PHARMACY

Breakthrough may allow scientists to overcome antibiotic resistance

BY Adam Kraemer

WARWICK , UNITED KINGDOM Scientists have discovered how the pneumonia-causing Streptococcus pneumoniae has become resistant, and have high hopes for their ability to redesign antibiotics to combat pneumonia and other resistant bacteria.

In a study published in the Journal of Biological Chemistry, a team of UK scientists at the University of Warwick discovered a protein called MurM that allows buildup of a protective cell wall in the bacteria. Penicillin was once able to disrupt the bacteria’s ability to build the cell wall.

Therefore, the Warwick team reasoned, the ability of a disease to build up an immunity to antibiotics should be compromised by disrupting the chemistry of MurM.

Researcher Adrian Lloyd said it was possible that new drugs could be developed in two to three years. “Because we now know in detail what this protein needs to be able to do its job and promote bacterial resistance we should be able to develop drugs to stop it from doing so,” he told the BBC.

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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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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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