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Aventis Pharma and Vertex Pharmaceuticals to Expand Development of Pralnacasan, Oral Cytokine Inhibitor for Inflammatory Diseases Clinical Proof-of-Mechanism and Good Tolerability for 24 Weeks Indicated in Phase II Rheumatoid Arthritis Clinical Trial
BRIDGEWATER, N.J., and CAMBRIDGE, Mass., Apr 24, 2002 /PRNewswire-FirstCall via
COMTEX/ -- Aventis Pharma (NYSE: AVE) and Vertex Pharmaceuticals Incorporated
(Nasdaq: VRTX) today announced that they are expanding clinical development of
the interleukin-1 beta converting enzyme inhibitor pralnacasan, based on
clinical proof-of-mechanism data obtained in a recently-completed Phase II
clinical trial in rheumatoid arthritis (RA). Pralnacasan is an oral, small
molecule drug candidate licensed for development by Aventis from Vertex. In this
Phase II clinical trial, proof-of-mechanism for pralnacasan as a novel
anti-inflammatory drug candidate was obtained based on an assessment of the
compound's clinical activity and tolerability. With this result, pralnacasan has
met Aventis' criteria for expanded clinical development.
The data from the Phase II clinical trial in RA supports further clinical
development of pralnacasan in RA, as well as initial Phase II clinical trials in
osteoarthritis and other potential indications. Aventis will evaluate the timing
of initiating such trials.
"These results demonstrate that pralnacasan, an oral cytokine inhibitor, has
anti-inflammatory effects in rheumatoid arthritis," said Frank Douglas,
executive vice president and head of Drug Innovation & Approval at Aventis. "We
and Vertex look forward to completing our analysis of this trial and designing
additional rheumatoid arthritis studies. At the same time, we will consider
initiating clinical studies in osteoarthritis and other indications, if
appropriate. This will allow us to define fully the clinical applications and
market opportunity for pralnacasan."
Pralnacasan is an orally administered inhibitor of interleukin-1 beta converting
enzyme (ICE), an important enzyme regulating inflammatory processes. ICE
regulates the production of interleukin-1 beta (IL-1 beta) and IL-18, key
proinflammatory cytokines that initiate and sustain the progression of
inflammation. Inhibiting ICE may be a useful strategy for curtailing damaging
inflammatory processes common to a number of acute and chronic conditions.
Study Design
The Phase II clinical trial was designed to evaluate the safety, efficacy and
pharmacokinetics of pralnacasan alone and in combination with other treatments
in patients with active RA. The clinical trial was conducted in Europe and
enrolled adult patients diagnosed with mild to moderate RA at least 6 months
prior to the start of the study. Patients in the study were able to continue
their treatment with anti-inflammatory therapies. Upon study entry, patients
were required to have received either: 1) a fixed dosage regimen of RA therapies
that included one or more disease-modifying anti-rheumatic drugs (DMARDs) and/or
corticosteroids for at least three months, or 2) no additional RA drug therapy.
The clinical trial was a 12-week, double blind, randomized, placebo-controlled
study. After the initial 12 weeks of the trial, patients had the option of
extending treatment for an additional 12 weeks. In the study, patients were
randomized to receive one of two doses of pralnacasan or placebo, in addition to
any other RA therapies they were receiving. There were 285 adult patients
enrolled in the study, of which 224 patients in the pralnacasan dose groups and
55 in the control group were available for evaluation. Approximately 80% of
patients were taking concomitant DMARDs and approximately 55% were taking
concomitant corticosteroids at study entry.
"This trial was designed to collect information about the activity of
pralnacasan alone and in combination with other RA treatments in a diverse
patient population," commented Dr. Douglas. "We believe that the study design
and the data will facilitate the design of a focused development plan."
Study Results
A broad range of clinical and pharmacodynamic measures was used to assess
pralnacasan's anti-inflammatory activity. Results showed that patients receiving
pralnacasan had a strong trend toward a dose-dependent improvement in signs and
symptoms of disease, as measured by ACR20 response rates after 12 weeks
(p=0.076). Patients are considered to have an ACR20 response if they achieve at
least a 20% improvement in their tender-joint and swollen-joint counts in
addition to 20% or more improvement in a minimum of three additional criteria
set by the American College of Rheumatology (ACR). Analyses of patient
sub-groups not receiving concomitant DMARDs, methotrexate or corticosteriods
showed similar strong trends indicative of pralnacasan's anti- inflammatory
effect. Patients receiving the high dose of pralnacasan in the
intention-to-treat population exhibited ACR20 response rates greater than 40%.
In addition, the high dose of pralnacasan induced significant decreases in the
inflammatory biomarkers C-reactive protein (CRP), erythrocyte sedimentation rate
(ESR), and serum amyloid A (SAA).
In the study, pralnacasan demonstrated good tolerability alone and in
combination with other RA therapies when administered for up to 24 weeks.
Based on the demonstrated anti-inflammatory effects, Aventis and Vertex conclude
that clinical proof-of-mechanism for pralnacasan as a novel, first- in-class
therapy for inflammatory diseases has been obtained.
"We and Aventis have pioneered the scientific development of ICE inhibitors,
starting with innovative early drug design efforts. This research provided the
framework for demonstrating that oral ICE inhibitors can lead to clinical
benefit in inflammatory diseases like rheumatoid arthritis," said Vicki Sato,
Ph.D., President of Vertex. "Pralnacasan is an example of our focus on unmet
medical needs and providing the next generation of first-in- class therapeutics
for patients seeking safer, more effective treatments."
Final data analysis is continuing, and the companies anticipate that additional
data from this study will be provided during Aventis' R&D Day presentations in
June.
Vertex and Aventis began collaborating in 1993 to discover and develop orally
available inhibitors of ICE. Their intensive design efforts were based on the
three-dimensional molecular structure of ICE, solved by Vertex researchers in
1994. In 1998, pralnacasan became the first ICE inhibitor to enter clinical
development. In September 1999, Vertex and Aventis expanded their original
agreement. Under this agreement, Aventis funds development of pralnacasan and
will pay Vertex up to $62 million for the successful development of pralnacasan
in RA, the first targeted indication. Aventis has retained the rights to develop
pralnacasan for additional indications and Vertex will receive similar
milestones on these indications. Vertex has co- promotion rights in the United
States and Europe and will receive royalties on global sales, as well as a
co-promotion royalty and reimbursement of co- promotion costs.
About Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a progressive, systemic autoimmune disease that is
characterized by the inflammation of the membrane lining in joints. This
inflammation causes a loss of joint shape and alignment and results in pain,
stiffness and swelling. As RA progresses, the inflamed joint lining invades and
damages both bone and cartilage, typically leading to loss of movement and
disability. RA is chronic, and it affects more than two million individuals in
the United States and an estimated six million people worldwide. As 40% of RA
patients are over the age of 60, the number of people afflicted with RA is
expected to increase as the population ages.
About Aventis
Aventis (NYSE: AVE) is dedicated to improving life by treating and preventing
human disease through the discovery and development of innovative pharmaceutical
products. Aventis focuses on prescription drugs for important therapeutic areas
such as oncology, cardiology, diabetes and respiratory disorders as well as on
human vaccines. In 2001, Aventis generated sales of Euros 17.7 billion, invested
approximately Euros 3 billion in research and development and employed
approximately 75,000 people in its core business. Aventis corporate headquarters
are in Strasbourg, France. For more information, please visit: www.aventis.com.
About Vertex
Vertex Pharmaceuticals Incorporated is a global biotechnology company. Vertex
seeks to discover, develop, and commercialize major pharmaceutical products
independently and with partners. Chemogenomics, Vertex's proprietary,
systematic, genomics-based platform, is designed to accelerate the discovery of
new drugs and to expand intellectual property coverage of drug candidate
compounds and classes of related compounds. This approach, which targets gene
families, has formed the basis for several commercial collaborations under which
Vertex retains rights to downstream revenue. Vertex's first approved product is
Agenerase(R) (amprenavir), an HIV protease inhibitor, which Vertex co-promotes
with GlaxoSmithKline. Vertex has more than 12 drug candidates in clinical and
preclinical development to treat viral diseases, inflammation, cancer,
autoimmune diseases, neurological disorders, and genetic disorders.
Statements in this document other than historical information are forward-
looking statements subject to risks and uncertainties. Actual results could
differ materially depending on factors such as the availability of resources,
the timing and effects of regulatory actions, the strength of competition, the
outcome of litigation and the effectiveness of patent protection. Additional
Aventis information regarding risks and uncertainties is set forth in the
current Annual Report on Form 20-F of Aventis on file with the Securities and
Exchange Commission. Additional Vertex information regarding risks and
uncertainties is set forth in the current Annual Report on Form 10-K of Vertex
on file with the Securities and Exchange Commission.
BRIDGEWATER, N.J., and CAMBRIDGE, Mass., Apr 24, 2002 /PRNewswire-FirstCall via
COMTEX/ -- Aventis Pharma (NYSE: AVE) and Vertex Pharmaceuticals Incorporated
(Nasdaq: VRTX) today announced that they are expanding clinical development of
the interleukin-1 beta converting enzyme inhibitor pralnacasan, based on
clinical proof-of-mechanism data obtained in a recently-completed Phase II
clinical trial in rheumatoid arthritis (RA). Pralnacasan is an oral, small
molecule drug candidate licensed for development by Aventis from Vertex. In this
Phase II clinical trial, proof-of-mechanism for pralnacasan as a novel
anti-inflammatory drug candidate was obtained based on an assessment of the
compound's clinical activity and tolerability. With this result, pralnacasan has
met Aventis' criteria for expanded clinical development.
The data from the Phase II clinical trial in RA supports further clinical
development of pralnacasan in RA, as well as initial Phase II clinical trials in
osteoarthritis and other potential indications. Aventis will evaluate the timing
of initiating such trials.
"These results demonstrate that pralnacasan, an oral cytokine inhibitor, has
anti-inflammatory effects in rheumatoid arthritis," said Frank Douglas,
executive vice president and head of Drug Innovation & Approval at Aventis. "We
and Vertex look forward to completing our analysis of this trial and designing
additional rheumatoid arthritis studies. At the same time, we will consider
initiating clinical studies in osteoarthritis and other indications, if
appropriate. This will allow us to define fully the clinical applications and
market opportunity for pralnacasan."
Pralnacasan is an orally administered inhibitor of interleukin-1 beta converting
enzyme (ICE), an important enzyme regulating inflammatory processes. ICE
regulates the production of interleukin-1 beta (IL-1 beta) and IL-18, key
proinflammatory cytokines that initiate and sustain the progression of
inflammation. Inhibiting ICE may be a useful strategy for curtailing damaging
inflammatory processes common to a number of acute and chronic conditions.
Study Design
The Phase II clinical trial was designed to evaluate the safety, efficacy and
pharmacokinetics of pralnacasan alone and in combination with other treatments
in patients with active RA. The clinical trial was conducted in Europe and
enrolled adult patients diagnosed with mild to moderate RA at least 6 months
prior to the start of the study. Patients in the study were able to continue
their treatment with anti-inflammatory therapies. Upon study entry, patients
were required to have received either: 1) a fixed dosage regimen of RA therapies
that included one or more disease-modifying anti-rheumatic drugs (DMARDs) and/or
corticosteroids for at least three months, or 2) no additional RA drug therapy.
The clinical trial was a 12-week, double blind, randomized, placebo-controlled
study. After the initial 12 weeks of the trial, patients had the option of
extending treatment for an additional 12 weeks. In the study, patients were
randomized to receive one of two doses of pralnacasan or placebo, in addition to
any other RA therapies they were receiving. There were 285 adult patients
enrolled in the study, of which 224 patients in the pralnacasan dose groups and
55 in the control group were available for evaluation. Approximately 80% of
patients were taking concomitant DMARDs and approximately 55% were taking
concomitant corticosteroids at study entry.
"This trial was designed to collect information about the activity of
pralnacasan alone and in combination with other RA treatments in a diverse
patient population," commented Dr. Douglas. "We believe that the study design
and the data will facilitate the design of a focused development plan."
Study Results
A broad range of clinical and pharmacodynamic measures was used to assess
pralnacasan's anti-inflammatory activity. Results showed that patients receiving
pralnacasan had a strong trend toward a dose-dependent improvement in signs and
symptoms of disease, as measured by ACR20 response rates after 12 weeks
(p=0.076). Patients are considered to have an ACR20 response if they achieve at
least a 20% improvement in their tender-joint and swollen-joint counts in
addition to 20% or more improvement in a minimum of three additional criteria
set by the American College of Rheumatology (ACR). Analyses of patient
sub-groups not receiving concomitant DMARDs, methotrexate or corticosteriods
showed similar strong trends indicative of pralnacasan's anti- inflammatory
effect. Patients receiving the high dose of pralnacasan in the
intention-to-treat population exhibited ACR20 response rates greater than 40%.
In addition, the high dose of pralnacasan induced significant decreases in the
inflammatory biomarkers C-reactive protein (CRP), erythrocyte sedimentation rate
(ESR), and serum amyloid A (SAA).
In the study, pralnacasan demonstrated good tolerability alone and in
combination with other RA therapies when administered for up to 24 weeks.
Based on the demonstrated anti-inflammatory effects, Aventis and Vertex conclude
that clinical proof-of-mechanism for pralnacasan as a novel, first- in-class
therapy for inflammatory diseases has been obtained.
"We and Aventis have pioneered the scientific development of ICE inhibitors,
starting with innovative early drug design efforts. This research provided the
framework for demonstrating that oral ICE inhibitors can lead to clinical
benefit in inflammatory diseases like rheumatoid arthritis," said Vicki Sato,
Ph.D., President of Vertex. "Pralnacasan is an example of our focus on unmet
medical needs and providing the next generation of first-in- class therapeutics
for patients seeking safer, more effective treatments."
Final data analysis is continuing, and the companies anticipate that additional
data from this study will be provided during Aventis' R&D Day presentations in
June.
Vertex and Aventis began collaborating in 1993 to discover and develop orally
available inhibitors of ICE. Their intensive design efforts were based on the
three-dimensional molecular structure of ICE, solved by Vertex researchers in
1994. In 1998, pralnacasan became the first ICE inhibitor to enter clinical
development. In September 1999, Vertex and Aventis expanded their original
agreement. Under this agreement, Aventis funds development of pralnacasan and
will pay Vertex up to $62 million for the successful development of pralnacasan
in RA, the first targeted indication. Aventis has retained the rights to develop
pralnacasan for additional indications and Vertex will receive similar
milestones on these indications. Vertex has co- promotion rights in the United
States and Europe and will receive royalties on global sales, as well as a
co-promotion royalty and reimbursement of co- promotion costs.
About Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a progressive, systemic autoimmune disease that is
characterized by the inflammation of the membrane lining in joints. This
inflammation causes a loss of joint shape and alignment and results in pain,
stiffness and swelling. As RA progresses, the inflamed joint lining invades and
damages both bone and cartilage, typically leading to loss of movement and
disability. RA is chronic, and it affects more than two million individuals in
the United States and an estimated six million people worldwide. As 40% of RA
patients are over the age of 60, the number of people afflicted with RA is
expected to increase as the population ages.
About Aventis
Aventis (NYSE: AVE) is dedicated to improving life by treating and preventing
human disease through the discovery and development of innovative pharmaceutical
products. Aventis focuses on prescription drugs for important therapeutic areas
such as oncology, cardiology, diabetes and respiratory disorders as well as on
human vaccines. In 2001, Aventis generated sales of Euros 17.7 billion, invested
approximately Euros 3 billion in research and development and employed
approximately 75,000 people in its core business. Aventis corporate headquarters
are in Strasbourg, France. For more information, please visit: www.aventis.com.
About Vertex
Vertex Pharmaceuticals Incorporated is a global biotechnology company. Vertex
seeks to discover, develop, and commercialize major pharmaceutical products
independently and with partners. Chemogenomics, Vertex's proprietary,
systematic, genomics-based platform, is designed to accelerate the discovery of
new drugs and to expand intellectual property coverage of drug candidate
compounds and classes of related compounds. This approach, which targets gene
families, has formed the basis for several commercial collaborations under which
Vertex retains rights to downstream revenue. Vertex's first approved product is
Agenerase(R) (amprenavir), an HIV protease inhibitor, which Vertex co-promotes
with GlaxoSmithKline. Vertex has more than 12 drug candidates in clinical and
preclinical development to treat viral diseases, inflammation, cancer,
autoimmune diseases, neurological disorders, and genetic disorders.
Statements in this document other than historical information are forward-
looking statements subject to risks and uncertainties. Actual results could
differ materially depending on factors such as the availability of resources,
the timing and effects of regulatory actions, the strength of competition, the
outcome of litigation and the effectiveness of patent protection. Additional
Aventis information regarding risks and uncertainties is set forth in the
current Annual Report on Form 20-F of Aventis on file with the Securities and
Exchange Commission. Additional Vertex information regarding risks and
uncertainties is set forth in the current Annual Report on Form 10-K of Vertex
on file with the Securities and Exchange Commission.
Mittwoch, 24. April 2002
Vor Börseneröffnung Ticker Zeitraum Gewinn pA Erwartet Vorjahr Umsatz Erwartet Vorjahr
Ariba ARBA Q2: GJ 02 0,00 -0,01 -0,20 57.190 55.920 90.650
Amer. Telegraph & Telephone (AT&T) T Q1: GJ 02 0,06 0,04 0,06 12,000.000 12,089.670 16,763.000
Biogen BGEN Q1: GJ 02 0,47 0,47 0,46 288.300 278.000 237.000
GlaxoSmithKline GSK Q1: GJ 02 0,54 0,53 0,47 7,300.000 7,369.340 6,898.000
Goodyear Tyre & Rubber GT Q1: GJ 02 -0,35 -0,32 -0,02 3,311.200 3,437.150 3,414.200
Moody´s MCO Q1: GJ 02 0,46 0,35 0,30 231.600 204.450 180.200
Sara Lee SLE Q3: GJ 02 0,31 0,31 0,27 4,200.000 4,768.330 4,308.000
USA Networks USAI Q1: GJ 02 0,05 0,02 -0,05 1,000.000 1,000.630 1,238.000
Wyeth (ex-Amer. Home Products) WYE Q1: GJ 02 0,65 0,65 0,55 3,643.520 3,695.200 3,449.180
Xerox XRX Q1: GJ 02 versch. auf unbekannt 0,00 -0,07 3,750.620 4,156.000
Während des Handels Ticker Zeitraum Gewinn pA Erwartet Vorjahr Umsatz Erwartet Vorjahr
Anheuser-Bush BUD Q1: GJ 02 0,48 0,43 3,115.230 2,980.600
Nach Börsenschluss Ticker Zeitraum Gewinn pA Erwartet Vorjahr Umsatz Erwartet Vorjahr
Affymetrix AFFX Q1: GJ 02 -0,02 -0,11 66.000 55.000
AOL Time Warner AOL Q1: GJ 02 0,13 0,23 9,501.340 9,080.000
BroadVision BVSN Q1: GJ 02 -0,05 -0,14 29.670 91.120
Chiron CHIR Q1: GJ 02 0,22 0,19 282.000 260.000
Citrix Systems CTXS Q1: GJ 02 0,15 0,17 141.840 132.810
CYTYC Corporation CYTC Q1: GJ 02 0,14 0,09 67.030 47.470
Digital River DRIV Q1: GJ 02 0,02 -0,07 18.000 13.050
Foundry Networks FDRY Q1: GJ 02 0,01 0,04 66.000 82.550
InfoSpace INSP Q1: GJ 02 -0,03 -0,02 28.740 46.570
Intersil ISIL Q1: GJ 02 0,13 0,07 129.560 127.800
LSI Logic LSI Q1: GJ 02 -0,14 0,03 413.210 517.200
Micromedia MACR Q4: GJ 02 -0,13 0,15 72.700 89.080
QUALCOMM QCOM Q2: GJ 02 0,20 0,29 646.870 713.260
Symantec SYMC Q4: GJ 02 0,35 0,31 289.630 250.610
Vertex Pharmaceuticals VRTX Q4: GJ 02 -0,28 -0,15 48.000 19.000
Vor Börseneröffnung Ticker Zeitraum Gewinn pA Erwartet Vorjahr Umsatz Erwartet Vorjahr
Ariba ARBA Q2: GJ 02 0,00 -0,01 -0,20 57.190 55.920 90.650
Amer. Telegraph & Telephone (AT&T) T Q1: GJ 02 0,06 0,04 0,06 12,000.000 12,089.670 16,763.000
Biogen BGEN Q1: GJ 02 0,47 0,47 0,46 288.300 278.000 237.000
GlaxoSmithKline GSK Q1: GJ 02 0,54 0,53 0,47 7,300.000 7,369.340 6,898.000
Goodyear Tyre & Rubber GT Q1: GJ 02 -0,35 -0,32 -0,02 3,311.200 3,437.150 3,414.200
Moody´s MCO Q1: GJ 02 0,46 0,35 0,30 231.600 204.450 180.200
Sara Lee SLE Q3: GJ 02 0,31 0,31 0,27 4,200.000 4,768.330 4,308.000
USA Networks USAI Q1: GJ 02 0,05 0,02 -0,05 1,000.000 1,000.630 1,238.000
Wyeth (ex-Amer. Home Products) WYE Q1: GJ 02 0,65 0,65 0,55 3,643.520 3,695.200 3,449.180
Xerox XRX Q1: GJ 02 versch. auf unbekannt 0,00 -0,07 3,750.620 4,156.000
Während des Handels Ticker Zeitraum Gewinn pA Erwartet Vorjahr Umsatz Erwartet Vorjahr
Anheuser-Bush BUD Q1: GJ 02 0,48 0,43 3,115.230 2,980.600
Nach Börsenschluss Ticker Zeitraum Gewinn pA Erwartet Vorjahr Umsatz Erwartet Vorjahr
Affymetrix AFFX Q1: GJ 02 -0,02 -0,11 66.000 55.000
AOL Time Warner AOL Q1: GJ 02 0,13 0,23 9,501.340 9,080.000
BroadVision BVSN Q1: GJ 02 -0,05 -0,14 29.670 91.120
Chiron CHIR Q1: GJ 02 0,22 0,19 282.000 260.000
Citrix Systems CTXS Q1: GJ 02 0,15 0,17 141.840 132.810
CYTYC Corporation CYTC Q1: GJ 02 0,14 0,09 67.030 47.470
Digital River DRIV Q1: GJ 02 0,02 -0,07 18.000 13.050
Foundry Networks FDRY Q1: GJ 02 0,01 0,04 66.000 82.550
InfoSpace INSP Q1: GJ 02 -0,03 -0,02 28.740 46.570
Intersil ISIL Q1: GJ 02 0,13 0,07 129.560 127.800
LSI Logic LSI Q1: GJ 02 -0,14 0,03 413.210 517.200
Micromedia MACR Q4: GJ 02 -0,13 0,15 72.700 89.080
QUALCOMM QCOM Q2: GJ 02 0,20 0,29 646.870 713.260
Symantec SYMC Q4: GJ 02 0,35 0,31 289.630 250.610
Vertex Pharmaceuticals VRTX Q4: GJ 02 -0,28 -0,15 48.000 19.000
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