Alcoholism Drug Moves Ahead: A Promising Treatment to Be Marketed By Cephalon Has Won Conditional Approval By the FDA for Sale
By Linda Loyd, The Philadelphia Inquirer, The Philadelphia Inquirer
Jan. 4–A promising treatment for alcoholism that will be marketed by Cephalon Inc. has won conditional approval from federal regulators, paving the way for it to be sold as soon as the second quarter of this year.
The drug, Vivitrol, formerly called Vivitrex, is made by a Cambridge, Mass., biotechnology company, Alkermes Inc. In June, Cephalon announced it would handle sales and marketing of the drug in the United States.
Under the deal, Cephalon paid $160 million in cash in June and will pay an additional $110 million if Vivitrol receives full marketing approval from the Food and Drug Administration.
Vivitrol, the first injectable medicine to treat alcoholics, is designed to be administered by physicians once a month. Treatment is to include counseling.
The FDA issued an “approvable letter” last week for Vivitrol, the injection form of the oral medication naltrexone, which has long been used for alcoholism. Such a letter means the agency is prepared to clear the drug to be sold, but requires certain conditions.
The FDA wants Alkermes to provide more scientific data, and the two need to agree on the wording on the product’s label.
Naltrexone is a nonaddictive agent that binds to opioid receptors in the brain and is believed to diminish the craving for alcohol.
“Our plans for the launch of Vivitrol in the second quarter of 2006 are on track,” said Frank Baldino Jr., chairman and chief executive officer of Cephalon, Frazer, maker of sleep-disorder drug Provigil.
Alkermes could receive an additional $220 million from Cephalon if Vivitrol reached certain sales targets. The companies will share profits equally from Vivitrol sales, and will share responsibility for developing future commercial uses, possibly to treat other addictions.
About 18 million people in the United States are dependent on or abuse alcohol, and 2.3 million annually seek treatment for it, said a 2002 survey by the Substance Abuse and Mental Health Services Administration. Vivitrol has the potential to offer physicians and patients a new approach, Baldino said.
Analyst Matthew Geller at CIBC World Markets said in an earlier research note that Vivitrol “could become the gold standard for treatment of alcohol dependence,” with peak annual sales of $500 million.
Geller said a late-stage study on Vivitrol published in April in the Journal of the American Medical Association showed a 25 percent “statistically significant” reduction in heavy drinking days among people with alcohol dependence.
The advantage of a once-monthly injection over a daily pill is that patients will be more likely to get successful treatment and won’t be tempted to stop taking their pills.
To sell the drug, Cephalon is hiring sales representatives and was designing education and training programs to help physicians and counselors “identify patients who could benefit the most,” Baldino said.
By adding Vivitrol to its product line, Cephalon will bolster sales at a time when investors are concerned that growth could slow in 2006 and 2007 because of an expected loss of revenue from other products. Cephalon reported more than $1 billion in 2004 sales, and has estimated 2005 sales at between $1.15 billion and $1.20 billion.
Shares of Cephalon closed yesterday at $65.76, up $1.02.
Contact staff writer Linda Loyd at 215-854-2831 or lloyd@phillynews.com.
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