PHARMACY

Celgene sees year-to-year revenue increase of more than 50 percent

BY Drew Buono

WARREN, N.J. Celgene’s revenue increased by more than 50 percent in 2007 as compared to 2006. The growth was due to sales of its cancer drug Revlimid.

Revlimid is used in combination with the corticosteroid dexamethasone to treat multiple myeloma patients who have received at least one prior therapy. Net sales of the drug increased more than 140 percent in 2007 to nearly $775 million.

The company also reported good sales results for its skin disease treatment drug Thalomid, the chemotherapy drug Alkeran and the attention deficit hyperactivity disorder drugs Focalin XR and Ritalin and the Ritalin family of products.

The company expects revenue to increase more than 30 percent this year to approximately $1.8 billion and adjusted diluted earnings per share to increase approximately 45 percent up to $1.55.

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PHARMACY

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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