Hoechst, Bayer, Novartis Seek Alzheimer's Cure Amid Setbacks
Bloomberg News
November 4, 1998, 11:01 a.m. ET
Hoechst, Bayer, Novartis Seek Alzheimer's Cure Amid Setbacks
Paris, Nov. 4 (Bloomberg) -- SmithKline Beecham Plc and
Eli Lilly & Co. have pulled the plug. Hoechst AG and Novartis
AG lost the first round of approval. And Bayer AG is
considering what to do, having suffered a setback.
Still, the world's top drugmakers are pressing ahead,
hoping to win the big prize: a treatment for Alzheimer's
disease. While Pfizer Inc.'s Aricept -- the only drug in the
$2 billion market to generate substantial revenue -- works
well in some cases, doctors like Bernard Groulx, who treats
Alzheimer suffers, say they are looking forward to trying
better drugs on their patients. He may have to wait a while.
Drugmakers have long seen big potential in treatments for
Alzheimer's disease -- a debilitating neurological disorder of
unknown origin that causes people to lose their memories and
devolve into infantile states. More than 4 million people are
affected by Alzheimer's in Europe and the U.S., and the market
is expected to surge as people live longer, analysts say.
''With Aricept, you can push back the disease for five or
six years,'' said Groulx, chief of the Department of
Psychogeriatrics at Ste-Anne Veterans Hospital, in Ste-Anne de
Bellevue, Quebec. While patients ''come back alive with the
capacity to feel emotions again,'' Groulx said he still hopes
for newer drugs because Aricept doesn't work in all cases and
sometimes loses effectiveness over a period of months.
Problems, Problems
Both Bayer and Hoechst faced problems in recent months
with their drugs, illustrating the difficulties in developing
safe and effective drugs for disorders of the brain.
Bayer in September suspended all eight clinical trials of
Bilarcil, chemically called metrifonate, after 20 of the 3,000
patients developed what the company described as ''muscle
weakness.'' Bayer earlier forecast Bilarcil would generate
more than $500 million in annual sales.
The Bayer setback was closely followed by another at
German rival Hoechst, whose Viviq drug failed to gain European
approval in October. Hoechst, which previously forecast $400
million in annual sales for the drug, plans to submit more
data to regulators soon.
And those drugmakers aren't alone.
Britain's SmithKline Beecham Plc last spring dropped its
Alzheimer's drug Memric from development in phase-three
clinical trials, the final and most expensive phase of a
drug's development, because it wasn't as effective as it had
hoped. Swiss drugmaker Novartis AG failed this year to get
U.S. Food and Drug Administration approval for Exelon, a new
Alzheimer's drug that is already approved in Europe and
elsewhere, because the FDA wanted more data on the safety of
the drug. Novartis said it plans to comply soon, hoping to
sell Exelon in the U.S., the world's biggest drug market.
And H. Lundbeck A/S, Denmark's third-biggest drugmaker,
in August abandoned a research project on a compound to treat
Alzheimer's disease after phase-two clinical trials.
Even with such setbacks, some doctors at the 11th
European Congress on Neuropsychopharmacology this week say
they are optimistic that better drugs are near.
Foot in the Door
''We now have our foot in the door,'' said Konrad
Beyreuther, director of the Center of Molecular Biology at the
University of Heidelberg. Beyreuther told doctors at one
symposium that said he is ''very optimistic'' that new
treatments will halt the progression of the disease.
''This is very exciting to me,'' Beyreuther said. ''Drugs
like metrifonate do a fantastic job. It's a beautiful drug.''
Alzheimer's, the best-known of a category of diseases
known as dementia, has for years been treated mostly with
antipsychotic medicines, an approach that treats only the
symptoms, not the disease itself. The drugs often have serious
side effects, and many elderly are simply left untreated in
nursing homes. Alzheimer's disease is now the most common
reason for nursing home placement in the U.S., experts say.
Only a few drug companies have so far generated any
substantial revenue in Alzheimer's drugs.
The first was Warner-Lambert Co., which this decade
launched Cognex, the first of a new class of drugs called
acetylcholinsterase inhibitors. The drug slows the breakdown
of acetylcholine, a brain chemical that seems to play an
important role in memory and cognition and is dramatically
reduced in Alzheimer's patients.
Cognex, chemically called tacrine, was hailed as a major
advance, although liver toxicity problems dampened demand.
Sales fell from $51 million in 1994 to $28 million in 1997.
Pfizer Leads
Next came Aricept, now the fastest-growing and leading
drug specifically designed to treat Alzheimer's. Developed by
Japan's Eisai Ltd. and co-marketed by New York-based Pfizer,
Aricept generated $263 million in the first nine months of
1998, double the same period a year ago.
Doctors say they are optimistic Hoechst, Bayer and
Novartis will eventually iron out their difficulties with
Alzheimer's drugs as demand is high. Johnson & Johnson and
others are also vying for a chunk of the market.
According to some estimates, it costs $100 billion a year
in the U.S. in direct and indirect costs for Alzheimer's
treatment, with long-term nursing home care the biggest
expenditure. An effective drug could garner a high price if it
can be shown to keep patients out of nursing care.
Doctors say no one drug will probably win out, however.
Treatment regimes will vary from patient to patient as
understanding about the disease grows, they said. And new anti-
inflammatory drugs in development by Merck & Co. and Monsanto
Co. are set to play a role.
''The brain is so complex, there is no simple way of
stimulating the whole organ,'' said Dick F. Swaab, an
Alzheimer's researcher at the Netherlands Institute for Brain
Research in Amsterdam.
--Dane Hamilton in Paris, through the London newsroom (44-171) |
