super godt for neurosearch
Til gengæld ser biotekselskabet Vivus aktionærer uden tvivl frem til åbningen. Aktien stiger ifølge Bloomberg News 56 pct. i førmarkedet, understøttet af positive fase 3 data med vægttabsmidlet, Qnexa.
Vivus vurderer, at data understøtter planen om at indsende registreringsansøgning for vægttabsmidlet mod slutningen af 2009. Vivus er en af NeuroSearch rivaler på biotekscenen i forhold til at få et vægttabsmiddel på markedet.
Til gengæld ser biotekselskabet Vivus aktionærer uden tvivl frem til åbningen. Aktien stiger ifølge Bloomberg News 56 pct. i førmarkedet, understøttet af positive fase 3 data med vægttabsmidlet, Qnexa.
Vivus vurderer, at data understøtter planen om at indsende registreringsansøgning for vægttabsmidlet mod slutningen af 2009. Vivus er en af NeuroSearch rivaler på biotekscenen i forhold til at få et vægttabsmiddel på markedet.
9/9 2009 18:04 troldmanden 1
18361 Ja det her er faktisk rigtig godt for Neurosearch. Fedme markedet er så stort at der er plads til rigtig mange konkurrenter. Og her og nu gælder det om at der er nogle selskaber der får succes hos FDA
Qneqa resultater er på nogle punkter ganske enkelt fantastiske. Det er f.eks særdeles imponerende at stoffet har så stor effekt på de sekundære endpoint så som for højt blodtryk, triglyceride (kolesteroel) og hemoglobin A1c (bliver brugt som sukkersyge markør)
Selve vægttabene er også utrolig finen. Ved dog ikke om jeg skal sige skide godt gået eller puha de sminker data. Rent PRmæssigt så er det i hvert fald til et rent 12 tal at de fremhæver et vægttab på 14,7% i EQUIP studiet. Det er ganske enkelt det tal der er rundt i alle medier. MEN det er altså ikke det "rigtige" tal i forhold til FDA. For det første er det ikke placebo justert. Så trækker man placebo effekten fra (2,5%)så giver det 12,2%. Stadig utroligt fornemt. Men det er data fra dem der har gennemført HELE forsøget. Den går ikke hos FDA. De vil se ITT data (intent to treat). Altså data fra ALLE dem som har deltaget i forsøget inkl dem som efterhånden stopper med behandlingen. Og det tal er placebo justert 9,4%. Unægtelig noget andet end 14,7% som er rundt i medierne.
9,4% er så stadig utrolg flot. Det er ca det samme som Tesofensine opnåede på 24 uger vs dette forsøg på 56 uger.
Endvidere er det også ret væsentlogt at notere sig at forsøgspersonerne i EQUIP studiet var meget store. De havde en gennemsnits BMI på hele 42 mod normalt omkring 36. Forskellen på en person på 1,70 m er 104kg med BMI på 36 og 121kg med BMI på 42. Så potentialet for at tabe sig har også været noget større i dette studie
Det andet fase 3 studie som forøvrigt er dobbelt så stort som EQUIP (2487 vs 1267) havde en snit bmi PÅ 36,6. Her var det placebojusterede ITT vægttab på 8,6%. Og det er altså stadig rigtig, rigtig flot. Specielt fordi de har så utrolig gode data på de sekundære endpoint.
Det er ret morsomt at se Arena Pharmaceuticals aktionærene på Yahoo board. De har i laaaang tid disset alle andre end lige præcis Lorcaserin som altså kun har givet et 3,4% vægttab. De er ikke så interesseret i at høre om Tesofensine, Qnexa osv.
Nå summa summarum er at dagens nyhed faktisk er god for Neurosearch da de flotte resultater øger sandsynligheden for både en FDA godkendels af Qnexa og en partner deal. Og Neurosearch har brug for positive resultater i branchen til at hjælpe deres vvej for Tesofensine
Vh
T.
PS noget der hørte CC? Va desværre ikke lige på pinden og kan ikke afspille den nu
Qneqa resultater er på nogle punkter ganske enkelt fantastiske. Det er f.eks særdeles imponerende at stoffet har så stor effekt på de sekundære endpoint så som for højt blodtryk, triglyceride (kolesteroel) og hemoglobin A1c (bliver brugt som sukkersyge markør)
Selve vægttabene er også utrolig finen. Ved dog ikke om jeg skal sige skide godt gået eller puha de sminker data. Rent PRmæssigt så er det i hvert fald til et rent 12 tal at de fremhæver et vægttab på 14,7% i EQUIP studiet. Det er ganske enkelt det tal der er rundt i alle medier. MEN det er altså ikke det "rigtige" tal i forhold til FDA. For det første er det ikke placebo justert. Så trækker man placebo effekten fra (2,5%)så giver det 12,2%. Stadig utroligt fornemt. Men det er data fra dem der har gennemført HELE forsøget. Den går ikke hos FDA. De vil se ITT data (intent to treat). Altså data fra ALLE dem som har deltaget i forsøget inkl dem som efterhånden stopper med behandlingen. Og det tal er placebo justert 9,4%. Unægtelig noget andet end 14,7% som er rundt i medierne.
9,4% er så stadig utrolg flot. Det er ca det samme som Tesofensine opnåede på 24 uger vs dette forsøg på 56 uger.
Endvidere er det også ret væsentlogt at notere sig at forsøgspersonerne i EQUIP studiet var meget store. De havde en gennemsnits BMI på hele 42 mod normalt omkring 36. Forskellen på en person på 1,70 m er 104kg med BMI på 36 og 121kg med BMI på 42. Så potentialet for at tabe sig har også været noget større i dette studie
Det andet fase 3 studie som forøvrigt er dobbelt så stort som EQUIP (2487 vs 1267) havde en snit bmi PÅ 36,6. Her var det placebojusterede ITT vægttab på 8,6%. Og det er altså stadig rigtig, rigtig flot. Specielt fordi de har så utrolig gode data på de sekundære endpoint.
Det er ret morsomt at se Arena Pharmaceuticals aktionærene på Yahoo board. De har i laaaang tid disset alle andre end lige præcis Lorcaserin som altså kun har givet et 3,4% vægttab. De er ikke så interesseret i at høre om Tesofensine, Qnexa osv.
Nå summa summarum er at dagens nyhed faktisk er god for Neurosearch da de flotte resultater øger sandsynligheden for både en FDA godkendels af Qnexa og en partner deal. Og Neurosearch har brug for positive resultater i branchen til at hjælpe deres vvej for Tesofensine
Vh
T.
PS noget der hørte CC? Va desværre ikke lige på pinden og kan ikke afspille den nu
9/9 2009 18:05 butterboy 018362 hele meddelelsen
spændende hvad de får hevet hjem i en partneraftale...Kan indikere potentilaet i neurosearch
Er data bedre end neurosearchs?
VIVUS Announces Positive Results From Two Phase 3 Studies; Obese Patients on Qnexa Achieve Average Weight Loss up to 14.7% and Significant Improvements in Co-Morbidities
Results of EQUIP and CONQUER Phase 3 Studies Exceed FDA Benchmarks for Obesity Treatments, Demonstrate Positive Safety Profile
MOUNTAIN VIEW, Calif., Sept 09, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- VIVUS, Inc. (Nasdaq: VVUS) today announced positive results from two final, phase 3 pivotal 56-week studies, EQUIP (OB-302) and CONQUER (OB-303), evaluating the safety and efficacy of Qnexa(TM), an investigational drug, in more than 3,750 patients across 93 sites. The EQUIP and CONQUER studies met all primary endpoints by demonstrating statistically significant weight loss with all three doses of Qnexa, as compared to placebo. Patients taking Qnexa also achieved significant improvements in cardiovascular and metabolic risk factors including blood pressure, lipid levels, and type 2 diabetes.
Key Data
Highlights from the EQUIP and CONQUER studies include:
-- Average weight loss of 14.7% (37 lbs) was achieved by patients treated
with Qnexa for 56 weeks in the EQUIP study;
-- Significant improvements in cardiovascular, metabolic and inflammatory
risk factors among patients treated with Qnexa;
-- FDA efficacy benchmarks for weight loss agents exceeded at all three
doses of Qnexa tested in the clinical program;
-- Completion rates up to 69% were significantly higher than placebo at all
three doses of Qnexa, indicating favorable tolerability; and
-- Favorable benefit/risk safety profile for Qnexa.
"The outstanding results from the EQUIP and CONQUER studies, in addition to the results from EQUATE that were reported late last year, confirm the positive effect of Qnexa and underscore the important role this therapy may play in the lives of patients battling obesity and related co-morbidities, if approved by the FDA," stated Leland Wilson, president and chief executive officer of VIVUS. "The results of the phase 3 program, designed and executed after Special Protocol Assessments were completed by the FDA, exceed the FDA benchmarks for clinically significant weight loss. The results support the company's plan to file a New Drug Application with the FDA by the end of 2009 and submit the results from the studies for publication in peer-reviewed journals. We believe these results may provide a compelling opportunity for global pharmaceutical companies, and we intend to initiate partnering discussions now that we have the full data set in hand."
Wilson added, "We are proud of the results of our Qnexa phase 3 program, and I would like to thank Dr. Thomas Najarian, the inventor of Qnexa, the entire development team at VIVUS, Dr. David Orloff and his staff at Medpace, the clinical research organization that managed these studies, and the clinical investigators and patients who participated in the Qnexa clinical trials."
Qnexa is a proprietary formulation and unique dosing regimen that combines two well known pharmaceutical therapies - phentermine and topiramate - to create a novel, patented therapy. The phase 3 program evaluated three doses of Qnexa (numbers reflect milligrams of phentermine and controlled release topiramate, respectively):
-- Qnexa 15/92 (full dose)
-- Qnexa 7.5/46 (mid dose)
-- Qnexa 3.75/23 (low dose)
"The weight loss observed with Qnexa in these two one-year, double-blind, randomized trials far exceeds the weight loss observed for other agents reported in literature," said Kishore Gadde, MD, director of obesity clinical trials at Duke University and a lead investigator. "The efficacy and safety results confirm the earlier findings of our phase 2 study, which showed a very good efficacy and benefit/risk profile. Importantly, the medical benefits of this treatment in reducing the risk of weight-related co-morbidities such as hypertension, diabetes, and dyslipidemia could establish Qnexa as a major advancement in the management of obesity."
EQUIP (OB-302) Results
The EQUIP study included 1,267 morbidly obese patients (1,050 females and 217 males) across 93 centers in the United States. The average baseline BMI of the study population was 42.1 kg/m(2) and baseline weight was 256 pounds. Patients had a 4-week dose titration period followed by 52 weeks of treatment. The study was a randomized, double-blind, placebo-controlled, 3-arm, prospective trial with patients randomized to receive once-a-day treatment with low-dose Qnexa, full-dose Qnexa or placebo. Patients were asked to follow a hypocaloric diet representing a 500-calorie/day deficit and advised to implement a simple lifestyle modification program. Results from the study are as follows:
ITT-LOCF Completers
---------------------------- ----------------------------
Qnexa Qnexa Qnexa Qnexa
EQUIP (OB-302) Placebo Low Dose Full Dose Placebo Low Dose Full Dose
56 Weeks (n=498) (n=234) (n=498) (n=241) (n=138) (n=301)
-------------- ------- -------- --------- ------- -------- ---------
Mean Weight
Loss (%) 1.6% 5.1%* 11.0%* 2.5% 7.0%* 14.7%*
Greater than
or equal to
5% weight
loss rate 17% 45%* 67%* 26% 59%* 84%*
ITT-LOCF: Intent-to-treat with last observation carried forward
*p<0.0001 vs. placebo
-- Average weight loss for Qnexa patients completing the EQUIP study was 37
pounds and 18 pounds with full-dose Qnexa and low-dose Qnexa,
respectively, as compared to 6 pounds in the placebo group;
-- 60% of the full-dose Qnexa patients who completed the study lost at
least 10% of their baseline weight;
-- 43% of the full-dose Qnexa patients who completed the study lost at
least 15% of their baseline weight;
-- Completion rate for EQUIP was 47%, 57%, 59% for patients taking placebo,
low-dose Qnexa and full-dose Qnexa, respectively; and
-- Patients treated with full-dose Qnexa had significant improvements in
blood pressure, triglycerides and cholesterol.
CONQUER (OB-303) Results
The CONQUER study included 2,487 overweight and obese patients (1,737 females and 750 males) with high blood pressure, high cholesterol or type 2 diabetes across 93 centers in the United States. The average baseline BMI of the study population was 36.6 kg/ m2 and baseline weight was 227 pounds. Patients had a 4-week dose titration period followed by 52 weeks of treatment. The study was a randomized, double-blind, placebo-controlled, 3-arm, prospective trial with patients randomized to receive once-a-day treatment with mid-dose Qnexa, full-dose Qnexa or placebo. Patients were asked to follow a hypocaloric diet representing a 500-calorie/day deficit and advised to implement a simple lifestyle modification program. Results from the study are as follows:
ITT-LOCF Completers
---------------------------- ----------------------------
Qnexa Qnexa Qnexa Qnexa
CONQUER (OB-303) Placebo Mid Dose Full Dose Placebo Mid Dose Full Dose
56 Weeks (n=979) (n=488) (n=981) (n=564) (n=344) (n=634)
-------- -------- --------- ------- -------- ---------
Mean Weight
Loss (%) 1.8% 8.4%* 10.4%* 2.4%* 10.5%* 13.2%*
Greater than
or equal to
5% weight
loss rate 21% 62%* 70%* 26% 75%* 85%*
*p<0.0001 vs. placebo
-- Average weight loss for Qnexa patients who completed the CONQUER study
was 30 pounds and 24 pounds with full-dose Qnexa and mid-dose Qnexa,
respectively, as compared to 6 pounds in the placebo group.
-- In the CONQUER study subset analysis, higher risk patients, defined as
those in the upper 25th percentile of a specific co-morbidity, who were
treated with full-dose Qnexa for 56 weeks achieved the following changes
in cardiovascular risk factors:
-- Reduction in systolic blood pressure of 20 mmHg from 147 mmHg at
baseline, as compared to a reduction of 14 mmHg in the placebo group
(p<0.0001). This improvement occurred in the presence of a
significant reduction in blood pressure medications in Qnexa-treated
patients as compared to placebo;
-- Reduction in triglyceride levels of 98 mg/dL from 268 mg/dL at
baseline, as compared to a decrease of 42 mg/dL from 262 mg/dL at
baseline in the placebo group (p<0.0001);
-- Reduction in hemoglobin A1c levels of 0.6% from 7.3% at baseline as
compared to a reduction of 0.1% from 7.4% at baseline for the
placebo patients (p<0.0001). These improvements occurred in the
presence of a significant reduction in antidiabetic medications in
Qnexa-treated patients compared with placebo. All patients were
treated to standard of care for type 2 diabetes. 64% of the
full-dose Qnexa patients who completed the study lost at least 10%
of their baseline weight;
-- 39% of the full-dose Qnexa patients who completed the study lost at
least 15% of their baseline weight; and
-- Completion rates for CONQUER were 57%, 69%, 64% for patients taking
placebo, mid-dose Qnexa, and full-dose Qnexa, respectively.
Across both 56-week studies comprised of more than 3,750 patients, the most commonly reported side effects were dry mouth, tingling, constipation, altered taste and insomnia. Monthly assessments using prospective psychometric instruments in accordance with FDA's guidance showed no signal for suicidality risk. There were no suicide attempts or suicidal behaviors, and there was no signal for suicidal ideation across all treatment groups including placebo. Depression or depressed mood adverse events of a moderate to severe nature were less than 2% and were similar among patients in the Qnexa and placebo groups. Overall, depression scores, quality of life including self esteem and general health significantly improved for patients on Qnexa.
"I have seen dramatic and sustained weight loss with Qnexa as well as notable improvements in cardiovascular risk factors, diabetes, emotional well being and quality of life in my patients," commented Michelle Look, M.D., FAAFP, of the San Diego Sports Medicine and Family Health Center and a lead investigator in the studies. "What is so striking for me is how many of my patients were able to achieve weight loss with Qnexa for the first time after many years of battling weight problems without success. The excellent tolerability of Qnexa allowed patients to stay on therapy for a year, as evidenced by the strong completer rates."
Other Safety Studies
VIVUS completed a thorough QT prolongation (TQT) study evaluating subjects taking Qnexa. The study was completed with no signal for QT prolongation. Subjects taking Qnexa also underwent complex and extensive cognitive and psychomotor testing using validated, FDA accepted testing methodologies. There was no clinically significant change in overall cognitive function or effect on psychomotor skills seen in patients taking Qnexa.
"These data are significant, and when coupled with my own experience treating patients with Qnexa, clearly demonstrate that it is one of the promising pharmaceutical therapies in development to assist patients in achieving significant weight loss," stated Louis Aronne, MD, Clinical Professor of Medicine and Director of the Comprehensive Weight Control Program at New York-Presbyterian Hospital/Weill Cornell Medical Center and one of the investigators involved in the clinical trials. "People with weight problems have a truly biologic disease, and we are in desperate need of more options and effective tools to help our patients combat this disease and the other serious medical conditions that arise as a result of weight gain. I am encouraged by the efficacy and safety seen in these late stage Qnexa trials."
spændende hvad de får hevet hjem i en partneraftale...Kan indikere potentilaet i neurosearch
Er data bedre end neurosearchs?
VIVUS Announces Positive Results From Two Phase 3 Studies; Obese Patients on Qnexa Achieve Average Weight Loss up to 14.7% and Significant Improvements in Co-Morbidities
Results of EQUIP and CONQUER Phase 3 Studies Exceed FDA Benchmarks for Obesity Treatments, Demonstrate Positive Safety Profile
MOUNTAIN VIEW, Calif., Sept 09, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- VIVUS, Inc. (Nasdaq: VVUS) today announced positive results from two final, phase 3 pivotal 56-week studies, EQUIP (OB-302) and CONQUER (OB-303), evaluating the safety and efficacy of Qnexa(TM), an investigational drug, in more than 3,750 patients across 93 sites. The EQUIP and CONQUER studies met all primary endpoints by demonstrating statistically significant weight loss with all three doses of Qnexa, as compared to placebo. Patients taking Qnexa also achieved significant improvements in cardiovascular and metabolic risk factors including blood pressure, lipid levels, and type 2 diabetes.
Key Data
Highlights from the EQUIP and CONQUER studies include:
-- Average weight loss of 14.7% (37 lbs) was achieved by patients treated
with Qnexa for 56 weeks in the EQUIP study;
-- Significant improvements in cardiovascular, metabolic and inflammatory
risk factors among patients treated with Qnexa;
-- FDA efficacy benchmarks for weight loss agents exceeded at all three
doses of Qnexa tested in the clinical program;
-- Completion rates up to 69% were significantly higher than placebo at all
three doses of Qnexa, indicating favorable tolerability; and
-- Favorable benefit/risk safety profile for Qnexa.
"The outstanding results from the EQUIP and CONQUER studies, in addition to the results from EQUATE that were reported late last year, confirm the positive effect of Qnexa and underscore the important role this therapy may play in the lives of patients battling obesity and related co-morbidities, if approved by the FDA," stated Leland Wilson, president and chief executive officer of VIVUS. "The results of the phase 3 program, designed and executed after Special Protocol Assessments were completed by the FDA, exceed the FDA benchmarks for clinically significant weight loss. The results support the company's plan to file a New Drug Application with the FDA by the end of 2009 and submit the results from the studies for publication in peer-reviewed journals. We believe these results may provide a compelling opportunity for global pharmaceutical companies, and we intend to initiate partnering discussions now that we have the full data set in hand."
Wilson added, "We are proud of the results of our Qnexa phase 3 program, and I would like to thank Dr. Thomas Najarian, the inventor of Qnexa, the entire development team at VIVUS, Dr. David Orloff and his staff at Medpace, the clinical research organization that managed these studies, and the clinical investigators and patients who participated in the Qnexa clinical trials."
Qnexa is a proprietary formulation and unique dosing regimen that combines two well known pharmaceutical therapies - phentermine and topiramate - to create a novel, patented therapy. The phase 3 program evaluated three doses of Qnexa (numbers reflect milligrams of phentermine and controlled release topiramate, respectively):
-- Qnexa 15/92 (full dose)
-- Qnexa 7.5/46 (mid dose)
-- Qnexa 3.75/23 (low dose)
"The weight loss observed with Qnexa in these two one-year, double-blind, randomized trials far exceeds the weight loss observed for other agents reported in literature," said Kishore Gadde, MD, director of obesity clinical trials at Duke University and a lead investigator. "The efficacy and safety results confirm the earlier findings of our phase 2 study, which showed a very good efficacy and benefit/risk profile. Importantly, the medical benefits of this treatment in reducing the risk of weight-related co-morbidities such as hypertension, diabetes, and dyslipidemia could establish Qnexa as a major advancement in the management of obesity."
EQUIP (OB-302) Results
The EQUIP study included 1,267 morbidly obese patients (1,050 females and 217 males) across 93 centers in the United States. The average baseline BMI of the study population was 42.1 kg/m(2) and baseline weight was 256 pounds. Patients had a 4-week dose titration period followed by 52 weeks of treatment. The study was a randomized, double-blind, placebo-controlled, 3-arm, prospective trial with patients randomized to receive once-a-day treatment with low-dose Qnexa, full-dose Qnexa or placebo. Patients were asked to follow a hypocaloric diet representing a 500-calorie/day deficit and advised to implement a simple lifestyle modification program. Results from the study are as follows:
ITT-LOCF Completers
---------------------------- ----------------------------
Qnexa Qnexa Qnexa Qnexa
EQUIP (OB-302) Placebo Low Dose Full Dose Placebo Low Dose Full Dose
56 Weeks (n=498) (n=234) (n=498) (n=241) (n=138) (n=301)
-------------- ------- -------- --------- ------- -------- ---------
Mean Weight
Loss (%) 1.6% 5.1%* 11.0%* 2.5% 7.0%* 14.7%*
Greater than
or equal to
5% weight
loss rate 17% 45%* 67%* 26% 59%* 84%*
ITT-LOCF: Intent-to-treat with last observation carried forward
*p<0.0001 vs. placebo
-- Average weight loss for Qnexa patients completing the EQUIP study was 37
pounds and 18 pounds with full-dose Qnexa and low-dose Qnexa,
respectively, as compared to 6 pounds in the placebo group;
-- 60% of the full-dose Qnexa patients who completed the study lost at
least 10% of their baseline weight;
-- 43% of the full-dose Qnexa patients who completed the study lost at
least 15% of their baseline weight;
-- Completion rate for EQUIP was 47%, 57%, 59% for patients taking placebo,
low-dose Qnexa and full-dose Qnexa, respectively; and
-- Patients treated with full-dose Qnexa had significant improvements in
blood pressure, triglycerides and cholesterol.
CONQUER (OB-303) Results
The CONQUER study included 2,487 overweight and obese patients (1,737 females and 750 males) with high blood pressure, high cholesterol or type 2 diabetes across 93 centers in the United States. The average baseline BMI of the study population was 36.6 kg/ m2 and baseline weight was 227 pounds. Patients had a 4-week dose titration period followed by 52 weeks of treatment. The study was a randomized, double-blind, placebo-controlled, 3-arm, prospective trial with patients randomized to receive once-a-day treatment with mid-dose Qnexa, full-dose Qnexa or placebo. Patients were asked to follow a hypocaloric diet representing a 500-calorie/day deficit and advised to implement a simple lifestyle modification program. Results from the study are as follows:
ITT-LOCF Completers
---------------------------- ----------------------------
Qnexa Qnexa Qnexa Qnexa
CONQUER (OB-303) Placebo Mid Dose Full Dose Placebo Mid Dose Full Dose
56 Weeks (n=979) (n=488) (n=981) (n=564) (n=344) (n=634)
-------- -------- --------- ------- -------- ---------
Mean Weight
Loss (%) 1.8% 8.4%* 10.4%* 2.4%* 10.5%* 13.2%*
Greater than
or equal to
5% weight
loss rate 21% 62%* 70%* 26% 75%* 85%*
*p<0.0001 vs. placebo
-- Average weight loss for Qnexa patients who completed the CONQUER study
was 30 pounds and 24 pounds with full-dose Qnexa and mid-dose Qnexa,
respectively, as compared to 6 pounds in the placebo group.
-- In the CONQUER study subset analysis, higher risk patients, defined as
those in the upper 25th percentile of a specific co-morbidity, who were
treated with full-dose Qnexa for 56 weeks achieved the following changes
in cardiovascular risk factors:
-- Reduction in systolic blood pressure of 20 mmHg from 147 mmHg at
baseline, as compared to a reduction of 14 mmHg in the placebo group
(p<0.0001). This improvement occurred in the presence of a
significant reduction in blood pressure medications in Qnexa-treated
patients as compared to placebo;
-- Reduction in triglyceride levels of 98 mg/dL from 268 mg/dL at
baseline, as compared to a decrease of 42 mg/dL from 262 mg/dL at
baseline in the placebo group (p<0.0001);
-- Reduction in hemoglobin A1c levels of 0.6% from 7.3% at baseline as
compared to a reduction of 0.1% from 7.4% at baseline for the
placebo patients (p<0.0001). These improvements occurred in the
presence of a significant reduction in antidiabetic medications in
Qnexa-treated patients compared with placebo. All patients were
treated to standard of care for type 2 diabetes. 64% of the
full-dose Qnexa patients who completed the study lost at least 10%
of their baseline weight;
-- 39% of the full-dose Qnexa patients who completed the study lost at
least 15% of their baseline weight; and
-- Completion rates for CONQUER were 57%, 69%, 64% for patients taking
placebo, mid-dose Qnexa, and full-dose Qnexa, respectively.
Across both 56-week studies comprised of more than 3,750 patients, the most commonly reported side effects were dry mouth, tingling, constipation, altered taste and insomnia. Monthly assessments using prospective psychometric instruments in accordance with FDA's guidance showed no signal for suicidality risk. There were no suicide attempts or suicidal behaviors, and there was no signal for suicidal ideation across all treatment groups including placebo. Depression or depressed mood adverse events of a moderate to severe nature were less than 2% and were similar among patients in the Qnexa and placebo groups. Overall, depression scores, quality of life including self esteem and general health significantly improved for patients on Qnexa.
"I have seen dramatic and sustained weight loss with Qnexa as well as notable improvements in cardiovascular risk factors, diabetes, emotional well being and quality of life in my patients," commented Michelle Look, M.D., FAAFP, of the San Diego Sports Medicine and Family Health Center and a lead investigator in the studies. "What is so striking for me is how many of my patients were able to achieve weight loss with Qnexa for the first time after many years of battling weight problems without success. The excellent tolerability of Qnexa allowed patients to stay on therapy for a year, as evidenced by the strong completer rates."
Other Safety Studies
VIVUS completed a thorough QT prolongation (TQT) study evaluating subjects taking Qnexa. The study was completed with no signal for QT prolongation. Subjects taking Qnexa also underwent complex and extensive cognitive and psychomotor testing using validated, FDA accepted testing methodologies. There was no clinically significant change in overall cognitive function or effect on psychomotor skills seen in patients taking Qnexa.
"These data are significant, and when coupled with my own experience treating patients with Qnexa, clearly demonstrate that it is one of the promising pharmaceutical therapies in development to assist patients in achieving significant weight loss," stated Louis Aronne, MD, Clinical Professor of Medicine and Director of the Comprehensive Weight Control Program at New York-Presbyterian Hospital/Weill Cornell Medical Center and one of the investigators involved in the clinical trials. "People with weight problems have a truly biologic disease, and we are in desperate need of more options and effective tools to help our patients combat this disease and the other serious medical conditions that arise as a result of weight gain. I am encouraged by the efficacy and safety seen in these late stage Qnexa trials."
Her er et lille klip fra Sydbanks analyse:
Konklusion:
De offentliggjorte data fra Vivus er en positiv nyhed for NeuroSearch i relation til tesofen-sine også selv om Qnexa bliver en konkurrent. Det er vores vurdering, at FDA er skepti-ske og grundige, når de skal vurdere forholdet mellem effekt og bivirkninger hos potenti-elle fedmeprodukter. Det vil derfor blive lettere for tesofensine at slippe gennem nåleøjet, hvis andre selskabet tidligere har forelagt fordele og ulemper for FDA og er sluppet igen-nem. Vi står stadig i en situation, hvor fedme ikke er anerkendt som en sygdom, og der er fortsat stor usikkerhed omkring, hvilken tilgang FDA har til fedmemedicin.
Qnexa er en kombination af to allerede markedsførte lægemidler (phentermine og topi-ramate), og Qnexa påvirker derigennem patienternes appetit og mæthedsfornemmelse. Samtidig viser Qnexa en bedre bivirkningsprofil end de allerede markedsførte lægemid-ler. Det er dog vores vurdering, at indlægssedlen ved en godkendelse vil indeholde alle bivirkninger for både phentermine og topiramate, da Qnexa er en kombinationspille. Det kan begrænse markedspotentialet for Qnexa.
For Neurosearch er det desuden interessant, at Qnexa endnu ikke er omfattet af en part-nerskabsaftale, da det kan give en indikation af værdien på en tesofensine-aftale. Vi vur-derer, at de store medicinalselskaber har stor fokus på fedmeområdet, men at det har vist sig svært at få dem til at satse stort på området. Det underbygges af, at Neuro-Search endnu ikke har lavet en partnerskabsaftale på tesofensine. Vi er dog af den over-bevisning, at ingen af de store medicinalselskaber på sigt vil stå udenfor et potentielt nyt stort vækstmarked, hvis usikkerheden i relation til FDA bliver mindre. Det er således et spørgsmål om, hvem af de store medicinalselskaber, der tør satse først.
I september 2009 forventer vi desuden også fase III data for lægemiddelkandidaten Lor-caserin fra Arena. Lorcaserin har tidligere vist et placebojusteret vægttab på bare 3,6%.
Vi fastholder vores Overvægt-anbefaling på NeuroSearch.
Ved ikke om I kan bruge det til noget, men er da en holdning fra en markedsdeltager.
Konklusion:
De offentliggjorte data fra Vivus er en positiv nyhed for NeuroSearch i relation til tesofen-sine også selv om Qnexa bliver en konkurrent. Det er vores vurdering, at FDA er skepti-ske og grundige, når de skal vurdere forholdet mellem effekt og bivirkninger hos potenti-elle fedmeprodukter. Det vil derfor blive lettere for tesofensine at slippe gennem nåleøjet, hvis andre selskabet tidligere har forelagt fordele og ulemper for FDA og er sluppet igen-nem. Vi står stadig i en situation, hvor fedme ikke er anerkendt som en sygdom, og der er fortsat stor usikkerhed omkring, hvilken tilgang FDA har til fedmemedicin.
Qnexa er en kombination af to allerede markedsførte lægemidler (phentermine og topi-ramate), og Qnexa påvirker derigennem patienternes appetit og mæthedsfornemmelse. Samtidig viser Qnexa en bedre bivirkningsprofil end de allerede markedsførte lægemid-ler. Det er dog vores vurdering, at indlægssedlen ved en godkendelse vil indeholde alle bivirkninger for både phentermine og topiramate, da Qnexa er en kombinationspille. Det kan begrænse markedspotentialet for Qnexa.
For Neurosearch er det desuden interessant, at Qnexa endnu ikke er omfattet af en part-nerskabsaftale, da det kan give en indikation af værdien på en tesofensine-aftale. Vi vur-derer, at de store medicinalselskaber har stor fokus på fedmeområdet, men at det har vist sig svært at få dem til at satse stort på området. Det underbygges af, at Neuro-Search endnu ikke har lavet en partnerskabsaftale på tesofensine. Vi er dog af den over-bevisning, at ingen af de store medicinalselskaber på sigt vil stå udenfor et potentielt nyt stort vækstmarked, hvis usikkerheden i relation til FDA bliver mindre. Det er således et spørgsmål om, hvem af de store medicinalselskaber, der tør satse først.
I september 2009 forventer vi desuden også fase III data for lægemiddelkandidaten Lor-caserin fra Arena. Lorcaserin har tidligere vist et placebojusteret vægttab på bare 3,6%.
Vi fastholder vores Overvægt-anbefaling på NeuroSearch.
Ved ikke om I kan bruge det til noget, men er da en holdning fra en markedsdeltager.
11/9 2009 01:04 troldmanden 018439 Her er lidt mere om Qnexa resultaterne.
http://www.cnbc.com/id/32757381/site/14081545?__source=yahoo%7Cheadline%7Cquote%7Ctext%7C&par=yahoo
Hatten af for den måde Vivus har kørt hele PR dele. Specielt det at de får pumpet tallet 14,7% vægttab ud i medierne. De sluger det råt. Så ingen nævner de relle ITT placebojusterede data som er 9,4%. Egentligt noget svineri at man ikke fremhæver de data som et stof skal eksamineres på. Vi så noget af det samme hos Arena Pharmaceuticals da de fik skuffende fase 3 resultater med Lorcaserin. Der var det også pludselig completer data frem for ITT data. Men det er jo hammerende effektivt. Så håber Neurosearch sidder på første parket og tager noter til hvorledes fremtidige Tesofensine data skal præsenteres
http://www.cnbc.com/id/32757381/site/14081545?__source=yahoo%7Cheadline%7Cquote%7Ctext%7C&par=yahoo
Hatten af for den måde Vivus har kørt hele PR dele. Specielt det at de får pumpet tallet 14,7% vægttab ud i medierne. De sluger det råt. Så ingen nævner de relle ITT placebojusterede data som er 9,4%. Egentligt noget svineri at man ikke fremhæver de data som et stof skal eksamineres på. Vi så noget af det samme hos Arena Pharmaceuticals da de fik skuffende fase 3 resultater med Lorcaserin. Der var det også pludselig completer data frem for ITT data. Men det er jo hammerende effektivt. Så håber Neurosearch sidder på første parket og tager noter til hvorledes fremtidige Tesofensine data skal præsenteres
