PHARMACY

AstraZeneca profits fall 13 percent in Q4

BY Drew Buono

LONDON AstraZeneca recently reported its fourth quarter and full year results. Profits for the company in the fourth quarter fell 13 percent to $1.84 billion due in part to a lower demand for its most popular drugs, according to published reports.

For the year, net profits fell 6.5 percent to $7.98 billion. AstraZeneca’s fourth-quarter profit fell from $2.1 billion to $1.84 billion, but the number was still better than the $1.71 billion that analysts had expected.

Sales of the company’s gastroesophageal reflux disease drug, Nexium, declined 9 percent to $1.3 billion in the quarter. The fall is due to generic competition, which will increase in 2008 with generic versions of Nexium’s rival, Protonix by Wyeth, and with generic manufacturers looking to launch generic versions of Nexium itself before its patent expires.

Another one of the company’s drugs, which may face generic competition in 2008, is the schizophrenia drug Seroquel, which had a sales increase of 19 percent to $1.1 billion in the fourth quarter.

In a move similar to that of its rivals, the company is attempting to adjust to increased generic competition and a shortfall of new drugs being launched into the market by cutting its workforce. Last year AstraZeneca unveiled a cost-savings plan that is expected to reduce its staff by about 7,600, or 11 percent, at a cost of $1.6 billion.

The company is expecting better numbers in 2008 and hopes that its three experimental drugs get approved this year in the United States. These drugs are Motavizumab for respiratory infections, Saxagliptin for diabetes and Zactima for lung cancer.

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PHARMACY

Study shows no link between ADHD medication and drug abuse

BY Diana Alickaj

WASHINGTON A new report published in the March issue of the American Journal for Psychiatry states that children who are given psycho-stimulants for attention deficit-hyperactivity disorder are not more susceptible to begin abusing drugs and alcohol than their peers.

ADHD is a disorder that includes systems of inability to focus, hyperactivity and impulsiveness. According to the Wall Street Journal, 9 percent of children have ADHD in America, but only 32 percent get the medication needed to treat it.

The report was funded by the National Institutes of health and was designed by the Massachusetts General Hospital investigators whose main goal was to make sure to cover all necessary angles in order to receive the correct data for the relationship between drug abuse and ADHD medication.

The researchers interviewed 112 men between the ages of 16 and 27, a decade after they were diagnosed with ADHD and asked about their consumption of tobacco, alcohol, drugs and the type of medication they used. The study concluded that there was no relationship between substance abuse and the prescription ADHD medicines.

“This study is a continuing effort to explicate the factors that mediate risk. It is methodologically sound and suggests that, as always, things are more complicated than we want them to be. The study demonstrates that the use of psycho-stimulants for ADHD children does not increase the risk for substance abuse in adulthood, but it also suggests there is no protective effect,” said Jon Shaw, director of the Division of Child and Adolescent Psychiatry and Behavioral Science at the University of Miami.

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PHARMACY

FDA rejects Labopharm’s Tramadol after response to second approvable letter

BY Drew Buono

WASHINGTON Labopharm’s appeal of a second approvable letter from the Food and Drug Administration for a once daily formulation of its pain drug Tramadol has been rejected by the agency.

The director of the Center for Drug Evaluation and Research’s Office of New Drugs, John Jenkins, “has suggested additional statistical analysis of existing data as a means to potentially satisfy the agency’s requirements,” according to Labopharm.

The method Jenkins is proposing is different from the method the FDA requested following its first approvable letter in May 2007, the company said. Jenkins also recommended the company meet with the agency prior to any resubmission.

Labopharm is trying to introduce the once-daily formulation of tramadol, which is its lead product, in various international markets, including Canada, France, Germany, Spain, Italy and the UK.

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