Addiction’s BioPharmas

Despite the Treatment Field’s “Pharmacophobia,” BioPharmas Target New Therapies for Addiction

Several years ago, Richard Pops took the time to look closely at the state of the addiction treatment field, and what he saw was opportunity.

Then CEO of drug delivery powerhouse Alkermes Inc., Pops – who early last month ascended to the chairmanship of the company, with former COO David Broecker moving up into the CEO post – began to realize that the company’s long lasting Medisorb drug delivery technology might fit ideally within an addiction pharmaceutical treatment context.

Having seen the extent to which doctors underreported medication non-compliance in the case of medicines for schizophrenia – Alkermes’ sales of Risperdal Consta, a long lasting version of Risperdal sold in conjunction with Johnson & Johnson, are currently soaring based on reports of the formulation’s effectiveness – Pops suspected a similar situation existed for addiction medicines.

It was a situation he felt Alkermes was uniquely suited to address: “In alcohol dependence, we were convinced that the pharmacology was sound,” Pops says. “We were confident in the science indicating that blocking brain opioid receptors could lead to reduced drinking and increased abstinence.”

It was thus that, last spring, the FDA approved Alkermes’ Vivitrol, a long lasting formulation of the opioid receptor blocker naltrexone, and one of the few medications ever to be specifically approved for the treatment of addiction.

Not understanding the long lead times required for introducing new addiction medications to the market – an example of this is Reckitt Benckiser’s Suboxone, which was slow to take off initially, but is now a bestseller – Wall Street analysts have been disappointed in Vivitrol sales so far. But that has not deterred Alkermes, according to the company’s new CEO.

Good Results

“The results we are getting clinically with Vivitrol are outstanding,” says Broecker. “We know this drug works, and because of this we are confidant sales will continue to steadily increase.” And Alkermes remains very strongly committed to the $2 billion a year addiction pharmacotherapy niche, a niche that biotech analysts like London-based Spectra Intelligence expect will grow by 50 percent over the next five years. “We have a fundamental commitment to addiction pharmacotherapy,” Broecker says. And, indeed, Alkermes is proving this by making a big commitment of its considerable resources – the company has a cash stockpile of almost $300 million – to developing new pharmacological treatments for addiction. Alkermes announced in early March that it is proceeding with Phase 1/2 trials of its ALKS 29 drug, an undisclosed oral compound for the treatment of alcoholism, and the company is exploring opportunities with other compounds it has licensed.

Small Fraternity

Alkermes has thus joined the small fraternity of drug makers who have decided to make a specialty of the underserved addiction pharmacotherapy niche.

Late last year, Reckitt Benckiser President Shaun Thaxter told Treatment Magazine that Reckitt will continue to focus exclusively on the addictions niche and that the company was looking beyond Suboxone for new treatments, although he declined to give details. In Europe, France’s Drug Abuse Sciences specializes entirely in addiction therapies, and others like the U.K’ s Xenova and Finland’s BioTie are also seeking to develop specialty addiction franchises.

And here in the U.S., in late 2006, Catalyst Pharmaceutical Partners of Coral Gables, FL, undertook what is probably the first ever specialty addiction biopharmaceutical IPO, with investors backing Catalyst’s play to commercialize a promising compound called Vigabatrin.

In early November, Catalyst launched its IPO, raising $20 million, after what its co-founder said was a difficult period of selling the company to investors, a fact that was reflected in Catalyst’s need to cut by about half the price at which it had initially hoped to sell its shares. “There is no question it was a tough sell,” says Patrick McEnany, Catalyst’s CEO and co-founder, who as an investment banker helped fund generics pioneer Royce Laboratories, which he later had to come and save from bankruptcy as CEO due to the mismanagement of the company by its founders who had, ironically, succumbed to the disease of addiction. Catalyst’s other co-founder is Hubert Huckel, a veteran of German chemicals and pharmaceuticals giant Hoechst, who was chairman of the pharmaceuticals company Hoechst USA, which is now part of Sanofi-Aventis, when he retired.

Catalyst has been granted “fast track” status by the FDA for its investigations into Vigabatrin, which the agency has often done for other pharmaceutical companies that are conducting trials for addiction medications – including giving a similar designation to Alkermes with Vivitrol – recognizing an urgent need where there are so few treatments. The key scientific heft behind Catalyst can be found on its scientific advisory board in the form of two members who are credited as the discoverers of Vigabatrin’s potential as an addiction remedy, Stephen Dewey and Dr. Jonathan Brodie. Both these men have been working for years at Brookhaven National Laboratory, where they did tests on a series of compounds, including Vigabatrin, thought to be potentially useful in treating addiction and for which Brookhaven holds use patents that have now been licensed exclusively to Catalyst for commercialization of potential addiction remedies.

While Catalyst believes that Vigabatrin may be effective across addictions to a wide variety of addictive substances, the company is focusing its efforts initially on cocaine and methamphetamine, for which promising open label studies have been conducted by Dr. Brodie and colleagues in Mexico.

As there are currently no approved medications for the treatment of addiction to cocaine or methamphetamine, McEnany believes this is where the best market opportunity exists for Vigabatrin in the near term. But Hythiam Inc. believes its Prometa Protocol, which the company has been promoting heavily, is also highly efficacious in treating addiction to cocaine and methamphetamine, with scientifically rigorous double blind placebo trial results on Prometa expected by late 2007. Of course, Catalyst will be conducting its own double blind placebo trials on Vigabatrin, which McEnany expects will begin this quarter. “We plan on beginning Phase 2 trials on cocaine in the second quarter, and will begin Phase 2 trials for methamphetamine in the third quarter,” says McEnany. But initiation of clinical trials is, of course, no guarantee of ultimate success, as McEnany knows. “We are confident of success, though,” he says. “The initial data on Vigabatrin is among the most promising I have seen on any compound.”

Promising, also, was data on a compound called nalmefene, which Somaxon Pharmaceuticals, also a recent IPO, thought would be highly efficacious for treating behavioral addictions such as gambling, sex and shopping. Analysts were equally enthusiastic, with Spectra Intelligence forecasting a potential $400 million a year market for Somaxon’s new drug. But in December, Somaxon announced highly disappointing results from Phase 2 trials, with nalmefene performing poorly against placebo. Nalmefene has thus, at least in the context of gambling, joined the growing list of compounds that were once thought to be promising in an addiction treatment context, but that nevertheless ultimately failed to breach the critical double blind placebo hurdle.