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Crestor gains FDA approval to treat atherosclerosis

BY DSN STAFF

WILMINGTON, Del. —AstraZeneca’s drug Crestor has joined the elite ranks of cholesterol-fighting agents that also have been indicated to fight atherosclerosis.

The Food and Drug Administration recently approved Crestor as an adjunct to diet to slow the progression of atherosclerosis in patients with elevated cholesterol. An enzyme blocker in the statin class, Crestor is used along with a proper diet to help lower triglycerides and cholesterol in the blood. Atherosclerosis is the progressive buildup of plaque in the inner walls of the arteries that occurs as a result of elevated cholesterol, and presents no visible symptoms.

“This new indication allows us to share what we’ve learned in clinical trials: That even in people with low Framingham risk scores or low risk of cardiovascular disease and early signs of atherosclerosis, the disease progresses if untreated,” said Mike Tilton, AstraZeneca’s vice president of cardiovascular primary care. “In the METEOR trial, patients with hyperlipidemia who took Crestor overall experienced no significant progression of atherosclerosis.”

METEOR—Measuring Effects on intima-media Thickness: an Evaluation Of Rosuvastatin—measured the effects of Crestor on plaque buildup in the arteries using carotid intima-media thickness, which is an early sign of atherosclerosis.

The trial, in which patients took Crestor 40 mg, demonstrated a slowing of progression of atherosclerosis in people with early signs of the disease, elevated LDL or bad cholesterol and low cardiovascular risk. The results of the METEOR trial were the main reason AstraZeneca asked the FDA to add this treatment to its labeling.

The FDA’s expanded approval of Crestor to fight the condition could give the product a significant boost. It joins a small but growing list of statins—including Lescol, Mevacor and Pravachol—containing language in their labels regarding slowing the progression of atherosclerosis, according to the FDA.

Another product, Niaspan—which is used to lower cholesterol and triglycerides in the blood—has language for slowing the progression and promoting the regression of atherosclerosis, in combination with a resin that binds to bile acid.

The FDA also stated that some of the drugs not approved to treat atherosclerosis were Lipitor, Zetia, Vytorin and Advicor. However, the agency noted, “A lot of this is semantics. Most of the statins have outcomes data demonstrating that their drug reduces the risk for a heart attack, angioplasty, etc. The indication may not say that the drug is indicated to treat atherosclerosis per se, but that is what is being treated regardless of the language for the indication.”

While it’s a big step for AstraZeneca to have another treatment option for its third-best-selling drug, other recent efforts by the company may have a bigger impact on future sale results for Crestor. Last month, AstraZeneca announced that it had filed patent-infringement actions in the United States against nine generic drug makers, all of which had submitted plans to sell me-too versions of Crestor. Cobalt Pharmaceuticals was the first company to announce its filing of an application to manufacture a generic version of Crestor in early November 2007. Since then, AstraZeneca has received similar patent challenges from eight additional generic drug makers.

All of them plan to market a cheaper generic form of Crestor in the key U.S. market before patents protecting the medicine expire.

Crestor, which had sales in the United States of $2 billion for 2006, is covered by three key patents valid until 2016, 2020 and 2021. But the generic firms claim they have either found a way not to infringe these patents—or that the patents themselves are invalid or unenforceable. AstraZeneca said challenges had come from Teva Pharmaceuticals, Auro-bindo Pharma, Apotex, Par Pharmaceuticals, Novartis, Sandoz, Mylan, Glenmark Pharmaceuticals and Sun Pharmaceuticals. Novartis and Glenmark are the only companies, as of yet, not involved in the patent-infringement cases by AstraZeneca.

The only positive for the company following all these patent challenges is that, if the companies launch their product before the court case is settled and if AstraZeneca wins, the branded drug maker would be entitled to a huge settlement to compensate for the amount it lost by the launch of a generic.

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S&P revises outlook on Rite Aid

BY Michael Johnsen

NEW YORK Standard & Poor’s Ratings Services revised its outlook on chain drug retailer Rite Aid to negative from stable, the firm reported Friday. At the same time, S&P affirmed the ‘B’ corporate credit rating on Rite Aid.

“The outlook change reflects the company’s weak same-store sales and our expectation that this trend will continue over the next few quarters,” stated Standard & Poor’s credit analyst Diane Shand. Rite Aid faces a more cautious consumer, strong growth of lower-priced generics and intense competition, she said. In addition, the current environment could make it more challenging for the company to integrate its recently-acquired Brooks/Eckerd stores.

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Boston Mayor decries in-store health clinics

BY Antoinette Alexander

BOSTON On the heels of the Massachusetts Public Health Council approving regulations allowing for in-store health clinics in the state, Boston Mayor Thomas Menino is reportedly looking to ban the clinics from opening in the city.

The decision by the health council “jeopardizes patient safety,” Menino said in a written statement, according to a Boston Globe report. “Limited service medical clinics run by merchants in for-profit corporations will seriously compromise quality of care and hygiene. Allowing retailers to make money off of sick people is wrong.”

The newspaper also reported that, in a separate letter, the mayor urged members of the city’s Public Health Commission to consider banning the clinics from opening within Boston. CVS has plans to open 20 to 30 MinuteClinics in the Greater Boston area but it is unclear how many of those would be within the city’s limits.

Defending its decision to allow clinics to operate, the state Public Health Council issued a statement that read: “The members of the Public Health Council were deliberative and thoughtful in their review of the limited service clinic regulation. We believe these types of clinics, operated either as part of a retail operation or in a nonprofit setting, can provide the public access to safe, convenient, and quality care for minor health issues.”

Officials at MinuteClinic were not immediately available for comment.

On Jan. 9, the state Public Health Council approved rules for limited service medical clinics. The new regulations took effect immediately.

“This is a new model for health care delivery that can benefit many people in the Commonwealth. These regulations will improve consumer convenience and make it easier for non-profit organizations to establish satellite clinics in a variety of settings to serve vulnerable populations,” stated secretary of Health and Human Services JudyAnn Bigby in a statement issued after the approval.

Added John Auerbach, commissioner of the Department of Public Health and chair of the PHC, “Properly regulated, these types of clinics will serve an important function, making care for minor medical care more convenient. The council was mindful of not wanting to create a stand-alone system of health care, so these regulations require coordination and linkages to primary care providers.”

The approval came at the end of a long review process that included two public hearings and the submission of hundreds of pages of testimony regarding the regulations, including testimony in favor of the clinics from the Convenient Care Association.

“We appreciate the Public Health Council’s careful deliberation regarding the adopted regulations that will now guide the operation of limited services clinics in Massachusetts. These retail-based clinics are providing consumers in 35 other states with easy access to high-quality, affordable health care in the face of a nationwide primary care physician shortage. Since this growing shortage is well documented in Massachusetts, and its related health care access issues have been exacerbated by the state’s near-universal healthcare coverage, we appreciate the Council embracing limited services clinics as a partial solution to these serious problems,” said Web Golinkin, president of the CCA and chief executive officer of in-store clinic operator RediClinic, in a statement issued after the council’s decision.

Sparking the move to create specialized regulations for these clinics was CVS’ application to open a MinuteClinic in one of its stores in Weymouth. According to the council, early in the application review process it became clear that DPH regulations governing medical clinics did not address the operation of medical clinics with limited scope of services. Rather than consider applications requiring numerous waivers from full-service clinic regulations, the department decided to create a specialized set of rules.

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