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lifting to satisfy the FDA. The company has been long known for making money on producing and licensing its drug-delivery micro-spheres made of biodegradable polymers—designed to extend the duration and improve the stability of a drug in a patient’s system—for other companies such as J&J. Yet in recent years the firm has put more emphasis on developing its pipeline of experimental drugs. Some of those drugs include its anti-addiction treatment ALKS 33, ALKS 37 for opioid-induced constipation, and its experimental schizophrenia drug ALKS 9070.
“We have a major economic interest in Bydureon,” Pops says, “but we also have this really robust pipeline that’s been shaping up over the past couple of years with 33, 37, 9070, and some others.”
Last month, the company reported positive results of a Phase I study of ALKS 33, which patients took in combination with buprenorphine for treating cocaine addiction. The plan is to advance the combination therapy into mid-stage clinical trials in the first half of next year with the help of a $2.4 million grant from the National Institute on Drug Abuse.
Over the next year, Alkermes will be able to say whether some of these experimental drugs will continue down the path to FDA approval. The firm plans to report the results of an ongoing Phase II trial of ALKS 37 for opioid-induced constipation in the first half of next year. Also in the first half of next year, the firm plans to report the results of a Phase I clinical trial of ALKS 9070, a long-acting formulation of the blockbuster schizophrenia drug aripiprazole (Abilify). (Otsuka Pharmaceutical of Japan discovered the drug, which is marketed in the U.S. by Bristol-Myers Squibb (NYSE:BMY).)
Importantly, the ALKS 9070 formulation is also the company’s first clinical candidate to use its LinkeRx technology, which is intended to extend the duration of a therapy in the bloodstream while being simpler to manufacture than previous extended-release drug technology. (Pops explained the intended advantages of the drug-delivery technology to Luke early this year.) The firm’s second drug candidate to use the LinkeRx technology is ALKS 7921, which is intended to be a once-per-month injection of the schizophrenia drug olanzapine (marketed by Eli Lilly as Zyprexa). The firm plans to begin human testing of the drug next year.
Boston-based investment firm Leerink Swann said in a note to investors last month that Alkermes has “an interesting and diverse early stage pipeline that could result in relatively near-term partnerships.” (Like many others, Leerink thinks that the FDA will eventually approve Bydureon.)
Yet the way Pops sees it, Wall Street isn’t really factoring Alkermes’s early-stage programs very much into its estimates of how much the company is worth. (The firm, which had $178.3 million in total revenue for its fiscal 2010, had a market cap of nearly $1.1 billion and a share price of $11.13 at the close of the market on Friday, November 12). But given the pause in the Bydureon story, the CEO says, it’s a good time to take a closer look at the company’s future prospects for revenue growth.