Link:
http://www.reuters.c...storyID=3638866Date: 10-17-03
Author: Lisa Richwine
Source: Reuters
Title: US OKs First Drug for Late-Stage Alzheimer's
US OKs First Drug for Late-Stage Alzheimer's Fri October 17, 2003 05:04 PM ET
By Lisa RichwineWASHINGTON (Reuters) - U.S. health officials on Friday approved the first medicine for the late stages of Alzheimer's, the degenerative brain disease that afflicts an estimated 4 million Americans.
Namenda, made by Forest Laboratories Inc., slowed the decline in awareness, reasoning and daily function experienced by patients with moderate to severe Alzheimer's who were treated in clinical trials, the Food and Drug Administration said.
The disease causes a gradual loss of brain cells that results in memory loss and dementia, and can eventually lead to death.
In the studies, most patients' mental and functional ability did deteriorate. But on average those given Namenda were better able to perform tasks such as feeding themselves or dialing a phone than those given a placebo, the FDA said.
Forest said Namenda will address an important medical need because the moderate to severe stages of Alzheimer's can last years.
"It certainly provides a modest, but we think meaningful, benefit," said Charles Triano, Forest's vice president for investor relations.
The drug should be available in January, Triano said.
The FDA action follows last month's unanimous recommendation for approval from an FDA advisory panel. Members of the panel agreed the drug was safe and effective but stressed that benefits appeared limited.
Namenda, known generically as memantine, is the first of a new type of medicines for treating Alzheimer's disease.
Researchers believe Namenda calms overstimulated nerve cells in the brain by blocking activity of the chemical glutamate.
The four other approved Alzheimer's drugs are cleared only for treating mild to moderate forms of the illness, and they also offer modest benefits.
Those drugs, which include Aricept from Pfizer Inc. and Eisai Co Ltd., work by helping to make the chemical acetylcholine more available in the brain. Acetylcholine plays an important role in learning and memory.
In clinical trials, Namenda was used alone or with another Alzheimer's treatment. Side effects were minor and included dizziness, headache and constipation, the FDA said.
Alzheimer's patients, families and caregivers had been waiting for regulatory approval of Namenda. At last month's advisory panel meeting, some said they had sought out supplies of the drug overseas.
Namenda is Forest's most important new drug, analysts have said. SG Cowen expects annual sales to reach up to $800 million, assuming that half of all people treated for Alzheimer's use the drug.
Shares of New York-based Forest Laboratories, also the maker of antidepressants Lexapro and Celexa, gained 46 cents to close at $49.92 on the New York Stock Exchange. (Additional reporting by Jed Seltzer in New York)
Link:
http://www.commentwi...entwire_ID=4936Date: 10-20-03
Author: -
Source: DataMonitor
Title: The FDA has approved Forest Laboratories' Namenda (memantine) for severe Alzheimer's.
Forest: Namenda finally approved for Azheimer'sThe FDA has approved Forest Laboratories' Namenda (memantine) for severe Alzheimer's. October 20, 2003 6:47 PM GMT (Datamonitor) - Namenda is the first drug aimed at treating severe Alzheimer's disease sufferers in the US, and is expected to experience strong uptake in the market. Despite delays to its launch, Namenda will be crucial to the growth of Forest's [FRX] CNS franchise, which includes the blockbuster antidepressant Cipramil.
The Alzheimer's field is becoming increasingly attractive to investors as the effects of an ageing global population take hold. The degenerative brain disease affects over four million elderly in the US alone. At present, Pfizer [PFE]/Eisai [ESALY.PK]'s Aricept (donepezil) is the gold-standard therapy, and has dominated the market since its launch in 1997. Sales of Aricept reached $995 million in 2002.
However, Aricept and other AD drugs are only approved for the treatment of mild to moderate AD in the US. Severe sufferers represent around 20% of the overall AD population, and, until now, this segment has been underserved by approved drug therapy. After a long approval process, Forest's Namenda will finally benefit from 'first-to-market' status in this niche sector. Forest claims Namenda will address an important medical need because the moderate to severe stages of Alzheimer's can last for years. FDA approval follows last month's unanimous recommendation from an FDA advisory panel, which agreed the drug was safe and effective.
Namenda, known generically as memantine, is the first of a new type of medicines for treating Alzheimer's disease. Researchers believe Namenda calms overstimulated nerve cells in the brain by blocking activity of the chemical glutamate.
However, from clinical data, it is unclear whether Namenda offers an improved ability to alleviate cognitive deficits compared to existing therapies. Potential beneficial effects are therefore unlikely to be great, although the drug is well tolerated. For example, Namenda is not as effective as Aricept at treating cognitive impairments. It is this lack of perceived cognitive efficacy that forced Forest to voluntarily withdraw its initial New Drug Application in September 2002.
Nevertheless, the fact that Forest will market the drug in the US (Lundbeck [LUN.CO] will market the drug under the brand Ebixa in Europe) will strongly enhance the sales potential of Namenda. Forest's strength in the CNS pharmaceutical arena is exemplified by the company's success in the multibillion-dollar antidepressant market with Cipramil (citalopram).