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Biotech / Medical : Neuroscience -- Ignore unavailable to you. Want to Upgrade?

To: Jim Oravetz who wrote (256)	8/27/2003 12:30:02 PM
From: Jim Oravetz	Read Replies (1) \| Respond to of 278

Checkup: Alzheimer's Disease By Jennifer Saranow Memantine Forest Laboratories Inc. Pending at FDA Phenserine Axonyx Inc. Phase III Trial Huperzine-A Savient Pharmaceuticals Inc. Phase I/II Trial Overview The condition: Alzheimer's Disease, the leading cause of dementia and memory loss, affects about four million Americans and is expected to affect 14 million by 2050. What's interesting about the condition: Alzheimer's has no known cause or cure. Current drugs can treat symptoms of mild-to-moderate cases, but can't slow down the progression of the disease, which stems from brain-cell loss. Currently prescribed drugs such as Aricept, Exelon and Reminyl, which are taken orally, work to increase concentrations of the neurotransmitter acetylcholine, which is important for memory. Side effects include nausea, diarrhea, vomiting and dizziness. What's in the pipeline: Companies are pursuing drugs they hope will slow or halt the progression of the disease. One drug approved in Europe is before the Food and Drug Administration now. Memantine/ Forest Laboratories Inc. (Pending at FDA) Medical Benefit: Memantine, approved by the European Union in 2002 for moderate-to-severe Alzheimer's, is said to block the effects of the neurotransmitter glutamate that may be involved in the death of neurons important for memory. It's taken orally in pill form. Side effects of dizziness, headache and constipation are said to be mild compared with drugs already on the market. Company Benefit: Forest, which has marketing rights for the drug in the U.S., says it could become a significant part of sales. Forest posted net sales of $2.21 billion for the year ended March 31. Corey Davis, an analyst at J.P. Morgan, predicts the drug will post sales of $100 million in 2004, $300 million in 2005 and $500 million in 2005, eventually climbing to a billion-dollar drug. Timing: Forest filed an application for approval with the FDA in January. If the drug is approved, Forest expects it will be on the market in the first half of 2004. Phenserine/ Axonyx Inc. (Phase III) Medical Benefit: Phenserine is taken orally and acts on acetylcholine like existing drugs, but may have fewer side effects. The company is also working to show that the drug may help prevent the death of brain cells involved in memory, which could slow the progression of the disease. However, those studies are less advanced. Company Benefit: Axonyx is a biopharmaceutical company that acquires and develops drugs primarily involved in memory and cognition. If Phenserine meets expectations, licensing could help Axonyx post a profit for the first time, said Marvin Hausman, chairman and CEO. Matt Kaplan, an analyst with Punk, Ziegel & Co. in New York, says Phenserine could make $300 million annually two-to-three years after approval and has the potential to be a billion-dollar drug if it does slow the disease's progression. Timing: A human trial is under way in Europe and Axonyx expects to begin a Phase III study in the U.S. by the end of the year. Huperzine-A/ Savient Pharmaceuticals Inc. (Phase I/II) Medical Benefit: Early data suggest that Huperzine-A, which is taken orally, could decrease brain-cell death caused by toxic levels of glutamate. The drug is also believed to act on the neurotransmitter acetylcholine like existing drugs, which alleviate symptoms. Company Benefit: Savient, which has been profitable since 1995, acquired marketing rights for Huperzine-A in July from N.Y.-based Marco Hi-Tech JV Ltd. through an equity investment. The companies would split profits, they said. Rights revert back to Marco if Savient decides not to pursue development after a Phase II trial, expected to be substantially funded by a National Institutes of Health grant. Macro said it would pursue development in that case. The modest investment for Savient could turn out to be beneficial if the drug meets its potential, says Andrew Scott, an analyst with the Maxim Group LLC in New York. Timing: Savient plans to begin a Phase II study toward the end of the year or the beginning of next year, the company says. WSJ online 8/27/03