Eisai builds defenses against generic Aricept

The FDA just gave Eisai a new weapon against generic competition for the company's flagship Alzheimer's therapy Aricept by approving a higher-dose form of the drug. And Eisai hopes the new version will keep generic copies from deeply slashing sales of its profitable drug.

The agency gave the nod to a 23-mg Aricept pill, which is meant to be taken once a day. Generic versions of the 10-milligram dose are on their way in November. According to recently released studies, patients using the higher dose got better results than those using the lower dose; patients with more advanced Alzheimer's benefited most from the 23-mg pill, Bloomberg reports.

Eisai, which now partners with Pfizer on Aricept, one of the top patent expirations of 2010, has said it's counting on new forms of Aricept, including this higher-dose version, to keep U.S. sales at half of the current $2 billion or so, once generic competition gathers steam. "Aricept is a key earnings pillar," Credit Suisse analyst Fumiyoshi Sakai, writes in a note to clients, and quoted by Bloomberg. "With the November 2010 patent expiration set to open the way for generic competition, Eisai had been keenly pursuing approval for a higher-dose formulation."

Meanwhile, Eisai has been plotting a manufacturing move to India, aiming to lower production costs for Aricept so that it can cut prices to compete with generics makers. That way, as overall sales drop, it can still make profits off the drug.

- see the joint release on the approval
- read the Bloomberg story