PHARMACY

Merck discloses Q2 earnings

BY Alaric DeArment

WHITEHOUSE STATION, N.J. Merck had global sales of $11.3 billion and profits of $752 million during second quarter 2010, according to an earnings report the drug maker released Friday. Sales and profits for the first six months of the year were $22.8 billion and $1.05 billion, respectively.

Those numbers compared with sales and profits of $5.9 billion and $1.6 billion in second quarter 2009, and $11.3 billion and $2.9 billion for the first six months of 2009. The changes reflect Merck’s purchase of Schering-Plough.

Several of Merck’s products had strong global sales during the period. The autoimmune disease drug Remicade (infliximab) had sales of $669 million during the quarter, while Merck also launched the once-monthly autoimmune treatment Simponi (golimumab). The cardiovascular drugs Zetia (ezetimibe) and Vytorin (ezetimibe and simvastatin) had sales of $564 million and $490 million, respectively. The Type 2 diabetes drug Januvia (sitagliptin) had $600 million in sales during second quarter 2010, a 30% increase over second quarter 2009 sales, while Janumet (sitagliptin and metformin hydrochloride) had sales of $218 million. The HIV drug Isentress (raltegravir) had sales of $267 million, a 55% increase over second quarter 2009, while the hepatitis C drug Pegintron (peginterferon alfa-2b) had sales of $185 million.

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NACDS urges FDA to move carefully in risk management rules for opioids

BY Jim Frederick

ROCKVILLE, Md. Note to the Food and Drug Administration from the chain pharmacy industry: when it comes to beefing up oversight and regulation of some high-risk medications, slow and steady is the best approach.

As the FDA mulls new, broad-based requirements on the dispensing and monitoring of all medications in the opioid class of painkillers, the National Association of Chain Drug Stores is weighing in with a cautious, if qualified, endorsement. That support came today from Kevin N. Nicholson, NACDS VP and pharmacy adviser for government affairs and public policy, who addressed a joint meeting of the FDA’s Anesthetic and Life Support Drugs Advisory and Drug Safety and Risk Management Advisory committees.

The meeting was set up to study the agency’s proposal to require all painkillers in the opioid class of medicines to follow the FDA’s Risk Evaluation and Mitigation Strategies guidelines. The agency first unveiled new REMS requirements for the makers of some higher-risk specialty medications in 2007. Thus far, the biggest target for those new REMS requirements has been the opioid class of painkillers, given their narcotic properties and the risks they carry for abuse and addiction.

Nicholson told the joint panel that NACDS "supports the measured approach to REMS that the FDA appears to be embracing, as evidenced by the FDA’s proposal for the classwide opioid REMS." However, he added, "The FDA must carefully navigate between mitigating the risks of these medications while also not negatively impacting patient care."

"We are pleased that the proposed REMS for long acting and extended release opioids follows the advice of stakeholders that emphasizes caution and deliberation over speed," said the NACDS executive. "Take time to develop the REMS and allow for stakeholder input to prevent negative consequences."

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Beacon Community program seeks to curb diabetes across country

BY Allison Cerra

WASHINGTON Vice President Joe Biden and the Department of Health and Human Services secretary Kathleen Sebelius have announced a pilot program designed to curb diabetes in 15 selected U.S. cities with the help of health-information technology.

The Beacon Community program will use health IT resources within their community as a foundation for bringing doctors, hospitals, community health programs, federal programs and patients together to design new ways of improving quality and efficiency to benefit patients and taxpayers, the White House said in a release.  Each Beacon Community has elected specific and measurable improvement goals in each of three vital areas for health systems improvement: quality, cost-efficiency, and population health. The goals vary according to the needs and priorities of each community.

Communities will use their Beacon Community awards to provide better control of blood pressure for diabetic and hypertensive patients, improvements in care coordination and chronic disease management, reductions in preventable emergency department visits and re-hospitalizations, reductions in health disparities, better rates of immunization for children and adults, and better adherence to smoking cessation and appropriate cancer screening guidelines, the White House said in a release. The Beacon projects are expected to initially create dozens of new jobs in each community paying an average of $70,000 per year for a total of 1,100 jobs up-front, while accelerating development of a nationwide health IT infrastructure that will eventually employ tens of thousands of Americans.

Cities included in the program are: Tulsa, Okla.; Stoneville, Miss.; Brewer, Maine; Danville, Pa.; Salt Lake City; Indianapolis; Spokane, Wash.; Rochester, Minn.; Providence, R.I.; Junction, Colo.; Concord, N.C.; San Diego; Hilo, Hawaii; and Buffalo, N.Y.

“The most important healthcare innovations are those that are designed and tested by providers and community leaders all across the country. Beacon Communities will offer insight into how health IT can make a real difference in the delivery of health care,” said Secretary Sebelius. “The Beacon Community Program will tap the best ideas across America and demonstrate the enormous benefit health IT will have to improving health and care within our communities.”

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