PHARMACY

Genentech posts strong 2007 numbers

BY Drew Buono

SAN FRANCISCO Genentech recently announced the financial results for the full year and fourth quarter of 2007.

The company had U.S. product sales of $8.5 billion, a 19 percent increase over the $7.17 billion in 2006. This increased was helped by the $2.19 billion in U.S. sales the company had in the fourth quarter, a 7 percent increase as compared to the fourth quarter of 2006.

Based on non-GAAP operating revenues, the company made $11.7 billion; 2006 operating revenues stood at $9.2 billion.

“We are pleased with our strong financial performance in 2007, which was our tenth consecutive year of double-digit revenue growth,” said Arthur Levinson, Genentech’s chairman and chief executive officer.

“We remain steadfast in our focus on building a pipeline of novel therapies that have the potential to make an important difference for patients suffering from significant diseases. In 2008, we will continue to invest in the 20 new molecular entities in clinical development and look forward to new data from a number of potentially important line extensions, including Rituxan for multiple sclerosis and lupus and Avastin in combination with Tarceva for advanced non-small cell lung cancer.”

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FDA to open office in India

BY Drew Buono

KOCHI The Food and Drug Administration is planning on opening an office of its agency in India, in an effort to ensure the quality of the food and drugs being imported by the U.S., according to published reports.

Health and Human Service secretary Michael Leavitt and FDA commissioner Andrew von Eschenbach are in the country presently assessing the manufacturing practices existing at drug and food processing units.

According to Leavitt, he set up the mission because, “there was a serious apprehension among the consumers in this country on the quality of food and drugs being imported.” “We are trying to ensure the quality in the entire system of supply chain, right from the seed to the last outlet from where people buy the goods,” he said.

The U.S. imports about $56 million worth of food and drug products from India.

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BioDelivery works on risk management plan for dissolving fentanyl patch

BY Drew Buono

RALEIGH, N.C. BioDelivery Services International is planning on developing a safety plan for its new BEMA fentanyl patch, which the Food and Drug Administration accepted for review last week, according to published reports.

In December, a public health advisory from the FDA was released following reports of life-threatening side effects and even death associated with inappropriate prescriptions or use of the patches. So, to be safe, BioDelivery has developed a Risk Minimization Action Plan, or RiskMap, for its patch, which dissolves in the mouth and is placed on the walls of the cheek, unlike other fentanyl patches, which are placed on the skin and have to be disposed of.

Fentanyl is a narcotic pain medication more powerful than morphine. It has been in use for years. The FDA first issued a public health advisory for fentanyl skin patches in July 2005 following reports of the deaths of some patients.

BioDelivery’s vice president of marketing stated that the company is more confident as to the differences between its patch and other fentanyl patches, and believes the confidence is extended to how the drug is meant to be used and how the drug is delivered in the body.

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