Dem der interessere sig for anti fedme markedet skal holde meget øje med amerikanske Arena Pharmaceuticals. De præsenterer fase 3 resultater fra deres stof Lorcaserin her i løbet af den næst time. De afholder en telefon konference kl 1430 dansk tid.
Aktien kommer enten til at falde eller stige med 50+ procent.
Acomplia som sidste år blev trukket tilbage fra det europæiske marked var det hidtil bedste stof. Det gav et placebo justeret vægttab på 4,7 kg over 12 mdr. Ud fra de informationer der hidtil er kommet ud så er mit bud at Lorcaserin vil opnå et vægttab på 5-7 kg.
5kg vil af mange blive tolket negativt idet en del har forventninger på 8-10kg. Men det er stadigt muligt at opnå en godkendelse af FDA (såfremt safty data er gode nok!) hvorfor det stadig bør give en ganske pæn stigning i aktien. Men 5kg er ikke nok til for alvor at få en kæmpe gennembrud på fedme markedet. Der regner man med at der skal mindst 8kg til. Og gerne over de 10 kg.
Til sammenligning så har Tesofensine fra Neurosearch givet 13-14kg vægttab på 12 mdr
Men hold øje med Arena den næste times tid
http://www.arenapharm.com/wt/page/home.html
Aktien kommer enten til at falde eller stige med 50+ procent.
Acomplia som sidste år blev trukket tilbage fra det europæiske marked var det hidtil bedste stof. Det gav et placebo justeret vægttab på 4,7 kg over 12 mdr. Ud fra de informationer der hidtil er kommet ud så er mit bud at Lorcaserin vil opnå et vægttab på 5-7 kg.
5kg vil af mange blive tolket negativt idet en del har forventninger på 8-10kg. Men det er stadigt muligt at opnå en godkendelse af FDA (såfremt safty data er gode nok!) hvorfor det stadig bør give en ganske pæn stigning i aktien. Men 5kg er ikke nok til for alvor at få en kæmpe gennembrud på fedme markedet. Der regner man med at der skal mindst 8kg til. Og gerne over de 10 kg.
Til sammenligning så har Tesofensine fra Neurosearch givet 13-14kg vægttab på 12 mdr
Men hold øje med Arena den næste times tid
http://www.arenapharm.com/wt/page/home.html
30/3 2009 14:49 troldmanden 0
6321 Så kom data. Og avavava for den da. De opnår kun placebojustert vægttab på 3,64 kg over 12 mdr (ITT gruppen som er de data man skal godkendes på) Dem der fuldførte alle 12 mdr opnåede 4,7kg.
Kan ikke se andet end at Arena Pharmaceuticals nu er færdige. Stoffet har ikke givet et bedre resultat end de 3,3 kg de opnåede i 12 ugers forsøg. Så de er ude af kampen nu.
Dermed er det her også godt for Neurosearch. For de big pharma som Arena har været i forhandlinger med har nu med stats garanti trukket sig igen. Arena var anset som den største konkurrent til Tesofensine
Betyder det her så at en aftaler med Tesofensine er sikker? Nej selvfølgelig ikke. NS mangler stadig den uhyre vigtige feedback fra FDA ang fase 3 design. Men dagens meddelelse har gjort muligheden for en aftale bedre.....
Arena Pharmaceuticals Announces Positive Lorcaserin Pivotal Phase 3 Obesity Trial Results: Meets All Primary Efficacy and Safety Endpoints
-- -- Lorcaserin Very Well Tolerated Throughout Two-Year Study -- Conference Call Scheduled for Today at 8:30 a.m. EDT
SAN DIEGO, March 30, 2009, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced today positive top-line results from BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management), the first of two pivotal trials evaluating the safety and efficacy of lorcaserin for weight management. Statistical significance (p<0.0001) was achieved on all three of the hierarchically ordered co-primary endpoints for patients treated with lorcaserin versus placebo. Treatment with lorcaserin was generally very well tolerated. An assessment of echocardiograms indicates no apparent drug-related effect on the development of US Food and Drug Administration (FDA)-defined valvulopathy over the two-year treatment period.
Primary Endpoint Analysis
The hierarchically ordered endpoints were the proportion of patients achieving 5% or greater weight loss after 12 months, the difference in mean weight loss compared to placebo after 12 months, and the proportion of patients achieving 10% or greater weight loss after 12 months. Compared to placebo, using an intent-to-treat last observation carried forward (ITT-LOCF) analysis, treatment with lorcaserin was associated with highly statistically significant (p<0.0001) categorical and average weight loss from baseline after 12 months:
-- 47.5% of lorcaserin patients lost greater than or equal to 5% of their
body weight from baseline compared to 20.3% in the placebo group. This
result satisfies the efficacy benchmark in the most recent FDA draft
guidance.
-- Average weight loss of 5.8% of body weight, or 12.7 pounds, was achieved
in the lorcaserin group, compared to 2.2% of body weight, or 4.7 pounds,
in the placebo group. Statistical separation from placebo was observed
by Week 2, the first post-baseline measurement.
-- 22.6% of lorcaserin patients lost greater than or equal to 10% of their
body weight from baseline, compared to 7.7% in the placebo group.
Lorcaserin patients who completed 52 weeks of treatment according to the protocol lost an average of 8.2% of body weight, or 17.9 pounds, compared to 3.4%, or 7.3 pounds, in the placebo group (p<0.0001).
"The BLOOM results, demonstrating lorcaserin's medically important weight loss coupled with the tolerability and safety profile displayed in this trial, differentiate lorcaserin from approved drugs or other agents in clinical trials," commented Steven R. Smith, M.D., Co-Principal Investigator and Professor and Assistant Director for Clinical Research at the Pennington Biomedical Research Center. "Obesity is a widespread disease; having a well tolerated and effective therapy that can be used by the majority of patients who need weight reduction could also have beneficial effects on co-morbid conditions, such as diabetes, lipid disorders, and cardiovascular disease."
Safety and Tolerability Profile
Lorcaserin was generally very well tolerated. The most frequent adverse events reported in Year 1 and their rates for lorcaserin and placebo patients, respectively, were as follows: headache (18.0% vs. 11.0%), upper respiratory tract infection (14.8% vs. 11.9%), nasopharyngitis (13.4% vs. 12.0%), sinusitis (7.2% vs. 8.2%) and nausea (7.5% vs. 5.4%). The most frequent adverse events reported in Year 2 and their rates for lorcaserin and placebo patients, respectively, were as follows: upper respiratory tract infection (14.5% vs. 16.1%), nasopharyngitis (16.4% vs. 12.6%), sinusitis (8.6% vs. 6.9%), arthralgia (6.6% vs. 6.2%) and influenza (6.6% vs. 6.0%). In patients crossing over from lorcaserin to placebo after Year 1, the rates of these Year 2 adverse events were: 11.0%, 13.8%, 10.6%, 6.0% and 4.9%, respectively.
Adverse events of depression, anxiety and suicidal ideation were infrequent and reported at a similar rate in each treatment group, and no seizures were reported. Serious adverse events occurred with similar frequency in each group throughout the trial without apparent relationship to lorcaserin. One death occurred during the trial, which was a patient in the placebo arm.
"The BLOOM trial, having met all of its primary endpoints and the FDA categorical efficacy benchmark as stated in their guidance, suggests lorcaserin has the potential to become the first in a new class of effective and very well tolerated weight management therapeutics that selectively target the serotonin 2C receptor," said William R. Shanahan, M.D., Arena's Vice President and Chief Medical Officer. "We look forward to building on these positive top-line data with the BLOSSOM study results expected around the end of September leading to an NDA submission by the end of this year. We also look forward to working with the FDA during the approval process to bring this treatment to patients in need of new options."
Echocardiogram Assessment
Using an ITT-LOCF analysis, the assessment of echocardiograms performed at baseline and after patients completed 6, 12, 18 and 24 months of dosing indicated no apparent drug-related effect on the development of FDA-defined valvulopathy (moderate or greater mitral insufficiency and/or mild or greater aortic insufficiency).
Lorcaserin met the primary safety endpoint of no significant difference in rates of valvulopathy at 12 months. Rates of valvulopathy at 6, 12, 18 and 24 months for lorcaserin versus placebo were 2.1% vs. 1.9%, 2.7% vs. 2.3%, 2.9% vs. 3.1% and 2.6% vs. 2.7%. At 18 and 24 months, rates of valvulopathy for lorcaserin patients crossing over to placebo were 3.6% and 1.9%, respectively.
The FDA has requested that Arena rule out a 1.5-fold or greater risk of valvulopathy with 80% power. Assuming similar results in BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management), the integrated data set from the two trials will be more than sufficiently large to meet this requirement.
"The echocardiographic safety data is very reassuring," commented Neil J. Weissman, M.D., Co-Principal Investigator, Director, Cardiac Ultrasound and Ultrasound Core Labs, President, MedStar Research Institute, and Professor of Medicine, Georgetown University. "In this double-blind, prospective study, there was no evidence of a difference in the development of valve disease in the large number of patients on lorcaserin versus control for up to two years of continuous use. No prospective valvulopathy trial has ever studied this many patients for this period of time, particularly under such well-controlled circumstances."
Secondary Endpoint Analysis
Treatment with lorcaserin was also associated with statistically significant improvements (ITT-LOCF) in a range of secondary endpoints compared to treatment with placebo, including:
-- Total cholesterol
-- LDL cholesterol
-- Triglycerides
-- Blood pressure
Changes in HDL cholesterol were similar in the two groups. Analysis of the above and additional endpoints, including glucose, insulin and waist circumference, is ongoing and will be announced at a later date.
During Year 2 of the trial, patients continuing on lorcaserin were better able to maintain more of the Week 52 weight loss than Year 1 lorcaserin patients re-randomized to placebo in Year 2.
Patient Disposition
Patient demographic characteristics at baseline were well balanced across the treatment groups. The Week 52 completion rate was higher for patients on lorcaserin (55.4%) compared to those on placebo (45.1%). The difference is primarily attributed to higher discontinuation rates for "Subject Decision" (19.2% lorcaserin vs. 27.7% placebo), which includes "Lack of Efficacy" (1.7% lorcaserin vs. 5.5% placebo). Discontinuations for adverse events (7.1% lorcaserin vs. 6.7% placebo) and other reasons were similar.
Completion rates for Year 2 were similar across the treatment groups: 74.3%, 72.7%, and 68.9% for patients continuing on lorcaserin for both years, patients taking placebo both years, and patients switching from lorcaserin to placebo in Year 2, respectively. Discontinuations for adverse events were also similar across the treatment groups.
"The positive outcome of the BLOOM trial serves as a very significant milestone for Arena, demonstrating lorcaserin's potential to provide a new treatment option for patients who need to lose weight and keep it off," stated Jack Lief, Arena's President and Chief Executive Officer. "Given lorcaserin's status as the only novel, single agent weight loss therapeutic in Phase 3 development, as well as data that continues to support our expectation for a well-tolerated and efficacious drug, I expect to have a range of commercialization options to consider."
BLOOM Trial Design
BLOOM, the first of three lorcaserin Phase 3 trials, is a double-blind, randomized, placebo-controlled trial involving 3,182 patients in approximately 100 sites in the US. The trial evaluated 10 mg of lorcaserin dosed twice daily versus placebo over a two-year treatment period in obese patients (Body Mass Index, or BMI, 30 to 45) with or without co-morbid conditions and overweight patients (BMI 27 to less than 30) with at least one co-morbid condition. The trial did not include any dose titration or run-in period. Patients were randomized in a 1:1 ratio to lorcaserin or placebo at baseline. At Week 52, 856 patients taking lorcaserin were re-randomized in a 2:1 ratio to continue lorcaserin or to switch to placebo, and 697 patients on placebo were continued on placebo. Patients received echocardiograms at screening, and at 6, 12, 18 and 24 months after initiating dosing in the trial; patients with FDA-defined valvulopathy were excluded from enrolling in the trial.
Phase 3 Program Overview
The Phase 3 program consists of three trials, BLOOM, BLOSSOM and BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus), and is planned to enroll a total of approximately 7,800 patients. BLOOM and BLOSSOM comprise the Phase 3 pivotal registration program. BLOSSOM has enrolled 4,008 patients and is evaluating 10 mg of lorcaserin dosed once or twice daily versus placebo over a one-year treatment period in obese patients with or without co-morbid conditions and overweight patients with at least one co-morbid condition at about 100 sites in the US. Results are expected around the end of September 2009. BLOOM-DM is currently enrolling and is evaluating 10 mg of lorcaserin dosed once or twice daily versus placebo over a one-year treatment period in obese and overweight patients with type 2 diabetes at about 60 sites in the US. Approximately 600 patients are expected to be enrolled in BLOOM-DM, which is planned as a supplement to the lorcaserin NDA.
A standardized program of moderate diet and exercise guidance is included in the Phase 3 program. The program's hierarchically ordered co-primary efficacy endpoints are: the proportion of patients achieving 5% or greater weight loss after 12 months, the difference in mean weight loss compared to placebo after 12 months, and the proportion of patients achieving 10% or greater weight loss after 12 months. Arena is also studying several key secondary endpoints, including changes in serum lipids and HbA1c levels and, in the BLOOM-DM trial, other indicators of glycemic control. In BLOSSOM and BLOOM-DM all patients will receive echocardiograms at baseline, at month 6, and at the end of the study to assess heart valve function over time. In contrast to the BLOOM trial, however, there are no echocardiographic exclusion criteria for entry into these trials and there is no monitoring by an independent monitoring board.
Conference Call & Webcast
Arena will host a conference call and webcast to discuss the results today, Monday, March 30, 2009 at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time). Jack Lief, President and Chief Executive Officer, Dominic P. Behan, Ph.D., Senior Vice President and Chief Scientific Officer, William R. Shanahan, M.D., Vice President and Chief Medical Officer, and Christen M. Anderson, M.D., Ph.D., Vice President, Clinical Development, will host the conference call.
The conference call may be accessed by dialing 877.874.1565 for domestic callers and 719.325.4758 for international callers. Please specify to the operator that you would like to join the "Lorcaserin BLOOM Trial Results" conference call. The conference call will be webcast live under the investor relations section of Arena's website at www.arenapharm.com, and will be archived there for 30 days following the call. Please connect to Arena's website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.
About Lorcaserin
Lorcaserin is a novel single agent that represents the first in a new class of selective serotonin 2C receptor agonists. The serotonin 2C receptor is located in areas of the brain involved in the control of appetite and metabolism, such as the hypothalamus. Stimulation of this receptor is strongly associated with feeding behavior and satiety. Lorcaserin is currently being evaluated in a Phase 3 program expected to enroll approximately 7,800 patients and potentially represents a targeted treatment option for the millions of patients who need to better manage their weight. Arena has patents that cover lorcaserin in the US and other jurisdictions, which in most cases are capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity Arena might obtain.
About Obesity
A 2007 report by the US Department of Health and Human Services states that approximately one-third of US adults are obese and two-thirds have been told by a health care provider that they are overweight. Medical and related costs of obesity are $123 billion per year according to a 2005 report by the International Diabetes Federation. Studies have shown that weight loss of 5% to 10% is medically significant and results in meaningful improvements in cardiovascular risk factors and a significant reduction in the incidence of type 2 diabetes. Diet and exercise should form the basis of healthy weight loss, but pharmaceutical treatment options for obesity are currently limited for the many patients that require additional help in achieving and maintaining medically important weight loss.
About the FDA Draft Guidance
The FDA draft guidance document for developing products for weight management dated February 2007 provides recommendations regarding the development of drugs for the indication of weight management. It contains two alternate efficacy benchmarks. The guidance provides that, in general, a product can be considered effective for weight management if after one year of treatment either of the following occurs: (1) the difference in mean weight loss between the active-product and placebo-treated groups is at least 5% and the difference is statistically significant, or (2) the proportion of subjects who lose greater than or equal to 5% of baseline body weight in the active-product group is at least 35%, is approximately double the proportion in the placebo-treated group, and the difference between groups is statistically significant.
About Arena Pharmaceuticals
Arena is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases. Arena's most advanced drug candidate, lorcaserin, is being investigated in a Phase 3 clinical trial program for weight management. Arena's broad pipeline of novel compounds target G protein-coupled receptors, an important class of validated drug targets, and includes compounds being evaluated independently and with partners, including Merck & Co., Inc., and Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Arena Pharmaceuticals(R) and Arena(R) are registered service marks of the company. "APD" is an abbreviation for Arena Pharmaceuticals Development.
Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements about the development, therapeutic indication, tolerability, safety, selectivity, efficacy and potential of lorcaserin; the significance of the review of echocardiographic data and lorcaserin's effect on the development of FDA-defined valvulopathy; the protocol, design, scope, enrollment and other aspects of the lorcaserin trials; the continued advancement of the related program; the significance of the BLOOM results; the impact of weight loss on health, including improving cardiovascular risk factors and reducing type 2 diabetes; future activities, results and announcements relating to lorcaserin, including the BLOSSOM results, the submission of an NDA for lorcaserin and the submission of the BLOOM-DM results as a supplement to the NDA; the potential of lorcaserin to meet the FDA's requirements for approval and the approval of lorcaserin for marketing; commercialization options and the coverage of lorcaserin patents; and about Arena's strategy, internal and partnered programs, and ability to develop compounds and commercialize drugs. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, Arena's ability to obtain additional funds, the timing, success and cost of Arena's lorcaserin program and other of its research and development programs, the results of clinical trials or preclinical studies may not be predictive of future results, clinical trials and studies may not proceed at the time or in the manner Arena expects or at all, Arena's ability to partner lorcaserin or other of its compounds or programs, the timing and ability of Arena to receive regulatory approval for its drug candidates, Arena's ability to obtain and defend its patents, and the timing and receipt of payments and fees, if any, from Arena's collaborators. Additional factors that could cause actual results to differ materially from those stated or implied by Arena's forward-looking statements are disclosed in Arena's filings with the Securities and Exchange Commission. These forward-looking statements represent Arena's judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
Kan ikke se andet end at Arena Pharmaceuticals nu er færdige. Stoffet har ikke givet et bedre resultat end de 3,3 kg de opnåede i 12 ugers forsøg. Så de er ude af kampen nu.
Dermed er det her også godt for Neurosearch. For de big pharma som Arena har været i forhandlinger med har nu med stats garanti trukket sig igen. Arena var anset som den største konkurrent til Tesofensine
Betyder det her så at en aftaler med Tesofensine er sikker? Nej selvfølgelig ikke. NS mangler stadig den uhyre vigtige feedback fra FDA ang fase 3 design. Men dagens meddelelse har gjort muligheden for en aftale bedre.....
Arena Pharmaceuticals Announces Positive Lorcaserin Pivotal Phase 3 Obesity Trial Results: Meets All Primary Efficacy and Safety Endpoints
-- -- Lorcaserin Very Well Tolerated Throughout Two-Year Study -- Conference Call Scheduled for Today at 8:30 a.m. EDT
SAN DIEGO, March 30, 2009, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced today positive top-line results from BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management), the first of two pivotal trials evaluating the safety and efficacy of lorcaserin for weight management. Statistical significance (p<0.0001) was achieved on all three of the hierarchically ordered co-primary endpoints for patients treated with lorcaserin versus placebo. Treatment with lorcaserin was generally very well tolerated. An assessment of echocardiograms indicates no apparent drug-related effect on the development of US Food and Drug Administration (FDA)-defined valvulopathy over the two-year treatment period.
Primary Endpoint Analysis
The hierarchically ordered endpoints were the proportion of patients achieving 5% or greater weight loss after 12 months, the difference in mean weight loss compared to placebo after 12 months, and the proportion of patients achieving 10% or greater weight loss after 12 months. Compared to placebo, using an intent-to-treat last observation carried forward (ITT-LOCF) analysis, treatment with lorcaserin was associated with highly statistically significant (p<0.0001) categorical and average weight loss from baseline after 12 months:
-- 47.5% of lorcaserin patients lost greater than or equal to 5% of their
body weight from baseline compared to 20.3% in the placebo group. This
result satisfies the efficacy benchmark in the most recent FDA draft
guidance.
-- Average weight loss of 5.8% of body weight, or 12.7 pounds, was achieved
in the lorcaserin group, compared to 2.2% of body weight, or 4.7 pounds,
in the placebo group. Statistical separation from placebo was observed
by Week 2, the first post-baseline measurement.
-- 22.6% of lorcaserin patients lost greater than or equal to 10% of their
body weight from baseline, compared to 7.7% in the placebo group.
Lorcaserin patients who completed 52 weeks of treatment according to the protocol lost an average of 8.2% of body weight, or 17.9 pounds, compared to 3.4%, or 7.3 pounds, in the placebo group (p<0.0001).
"The BLOOM results, demonstrating lorcaserin's medically important weight loss coupled with the tolerability and safety profile displayed in this trial, differentiate lorcaserin from approved drugs or other agents in clinical trials," commented Steven R. Smith, M.D., Co-Principal Investigator and Professor and Assistant Director for Clinical Research at the Pennington Biomedical Research Center. "Obesity is a widespread disease; having a well tolerated and effective therapy that can be used by the majority of patients who need weight reduction could also have beneficial effects on co-morbid conditions, such as diabetes, lipid disorders, and cardiovascular disease."
Safety and Tolerability Profile
Lorcaserin was generally very well tolerated. The most frequent adverse events reported in Year 1 and their rates for lorcaserin and placebo patients, respectively, were as follows: headache (18.0% vs. 11.0%), upper respiratory tract infection (14.8% vs. 11.9%), nasopharyngitis (13.4% vs. 12.0%), sinusitis (7.2% vs. 8.2%) and nausea (7.5% vs. 5.4%). The most frequent adverse events reported in Year 2 and their rates for lorcaserin and placebo patients, respectively, were as follows: upper respiratory tract infection (14.5% vs. 16.1%), nasopharyngitis (16.4% vs. 12.6%), sinusitis (8.6% vs. 6.9%), arthralgia (6.6% vs. 6.2%) and influenza (6.6% vs. 6.0%). In patients crossing over from lorcaserin to placebo after Year 1, the rates of these Year 2 adverse events were: 11.0%, 13.8%, 10.6%, 6.0% and 4.9%, respectively.
Adverse events of depression, anxiety and suicidal ideation were infrequent and reported at a similar rate in each treatment group, and no seizures were reported. Serious adverse events occurred with similar frequency in each group throughout the trial without apparent relationship to lorcaserin. One death occurred during the trial, which was a patient in the placebo arm.
"The BLOOM trial, having met all of its primary endpoints and the FDA categorical efficacy benchmark as stated in their guidance, suggests lorcaserin has the potential to become the first in a new class of effective and very well tolerated weight management therapeutics that selectively target the serotonin 2C receptor," said William R. Shanahan, M.D., Arena's Vice President and Chief Medical Officer. "We look forward to building on these positive top-line data with the BLOSSOM study results expected around the end of September leading to an NDA submission by the end of this year. We also look forward to working with the FDA during the approval process to bring this treatment to patients in need of new options."
Echocardiogram Assessment
Using an ITT-LOCF analysis, the assessment of echocardiograms performed at baseline and after patients completed 6, 12, 18 and 24 months of dosing indicated no apparent drug-related effect on the development of FDA-defined valvulopathy (moderate or greater mitral insufficiency and/or mild or greater aortic insufficiency).
Lorcaserin met the primary safety endpoint of no significant difference in rates of valvulopathy at 12 months. Rates of valvulopathy at 6, 12, 18 and 24 months for lorcaserin versus placebo were 2.1% vs. 1.9%, 2.7% vs. 2.3%, 2.9% vs. 3.1% and 2.6% vs. 2.7%. At 18 and 24 months, rates of valvulopathy for lorcaserin patients crossing over to placebo were 3.6% and 1.9%, respectively.
The FDA has requested that Arena rule out a 1.5-fold or greater risk of valvulopathy with 80% power. Assuming similar results in BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management), the integrated data set from the two trials will be more than sufficiently large to meet this requirement.
"The echocardiographic safety data is very reassuring," commented Neil J. Weissman, M.D., Co-Principal Investigator, Director, Cardiac Ultrasound and Ultrasound Core Labs, President, MedStar Research Institute, and Professor of Medicine, Georgetown University. "In this double-blind, prospective study, there was no evidence of a difference in the development of valve disease in the large number of patients on lorcaserin versus control for up to two years of continuous use. No prospective valvulopathy trial has ever studied this many patients for this period of time, particularly under such well-controlled circumstances."
Secondary Endpoint Analysis
Treatment with lorcaserin was also associated with statistically significant improvements (ITT-LOCF) in a range of secondary endpoints compared to treatment with placebo, including:
-- Total cholesterol
-- LDL cholesterol
-- Triglycerides
-- Blood pressure
Changes in HDL cholesterol were similar in the two groups. Analysis of the above and additional endpoints, including glucose, insulin and waist circumference, is ongoing and will be announced at a later date.
During Year 2 of the trial, patients continuing on lorcaserin were better able to maintain more of the Week 52 weight loss than Year 1 lorcaserin patients re-randomized to placebo in Year 2.
Patient Disposition
Patient demographic characteristics at baseline were well balanced across the treatment groups. The Week 52 completion rate was higher for patients on lorcaserin (55.4%) compared to those on placebo (45.1%). The difference is primarily attributed to higher discontinuation rates for "Subject Decision" (19.2% lorcaserin vs. 27.7% placebo), which includes "Lack of Efficacy" (1.7% lorcaserin vs. 5.5% placebo). Discontinuations for adverse events (7.1% lorcaserin vs. 6.7% placebo) and other reasons were similar.
Completion rates for Year 2 were similar across the treatment groups: 74.3%, 72.7%, and 68.9% for patients continuing on lorcaserin for both years, patients taking placebo both years, and patients switching from lorcaserin to placebo in Year 2, respectively. Discontinuations for adverse events were also similar across the treatment groups.
"The positive outcome of the BLOOM trial serves as a very significant milestone for Arena, demonstrating lorcaserin's potential to provide a new treatment option for patients who need to lose weight and keep it off," stated Jack Lief, Arena's President and Chief Executive Officer. "Given lorcaserin's status as the only novel, single agent weight loss therapeutic in Phase 3 development, as well as data that continues to support our expectation for a well-tolerated and efficacious drug, I expect to have a range of commercialization options to consider."
BLOOM Trial Design
BLOOM, the first of three lorcaserin Phase 3 trials, is a double-blind, randomized, placebo-controlled trial involving 3,182 patients in approximately 100 sites in the US. The trial evaluated 10 mg of lorcaserin dosed twice daily versus placebo over a two-year treatment period in obese patients (Body Mass Index, or BMI, 30 to 45) with or without co-morbid conditions and overweight patients (BMI 27 to less than 30) with at least one co-morbid condition. The trial did not include any dose titration or run-in period. Patients were randomized in a 1:1 ratio to lorcaserin or placebo at baseline. At Week 52, 856 patients taking lorcaserin were re-randomized in a 2:1 ratio to continue lorcaserin or to switch to placebo, and 697 patients on placebo were continued on placebo. Patients received echocardiograms at screening, and at 6, 12, 18 and 24 months after initiating dosing in the trial; patients with FDA-defined valvulopathy were excluded from enrolling in the trial.
Phase 3 Program Overview
The Phase 3 program consists of three trials, BLOOM, BLOSSOM and BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus), and is planned to enroll a total of approximately 7,800 patients. BLOOM and BLOSSOM comprise the Phase 3 pivotal registration program. BLOSSOM has enrolled 4,008 patients and is evaluating 10 mg of lorcaserin dosed once or twice daily versus placebo over a one-year treatment period in obese patients with or without co-morbid conditions and overweight patients with at least one co-morbid condition at about 100 sites in the US. Results are expected around the end of September 2009. BLOOM-DM is currently enrolling and is evaluating 10 mg of lorcaserin dosed once or twice daily versus placebo over a one-year treatment period in obese and overweight patients with type 2 diabetes at about 60 sites in the US. Approximately 600 patients are expected to be enrolled in BLOOM-DM, which is planned as a supplement to the lorcaserin NDA.
A standardized program of moderate diet and exercise guidance is included in the Phase 3 program. The program's hierarchically ordered co-primary efficacy endpoints are: the proportion of patients achieving 5% or greater weight loss after 12 months, the difference in mean weight loss compared to placebo after 12 months, and the proportion of patients achieving 10% or greater weight loss after 12 months. Arena is also studying several key secondary endpoints, including changes in serum lipids and HbA1c levels and, in the BLOOM-DM trial, other indicators of glycemic control. In BLOSSOM and BLOOM-DM all patients will receive echocardiograms at baseline, at month 6, and at the end of the study to assess heart valve function over time. In contrast to the BLOOM trial, however, there are no echocardiographic exclusion criteria for entry into these trials and there is no monitoring by an independent monitoring board.
Conference Call & Webcast
Arena will host a conference call and webcast to discuss the results today, Monday, March 30, 2009 at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time). Jack Lief, President and Chief Executive Officer, Dominic P. Behan, Ph.D., Senior Vice President and Chief Scientific Officer, William R. Shanahan, M.D., Vice President and Chief Medical Officer, and Christen M. Anderson, M.D., Ph.D., Vice President, Clinical Development, will host the conference call.
The conference call may be accessed by dialing 877.874.1565 for domestic callers and 719.325.4758 for international callers. Please specify to the operator that you would like to join the "Lorcaserin BLOOM Trial Results" conference call. The conference call will be webcast live under the investor relations section of Arena's website at www.arenapharm.com, and will be archived there for 30 days following the call. Please connect to Arena's website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.
About Lorcaserin
Lorcaserin is a novel single agent that represents the first in a new class of selective serotonin 2C receptor agonists. The serotonin 2C receptor is located in areas of the brain involved in the control of appetite and metabolism, such as the hypothalamus. Stimulation of this receptor is strongly associated with feeding behavior and satiety. Lorcaserin is currently being evaluated in a Phase 3 program expected to enroll approximately 7,800 patients and potentially represents a targeted treatment option for the millions of patients who need to better manage their weight. Arena has patents that cover lorcaserin in the US and other jurisdictions, which in most cases are capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity Arena might obtain.
About Obesity
A 2007 report by the US Department of Health and Human Services states that approximately one-third of US adults are obese and two-thirds have been told by a health care provider that they are overweight. Medical and related costs of obesity are $123 billion per year according to a 2005 report by the International Diabetes Federation. Studies have shown that weight loss of 5% to 10% is medically significant and results in meaningful improvements in cardiovascular risk factors and a significant reduction in the incidence of type 2 diabetes. Diet and exercise should form the basis of healthy weight loss, but pharmaceutical treatment options for obesity are currently limited for the many patients that require additional help in achieving and maintaining medically important weight loss.
About the FDA Draft Guidance
The FDA draft guidance document for developing products for weight management dated February 2007 provides recommendations regarding the development of drugs for the indication of weight management. It contains two alternate efficacy benchmarks. The guidance provides that, in general, a product can be considered effective for weight management if after one year of treatment either of the following occurs: (1) the difference in mean weight loss between the active-product and placebo-treated groups is at least 5% and the difference is statistically significant, or (2) the proportion of subjects who lose greater than or equal to 5% of baseline body weight in the active-product group is at least 35%, is approximately double the proportion in the placebo-treated group, and the difference between groups is statistically significant.
About Arena Pharmaceuticals
Arena is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases. Arena's most advanced drug candidate, lorcaserin, is being investigated in a Phase 3 clinical trial program for weight management. Arena's broad pipeline of novel compounds target G protein-coupled receptors, an important class of validated drug targets, and includes compounds being evaluated independently and with partners, including Merck & Co., Inc., and Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Arena Pharmaceuticals(R) and Arena(R) are registered service marks of the company. "APD" is an abbreviation for Arena Pharmaceuticals Development.
Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements about the development, therapeutic indication, tolerability, safety, selectivity, efficacy and potential of lorcaserin; the significance of the review of echocardiographic data and lorcaserin's effect on the development of FDA-defined valvulopathy; the protocol, design, scope, enrollment and other aspects of the lorcaserin trials; the continued advancement of the related program; the significance of the BLOOM results; the impact of weight loss on health, including improving cardiovascular risk factors and reducing type 2 diabetes; future activities, results and announcements relating to lorcaserin, including the BLOSSOM results, the submission of an NDA for lorcaserin and the submission of the BLOOM-DM results as a supplement to the NDA; the potential of lorcaserin to meet the FDA's requirements for approval and the approval of lorcaserin for marketing; commercialization options and the coverage of lorcaserin patents; and about Arena's strategy, internal and partnered programs, and ability to develop compounds and commercialize drugs. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, Arena's ability to obtain additional funds, the timing, success and cost of Arena's lorcaserin program and other of its research and development programs, the results of clinical trials or preclinical studies may not be predictive of future results, clinical trials and studies may not proceed at the time or in the manner Arena expects or at all, Arena's ability to partner lorcaserin or other of its compounds or programs, the timing and ability of Arena to receive regulatory approval for its drug candidates, Arena's ability to obtain and defend its patents, and the timing and receipt of payments and fees, if any, from Arena's collaborators. Additional factors that could cause actual results to differ materially from those stated or implied by Arena's forward-looking statements are disclosed in Arena's filings with the Securities and Exchange Commission. These forward-looking statements represent Arena's judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
30/3 2009 14:52 stengård 06322 den mest anerkendte og sikre måde at tabe sig på er at købe aktier....
30/3 2009 15:07 troldmanden 06324 Har du aldrig hørt om trøste spisning....... men selvfølgelig det skal der jo også være penge til
31/3 2009 08:18 stengård 06406 de fik da et pænt hak i trynen.... selvom vi jo har set større fald ved mindre negative meddelelser..
stengård
stengård
31/3 2009 12:37 troldmanden 06419 Jeg havde bestemt regnet med over 50% fald. Men når man lyttede til CC så ser man endnu engang hvordan amerikanerne bare er verdensmestre til at spinde dårlige nyheder som gode nyheder.
For at et fedme stof kan godkendes skal mindst en ud af 2 nedenstående krav opfyldes.
1) et placebo justert vægttab på 5%
2) der skal være mindst 35% der oplever et vægttab større end 5%. Og dette tal skal være dobbelt så stort som den del der får placebo
Rent teknisk kan et stof altså blive godkendt ved blot at opfylde krav nummer 2. Men ALLE anser krav nummer 1 som den ABSOLUTTE vigtigste. Og her opnåede Lorcaserin kun 3,6%. Det udelukker dermed også muligheden for at opnå reimbursment (tilskud)
Lorcaserin opnår så godtnok at 47% taber sig >5% mod 20% på placebo hvorfor de teknisk set godt kan blive godkendt (hvis safty er gode nok detaljerne kender vi ikke endnu) men stoffet kan ikke blive en blockbuster (slag mere end $1 mia om året) ved dette ringe vægttab. Det er jo også mindre end Sibutramine som giver et vægttab på 4,3%
Jeg tror ikke på at noget bigpharma selskab vil overtage stoffet med disse resultater. Men kan da ikke udelukke at et mindre reginalt pharmaselskab vil prøve. Men det bliver så en aftale der ikke vil indbruge de $200 mio upfront.
Arena forsøgtet at overbevise folk (hvilket delvis lykkedes siden aktien ikke faldt mere) om at Lorcaserin er det eneste stof der opfylder 3 nedenstående krav som de praktiserende læger vil stille til et anti fedmestof. Og de gentog nedenstående mantra flere gange under CC
1) man kan give stoffet til hovedparten af sine patienter (safty)
2) man kan tabe sig hurtigt
3) man kan forblive på stoffet (lav drop out)
Men reelt set så er det kun nummer 1 Lorcaserin synes at opfylde.
Her er lidt data der sammenligner Lorcasering på effekt og drop out rate.
Et års vægttab
Acomplia 4,7%
Sibutramine 4,3%
Lorcaserin 3,6%
48 uger
Empatic ca 13%
Tesofensine 13-14%
6 mdr data
Tesofensine 9%
Qnexa 7,5% og 6,8%
Empatic 7,5%
Contrave 4,3%
12 ugers data
Tesofensine around 7% (taget fra 24 ugers graf)
Lorcaserin 3%
Mere end 5% vægttab vs placebo
Et års data
Acomplia 49% vs 20%
Sibutramine ingen data
Lorcaserin 47,5% vs 20,3%
48 uger
Empatic ingen data
Tesofensine ingen data
6 mdr data
Tesofensine 87% vs 29%
Qnexa 66% vs 15% (og 62% for midderste dosis)
Empatic ingen data
Contrave 52% vs 15%
12 uger data
Lorcaserin 31% vs 2%
Mere end 10% vægttab vs placebo
Et års data
Acomplia 25% vs 8%
Sibutramine ingen data
Lorcaserin 22,6% vs 7,7%
48 uger
Empatic 66% vs??
Tesofensine ingen data
6 mdr data
Tesofensine 53% vs 7%
Qnexa 41% vs 7% (og 39% for midderste dosis)
Empatic ingen data
Contrave 52% vs 15%
12 ugers data
Lorcaserin ingen data
Drop out
Et års data
Acomplia 40%
Sibutramine 31%
Lorcaserin 45%
48 uger data
Empatic 36% (mest effektive dosis)
Tesofensine ??
6 mdr data
Contrave 30%
Qnexa 29%
Tesofensine 22% (12% i 0,5mg dosis som er den der vil blive brugt i fase 3)
Empatic 17%(26% i den mest effektive dosis)
12 uger data
Lorcaserin 30%
For at et fedme stof kan godkendes skal mindst en ud af 2 nedenstående krav opfyldes.
1) et placebo justert vægttab på 5%
2) der skal være mindst 35% der oplever et vægttab større end 5%. Og dette tal skal være dobbelt så stort som den del der får placebo
Rent teknisk kan et stof altså blive godkendt ved blot at opfylde krav nummer 2. Men ALLE anser krav nummer 1 som den ABSOLUTTE vigtigste. Og her opnåede Lorcaserin kun 3,6%. Det udelukker dermed også muligheden for at opnå reimbursment (tilskud)
Lorcaserin opnår så godtnok at 47% taber sig >5% mod 20% på placebo hvorfor de teknisk set godt kan blive godkendt (hvis safty er gode nok detaljerne kender vi ikke endnu) men stoffet kan ikke blive en blockbuster (slag mere end $1 mia om året) ved dette ringe vægttab. Det er jo også mindre end Sibutramine som giver et vægttab på 4,3%
Jeg tror ikke på at noget bigpharma selskab vil overtage stoffet med disse resultater. Men kan da ikke udelukke at et mindre reginalt pharmaselskab vil prøve. Men det bliver så en aftale der ikke vil indbruge de $200 mio upfront.
Arena forsøgtet at overbevise folk (hvilket delvis lykkedes siden aktien ikke faldt mere) om at Lorcaserin er det eneste stof der opfylder 3 nedenstående krav som de praktiserende læger vil stille til et anti fedmestof. Og de gentog nedenstående mantra flere gange under CC
1) man kan give stoffet til hovedparten af sine patienter (safty)
2) man kan tabe sig hurtigt
3) man kan forblive på stoffet (lav drop out)
Men reelt set så er det kun nummer 1 Lorcaserin synes at opfylde.
Her er lidt data der sammenligner Lorcasering på effekt og drop out rate.
Et års vægttab
Acomplia 4,7%
Sibutramine 4,3%
Lorcaserin 3,6%
48 uger
Empatic ca 13%
Tesofensine 13-14%
6 mdr data
Tesofensine 9%
Qnexa 7,5% og 6,8%
Empatic 7,5%
Contrave 4,3%
12 ugers data
Tesofensine around 7% (taget fra 24 ugers graf)
Lorcaserin 3%
Mere end 5% vægttab vs placebo
Et års data
Acomplia 49% vs 20%
Sibutramine ingen data
Lorcaserin 47,5% vs 20,3%
48 uger
Empatic ingen data
Tesofensine ingen data
6 mdr data
Tesofensine 87% vs 29%
Qnexa 66% vs 15% (og 62% for midderste dosis)
Empatic ingen data
Contrave 52% vs 15%
12 uger data
Lorcaserin 31% vs 2%
Mere end 10% vægttab vs placebo
Et års data
Acomplia 25% vs 8%
Sibutramine ingen data
Lorcaserin 22,6% vs 7,7%
48 uger
Empatic 66% vs??
Tesofensine ingen data
6 mdr data
Tesofensine 53% vs 7%
Qnexa 41% vs 7% (og 39% for midderste dosis)
Empatic ingen data
Contrave 52% vs 15%
12 ugers data
Lorcaserin ingen data
Drop out
Et års data
Acomplia 40%
Sibutramine 31%
Lorcaserin 45%
48 uger data
Empatic 36% (mest effektive dosis)
Tesofensine ??
6 mdr data
Contrave 30%
Qnexa 29%
Tesofensine 22% (12% i 0,5mg dosis som er den der vil blive brugt i fase 3)
Empatic 17%(26% i den mest effektive dosis)
12 uger data
Lorcaserin 30%
31/3 2009 09:48 dummy 06410 Har de, som interesserer sig for fedme-markedet hørt om "hjerne-operationen", som er omtalt i Go' norgen Danmark ?
Mvh Kim
Mvh Kim
31/3 2009 11:47 Fyrtaarnet 06415 ja må sige at jeg var sikker på at det var 1. april, men datoen siger stadig 31/3... det lyder da for vildt at det kan lade sig gøre! hvad man så mener om at man nu skal anskue lyst til mad som en psykisk sygdom, er jo så en helt diskussion
http://ekstrabladet.dk/kup/sundhed/article1147688.ece
http://ekstrabladet.dk/kup/sundhed/article1147688.ece
31/3 2009 12:45 troldmanden 06420 Såfremt de kan vise en uovertruffen sikkerhed ved indgrebet så synes jeg det er en god ide. Men det er klart det ikke skal gælde hvis man blot har lidt ekstra på sidebenene. Det skal være den gruppe som er så svært overvægtige at de ikke bare kan men vil dø af de følgesygdomme som fedme er skyld i. Så vi taler nok folk med en BMI over 45 som vil få tilbudt sådan et indgreb. Dvs en person på 1,80 m vejer 146 kg
31/3 2009 13:26 collersteen 06426 Den stiger da 6-7% indtil nu
3/31/2009 12:20:18 - OMX Copenhagen, News
NeuroSearch A/S Selskabsmeddelelse NeuroSearch har successfuldt afsluttet patientrekrutteringen til MermaiHD, et klinisk fase III-studie med ACR16 inden for Huntingtons sygdom - og opdaterer samtidig på andre pipelinenyheder
- ACR16 til behandling af Huntingtons sygdom: Fuldført rekruttering af 420
Huntingtonpatienter til det europæiske fase III MermaiHD-studie
- Tesofensine til behandling af fedme: FDA har godkendt afholdelsen af et ”End
of Phase II”-møde og bekræftet en dato i 2. kvartal 2009
- ABT-107 (Abbott-samarbejde): Videre udvikling af stoffet indstilles i fase I
Patientrekrutteringen til fase III-studie af ACR16 inden for Huntingtons sygdom
fuldført
NeuroSearch har successfuldt afsluttet rekrutteringen af patienter til
MermaiHD-studiet, et europæisk fase III-studie af ACR16, der er en doperminerg
stabilisator og selskabets nye lægemiddelkandidat til behandling af Huntingtons
sygdom. Rekrut-teringen er fuldendt mindre end et år efter, den første
Huntingtonpatient blev screenet til studiet, som med planlagt indrullering af i
alt 420 patienter er det største, der nogensinde er blevet udført inden for
Huntingtons sygdom i Europa.
MermaiHD er et multicenter, randomiseret, dobbeltblindet og placebokontrolleret
studie, der skal evaluere ACR16's effekt og sikkerhed som en ny behandling af
Huntingtons sygdom. Patienterne i studiet bliver randomiseret til at modtage
enten 45 mg ACR16 én gang daglig, 45 mg ACR16 to gange daglig eller placebo i
en behand-lingsperiode på 26 uger. Studiet udføres på centre i otte eurpæiske
lande: Østrig, Belgien, Frankrig, Tyskland, Italien, Portugal, Spanien og
Storbritannien.
På nuværende tid
spunkt har 80 patienter, der har afsluttet 26 ugers behandling
i MermaiHD-studiet, valgt at fortsætte behandlingen i det seks måneder lange
åbne for-længelsesstudie, og de første patienter nærmer sig nu en samlet
behandlingstid på 12 måneder. Indtil videre har ACR16's sikkerhedsprofil vist
sig at være meget tilfredssstillende.
MermaiHD udføres i samarbejde med the European Huntington's Disease Network
(EHDN), der er en gruppe af investigatorer, som arbejder dedikeret for at
forbedre be-handlingen af Huntingtonpatienter gennem klinisk forskning. Deres
indsats med at identificere egnede patienter samt deres opbakning til de
indvolverede kliniske centre har spillet en væsentlig rolle for at
patientrekrutteringen har kunnet fuldendes rettidigt.
MermaiHD er et fase III studie under NeuroSearchs samlede udviklingsprogram med
ACR16, der skal understøtte produktregistrering og markedsføringstilladelse.
Udvik-lingsprogrammet omfatter også HART, som er et fase IIb-studie, der
udføres i Nord-amerika. HART blev indledt i oktober 2008, og
patientrekrutteringen forventes afsluttet senere i 2009.
Dieter Meier, dr. med. og medicinsk direktør i NeuroSearch, udtaler:
”Vi vil gerne takke de patienter og pårørende, som med deres deltagelse gør
dette studie muligt. En tak skal også lyde til Huntingtonforeningerne i de
deltagende lande, der har hjulpet med til at skabe opmærksomhed om studiet
blandt patienter. I fælles-skab er det lykkedes o
s at rekruttere mere end 400
patienter med Huntingtons sygdom inden for mindre end ét år. Dette er i fuld
overensstemmelse med vores mål-sætning, og at kunne fuldende
patientrekrutteringen i MermaiHD, der er det største europæiske fase
III-Huntingtonstudie nogensinde, er en meget væsentlig milepæl for os.”
Flemming Pedersen, adm. direktør i NeuroSearch, tilføjer:
”Vi er begejstrede over den mulige udsigt til at kunne lancere ACR16 i 2011 som
en ny og bedre behandling af Huntingtons sygdom. Der er inden for dette område
et enormt behov for bedre lægemidler, og at kunne bringe ACR16 til markedet og
der-med hjælpe med at forbedre livet for både patienter og deres pårørende vil
markere den vigtigste milepæl for vores virksomhed nogensinde”.
Tesofensine til behandling af fedme - ”End of Phase II”-møde i 2. kvartal 2009
NeuroSearch har modtaget godkendelse fra de amerikanske sundhedsmyndigheder,
FDA, på afholdelse af et ”End of Phase II”-møde vedrørende tesofensine til
behand-ling af fedme og med en aftalt mødedato i 2. kvartal 2009.
I et fase II Proof of Concept-studie med tesofensine, TIPO-1, der omfattede 203
patienter med fedme (gennemsnitligt BMI på 34,5 og en gennemsnitsvægt på 100
kg), resulterede en behandlingsperiode på 24 uger i et enestående
placebokontrolleret vægttab på ca. 10%. De samlede resultater af studiet blev
publiceret i the Lancet i oktober 2008 med den konklusion, at der med
te
sofensine kan opnås et vægttab, der er dobbelt så stort som det, der kan
opnås med eksisterende antifedmemidler, og at der dermed er basis for at
evaluere tesofensine i fase III-studier.
NeuroSearch har igennem 2008 udført et antal supplerende kliniske studier og
dermed føjet yderligere til den omfattende effekt- og sikkerhedsdatapakke, der
underbygger tesofensines stærke produktprofil. De foreliggende data og det
planlagte fase III-udviklingsprogram vil nu blive drøftet med FDA, og.
NeuroSearch forbereder også møder med de europæiske sundhedsmyndigheder, EMEA,
senere i 2009.
Efter drøftelserne med de regulatoriske myndigher vil NeuroSearch endeligt
udforme fase III-programmet for tesofensine, som skal kunne føre til
produktregistering og markedsføringstilladelse, samt fastlægge strategien for
den afsluttende udvikling af produktet.
Videreudvikling af ABT-107 indstilles i fase I under samabejde med Abbott
ABT-107 er en alfa7-specifik neuronal nikotinreceptor-modulator (NNR), som
Abbott har evalueret i prækliniske og kliniske fase I-studier under en
licensaftale med NeuroSearch. På basis af resultaterne fra disse studier har
Abbott og NeuroSearch besluttet ikke at videreføre udviklingen af stoffet på
nuværende tidspunkt.
Flemming Pedersen
Adm. direktør
Kontaktpersoner:
Flemming Pedersen, adm. direktør, telefon: 4460 8214 eller 2148 0118
Hanne Leth Hillman, Vice President, Director of Investor Re
lations & Corporate
Communications, telefon: 4460 8212 eller 4017 5103
Om ACR16 - En dopaminerg stabilisator
ACR16 tilhører en klasse af lægemiddelstoffer, der betegnes dopaminerge
stabilisatorer, og som har den unikke evne både at kunne forstærke og hæmme
dopaminkontrollerede funktioner i hjernen afhængigt af udgangsniveauet for
dopaminaktiviteten. Dopamin er en vigtig neuro-transmitter (signalstof) i
hjernen, og det dopaminerge system spiller en central rolle for kontrol-len af
motoriske og mentale funktioner. Doperminerge stabilisatorer har i prækliniske
studier vist sig at kunne stabilisere forstyrrelser i bevægelsesapparatet samt
kognitive og psykiatriske forstyrrelser uden at medføre en negativ påvirkning
af normale hjernefunktioner.
NeuroSearch evaluerer ACR16 i et pivotalt (registreringsunderstøttende)
udviklingsprogram inden for behandling af Huntingtons sygdom. Programmet består
af et europæisk fase III-studie, MermaidHD, og et nordamerikansk understøttende
fase IIb-studie, HART, og omfatter i alt 640 Huntington patienter. ACR16 er
tidligere blevet undersøgt i et fase II Proof of Concept-studie inden for
Huntingtons sygdom med positive resultater, der viste en statistisk signifikant
forbed-ring i patienternes bevægelsesfunktion (gang og parkinsonisme) samt også
en forbedring af patienternes opmærksomhed og psykiatriske symptomer. ACR16 er
også blevet undersøgt i kliniske fase I-studier inden for hhv. Huntingtons
s
ygdom, Parkinsons sygdom og skizofreni med gode og samstemmende resultater.
ACR16 blev fundet af NeuroSearch, som ejer de globale rettigheder til stoffet.
ACR16 er tildelt ''Orphan Drug''-status til behandling af Huntingtons sygdom af
sundhedsmyndighederne i både Europa (EMEA) og USA (FDA).
Om NeuroSearch - Virksomhedsprofil
NeuroSearch (NEUR) er et skandinavisk biofarmaceutisk selskab noteret på Nasdaq
OMX København. Selskabets kerneforretning dækker udvikling af nye lægemidler
baseret på en bred og veletableret forskningsplatform med fokus på ionkanaler
og sygdomme i centralnerve-systemet (CNS). En betydelig del af aktiviteterne er
partnerfinansieret via en strategisk alliance med Eli Lilly and Company og
samarbejdsaftaler med GlaxoSmithKline (GSK) og Abbott. NeuroSearchs
produktpipeline omfatter syv kliniske (fase I-III) udviklingsprogrammer: ACR16
inden for Huntingtons sygdom (fase III), tesofensine inden for fedme (klar til
fase III), ABT-894 inden for ADHD (fase II) i samarbejde med Abbott, ACR325
inden for Parkinsons sygdom (klar til fase II), ACR343 inden for Parkinsons
sygdom (fase I), ABT-560 til behandling af flere forskellige CNS-lidelser (fase
I) i samarbejde med Abbott samt NSD-788 inden for angst/depression (fase I).
NeuroSearch har desuden en bred portefølje af prækliniske læge-middelkandidater
og har kapitalandele i flere biotekvirksomheder.
See attachment: https://newsclient.omxgroup.com/cds/DisclosureAttachmentServlet?messageAttachmentId=218952
3/31/2009 12:20:18 - OMX Copenhagen, News
NeuroSearch A/S Selskabsmeddelelse NeuroSearch har successfuldt afsluttet patientrekrutteringen til MermaiHD, et klinisk fase III-studie med ACR16 inden for Huntingtons sygdom - og opdaterer samtidig på andre pipelinenyheder
- ACR16 til behandling af Huntingtons sygdom: Fuldført rekruttering af 420
Huntingtonpatienter til det europæiske fase III MermaiHD-studie
- Tesofensine til behandling af fedme: FDA har godkendt afholdelsen af et ”End
of Phase II”-møde og bekræftet en dato i 2. kvartal 2009
- ABT-107 (Abbott-samarbejde): Videre udvikling af stoffet indstilles i fase I
Patientrekrutteringen til fase III-studie af ACR16 inden for Huntingtons sygdom
fuldført
NeuroSearch har successfuldt afsluttet rekrutteringen af patienter til
MermaiHD-studiet, et europæisk fase III-studie af ACR16, der er en doperminerg
stabilisator og selskabets nye lægemiddelkandidat til behandling af Huntingtons
sygdom. Rekrut-teringen er fuldendt mindre end et år efter, den første
Huntingtonpatient blev screenet til studiet, som med planlagt indrullering af i
alt 420 patienter er det største, der nogensinde er blevet udført inden for
Huntingtons sygdom i Europa.
MermaiHD er et multicenter, randomiseret, dobbeltblindet og placebokontrolleret
studie, der skal evaluere ACR16's effekt og sikkerhed som en ny behandling af
Huntingtons sygdom. Patienterne i studiet bliver randomiseret til at modtage
enten 45 mg ACR16 én gang daglig, 45 mg ACR16 to gange daglig eller placebo i
en behand-lingsperiode på 26 uger. Studiet udføres på centre i otte eurpæiske
lande: Østrig, Belgien, Frankrig, Tyskland, Italien, Portugal, Spanien og
Storbritannien.
På nuværende tid
spunkt har 80 patienter, der har afsluttet 26 ugers behandling
i MermaiHD-studiet, valgt at fortsætte behandlingen i det seks måneder lange
åbne for-længelsesstudie, og de første patienter nærmer sig nu en samlet
behandlingstid på 12 måneder. Indtil videre har ACR16's sikkerhedsprofil vist
sig at være meget tilfredssstillende.
MermaiHD udføres i samarbejde med the European Huntington's Disease Network
(EHDN), der er en gruppe af investigatorer, som arbejder dedikeret for at
forbedre be-handlingen af Huntingtonpatienter gennem klinisk forskning. Deres
indsats med at identificere egnede patienter samt deres opbakning til de
indvolverede kliniske centre har spillet en væsentlig rolle for at
patientrekrutteringen har kunnet fuldendes rettidigt.
MermaiHD er et fase III studie under NeuroSearchs samlede udviklingsprogram med
ACR16, der skal understøtte produktregistrering og markedsføringstilladelse.
Udvik-lingsprogrammet omfatter også HART, som er et fase IIb-studie, der
udføres i Nord-amerika. HART blev indledt i oktober 2008, og
patientrekrutteringen forventes afsluttet senere i 2009.
Dieter Meier, dr. med. og medicinsk direktør i NeuroSearch, udtaler:
”Vi vil gerne takke de patienter og pårørende, som med deres deltagelse gør
dette studie muligt. En tak skal også lyde til Huntingtonforeningerne i de
deltagende lande, der har hjulpet med til at skabe opmærksomhed om studiet
blandt patienter. I fælles-skab er det lykkedes o
s at rekruttere mere end 400
patienter med Huntingtons sygdom inden for mindre end ét år. Dette er i fuld
overensstemmelse med vores mål-sætning, og at kunne fuldende
patientrekrutteringen i MermaiHD, der er det største europæiske fase
III-Huntingtonstudie nogensinde, er en meget væsentlig milepæl for os.”
Flemming Pedersen, adm. direktør i NeuroSearch, tilføjer:
”Vi er begejstrede over den mulige udsigt til at kunne lancere ACR16 i 2011 som
en ny og bedre behandling af Huntingtons sygdom. Der er inden for dette område
et enormt behov for bedre lægemidler, og at kunne bringe ACR16 til markedet og
der-med hjælpe med at forbedre livet for både patienter og deres pårørende vil
markere den vigtigste milepæl for vores virksomhed nogensinde”.
Tesofensine til behandling af fedme - ”End of Phase II”-møde i 2. kvartal 2009
NeuroSearch har modtaget godkendelse fra de amerikanske sundhedsmyndigheder,
FDA, på afholdelse af et ”End of Phase II”-møde vedrørende tesofensine til
behand-ling af fedme og med en aftalt mødedato i 2. kvartal 2009.
I et fase II Proof of Concept-studie med tesofensine, TIPO-1, der omfattede 203
patienter med fedme (gennemsnitligt BMI på 34,5 og en gennemsnitsvægt på 100
kg), resulterede en behandlingsperiode på 24 uger i et enestående
placebokontrolleret vægttab på ca. 10%. De samlede resultater af studiet blev
publiceret i the Lancet i oktober 2008 med den konklusion, at der med
te
sofensine kan opnås et vægttab, der er dobbelt så stort som det, der kan
opnås med eksisterende antifedmemidler, og at der dermed er basis for at
evaluere tesofensine i fase III-studier.
NeuroSearch har igennem 2008 udført et antal supplerende kliniske studier og
dermed føjet yderligere til den omfattende effekt- og sikkerhedsdatapakke, der
underbygger tesofensines stærke produktprofil. De foreliggende data og det
planlagte fase III-udviklingsprogram vil nu blive drøftet med FDA, og.
NeuroSearch forbereder også møder med de europæiske sundhedsmyndigheder, EMEA,
senere i 2009.
Efter drøftelserne med de regulatoriske myndigher vil NeuroSearch endeligt
udforme fase III-programmet for tesofensine, som skal kunne føre til
produktregistering og markedsføringstilladelse, samt fastlægge strategien for
den afsluttende udvikling af produktet.
Videreudvikling af ABT-107 indstilles i fase I under samabejde med Abbott
ABT-107 er en alfa7-specifik neuronal nikotinreceptor-modulator (NNR), som
Abbott har evalueret i prækliniske og kliniske fase I-studier under en
licensaftale med NeuroSearch. På basis af resultaterne fra disse studier har
Abbott og NeuroSearch besluttet ikke at videreføre udviklingen af stoffet på
nuværende tidspunkt.
Flemming Pedersen
Adm. direktør
Kontaktpersoner:
Flemming Pedersen, adm. direktør, telefon: 4460 8214 eller 2148 0118
Hanne Leth Hillman, Vice President, Director of Investor Re
lations & Corporate
Communications, telefon: 4460 8212 eller 4017 5103
Om ACR16 - En dopaminerg stabilisator
ACR16 tilhører en klasse af lægemiddelstoffer, der betegnes dopaminerge
stabilisatorer, og som har den unikke evne både at kunne forstærke og hæmme
dopaminkontrollerede funktioner i hjernen afhængigt af udgangsniveauet for
dopaminaktiviteten. Dopamin er en vigtig neuro-transmitter (signalstof) i
hjernen, og det dopaminerge system spiller en central rolle for kontrol-len af
motoriske og mentale funktioner. Doperminerge stabilisatorer har i prækliniske
studier vist sig at kunne stabilisere forstyrrelser i bevægelsesapparatet samt
kognitive og psykiatriske forstyrrelser uden at medføre en negativ påvirkning
af normale hjernefunktioner.
NeuroSearch evaluerer ACR16 i et pivotalt (registreringsunderstøttende)
udviklingsprogram inden for behandling af Huntingtons sygdom. Programmet består
af et europæisk fase III-studie, MermaidHD, og et nordamerikansk understøttende
fase IIb-studie, HART, og omfatter i alt 640 Huntington patienter. ACR16 er
tidligere blevet undersøgt i et fase II Proof of Concept-studie inden for
Huntingtons sygdom med positive resultater, der viste en statistisk signifikant
forbed-ring i patienternes bevægelsesfunktion (gang og parkinsonisme) samt også
en forbedring af patienternes opmærksomhed og psykiatriske symptomer. ACR16 er
også blevet undersøgt i kliniske fase I-studier inden for hhv. Huntingtons
s
ygdom, Parkinsons sygdom og skizofreni med gode og samstemmende resultater.
ACR16 blev fundet af NeuroSearch, som ejer de globale rettigheder til stoffet.
ACR16 er tildelt ''Orphan Drug''-status til behandling af Huntingtons sygdom af
sundhedsmyndighederne i både Europa (EMEA) og USA (FDA).
Om NeuroSearch - Virksomhedsprofil
NeuroSearch (NEUR) er et skandinavisk biofarmaceutisk selskab noteret på Nasdaq
OMX København. Selskabets kerneforretning dækker udvikling af nye lægemidler
baseret på en bred og veletableret forskningsplatform med fokus på ionkanaler
og sygdomme i centralnerve-systemet (CNS). En betydelig del af aktiviteterne er
partnerfinansieret via en strategisk alliance med Eli Lilly and Company og
samarbejdsaftaler med GlaxoSmithKline (GSK) og Abbott. NeuroSearchs
produktpipeline omfatter syv kliniske (fase I-III) udviklingsprogrammer: ACR16
inden for Huntingtons sygdom (fase III), tesofensine inden for fedme (klar til
fase III), ABT-894 inden for ADHD (fase II) i samarbejde med Abbott, ACR325
inden for Parkinsons sygdom (klar til fase II), ACR343 inden for Parkinsons
sygdom (fase I), ABT-560 til behandling af flere forskellige CNS-lidelser (fase
I) i samarbejde med Abbott samt NSD-788 inden for angst/depression (fase I).
NeuroSearch har desuden en bred portefølje af prækliniske læge-middelkandidater
og har kapitalandele i flere biotekvirksomheder.
See attachment: https://newsclient.omxgroup.com/cds/DisclosureAttachmentServlet?messageAttachmentId=218952
31/3 2009 14:11 troldmanden 06431 jep så kom NS med en trippelnyhed
ACR16 har afsluttet rekrutteringen af patienter til det europæiske fase 3
NS har få aftalt et end of fase 2 møde med FDA ang design af fase 3 forsøget for Tesofensine
ABT107 bliver lukket ned
Aktien stiger primært på den første nyhed. Indrømmet jeg var ret skeptisk for at de kunne indrullere så mange patienter på så kort tid. Så det er rigtig godt. Det betyder at resultatet af dette forsøg kan ventes dec/jan
NS fortæller så også at 80 patienter har valgt at fortsætte behandlingen i yderligere 6 mdr. Skal måske lige forklare at forsøget tager 6 mdr. Det er disse data stoffet evt kan blive godkendt på. Men hvis man ønsker det så kan man få lov at fortsætte yderligere 6 mdr på et åbent forsøg. Dvs alle vil få ACR16 (også dem der fik placebo i de første 6 mdr) Og det er der så hidtil 80 personer der har valgt. Det svare formentligt til omkring 50% af de patienter der har afsluttet 6 mdr behandling.
NS fortæller også om et kommende møde med FDA. Udfaldet af dette møde er særdeles vigtigt. Det er i hvert fald min påstand at ingen selskaber ønsker at købe Tesofensine før de har set hvad FDA siger til bivirknings profilen. Altså om FDA stiller specielle krav til designet af fase 3 forsøgene for at belyse de kendte issues.
Og så må NS endnu engang lukke et program ned. Denne gang er det ABT107 som var i fase 1. Det er muligt at NS gennem en laaaang periode var så heldige/dygtige at undgå nedlukninger af deres programmer. Men føj for en stribe de er løbet ind i. De har nu lukket 7 programmer ned indenfor ca 6 mdr. Og det ud af 19. Så nu er der blot 12 tilbage. Ikke just den vej man ønsker at se det gå. Nuvel de har 3 nye GSK stoffer lige på trapperne (her 1. Halvår) men det er jo kun de tidlige prækliniske programmer. De begynder efterhånden at mangle noget dybde i den lidt mere modne ende af pipelinen. Jeg vil derfor faktisk ikke blive monster overrasket hvis de vælger at fortage endnu et opkøb. Selvom NS aktiekurs er lagt rigtig meget ned så er der stadig en række interessante cns selskaber hvis mcap er endnu lavere. Der findes flere interessante muligheder til $15-35 mio
ACR16 har afsluttet rekrutteringen af patienter til det europæiske fase 3
NS har få aftalt et end of fase 2 møde med FDA ang design af fase 3 forsøget for Tesofensine
ABT107 bliver lukket ned
Aktien stiger primært på den første nyhed. Indrømmet jeg var ret skeptisk for at de kunne indrullere så mange patienter på så kort tid. Så det er rigtig godt. Det betyder at resultatet af dette forsøg kan ventes dec/jan
NS fortæller så også at 80 patienter har valgt at fortsætte behandlingen i yderligere 6 mdr. Skal måske lige forklare at forsøget tager 6 mdr. Det er disse data stoffet evt kan blive godkendt på. Men hvis man ønsker det så kan man få lov at fortsætte yderligere 6 mdr på et åbent forsøg. Dvs alle vil få ACR16 (også dem der fik placebo i de første 6 mdr) Og det er der så hidtil 80 personer der har valgt. Det svare formentligt til omkring 50% af de patienter der har afsluttet 6 mdr behandling.
NS fortæller også om et kommende møde med FDA. Udfaldet af dette møde er særdeles vigtigt. Det er i hvert fald min påstand at ingen selskaber ønsker at købe Tesofensine før de har set hvad FDA siger til bivirknings profilen. Altså om FDA stiller specielle krav til designet af fase 3 forsøgene for at belyse de kendte issues.
Og så må NS endnu engang lukke et program ned. Denne gang er det ABT107 som var i fase 1. Det er muligt at NS gennem en laaaang periode var så heldige/dygtige at undgå nedlukninger af deres programmer. Men føj for en stribe de er løbet ind i. De har nu lukket 7 programmer ned indenfor ca 6 mdr. Og det ud af 19. Så nu er der blot 12 tilbage. Ikke just den vej man ønsker at se det gå. Nuvel de har 3 nye GSK stoffer lige på trapperne (her 1. Halvår) men det er jo kun de tidlige prækliniske programmer. De begynder efterhånden at mangle noget dybde i den lidt mere modne ende af pipelinen. Jeg vil derfor faktisk ikke blive monster overrasket hvis de vælger at fortage endnu et opkøb. Selvom NS aktiekurs er lagt rigtig meget ned så er der stadig en række interessante cns selskaber hvis mcap er endnu lavere. Der findes flere interessante muligheder til $15-35 mio
