PHARMACY

U.S. prescription sales grew modestly to $286.5 billion in 2007

BY Adam Kraemer

NORWALK, Conn. IMS Health today released its annual U.S. Pharmaceutical Market Performance Review, reporting that overall sales growth in the U.S. prescription market moderated to 3.8 percent in 2007, compared with growth of more than 8 percent in 2006.

Total U.S. prescription sales reached $286.5 billion, with slower sales growth resulting from loss of exclusivity of branded medicines, fewer new product approvals, the leveling of year-over-year growth from the Medicare Part D program and the impact of safety issues, IMS Health reported. The 2006 growth was an anomaly, in other words, due to the implementation of Medicare Part D, but 2007’s slowing growth rate is a continued trend that began in 2001, according to the report

Compared with a 4.6 percent growth in 2006, total U.S. dispensed prescription volume grew at a 2.8 percent pace. The top five therapeutic categories—antidepressants, lipid regulators, codeine & combination pain medications, ace inhibitors and beta blockers—continued to lead the market in terms of prescription utilization.

“In 2007, the U.S. pharmaceutical market experienced its lowest growth rate since 1961,” said IMS’s Murray Aitken, senior vice president of Healthcare Insight. “Last year, we saw a continuing shift away from primary care classes to biotech and specialist-driven therapies, which grew at a 9 percent and 10 percent pace, respectively. Among the leading therapy classes, oncology drugs continued their rapid growth, at 14 percent—the result of innovative new medicines, expanded indications and accelerated uptake of products to fill unmet needs.”

Sales of lipid regulators declined by 15.4 percent year-over-year, though continued to represent the largest therapy class in the nation, with prescription sales of $18.4 billion. Proton pump inhibitors ranked second, with prescription sales of $14.1 billion and growth of 2.8 percent. Antipsychotics replaced antidepressants as the third-largest therapeutic class in 2007, with prescription sales growth of 12.1 percent to $13.1 billion. 

The IMS report forecasts compound annual pharmaceutical sales growth through 2012 of 3 percent to 6 percent, based on predicted loss of exclusivity in major therapy areas, new specialist-driven products, greater levels of therapeutic substitution, and greater awareness and focus on safety issues.

“We will see additional lower-cost treatment options for many patients, while new and innovative therapies are delivered to specific patient groups, such as those suffering with cancer. Safety issues will be closely monitored and are likely to bring added caution to the market over the next several years,” said Aitken.

More information can be found at www.imshealth.com/media.

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PHARMACY

Hi-Tech Pharmacal Q3 sales down

BY Drew Buono

AMITYVILLE, N.Y. Hi-Tech Pharmacal has released the results of its third quarter, which ended on Jan. 31.

For the three-month period, the company saw its net sales for generic pharmaceuticals products decrease by 10 percent from $13.8 million during third quarter 2007 to $12.5 million for the same period in 2008.

The healthcare products division, which markets the company’s branded over-the-counter products, had net sales of $2.6 million for the quarter, a decrease of $0.8 million compared with the same period for 2007.

Research and product development costs for the three-month period increased $0.1 million to $1.4 million as compared with $1.3 million for the three-month period ended Jan. 31, 2007, as the company increased expenditures on external projects.

The company experienced a net loss for the period ended Jan. 31, 2008, of $1.5 million compared with net income of $0.7 million in the prior period.

David Seltzer, president and chief executive officer, commented, “The quarter was challenging as we experienced a milder that expected cough-and-cold season, which affected our higher margin prescription products, as well as our OTC brands. Additionally we faced increased competition on selected generic products.”

Seltzer further commented, “We are very upbeat about our generic business due to our recent approval of generic Flonase, and more recently, the approval for the generic alternative to Hycodan. Also, our Midlothian Laboratories division has performed well. To date, the Midlothian division has already launched two new generic prescription products since we announced the acquisition on Dec. 31, 2007. In the healthcare products division, we are excited about the upcoming launch of new and unique products, both in the areas of diabetes management, as well as broader nondiabetes related markets.”

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PHARMACY

FDA names Woodcock director of CDER

BY Drew Buono

WASHINGTON Food and Drug Administration commissioner Andrew von Eschenbach has named Janet Woodcock as director of the agency’s Center for Drug Evaluation and Research.

In October 2007, while serving as the agency’s deputy commissioner and chief medical officer, where she oversaw scientific and regulatory operations, Woodcock agreed to assume the role of acting director of CDER.

Throughout her career at the FDA, Woodcock has played an integral role in advancing the health of the American public. Under her guidance, the FDA launched the Critical Path Initiative designed to close the gap between basic scientific research and the medical product development process. This initiative called for a collaborative effort to modernize the drug development process and has resulted in several prominent partnerships looking at a wide variety of scientific issues.

“Dr. Woodcock’s exemplary service since October was confirmation of her being ideally suited to lead the center during this crucial period following the passage of the Food and Drug Administration Amendments Act of 2007,” noted von Eschenbach. “The agency is fully committed to implementing the drug safety programs laid out by this act and meeting the goals set under the prescription drug user fee program, which will help ensure that CDER has the additional resources that are needed to conduct these very complex and comprehensive reviews.”

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