Features
| Vivitrol Approved |
| Written by John Worley |
| June 2006 |
For clinicians in the behavioral health fields, the issue of
medication non-compliance has been one that has dogged
practitioners for decades. Studies have shown that failure to
comply with medication regimens, both in psychiatric and
physical medicine, is among the leading causes of treatment
failure.  Studies have also shown that medication non-compliance is significantly greater on the behavioral health side than on the physical side. A research paper on compliance rates, published by two faculty members of the Yale School of Medicine, surveyed compliance studies done in a 20 year period, finding that the mean non-compliance rate for two common types of psychiatric meds was 42 percent. Results on the physical side were much better, with mean non-compliance at 24 percent, but still quite high. And with addiction, studies have shown that poor adherence to medications is strongly correlated to higher relapse rates. It is little wonder, then, with the advances in biotechnological science in recent years, that drug companies would turn their attention to the issue of medication non-compliance, seeking ways to improve the formulation of pharmacotherapies to boost compliance rates. In fact, a growing number of biotech concerns have popped up in the last fifteen years that dedicate themselves primarily to developing “delivery systems” for drugs, often seeking to increase the effectiveness of existing pharmacotherapies by creating long-lasting formulations that obviate the need for daily, or even more frequent, dosing. Among the leading drug delivery developers is Alkermes, which 6 years ago turned its attention to the underdeveloped addiction pharmacotherapy niche, seeking to apply its proprietary Medisorb drug delivery technology to the problem of compliance for drugs in the treatment of addiction. “We are quite convinced now that addiction will more and more become accepted as a chronic medical illness,” says Alkermes CEO Richard Pops, pointing out that he, and others at the Cambridge, MA-based biotech concern, believe that addiction pharmacotherapy is on the cusp of a revolution similar to that which occurred in the psychiatric field beginning in 1980s with the introduction of blockbuster drugs like Prozac and Zoloft, among many others. Alkermes focused its attention on naltrexone, one of just a handful of drugs to ever to be approved specifically to fight addiction. Originally developed in 1963 for substance abuse, naltrexone was approved by the FDA in the 1980s for opiate addiction and later, in 1994, for the treatment of alcoholism. After a series of successful clinical trails, Alkermes was granted “priority review” status by the FDA, recognizing the importance of pushing along approval of drugs for addiction, for which there are so few pharmacological treatments. In April, the FDA granted final approval for After a series of successful clinical trails, Alkermes was Alkermes’s reformulated naltrexone, by now called Vivitrol. Being exclusively a drug developer, Alkermes long recognized the need to find a strong marketing partner for Vivitrol, ultimately signing with one of the most respected and aggressive drug marketers in the U.S., Frazer, PA-based Cephalon Inc. Founded by CEO Frank Baldino Jr., Cephalon has grown from a company with just over $100 million of startup capital in 1987 into a $1.2 billion a year enterprise involved in the development and marketing of a variety of drugs. In June 2005, Cephalon agreed to pay Alkermes an initial payment of $160 million and another $110 million on approval, as well as hundreds of millions more based on sales performance, for the right to market Vivitrol. Like Alkermes’s Pops, Baldino sees plenty of opportunity in the under served marketplace for addiction pharmacology: “This is a market we are examining very closely,” he said, adding that part of the challenge will be that drugs have not often played much of a role in the treatment of addiction, with therapies being overwhelmingly psychosocial in nature. And Baldino certainly recognizes the continued primacy of these types of therapies in treating addiction, pointing out that Vivitrol will be marketed principally as a powerful tool for boosting the success rates of traditional addiction treatment. “People who take naltrexone do significantly better with their treatment,” says Baldino. “And with Vivitrol, compliance is far better, which boosts the success rate even more.”  Expectations are strong that Vivitrol will also be a success financially for both Cephalon and Alkermes. The global market for pharmacotherapies aimed at alcohol is currently estimated to be in the range of $120 million to $140 million annually, but analysts expect sales to ramp up substantially, largely because of Vivitrol. Estimates are that global sales of Vivitrol alone could be between $450 million and $550 million annually by the year 2010. Alkermes and Cephalon haven’t been shy about pricing Vivitrol as a premium product, with the cost of the monthly injection recently set at almost $700.00. Although confessing to sticker shock - naltrexone in pill form costs about $100 a month - centers that make extensive use of naltrexone say they will likely use Vivitrol. “The biggest problem with naltrexone is that our clients often still want to drink and decide not to take their meds for a weekend,” said Terry Bruce, CEO of Savanah-based Assisted Recovery Centers of Georgia, which also uses naltrexone in its opiate treatment efforts, as well as other pharmacotherapies. “The ones that relapse, in our experience here, are usually the ones that haven’t been taking their meds. The long lasting nature of Vivitrol is a major attraction for us. It allows us to make sure our clients are medication compliant.” JW |
