US-ZULASUNG FÜR REMINYL!!!!! (Sanochemia ist der Wirkstoffproduzent!!!) - 500 Beiträge pro Seite

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Das hab ich heut in der nacht reingestellt ins austrostocks-board...*g*
für alle, die noch nicht bei austrostocks reingeschaut haben:
http://www.austrostocks.com/aus_index.epl?forum=1&fo_gruppen…

hier der vollständige bericht über reminyl bezüglich us-zulassung, gefunden bei johnson & johnson:

Receives FDA Approval

REMINYL® Derived from the Daffodil

Titusville, NJ (February 28, 2001) -- REMINYL® (galantamine
hydrobromide) -- a new treatment for mild to moderate Alzheimer’s
disease derived from the bulbs of daffodils -- was approved today
by the U.S. Food and Drug Administration (FDA).

Data from four placebo-controlled, double-blind clinical trials
involving more than 2,650 patients show that REMINYL® can have
a beneficial effect on patients’ daily function and ability to think. To
be available by prescription in May, REMINYL® was developed by
the Janssen Research Foundation under a co-development and
licensing agreement with the UK-based Shire Pharmaceuticals
Group plc.

An estimated four million Americans have Alzheimer’s disease -- a
progressive loss of cognitive function (thinking, remembering and
reasoning) so severe that it interferes with an individual’s ability to
function. That number is expected to grow to 14 million by the
middle of the next century. The disorder is the third-most-expensive
illness in the United States, behind only heart disease and cancer.

“Alzheimer’s disease patients progressively deteriorate,” says Gary
Small, MD, director of the Center on Aging and professor of
psychiatry and biobehavioral sciences at the University of California
in Los Angeles. “But the studies show that REMINYL® can
benefit many individuals with the disease. In studies lasting up to six
months, many patients’ symptoms initially improved or stabilized,
and even when they begin to decline, they remained better than
those who were treated with placebo.”

In studies ranging from 12 to 26 weeks, the effectiveness of
REMINYL® was measured using two primary tools. Patients`
abilities related to memory, orientation, reasoning and language
were assessed using the cognitive portion of the Alzheimer’s
Disease Assessment Scale (ADAS-cog). Across all studies, the
results consistently demonstrated that more patients taking
REMINYL® showed significant improvement in their cognitive
performance than those receiving placebo (inactive medication).

The second primary measure of effectiveness was the Clinician’s
Interview-Based Impression of Change plus Caregiver Information
(CIBIC-plus), which provides an overall assessment of patient
functioning -- including behavior, organized thinking and activities of
daily living (such as dressing, eating and managing family finances).
The CIBIC-plus results from all studies also showed that the overall
scores for patients taking REMINYL® were statistically superior to
placebo.

REMINYL® will be available in 4 mg, 8 mg or 12 mg tablets. It
should be taken by patients twice a day, preferably with meals. The
approved product labeling recommends that physicians start by
prescribing 8 mg of REMINYL® per day (in two divided doses),
then increase the dose to 16 mg after at least four weeks.
Physicians have the flexibility to increase the daily dose to 24 mg
after an additional four weeks.

With this recommended dosing regimen, the percentage of patients
who dropped out of the clinical research due to side effects after
taking REMINYL® (seven to 10 percent) was comparable to the
discontinuation rate for individuals receiving placebo (seven
percent). Overall, the most common side effects experienced by
patients who followed the recommended schedule for REMINYL®
were primarily gastrointestinal in nature. Side effects that occurred
in five percent or greater of patients included nausea, vomiting,
anorexia, diarrhea and weight loss.

“REMINYL® is a major addition to Janssen’s growing CNS
(central nervous system) franchise. We are committed to improving
the lives of both Alzheimer’s disease patients and their caregivers,”
says Luc Truyen, MD, PhD, global medical leader for REMINYL®
with the Janssen Research Foundation. “In fact, support for family
caregivers will be an important element of the educational programs
we will initiate in conjunction with the introduction of
REMINYL®.”

REMINYL® also has been approved in 21 other countries to date,
including most major European markets. REMINYL® will be
marketed by Janssen Pharmaceutica and Ortho-McNeil
Pharmaceutical in the United States, Janssen-Ortho in Canada
(approval pending) and Janssen-Cilag elsewhere -- with the
exception of the United Kingdom and Ireland, where it is registered
and marketed by Shire under a co-promotion agreement with
Janssen-Cilag.

Janssen Pharmaceutica Products, L.P., is a wholly owned
subsidiary of Johnson & Johnson with a long track record in
developing and marketing treatments for central nervous system
disorders. Other specialty areas include pain management,
treatment of fungal infections and therapy for gastrointestinal
conditions. More information on the company can be found at
www.us.janssen.com.

Shire Pharmaceuticals Group plc is an international specialty
pharmaceutical company with a strategic focus on four therapeutic
areas: central nervous system disorders, metabolic diseases,
oncology and gastroenterology. The group has a sales-and-
marketing infrastructure with a broad portfolio of products. On
December 11, Shire entered into an agreement to merge with
BioChem Pharma Inc. to form a leading global specialty
pharmaceutical company. More information on the company can be
found at www.shire.com.


******************************************************************************************************

Sanochemia hält sich ja recht gut...gegen den Trend...mal sehen, wann die Adhoc von Sanochemia kommt...die haben wohl noch
gefrühstückt...*g*

hier der vollständige bericht über reminyl bezüglich us-zulassung, gefunden bei johnson & johnson:

Receives FDA Approval

REMINYL® Derived from the Daffodil

Titusville, NJ (February 28, 2001) -- REMINYL® (galantamine
hydrobromide) -- a new treatment for mild to moderate Alzheimer’s
disease derived from the bulbs of daffodils -- was approved today
by the U.S. Food and Drug Administration (FDA).

Data from four placebo-controlled, double-blind clinical trials
involving more than 2,650 patients show that REMINYL® can have
a beneficial effect on patients’ daily function and ability to think. To
be available by prescription in May, REMINYL® was developed by
the Janssen Research Foundation under a co-development and
licensing agreement with the UK-based Shire Pharmaceuticals
Group plc.

An estimated four million Americans have Alzheimer’s disease -- a
progressive loss of cognitive function (thinking, remembering and
reasoning) so severe that it interferes with an individual’s ability to
function. That number is expected to grow to 14 million by the
middle of the next century. The disorder is the third-most-expensive
illness in the United States, behind only heart disease and cancer.

“Alzheimer’s disease patients progressively deteriorate,” says Gary
Small, MD, director of the Center on Aging and professor of
psychiatry and biobehavioral sciences at the University of California
in Los Angeles. “But the studies show that REMINYL® can
benefit many individuals with the disease. In studies lasting up to six
months, many patients’ symptoms initially improved or stabilized,
and even when they begin to decline, they remained better than
those who were treated with placebo.”

In studies ranging from 12 to 26 weeks, the effectiveness of
REMINYL® was measured using two primary tools. Patients`
abilities related to memory, orientation, reasoning and language
were assessed using the cognitive portion of the Alzheimer’s
Disease Assessment Scale (ADAS-cog). Across all studies, the
results consistently demonstrated that more patients taking
REMINYL® showed significant improvement in their cognitive
performance than those receiving placebo (inactive medication).

The second primary measure of effectiveness was the Clinician’s
Interview-Based Impression of Change plus Caregiver Information
(CIBIC-plus), which provides an overall assessment of patient
functioning -- including behavior, organized thinking and activities of
daily living (such as dressing, eating and managing family finances).
The CIBIC-plus results from all studies also showed that the overall
scores for patients taking REMINYL® were statistically superior to
placebo.

REMINYL® will be available in 4 mg, 8 mg or 12 mg tablets. It
should be taken by patients twice a day, preferably with meals. The
approved product labeling recommends that physicians start by
prescribing 8 mg of REMINYL® per day (in two divided doses),
then increase the dose to 16 mg after at least four weeks.
Physicians have the flexibility to increase the daily dose to 24 mg
after an additional four weeks.

With this recommended dosing regimen, the percentage of patients
who dropped out of the clinical research due to side effects after
taking REMINYL® (seven to 10 percent) was comparable to the
discontinuation rate for individuals receiving placebo (seven
percent). Overall, the most common side effects experienced by
patients who followed the recommended schedule for REMINYL®
were primarily gastrointestinal in nature. Side effects that occurred
in five percent or greater of patients included nausea, vomiting,
anorexia, diarrhea and weight loss.

“REMINYL® is a major addition to Janssen’s growing CNS
(central nervous system) franchise. We are committed to improving
the lives of both Alzheimer’s disease patients and their caregivers,”
says Luc Truyen, MD, PhD, global medical leader for REMINYL®
with the Janssen Research Foundation. “In fact, support for family
caregivers will be an important element of the educational programs
we will initiate in conjunction with the introduction of
REMINYL®.”

REMINYL® also has been approved in 21 other countries to date,
including most major European markets. REMINYL® will be
marketed by Janssen Pharmaceutica and Ortho-McNeil
Pharmaceutical in the United States, Janssen-Ortho in Canada
(approval pending) and Janssen-Cilag elsewhere -- with the
exception of the United Kingdom and Ireland, where it is registered
and marketed by Shire under a co-promotion agreement with
Janssen-Cilag.

Janssen Pharmaceutica Products, L.P., is a wholly owned
subsidiary of Johnson & Johnson with a long track record in
developing and marketing treatments for central nervous system
disorders. Other specialty areas include pain management,
treatment of fungal infections and therapy for gastrointestinal
conditions. More information on the company can be found at
www.us.janssen.com.

Shire Pharmaceuticals Group plc is an international specialty
pharmaceutical company with a strategic focus on four therapeutic
areas: central nervous system disorders, metabolic diseases,
oncology and gastroenterology. The group has a sales-and-
marketing infrastructure with a broad portfolio of products. On
December 11, Shire entered into an agreement to merge with
BioChem Pharma Inc. to form a leading global specialty
pharmaceutical company. More information on the company can be
found at www.shire.com.


******************************************************************************************************

Sanochemia hält sich ja recht gut...gegen den Trend...mal sehen, wann die Adhoc von Sanochemia kommt...die haben wohl noch
gefrühstückt...*g*
hier der vollständige bericht über reminyl bezüglich us-zulassung, gefunden bei johnson & johnson:

Receives FDA Approval

REMINYL® Derived from the Daffodil

Titusville, NJ (February 28, 2001) -- REMINYL® (galantamine
hydrobromide) -- a new treatment for mild to moderate Alzheimer’s
disease derived from the bulbs of daffodils -- was approved today
by the U.S. Food and Drug Administration (FDA).

Data from four placebo-controlled, double-blind clinical trials
involving more than 2,650 patients show that REMINYL® can have
a beneficial effect on patients’ daily function and ability to think. To
be available by prescription in May, REMINYL® was developed by
the Janssen Research Foundation under a co-development and
licensing agreement with the UK-based Shire Pharmaceuticals
Group plc.

An estimated four million Americans have Alzheimer’s disease -- a
progressive loss of cognitive function (thinking, remembering and
reasoning) so severe that it interferes with an individual’s ability to
function. That number is expected to grow to 14 million by the
middle of the next century. The disorder is the third-most-expensive
illness in the United States, behind only heart disease and cancer.

“Alzheimer’s disease patients progressively deteriorate,” says Gary
Small, MD, director of the Center on Aging and professor of
psychiatry and biobehavioral sciences at the University of California
in Los Angeles. “But the studies show that REMINYL® can
benefit many individuals with the disease. In studies lasting up to six
months, many patients’ symptoms initially improved or stabilized,
and even when they begin to decline, they remained better than
those who were treated with placebo.”

In studies ranging from 12 to 26 weeks, the effectiveness of
REMINYL® was measured using two primary tools. Patients`
abilities related to memory, orientation, reasoning and language
were assessed using the cognitive portion of the Alzheimer’s
Disease Assessment Scale (ADAS-cog). Across all studies, the
results consistently demonstrated that more patients taking
REMINYL® showed significant improvement in their cognitive
performance than those receiving placebo (inactive medication).

The second primary measure of effectiveness was the Clinician’s
Interview-Based Impression of Change plus Caregiver Information
(CIBIC-plus), which provides an overall assessment of patient
functioning -- including behavior, organized thinking and activities of
daily living (such as dressing, eating and managing family finances).
The CIBIC-plus results from all studies also showed that the overall
scores for patients taking REMINYL® were statistically superior to
placebo.

REMINYL® will be available in 4 mg, 8 mg or 12 mg tablets. It
should be taken by patients twice a day, preferably with meals. The
approved product labeling recommends that physicians start by
prescribing 8 mg of REMINYL® per day (in two divided doses),
then increase the dose to 16 mg after at least four weeks.
Physicians have the flexibility to increase the daily dose to 24 mg
after an additional four weeks.

With this recommended dosing regimen, the percentage of patients
who dropped out of the clinical research due to side effects after
taking REMINYL® (seven to 10 percent) was comparable to the
discontinuation rate for individuals receiving placebo (seven
percent). Overall, the most common side effects experienced by
patients who followed the recommended schedule for REMINYL®
were primarily gastrointestinal in nature. Side effects that occurred
in five percent or greater of patients included nausea, vomiting,
anorexia, diarrhea and weight loss.

“REMINYL® is a major addition to Janssen’s growing CNS
(central nervous system) franchise. We are committed to improving
the lives of both Alzheimer’s disease patients and their caregivers,”
says Luc Truyen, MD, PhD, global medical leader for REMINYL®
with the Janssen Research Foundation. “In fact, support for family
caregivers will be an important element of the educational programs
we will initiate in conjunction with the introduction of
REMINYL®.”

REMINYL® also has been approved in 21 other countries to date,
including most major European markets. REMINYL® will be
marketed by Janssen Pharmaceutica and Ortho-McNeil
Pharmaceutical in the United States, Janssen-Ortho in Canada
(approval pending) and Janssen-Cilag elsewhere -- with the
exception of the United Kingdom and Ireland, where it is registered
and marketed by Shire under a co-promotion agreement with
Janssen-Cilag.

Janssen Pharmaceutica Products, L.P., is a wholly owned
subsidiary of Johnson & Johnson with a long track record in
developing and marketing treatments for central nervous system
disorders. Other specialty areas include pain management,
treatment of fungal infections and therapy for gastrointestinal
conditions. More information on the company can be found at
www.us.janssen.com.

Shire Pharmaceuticals Group plc is an international specialty
pharmaceutical company with a strategic focus on four therapeutic
areas: central nervous system disorders, metabolic diseases,
oncology and gastroenterology. The group has a sales-and-
marketing infrastructure with a broad portfolio of products. On
December 11, Shire entered into an agreement to merge with
BioChem Pharma Inc. to form a leading global specialty
pharmaceutical company. More information on the company can be
found at www.shire.com.


******************************************************************************************************

Sanochemia hält sich ja recht gut...gegen den Trend...mal sehen, wann die Adhoc von Sanochemia kommt...die haben wohl noch
gefrühstückt...*g*

[Edeluser]

Die WKN?????

[OesiStockpicker]

WKN 919963!

[Edeluser]

Danke Dir


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