NeoTherapeutics to Begin Alzheimer’s Drug Studies

NeoTherapeutics Inc. is planning a pivotal study in developing its lead drug compound, Neotrofin, to combat Alzheimer’s disease.

The Irvine biopharmaceutical company said the study, set to start in April, will test whether a higher dose of Neotrofin counters Alzheimer’s symptoms, particularly memory loss, over 12 weeks. The study would be completed by the end of the year, assuming no enrollment delays.

Later this year, the company plans a second, longer study to evaluate whether a year of Neotrofin can modify the course of Alzheimer’s.

“Our first focus is to get the [new drug application] filed for symptomatic treatment in the shortest time frame possible,” said Jacob Huff, NeoTherapeutics vice president of medical affairs.

The strategy is to get Neotrofin onto the market quickly so it can begin to compete with rivals Aricept from Pfizer Inc. and Eisai Ltd., and Exelon from Novartis AG in treating the 4 million Americans who suffer from Alzheimer’s.

NeoTherapeutics President Rajesh Shrotriya said it would take about two years to get Neotrofin’s first approval. He expects Neotrofin could be approved one or two years later.

The company’s stock, which has been battered over the past year, moved up nearly 14%, or 34 cents a share, Monday to $2.78 on Nasdaq volume of 822,300 shares, nearly five times the average daily volume over the last three months. Still, the shares have lost 76% of their value over the past year.

Even though it plans to establish its own small sales force, NeoTherapeutics wants to find a marketing partner in the U.S.

“To get the most out of the drug quickly, we want the help of a major pharmaceutical company,” said Shrotriya, adding that NeoTherapeutics is talking to a number of firms.

The company also is setting its sights overseas, where 8 million people suffer from the disease.

NeoTherapeutics intends to file with European authorities soon after its U.S. submission and is seeking a licensing partner to launch Neotrofin in Europe, Shrotriya said.

The company also is talking to a Japanese firm to help develop a registration and launch strategy there.