaps some of it stems from her background in the U.S. Air Force.

In the military, which she joined right out of college, Ryan initially worked as a registered nurse and then was selected to return to school to earn her master’s degree. During her years in the military, she worked pediatrics to geriatrics and served as director of ambulatory outpatient services in a military medical facility coordinating patient care. In 1999, she retired from the U.S. Air Force after 16 years of service due to a downsizing of medical personnel following Operation Desert Shield/Desert Storm, and then went to work in a private practice.

While working in private practice, a friend of Ryan’s came across a listing for a job opening at Take Care Health Systems for a national director of nursing, which is what the title was at the time, and felt Ryan would be an ideal fit for the role. Ryan called up the recruiter and eventually met with Take Care founders Hal Rosenbluth 
and Peter Miller, who wound up offering her the job.

“[Hal and Peter] were looking for someone who could represent nurse practitioners extremely well, and advocate for them as a professional role and what they bring to the table, but also someone who could work collaboratively with the physician side of the world,” Ryan said.

Ryan joined the executive team at Take Care Health Systems in July 2005 — just months before the venture opened its first in-store health clinic. In 2007, it was acquired by Walgreens. For Ryan, being a nurse practitioner serving at the executive level has afforded her the benefit of helping to guide the direction of the industry and represent not only the nurse practitioners within Take Care, but also the nurse practitioners nationwide.

Today, Take Care Health Systems manages more than 700 worksite and retail health clinics. “It has been the opportunity of a lifetime, and not really just for me, but I think for all nurse practitioners because Hal and Peter, as founders of this company, really did give the opportunity to have a platform that could really raise the bar of recognition on nurse practitioners. … It really has been a fantastic journey for me,” Ryan said.

The journey and the important role that Ryan plays, on behalf of nurse practitioners nationwide, is far from over. In August 2011, the Robert Wood Johnson Foundation announced the selection of 21 nurses from 138 applicants for its highly competitive national nurse fellowship program. Ryan was among those selected in 2011. The three-year fellowship program is designed to expand nurse leadership and position nurses to help lead change in the U.S. healthcare system.

Also in late 2011, the Fellowship of The College of Physicians of Philadelphia elected Ryan to its ranks, marking the first nurse practitioner to be elected. “Through [Ryan’s] leadership, she has demonstrated commitment to enhancing the role that nursing can play in the future of health care,” stated George Wohlreich, director and CEO and the Thomas W. Langfitt chair, when announcing Ryan’s election. “Through her dedication and advocacy, she’s benefitted nurses and nurse practitioners by opening doors to new opportunities, helped to reinforce the value of a collaborative healthcare team to take care of a patient and increased access for patients to receive high-quality, convenient health care.”

The college was founded in 1787 by a group of physicians and is the nation’s oldest medical society dedicated to advancing the cause of health while upholding the ideals and heritage of medicine.

Clearly, Ryan is a trailblazer and a leader to many within the industry.

However, one has to wonder, whom does Ryan consider a leader? “I really think it is people who strive to do something that is so impactful. But it is not just impactful for themselves or a small group, but for more of that social responsibility and greater good,” Ryan said. “Obviously, I think highly of Hal Rosenbluth, one of our co-founders, and Loretta Ford.”

Yes, one could quip that the convenient care industry is where it is today because of a fortune cookie, but clearly it is because of Ryan’s passion, fearless ambition, commitment to enhancing the role of nurse practitioners and her desire to reinforce the value of a collaborative healthcare team.

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Winn-Dixie sets date for shareholders’ vote on Bi-Lo acquisition

BY Michael Johnsen

JACKSONVILLE, Fla. — Winn-Dixie on Tuesday announced it will hold a special meeting of shareholders at Winn-Dixie’s headquarters on March 9 to vote on the proposed Bi-Lo buyout of the southeastern grocer.

Under the terms of that definitive agreement, Bi-Lo will acquire all of the outstanding shares of Winn-Dixie stock in the merger at $9.50 in cash per share of Winn-Dixie common stock, representing a premium of approximately 75% over the closing price of Winn-Dixie common stock on Dec. 16.

Jan. 27, 2012, has been fixed as the record date for determination of the Winn-Dixie shareholders entitled to notice of (and to vote) at the special meeting.

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