National Editor

Alkermes Inc. at last reached the hoped-for pot of gold at the end of the regulatory rainbow with FDA approval of Risperdal Consta (risperidone), the long-acting schizophrenia drug.

Janssen Pharmaceutica Products LP, a subsidiary of Alkermes partner Johnson & Johnson, of New Brunswick, N.J., will market the drug, launching it "aggressively over the next few weeks," said Richard Pops, CEO of Cambridge, Mass.-based Alkermes, with pricing yet to be disclosed.

"This is a really important brand for them, because Risperdal oral tablets is Janssen's major product," Pops said, adding the company has "had great experience with [Risperdal Consta]" outside the U.S.

Wall Street was nonplussed by the expected approval, as the company's stock (NASDAQ:ALKS) fell 99 cents Thursday to close at $12.74. But the first half of October saw the shares rising to around $15.50 in anticipation of the FDA nod.

"It's extremely difficult to measure these things in single days," Pops said. "This is a huge positive for the company. Whether people buy or sell on the news, we don't pay a whole lot of attention."

Already approved in more than 40 countries, Risperdal Consta is injected once every two weeks. The less-frequent dosing is considered a major boon since getting patients to take their oral medication on schedule has been a challenge.

"Outcomes are better for these patients as well," Pops told BioWorld Today, which suggests that non-compliance might be higher than suspected, and that risperidone confers a specific benefit when injected.

He noted that literature on asthma patients, who get almost immediate results from their medications, shows non-compliance as high as 40 percent to 50 percent.

"It stands to reason the compliance would be even lower [with a schizophrenia drug]," Pops said.

Risperdal Consta itself has faced challenges in the U.S., where Alkermes and partner Johnson & Johnson Pharmaceutical Research & Development LLC submitted a new drug application in August 2001 and received a non-approvable letter the following June.

Alkermes didn't specify the agency's concerns, but the company's stock dropped $10.86 on the news, or 67.8 percent, to close at $5.15. In April, the firm submitted a complete response letter, addressing the FDA's questions. (See BioWorld Today, April 30, 2003.)

Pops declined to talk about the FDA's questions.

"It's kind of old news by now," he said, adding that the response "really, from whole cloth, articulated the clinical need and the data that had been generated clinically and preclinically" for the drug.

Risperdal Consta uses Alkermes' Medisorb drug delivery technology, which encapsulates active medication into polymer-based microspheres that are injected into the body, where they degrade to release the drug at a controlled rate.

Medisorb technology also is used in Vivitrex, an injectable form of naltrexone, which is in Phase III trials for alcoholism and opiate abuse, with results expected early next year.