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Biotech Firms to Launch Injectable Alcoholism Treatment

Posted on: Tuesday, 13 June 2006, 09:01 CDT

By Linda Loyd, The Philadelphia Inquirer

Jun. 13--A new once-monthly injectable treatment for alcoholism is available starting today, offering patients and physicians another medical option for alcohol addiction.

The drug, marketed by Cephalon Inc., in Frazer, and developed by Alkermes Inc. of Cambridge, Mass., is an extended-release injection form of naltrexone, which has long been available as a daily pill.

Vivitrol works by blocking neurotransmitters in the brain believed to be associated with alcohol dependence, diminishing the craving for alcohol.

Vivitrol is approved by the Food and Drug Administration for adults who are able to abstain from drinking alcohol in an outpatient setting, and are not actively drinking when they begin treatment.

The monthly intramuscular shot will cost $695. The companies said they expect Vivitrol will be reimbursed as a medical benefit, rather than as a pharmaceutical.

Under their agreement, Alkermes and Cephalon will share profits from Vivitrol sales equally and will share responsibility for developing future commercial uses, possibly to treat other addictions.

Vivitrol will be administered by health-care personnel, in offices, hospitals, clinics, but not sold in pharmacies. Treatment is to include counseling.

"We see this drug as a great tool for recovery," said David Rosenker, executive vice president of treatment for the Caron Treatment Centers, a well-known drug and alcohol addiction treatment center in Wernersville near Reading.

"One of the biggest things our patients experience when they leave treatment is cravings. To have a drug that addresses the cravings, for people returning to their home or their recovery environment, is wonderful. It's another tool."

The only way patients and physicians can learn where to get Vivitrol is by calling a toll-free number, 1-800-VIVITROL. Physicians can sign up to administer the injection treatments, and patients can learn locations in their area where the shots will be given. To date, more than 400 doctors have signed up to administer Vivitrol.

The companies said a limited network of specialty pharmacy providers, including Coram Inc., Caremark, and Aetna Specialty Pharmacy, will distribute the product, which requires special handling and storage.

Alkermes, which makes the shots, and Cephalon, in Frazer, which will sell them, plan to have visiting-nurse programs administer the injections in alcohol treatment centers and psychiatrist group practices which may not have nurses skilled in administering intramuscular injections.

Of the estimated 18 million Americans who abuse or are dependent on alcohol, about 2.2 million seek treatment each year, Cephalon said. More than 75 percent of these patients relapse and resume drinking within the first year of beginning treatment.

The advantage of Vivitrol is that a single shot provides medication over one month, and patients do not need to remember to take their daily naltrexone pills. "The ease of use for an addict is the best advantage," Rosenker said.

When combined with counseling, Vivitrol in two studies was shown to reduce the number of days per month that people drank heavily. The most common side effects were nausea, vomiting, headache, dizziness, fatigue and injection site reactions.

Treating alcoholism is more complex than just taking medicine, and some experts worry that some may see the drug as a one-shot cure. "This is not a magic bullet. It doesn't work alone," Rosenker cautioned. "You need to use it in conjunction with therapy, counseling, or outpatient services."

The cost -- $695 for a 380-milligram shot -- surprised Wall Street analysts.

"It was higher than we thought, but I actually interpret that bullishly for the stock," said James Reddoch, biotech analyst at Friedman, Billings, Ramsey & Co. Reddoch raised his annual Vivitrol sales predictions based on the higher price.

"We are assuming that discussions with payors must have gone well," Reddoch wrote in a note, projecting 18,000 patients will take Vivitrol in the first year, for an average four months, resulting in $45 million in sales.

Caron's treatment director, Rosenker, said the price may keep some people from using Vivitrol, but not "the population we see at Caron. We don't see that [price] as an issue."

Ian Sanderson, biotech analyst at Cowen & Co., said Vivitrol has been granted a J-code by the Centers for Medicare & Medicaid Services, which means the drug will receive Medicare coverage. "Vivitrol is expected to be reimbursed as a medical benefit, not a pharmaceutical benefit, which should make reimbursement easier," he said in a research note.

Because Vivitrol has Medicare approval, and will be administered in a physician's office, "it will be more difficult for health plans to push back and say patients have to fail on oral naltrexone first before going to Vivitrol," said Sanderson. Naltrexone pills cost $110 for a month's supply.

To sell the drug, Cephalon has a 120-person sales force focusing initially on 2,000 to 3,000 physicians who are addiction specialists and psychiatrists. Alkermes has 28 specialists to assist doctors with reimbursement, drug administration and patient compliance.

Cephalon plans eventually to broaden its focus to primary-care doctors.

By adding Vivitrol to its product line, Cephalon hopes to bolster sales at a time investors are concerned that growth could slow. Cephalon paid $160 million in cash up front to Alkermes last June and an additional $110 million when the drug was approved by the FDA in April.

Vivitrol is one of three new products Cephalon plans to launch this year.

Contact staff writer Linda Loyd at 215-854-2831 or lloyd@phillynews.com.

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Copyright (c) 2006, The Philadelphia Inquirer

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Source: The Philadelphia Inquirer

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