Alkermes's alcoholism drug wins OK
By Stephen Heuser, Globe Staff | April 14, 2006
The Food and Drug Administration yesterday approved a new drug to treat alcoholism, a monthly injection that many analysts say could significantly change the way alcohol dependence is treated.
The drug, Vivitrol, was developed by Alkermes Inc. of Cambridge and will be launched in June.
According to a study published last year, patients on Vivitrol had fewer ''heavy drinking days" per month than patients who did not get the drug. Although its mechanism is not well understood, it is believed to reduce the euphoria alcoholics feel when they drink.
''There is a very real brain component to addiction, and society up to now has for the most part has viewed it as failure of will," said Alkermes chief executive Richard Pops.
Yesterday's approval was a milestone for Alkermes, a 19-year-old company that has never had a profitable year. Analysts project sales of the drug to start slowly but build to as much as $300 million annually.
''We think that 10 years from now people will look back and, hopefully, view Vivitrol as one of the first steps to a new approach to treating these diseases," said Pops.
It will be sold in a joint deal with Cephalon Inc., a Pennsylvania company that specializes in neurological drugs.
Patients who now take medication to treat alcoholism must take up to six pills a day.
Despite the enthusiasm from many alcoholics and addiction psychiatrists about a once-a-month drug to help cut down on drinking, Vivitrol faces significant challenges to wide acceptance.
One is the US alcohol-treatment system, which relies chiefly on clinics whose staff members are not doctors and cannot write prescriptions. The drug carries a warning of potential liver toxicity in high doses, and patients are supposed to refrain from drinking alcohol before receiving it.
Vivitrol will likely be more expensive than other drugs and could face resistance from insurance companies. The company has not yet disclosed a price.
The most significant hurdle, however, is how alcohol dependence is viewed by doctors: Few alcoholics are treated with medication of any kind. The handful of existing drugs have far lower sales numbers than what Vivitrol is aiming to reach.
Cephalon has targeted 2,000 to 3,000 addiction specialists and psychiatrists around the country, said Shawn Ferry, who is in charge of marketing Vivitrol at Cephalon. Alkermes has assembled a separate 28-person team. Its members have traveled to cities throughout the United States to coordinate doctors, clinics, and nurses who can administer the regimen.
''I think this really represents a qualitative advance. It's the only treatment that can be given once a month that's effective," said Dr. Michael Bohn, an addiction specialist at Aurora Healthcare in Wisconsin who worked with Alkermes on its latest Vivitrol study.
Bohn said that among people in the study who stayed on the drug for six months, 85 percent asked to remain on the drug after the study ended.
That level of popularity would be welcome news for Alkermes, which specializes in long-acting versions of existing drugs. Vivitrol is based on a generic compound called naltrexone, and the company has signed deals to work with other companies' drugs, including a possible inhaled insulin.
Alkermess' stock jumped after the FDA decision was released late yesterday, gaining more than 4 percent to close at $21.96.
''If we're right, and Alkermes now moves from one of several hundred money-losing biotech companies into one of the companies in the tier of profitability, then there's real opportunities for growth," Pops said.
Stephen Heuser can be reached at sheuser@globe.com.
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