* Baxter to stop late-stage studies of the drug for mild to
* Drug failed to reduce decline of cognitive functions
* Drug failed to preserve functional abilities of patients
* Shares down 3 percent
By Julie Steenhuysen
NEW YORK, May 7 In a blow for Alzheimer's
patients, Baxter International Inc said it will scrap
late-stage trials of its antibody treatment for the disease
after the drug failed to improve cognitive decline and
functional ability in patients.
Baxter's treatment, known as Gammagard, did show a benefit
in some patients with moderate disease and in those who are
carriers of a gene known as ApoE4 that raises the risk of
Alzheimer's. The company said it will continue to analyze
results in these populations, but more trials would be needed to
support the drug's approval.
An earlier study of the treatment released last summer
showed the drug help stabilize the disease in four patients for
at least three years, raising hope that the drug from Baxter
International Inc will prove effective in larger trials. Most
Alzheimer's patients typically decline over three to six months.
There are no licensed drugs that can slow the progression of
Alzheimer's, and currently approved medications only treat
Shares of Baxter fell 3.29 percent, or $3.32, to $67.99 in
morning trading on the New York Stock Exchange.
Gammagard was the only remaining drug in late-stage
development for Alzheimer's, a brain-wasting disease that slowly
robs patients of their ability to think and care for themselves.
After 18 months of treatment, patients with mild to moderate
Alzheimer's disease taking the drug failed to show a significant
benefit on scales of cognitive decline and functional ability
compared with those taking a placebo, missing the study's two
Dr. Norman Relkin of Weill Cornell Medical College, who led
the study, said in a telephone interview that were "some
significant findings" in another dementia screening test known
as the modified mini-mental state in a subgroup of patients who
were ApoE4 carriers.
"There were also trends of significance looking at patients
with moderate versus mild disease," he said.
Relkin said the study reflects a "very different type of
result" than seen in most other phase 3 trials of
immunotherapies, including results of Eli Lilly & Co's
treatment solanezumab and Pfizer and Johnson & Johnson's
bapineuzumab, both of which seemed to show an effect in
patients with mild disease.
However, none of the secondary endpoints in these groups
showed a statistically significant difference. Relkin said the
results are worth further study.
Based on the results, Baxter will reconsider its Alzheimer's
program and will determine next steps after full data analyses,
it said in a statement on Tuesday. The company
said it is not changing its financial guidance for 2013.
"We are currently re-evaluating our approach," Ludwig
Hantson, president of Baxter's bioscience business, said on a
conference call. Hantson said the company will present full data
from the study at the Alzheimer's Association International
Conference in July in Boston.
"While the headline is disappointing, we believe
expectations were low, and this may prove a clearing event for
the stock," said BMO analyst Joanne Wuensch in a note to
Although there was no response to the drug at the lower 200
mg dose, Wuensch said the full results may show whether there
was any response the higher, 400 mg dose.
Baxter said it was likely to make a decision about moving
forward by year's end.
Gammagard is an intravenous immune system treatment made
from natural antibodies taken from young, healthy blood donors.
Known generically as intravenous immunoglobulin, or IVIG, the
therapy is typically used to fight infections in patients with
weakened immune systems.
In the trials, there were 17 serious adverse reactions
considered to be treatment-related in the study, but Hantson
said the study was generally well tolerated.
Alzheimer's is the most common form of dementia and the
sixth leading cause of death in the United States. An estimated
5 million Americans are believed to have the disease. An
estimated 38 million people worldwide are believed to have
dementia, including Alzheimer's disease.