Forest Alzheimer's disease agent Namenda (memantine) has 10% off-label use based on early launch data.

"About 90% of its use is in moderate-to-severe patients, 70% moderate and 20% severe," Forest Chief Operating Officer Kenneth Goodman said during an earnings call April 20.

The remaining 10% of Namenda use was off-label in patients diagnosed with mild-to-moderate Alzheimer's disease.

Namenda was approved Oct. 16 for moderate-to-severe Alzheimer's disease. However, the company anticipates submitting an sNDA for mild-to-moderate Alzheimer's disease by "late this summer."

The 10% off-label use suggests that Forest could expect significant sales growth once it is allowed to promote the additional indication.

During the call, Forest also said that it has been pleased by the third-party payor coverage for Namenda during the first full quarter the drug has been on the market.

"I know that it is going through almost every place. There are not a lot of prior [authorization] requirements and certainly not a lot of 'turn-downs,'" Goodman said. "There are no plans that are stopping prescriptions from going through, even though it's not on the plan," he added.

Forest expects that third-party coverage will improve over time.

"But, it's certainly not approved everyplace or on second tier everyplace because it's so new. We're still facing a lot of six month moratoria that takes time," Goodman said. "There are some that require prior authorization work to be done."

Namenda generated $34 mil. in revenues during Forest's fiscal fourth quarter ended March 31.

- Lee Kalowski

Forest Namenda Has 10% Off-Label Use Based On Initial Launch Data

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