Arena Pharmaceuticals, ein neuer 1000%ter? - 500 Beiträge pro Seite

[derneureiche]

habe nirgends einen thread über diese company gefunden, drum mach ich einen neuen auf.

Diese firma stellt appetitzügler her und hat ne FDA zulassung beantragt.
Am 16.9.10 ist FDA comittee meeting termin.

Der wert ist im vorfeld schon ordentlich gestiegen.
ist sicher eine heisse kiste, aber wenn es hier ne zulassung gibt, dann bestimmt noch einiges möglich.

Würde mich über regen gedankenaustausch freuen.

[Netflirter]

Antwort auf Beitrag Nr.: 39.908.341 von derneureiche am 31.07.10 19:34:59

klick mal auf den Chart dann hast einige threads sind zwar alle schon ein bissel älter aber naja.
Jetzt zum unternehmen solte eine zulassung erfolgen welche sehr wahrscheinlich ist, dann werden wir hier eine zweite Human genome sehen.
Die letzten Berichte lassen sehr darauf schliessen. Besitze nur eine kleine posi (2k seid 2,5USD) werde aber nächste Woche noch zukaufen. Bei einer ablehnung seitens FDA werden wir wieder in die alte Range fallen um die 3-4 USD

[Netflirter]

aus Charttechnischer sicht ist 8 USD ein guter wiederstand solte der genommen werden ist das nächste Ziel 10 und 14 bis dahin solten aber schon die Entscheidung da sein

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 39.908.813 von Netflirter am 01.08.10 09:20:04

Hi miteinander,

Arena wird seinen Weg gehen, bestes Sicherheitsprofil gegenüber Konkurrenten wie Vivus, der Newworldinvestor, der auch schon meinen Tenbagger, Dendreon, empfahl, sieht Arena vor der Zulassung bei 12 US Dollar und nach der Zulassung bei 30 US Dollar!

Ich persönlich glaube, daß die 15 US Dollar bei Zulassung realistisch sind!

[Corgar]

Antwort auf Beitrag Nr.: 39.908.341 von derneureiche am 31.07.10 19:34:59

warum hast du den thread denn nicht schon vor 4 wochen aufgemacht?

naja..inzwischen ist der wert sehr sehr gut gelaufen und die marktkapitalisierung beträgt schon über 680 mio euro.

werde den wert mal auf meine watchlist nehmen

[derneureiche]

eine interessante Einschätzung.
http://seekingalpha.com/article/218277-arena-pharmaceuticals…

Es bleibt natürlich das Risoko eines Scheiterns beim FDA Comittee.

[derneureiche]

Antwort auf Beitrag Nr.: 39.909.596 von Magnetfeldfredy am 01.08.10 17:13:29

Ich habe gelernt im zusammenhang mit solchen hoch spekulativen werten nichts zu glauben.

wenn es eine zulassung geben wird, ist erst mal jedes kursziel möglich. es werden sich dann vermutlich die insties positionieren(müssen).
wenn nicht, kommt es drauf an wiviele aktien geschmissen werden. vermutlich wird es dann auch erst mal ne übertreibung nach unten geben (siehe VIVUS)
Charttechnik wird bei solchen ereignissen ausgehebelt und ist m.m.n irrrelevant.

Ich habe einen durchschittskaufkurs von 2,52€ und der depotanteil liegt bei >100% plus, nur knapp bei 6%.
Immer vorsichtig bleiben. gier frisst hirn.

viel erfolg euch allen. (und natürlich auch mir)

[take-care]

Hallo zusammen,

ich freue mich, dass nun jemand einen neuen thread hier zu ARNA eröffnet hat.
ich hatte auch in der vergangenheit mal drüber nachgedacht, es aber dann doch gelassen und ab und an im VVUS thread zu ARNA gepostet und auf die enormen chancen hingewiesen.
ich bin seit mai investiert und habe einige monate seitwärts ( bis süden ) im kursverlauf mitgemacht und bin nun aber mehr als entschädigt worden. ( bin übrigens auch ein member des newworldinvestors von michael murphy ).

seit dem vvus-panel ist die sichtweise der fda zum thema obesity klar -- safety.
arna hat sehr gute chancen ein positives panel am 16.09. zu bekommen - kurs bei einem pos. panel am 17.09 zwischen 15-20 USD meiner meinung nach.

bis zum panel im sept. denke ich, könnten wir an den 10 USD kratzen. 2 tage vorher werden die fragen des AC schon veröffentlicht...dann sehen wir wohin die reise ungefähr geht

schönes wochenende noch

take-care

[Fruehrentner]

FDA Confirms September 16th Advisory Committee Meeting to Review Lorcaserin for Obesity and Weight Management

06 Aug 2010

Arena Pharmaceuticals and Eisai announced that the US Food and Drug Administration (FDA) has notified the company of the confirmed scheduling of an Endocrinologic and Metabolic Drugs Advisory Committee meeting on September 16, 2010, for the review of the lorcaserin New Drug Application (NDA)

SAN DIEGO, CA, USA and WOODCLIFF LAKE, NJ, USA | August 6, 2010 | Arena Pharmaceuticals, Inc. (Nasdaq:ARNA - News) and Eisai Inc. announced today that the US Food and Drug Administration (FDA) has notified the company of the confirmed scheduling of an Endocrinologic and Metabolic Drugs Advisory Committee meeting on September 16, 2010, for the review of the lorcaserin New Drug Application (NDA). Lorcaserin, which Arena discovered and has developed for weight management, is intended for obese patients as well as overweight patients who have at least one weight-related co-morbid condition.

"Our primary objective at this time is to obtain FDA approval of lorcaserin," said Jack Lief, Arena's President and Chief Executive Officer. "We have been preparing for this anticipated Advisory Committee meeting, and look forward to reviewing lorcaserin's profile with the panel members."

Arena submitted the lorcaserin NDA on December 22, 2009, and the FDA assigned a PDUFA date, the target date for the agency to complete its review of the application, of October 22, 2010.

Lorcaserin New Drug Application

The lorcaserin New Drug Application is based on a data package from lorcaserin's development program that includes 18 clinical trials totaling 8,576 patients. The pivotal Phase 3 clinical trial program, BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management) and BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management), evaluated nearly 7,200 patients treated for up to two years. In both trials, lorcaserin was well tolerated and produced statistically significant weight loss.

About Lorcaserin

Lorcaserin is a new chemical entity that is believed to act as a selective serotonin 2C receptor agonist. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area involved in the control of appetite and metabolism. Stimulation of the serotonin 2C receptor in the hypothalamus is associated with feeding behavior and satiety. Arena has patents that cover lorcaserin in the United States 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 Arena Pharmaceuticals

Arena is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs that target G protein-coupled receptors, an important class of validated drug targets, in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases. Arena's most advanced drug candidate, lorcaserin, is intended for weight management and has completed a pivotal Phase 3 clinical trial program. Arena has filed an NDA for lorcaserin with the FDA, and the FDA has assigned a PDUFA date of October 22, 2010, for review of the application. Arena's wholly owned subsidiary, Arena Pharmaceuticals GmbH, has granted Eisai Inc. exclusive rights to market and distribute lorcaserin in the United States.

Arena Pharmaceuticals(R) and Arena(R) are registered service marks of the company.

About Eisai Inc.

Eisai Inc. was established in 1995 and is ranked among the top-20 U.S. pharmaceutical companies (based on retail sales). The company began marketing its first product in the United States in 1997 and has rapidly grown to become a fully integrated pharmaceutical business with fiscal year 2009 (year ended March 31, 2010) sales of approximately $3.9 billion. Eisai's areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd.

Eisai has a global product creation organization that includes U.S.-based R&D facilities in Maryland, Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina. The company's areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs. For more information about Eisai, please visit www.eisai.com.

SOURCE: Arena Pharmaceuticals, Inc.

http://www.pipelinereview.com/index.php/2010080636151/Small-…

[derneureiche]

eine vorsichtig kritische Pressestimme.
http://www.thestreet.com/story/10829837/2/arena-pharma-deja-…

Natürlich wird die Entscheidung am 16 September eine längerfristige gravierende auswirkung haben.
Zeigt aber auch dass Arena große Aufmerksamkeit gewidmet wird.
Ist das Ergebnis von dem Comittee positiv, wirds ein knaller. Wenn negativ dann auch, aber nur in die andere Richtung.

[take-care]

Antwort auf Beitrag Nr.: 39.951.866 von derneureiche am 09.08.10 14:46:07

tja, thestreet.com mit dem schlimmsten biotech rep. adam feuerstein...naja die hängen alle zusammen...jim cramer, matthew herper ( forbes.com ).
erinner mich noch an die gute alte dndn zeit, da haben die jungs gebasht ohne ende...

schaut den forbes bericht von gestern von h. herper.... hat alle facts FALSCH zusammengetragen bzgl. der Effektivität von LORQESS

der kurs hält sich trotzdem weiterhin sehr gut und konsolidiert in ruhe...10 USD vor dem panel ist mein erstes ziel.

take-care

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 39.976.908 von take-care am 12.08.10 21:09:02

Sehr gut analysiert, die haben bei DNDN schon FUD gesteut und jetzt versuchen sie es bei ARNA!
Mein Kursziel nach dem Panel 12 US Dollar!

[take-care]

Antwort auf Beitrag Nr.: 39.986.208 von Magnetfeldfredy am 15.08.10 08:49:04

@magnet

oh ja....und am Freitag nun auch schon wieder der Thomas Wei von Jefferies....hat dem Kurs leider erstmal geschadet...
Auf IV und yahoo.com sind bereits erste Stellungnahmen seitens ARENA gepostet aus Mails mit der IR von ARENA.
Alles bullshit von H. Wei, aber ein Schelm wer Böses dabei denkt. Denke und hoffe heute auf eine nette Korrektur ( MM hat übrigens auch die Aussagen von H.Wei zerpflückt ).

take-care

[take-care]

Piper Jaffray reiterates an "overweight" rating on ARNA

Piper analyst says, "we contend that Lorcaserin
is the safest of the 3 weight loss drugs up for approval by the FDA and that the recent Qnexa panel proves that safety is the key to success. We are buyers of ARNA shares on Friday's weakness ahead of Lorcaserin,s Sept. 16 FDA panel."

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 39.990.812 von take-care am 16.08.10 15:01:20

Jetzt wirds spannend, 16 9.2010 Panel, deswegen bin ich optimistisch:

March 30, 2009
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 /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® and Arena® 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.

Contacts: Jack Lief Julie Normart
President and CEO WeissComm Partners
Media Relations
415.946.1087
David Walsey
Senior Director,
Corporate Communications

Arena Pharmaceuticals, Inc.
858.453.7200, ext. 1682

SOURCE Arena Pharmaceuticals, Inc.

http://www.arenapharm.com
Copyright © 2009 PR Newswire. All rights reserved



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Copyright 2010 Arena Pharmaceuticals, Inc.

[derneureiche]

Zurückhaltung und Unsicherheit zeigt sich auch im Optionshandel
Am 16.9. sollte es dann hoffentlich klar sein: Hop oder Top

http://www.schaeffersresearch.com/commentary/observations.as…

Arena Pharmaceuticals (ARNA)

Options trading was brisk on Arena Pharmaceuticals Inc. (ARNA) on Wednesday, as more than 55,600 contracts crossed the tape. This surge in volume was more than double the stock's average daily trading volume of 22,615 contracts, according to data from WhatsTrading.com. In addition, traders were feeling somewhat bullish, as 63% of the volume changed hands on the call side.

There is still ample room for optimism to grow toward the shares. The Schaeffer's put/call open interest ratio (SOIR) for ARNA comes in at 0.80, which is higher than 52% of all those taken during the past year. This ratio indicates that there is a slight bearish bias toward the shares among options players.

Meanwhile, short sellers are adding to their bearish bets. During the past month, the number of ARNA shares sold short increased by 34% to 31 million. This accumulation of bearish bets accounts for a whopping 28% of the company's total float. A continuation of this trend could add additional selling pressure on the shares.

Elsewhere, we find that Wall Street is skeptical. According to Zacks, the stock has earned five "buy" ratings, 10 "holds," and one "strong sell." This bearish configuration leaves ample room for potential upgrades that could boost the security higher.

From a technical perspective, the shares of ARNA are up more than 85% since the start of 2010. However, the security is starting to show some significant signs of weakness. Since reaching a peak of 8 at the end of July, the stock has steadily declined under its 10-day and 20-day moving averages. The equity is now testing support at the 6.40 level.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.090.099 von derneureiche am 02.09.10 16:44:47

Es schaut nach top aus:

Re: Piper Jaffray/ Now on Schwab (finally!)


Piper Jaffray Tells Clients to Buy Arena Pharmaceuticals (ARNA) Ahead of 9/16 FDA FDA Meeting
9:00 am ET 09/07/2010- StreetInsider
Shares of Arena Pharmaceuticals (Nasdaq: ARNA) are seeing pre-open action following positive comments from analysts a Piper Jaffray, which is telling clients to buy the stock ahead of the 9/16 FDA advisory panel meeting.

The firm said, "Based on our interpretation of FDA guidance criteria for weight management products, we anticipate a positive committee vote. We recommend investors buy ARNA shares ahead of the upcoming panel meeting and October 22nd PDUFA date."

The firm has an Overweight rating and $10 price target on ARNA.

Shares of ARNA are up 5 percent to $7.20 in pre-open trading today.

[take-care]

schaut doch gut aus....
wird interessant nun, anfang kommender woche werden wir wissen durch die veröffentlichung
der dokumente für die AC sitzung, in welche richtung der hase läuft...

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.125.723 von take-care am 09.09.10 14:55:26

Gestern wurde wieder FUD gestreut und es wird täglich von den Shorties versucht werden irgendwelchen Blödsinn zu verbreiten!
Ich bleib long!

[take-care]

Antwort auf Beitrag Nr.: 40.130.112 von Magnetfeldfredy am 10.09.10 07:46:40

heute und montag werden sehr interessant
am dienstag kommen die briefing documents raus
ich erwarte einen anstieg über 8 usd bis zum montag abend...könnte aber ne echte achterbahnfahrt werden
danach...the sky is the limit

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.131.261 von take-care am 10.09.10 11:15:01

Hätte Nichts gegen Deine Aussichten!

Michael Murphy vom NewWorldInvestor bleibt optimistisch 20 US Dollar nach dem Panel, 30 US Dollar nach der Zulassung sagt er voraus, hätte auch Nichts dagegen!

[Elrond]

aus die Maus ......


Arena's Diet Pill Lorcaserin Works by a `Slim Margin,' FDA Staff Says

Arena Pharmaceuticals Inc.’s experimental diet pill may cause cancer and works only by a ‘slim margin,’ U.S. regulators said, sending shares down the most ever.

The medicine, lorcaserin, was linked to “a number of malignant tumor types” in studies of rats, Food and Drug Administration staff said in a report released today. The drug helped people lose 3 percent more weight than a placebo, short of the recommended 5 percent, the agency said.


http://www.bloomberg.com/news/2010-09-14/arena-s-diet-pill-l…

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.149.225 von Elrond am 14.09.10 17:17:25

Seh ich auch so, versteh nur nicht, daß diese Tumorbildung bei Ratten und Mäusen nicht dazu geführt haben daß es überhaupt Phase I-III gab?

[Fruehrentner]

Damit schließen wir diesen thread. Ruhe in Frieden, Amen!

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.158.126 von Fruehrentner am 15.09.10 21:05:34

Ich würde nicht so voreilig sein, morgen ist das Panel, wenns ähnlich läuft wie bei Dendreon kanns ganz schnell in die andere Richtung gehen!

[Fruehrentner]

und morgen (Freitag) ist auch dreifacher Hexensabbat!

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.158.997 von Fruehrentner am 16.09.10 00:54:35

und das auch noch!

Heute ist der entscheidende Tag (vorerst) mit dem Panel und da dachte ich an das Pendel, man ich were zum Dichter!

[take-care]

tja, wer hatte mit so einem preisverfall gerechnet ?

ICH NICHT...

Heute ist der Tag, an dem alles entschieden wird. Nach dem MERIDIA panel von gestern und den aussagen der panel members und dem voting 8:8 bei den voraussetzungen und vorfällen bei meridia bin ich wieder optimistischer gestimmt.

we´ll see

take-care

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.160.124 von take-care am 16.09.10 10:26:54

Mir gehts wie Dir, aber Nichts Genaues weiß man nicht hätte Karl Valentin wahrscheinlich gesagt

[MACD]

Antwort auf Beitrag Nr.: 40.160.610 von Magnetfeldfredy am 16.09.10 11:25:04

Die Optionspreise vor dem Panel sind wirkllich wahnsinnig. Die September-Strikes haben eine Vola annähernd von 1000 %. Selbst die Calls mit Strikes 5 und höher für den September bringen noch ordentlich Prämie ein.

[JimmySpoon]

So, nix geht mehr !!!

Trading Halt - Arena Casino closed !

Für mich wird es richtig bitter, falls es negativ ausgeht !

Einstiegsposi 1k zu 5,24 Euro
Nachkauf 1k zu 3,70 Euro
Nachkauf 1k zu 3,15 Euro

Kommt es hier knüppeldick, setze ich mal eben 10k in den Sand !!!

No Risk, no Fun !!!

[Elrond]

Antwort auf Beitrag Nr.: 40.161.570 von JimmySpoon am 16.09.10 13:56:46

was soll´s ... 10 gute Abendessen ....

[Xyronimus]

FDA Advisory Panel Votes Against Arena Pharmaceuticals, Inc's Drug (NASDAQ: ARNA)


(0 votes, average 0 out of 5)
Written by Tapebeat Staff
Thursday, 16 September 2010 14:25
0diggsdigg

FDA Advisory panel today voted against lorcaserin, the new weight loss drug from Arena Pharmaceuticals, Inc (NASDAQ: ARNA) which is currently under FDA review with a PDUFA date of October 22, 2010.

The question for which the panel voted:

Has the available data demonstrate that the potential benefits of lorcaserin outweigh the potential risks when used long-term in a population of overweight and obese individuals to allow marketing approval?

Yes Votes: 5
No Votes: 9

http://www.tapebeat.com/2010091611376/Research/fda-advisory-…

[Fruehrentner]

[Fruehrentner]

Antwort auf Beitrag Nr.: 40.165.258 von Xyronimus am 16.09.10 22:40:20

gibts nachbörslich US-Kurse zu Arena?

[Xyronimus]

Antwort auf Beitrag Nr.: 40.165.297 von Fruehrentner am 16.09.10 22:48:20

Nein, ich denke die gehen morgen wieder an den Start, nur halt um einiges tiefer.

[Xyronimus]

Antwort auf Beitrag Nr.: 40.165.289 von Fruehrentner am 16.09.10 22:47:05

die ersten Kurse kommen, man oh man 2,11 USD

[Xyronimus]

Antwort auf Beitrag Nr.: 40.165.364 von Xyronimus am 16.09.10 23:06:13

sorry war falsch 2,35 USD

[Elrond]

LAST 2,26 ......

[MrBean07]

Antwort auf Beitrag Nr.: 40.161.570 von JimmySpoon am 16.09.10 13:56:46

Kommt es hier knüppeldick, setze ich mal eben 10k in den Sand !!!

Mein Beileid, Jimmy.

Allerdings kann sowas auch nicht gutgehen. Die Firma versuchte einen ganz ähnlichen Wirkstoff (Lorcaserin) wie das Fenfluramin zur Zulassung zu bringen, die Struktur ist bloß eine medizinalchemische Variante dieses Moleküls mit gleichem Target: Serotonin-Antagonist. Fenfluramin wurde schon vor längerem wegen Herzklappenschäden und Beschädigung der Hirn-Serotonin-Neuronen aus dem Verkehr gezogen, damit war das´pharmazeutische Target als Schlankmacher längst tot.

Die Entscheidung ist also folgerichtig, und was lernen wir daraus: Aktie einer Biotech- oder Pharmaklitsche nur kaufen, wenn man die Zusammenhänge kennt!

[Fruehrentner]

Antwort auf Beitrag Nr.: 40.166.039 von MrBean07 am 17.09.10 08:31:16

und es kam knüppeldick.

Naja, ich hatte mit anderen Biotechwerten ebenfalls Pech. Es ist und bleibt ein Zock.

[Fruehrentner]

Damit schließen wir diesen thread. Ruhe in Frieden.

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.166.313 von Fruehrentner am 17.09.10 09:17:30

Jetzt können wir ihn schließen, aber für mich unvergeßlich, daß die FDA Phase I-III genehmigt und dann feststellt, daß bei Rattenversuchen Krebs festgestellt wurde!
Die Studienteilnehmer wurden also mit der Genehmigung der FDA in diese Versuche geschickt! Wahnsinn!
Bei den Phase I-III Test wurde nie Krebs beobachtet aber aufgrund der Rattenversuche scheitert die Firma und die Investoren? In was soll man dann noch investieren wenn man nicht mal den Richtlinien der FDA trauen kann?:O

[MACD]

Antwort auf Beitrag Nr.: 40.166.618 von Magnetfeldfredy am 17.09.10 09:55:07

"In was soll man dann noch investieren wenn man nicht mal den Richtlinien der FDA trauen kann?"

Hast du das etwa jemals getan? Ich bin sehr skeptisch gegenüber der ganzen Zulassungsthematik, wenn man bedenkt wieviel Geld dort im Spiel, z. B. im Aktien- und Optionshandel.

Man kann im Vorfeld recherchieren wie man will, letztenendes kann man niemandem Glauben schenken und diese FDA-Panels sind und bleiben immer Ratespiele. Wir haben keine Einblicke hinter die Kulissen.

Zum Glück war ich hier nur mit Peanuts dabei, Long Aktie gedeckt mit Long Puts in the money Strike 10, Spekulation im Vorfeld des Termins auf weiteren Anstieg der Aktie da der Zeitwert in der Option vor solchen Terminen konstant bleibt...

Anscheinend haben die OREX-Investoren jetzt zugeschlagen, 40 % Plus gestern...

[Magnetfeldfredy]

Antwort auf Beitrag Nr.: 40.167.455 von MACD am 17.09.10 11:27:35

Du hast Recht, man kann Keinem mehr trauen, weder den Firmen noch der FDA, Dendreon....lassen grüßen!

[moneyonstreet]

laut chart deutet sich ein rebound an. bei yahoo wird auch wie verrückt diskutiert über die "rats".

[Mareio1976]

Antwort auf Beitrag Nr.: 40.173.935 von moneyonstreet am 18.09.10 21:53:54

Oh ja ein rebound mit wieviel Aktien muss ich dabei sein damit du deine verkaufen kannst

Ich denke hier gehts noch weiter runter...an der Börse wird die Zukunft gehandelt und diese ist mehr als miserabel bei Arena

[Mareio1976]

Antwort auf Beitrag Nr.: 40.166.313 von Fruehrentner am 17.09.10 09:17:30

Ich mach dann mal das Licht aus.thread over.

[take-care]

Exclusive: a doctor part of the FDA weight loss AdCom was physically threatened by a hedge fund investor at the hotel. FDA investigating.

http://twitter.com/THEHCC

[derneureiche]

hat von euch jemand ne ahnung was da abgeht?

21.09.2010 18:53
Sarraf Gentile LLP Files Securities Class Action Against Arena Pharmaceuticals, Inc.

NEW YORK, NY -- (Marketwire) -- 09/21/10 -- On September 21, 2010, the law firm of Sarraf Gentile LLP commenced a securities fraud class action lawsuit on behalf of those investors who acquired the securities of Arena Pharmaceuticals, Inc. ("Arena" or the "Company") (NASDAQ: ARNA) during the period March 30, 2009 to September 17, 2010, inclusive (the "Class Period"). The lawsuit is pending in the United States District Court for the Southern District of California and names as defendants Arena and certain of its top officers.

According to the complaint, the defendants made several statements during the Class Period about the Company's weight loss drug lorcaserin which were false and misleading because they omitted and failed to disclose that tests for lorcaserin indicated that the drug caused cancer in lab rats. When the results of the rat carcinogenicity studies became public on September 14, 2010, the Company's stock fell from a closing price of $6.85 on September 13, 2010, to a closing price of $4.13 on September 14, 2010, a one day drop of $2.72 or roughly 40%, according to the complaint. On September 16, 2010, the FDA's advisory committee held a meeting to review lorcaserin and, according to the complaint, rejected the drug in light of the concern that the potential risks of long-term use, including the risk of cancer, outweighed its benefit. As a result of this news, the Company's stock fell from a closing price of $3.74 on September 16, 2010 to a closing price of $1.99 on September 17, 2010, a one day drop of $1.75 or roughly 46%, according to the complaint.

Plaintiffs are represented by the law firm of Sarraf Gentile LLP, which has extensive experience in the prosecution of class actions on behalf of investors.

If you bought the securities of Arena between March 30, 2009 and September 17, 2010, you may, no later than November 19, 2010, move the Court to appoint you as lead plaintiff, a representative party that acts on behalf of other class members. The Court must determine whether the class member's claim is typical of other class members' claims, and whether the class member will adequately represent the class. Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. You may retain Sarraf Gentile LLP or other counsel of your choice, to serve as your counsel in this action.

If you would like to participate in this action or would like additional information about the lawsuit, please contact Joseph Gentile at Sarraf Gentile LLP, 116 John Street, Suite 2310, New York, NY 10038 (telephone: [phone]; e-mail: [e-mail]).

Contact:

Joseph Gentile
[e-mail]
SARRAF GENTILE LLP
116 John Street, Suite 2310
New York, NY 10038
T 212.868.3610
F 212.918.7967
www.sarrafgentile.com



© 2010 MarketWire


Klicken Sie hier, um weitere aktuelle Nachrichten zum Unternehmen zu finden:

ARENA PHARMACEUTICALS News

[MrBean07]

Antwort auf Beitrag Nr.: 40.188.896 von derneureiche am 21.09.10 22:57:23

hat von euch jemand ne ahnung was da abgeht?

Das Managenent wird auf Schadenersatz verklagt, weil es bereits früher über das Auftreten von Krebs bei den Laborratten informiert gewesen sein soll und die Aktionäre nicht informiert hätte ...


Kursziel: 0.0000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000001

[Xyronimus]

Antwort auf Beitrag Nr.: 40.168.355 von Magnetfeldfredy am 17.09.10 13:22:15

So muss das in einer Ehe sein, beide in besten Positionen, dann brauch man sich auch nicht wundern. http://online.wsj.com/article/SB124328188115551961.html

[Xyronimus]

Antwort auf Beitrag Nr.: 40.196.219 von MrBean07 am 23.09.10 08:46:52

Ich würde das Kursziel doch etwas höher einschätzen, na dann heute auf zu neuen ( alten ) Höhen.

[Kursziel1000]

15min chart hat soeben bei $1.56 ein Kaufsignal geliefert!
Einsteigen und mindestens bis $2+ halten.
Shortsqueeze wird hier kommen!

[MrBean07]

Antwort auf Beitrag Nr.: 40.243.267 von Kursziel1000 am 30.09.10 19:37:18

15min chart hat soeben bei $1.56 ein Kaufsignal geliefert!
Einsteigen und mindestens bis $2+ halten.
Shortsqueeze wird hier kommen!

[Kursziel1000]

online petition
http://www.petitiononline.com/passlorc/petition.html

[Corgar]

lol...der chart sieht meiner meinung nach nicht aus als wenn shorties covern müssten

[Kursziel1000]

[Kursziel1000]

[Corgar]

Antwort auf Beitrag Nr.: 40.247.159 von Kursziel1000 am 01.10.10 11:24:21

lol....hier ist nix mehr zu holen die nächste zeit. arena pharm war so oder so zu hoch bewertet....jetzt haben sie versagt und die phantasie ist komplett raus. da wird weder gecovert noch irgendwelche charttechnischen gaps geschlossen. kapier das endlich und halt die leute nicht für blöd um deinen zu teuer gekauften scheiss noch an irgendjemanden teuer abzuladen

[MrBean07]

Antwort auf Beitrag Nr.: 40.255.703 von Corgar am 03.10.10 14:49:39

....hier ist nix mehr zu holen

das ist richtig. Chartanalysen bringen hier nichts. Arena war ein one-trick-pony und das Pferdchen ist nun tot. Das wird dann eben ein Pennystock werden.

[Kursziel1000]

Antwort auf Beitrag Nr.: 40.255.703 von Corgar am 03.10.10 14:49:39

Also ich habe bei $1.58 gekauft.
Weiß nicht was daran teuer sein soll, wenn wir einen garantierten Cashbestand von $1.48 bis Ende des Jahres haben werden.
Am 22. Oktober gibt ein grünes oder ein rotes Licht der FDA.
Bis dahin haben wir Phantasie in diesem Wert , da auch DNDN damals es geschafft ein Produkt zugelassen zu bekommen , obwohl im Vorfeld negativ abgestimmt wurde.
Es wird ein Reaktion nach oben geben , da Shorts ihre Gewinne früher oder später realisieren werden, das ist so sicher wie das Amen in der Kirche.
$2+ ist daher hier nur eine Frage der Zeit , zumal sich charttechnisch die Indikatoren von Tag zu Tag verbessern und einen Turnaround anzeigen.

[Corgar]

Antwort auf Beitrag Nr.: 40.259.369 von Kursziel1000 am 04.10.10 14:23:53

Es wird ein Reaktion nach oben geben , da Shorts ihre Gewinne früher oder später realisieren werden

wenn du mir den satz vielleicht bitte erklären könntest?

...selten so einen quatsch gelesen. meine meinung ist:du hast total keine ahnung von börse!

[Kursziel1000]

Antwort auf Beitrag Nr.: 40.260.901 von Corgar am 04.10.10 18:33:13

Weißt Du ich brauche keinen hier schlau zu machen...
ARNA wird auf mindestens $2 laufen.
Heute ist der Anfang gemacht.
Schlusskurs $1.71 Doppelbottom bei $1.51.
Mein Vater hat mal gesagt: "Versuch mal aus 10 Idioten einen Schlauen zu machen!"

[Kursziel1000]

Posted on 09/30/2010 by Leo Goldman

NEW YORK (Market Intellisearch) -- ARNA options saw interesting call activity today. A total of 830 put and 5,536 call contracts were traded raising a low Put/Call volume alert. Today's traded Put/Call ratio is 0.15. There were 6.67 calls traded for each put contract.

The skewed options ratio suggests that traders are rebalancing their portfolios in anticipation of a price shift. Today’s unusual volume activity directly reflects investor outlook and confirms that a stock move is imminent.

Arena Pharmaceuticals closed at $1.59 in the last trading session and opened today at $1.60. The stock price declined $0.02 (-1.26%) to $1.57 in today's trading session. ARNA is trading between the range of $1.54 - $1.60. Volume is 5,327,731 in relation to the three month average volume of 14,194,000 shares. The technical momentum Relative Strengh Index indicator shows oversold conditions. ARNA is trading below the 50 day moving average and lower than the 200 day moving average. The stock's 52 week low is $1.51 and 52 week high is $8.00.

[Kursziel1000]

[Kursziel1000]

$2 könnten morgen schon angetestet werden, falls das Volume höher als heute ausfällt!

[Kursziel1000]

[Kursziel1000]

Pre-Market

Time (ET) 	Pre-Market

Price 	Pre-Market

Share Volume

08:17 	 $ 1.73 	500

08:17 	 $ 1.73 	500

08:17 	 $ 1.73 	100

08:17 	 $ 1.73 	1,000

08:14 	 $ 1.73 	500

08:14 	 $ 1.73 	200

08:14 	 $ 1.73 	3,800

Read more: http://www.nasdaq.com/aspxcontent/ExtendedTradingTrades.aspx…

[Kursziel1000]

Investors Smell a Rat
Last month, an FDA advisory committee voted 9-to-5 that the risks of the Lorqess diet drug developed by Arena Pharmaceuticals (ARNA) outweigh the benefits. That move came after concerns about valvulopathy and, in particular, links to malignancies in rats at higher doses, which were revealed in FDA briefing documents and caught some people, including Wall Street analysts, by surprise.

The decision caused a stir among investors and a subsequent controversy about whether Arena properly and promptly disclosed the existence of the tumor data (look here). In comments made to Wall Street analysts following the FDA panel vote, CEO Jack Lief insisted the info was handled correctly. An FDA decision is expected later this month.

Now, a petition has begun circulating the Internet ,in which the FDA is being asked to override the panel vote and approve the diet pill. The basic case is that the FDA staff made some fundamental mistakes in their analysis. In the FDA briefing documents, the petition contends, an FDA reviewer made “a highly damaging, but incorrect, statement” that “an excess number of malignant tumors developed in female rats with (Lorqess) at doses within seven-fold of the proposed clinical dose of 10mg BID.” In other words, the FDA analysis overstated the case and confused some of the panelists, who were not experts in such matters.

For instance, the petition argues that of the nine panelists who voted ‘no,’ only two did not cite tumors in rats as their main concern. “This suggests seven panelists that voted no might have voted yes if the FDA had provided a toxicology or a carcinogenic expert as support for any concerns the panelists might have had regarding the relevance to human subjects.It is clear that these panelists were confused or uncertain what the rat data showed, and therefore voted no, not based on scientific evidence but rather the fear of uncertainty.

And then there’s this closing appeal to FDA officials:

“We believe that the long term effects of this event could result in irreparable damage to the biotechnology and pharmaceutical industry as a whole. The dramatic elevation of concern over rat cancer…has prompted class action lawuits against Arena Pharmaceuticals. Clearly these data were adjusted to show significance in cancer occurrence where none existed. If all pharmaceutical and research firms were to release all toxicological results from their pre-clinical or animal studies to the investing community, equity markets in that industry might cease to exist…”

“The pendulum has swung too far at the FDA if they influence Advisory Committees to vote no for a drug that poses very little risk to the public at large, and certainly less than currently available therapies, and where there is a demonstrable clinical benefit in terms of additional weight loss and reduction in cardiovascular risk factors. This is particularly true if the methodology underlying that influence is unscientific and based upon assumptions that are contrary to accepted scientific knowledge.”

The people who initiated the petition do not reveal their identity and instead preferred to be called ‘Concerned Citizen,’ and they argue that by approving the Lorqess pill, the agency would promote public health, saving untold dollars from the nation’s health costs. Beyond such concerns, however, it is unclear whether the petitioners are tied to Arena or are simply investors who were angered by the FDA review.

In any event, their belief that releasing all toxicology data from pre-clinical or animal studies may fatally damage equity markets may be construed as rather sweeping, if not dramatic. Proper disclosure - and proper analysis - remain desirable. The real issue, of course, was whether the rat data was not only disclosed as it should have been, but scrutinized correctly by the FDA staff.

Diet pills, though, are a whole other animal, you’ll pardon the pun. For more than a decade, as you may recall, various diet drugs have been linked to safety issues, most notably the fen-phen weight-loss cocktail, half of which was withdrawn in 1997 over serious links to heart and lung conditions. Given the current environment in which safety is a prime concern, one should not be surprised if the FDA errs on the side of caution. Whether the equity markets then collapse also remains to be seen.

http://seekingalpha.com/article/228464-arena-pharmaceuticals…

[Kursziel1000]

Aktueller Kurs $1.81!

[Kursziel1000]

5M Aktien innerhalb von einer Stunde umgesetzt , das nenne ich mal gutes Volumen!

[Kursziel1000]

Schlusskurs $1.72 Volumen ist nach einer guten Anfangsstunde eingebrochen.
Volume:12,075,467

[fisci]

Quelle: http://seekingalpha.com/article/228464-arena-pharmaceuticals…



Last month, an FDA advisory committee voted 9-to-5 that the risks of the Lorqess diet drug developed by Arena Pharmaceuticals (ARNA) outweigh the benefits. That move came after concerns about valvulopathy and, in particular, links to malignancies in rats at higher doses, which were revealed in FDA briefing documents and caught some people, including Wall Street analysts, by surprise.

The decision caused a stir among investors and a subsequent controversy about whether Arena properly and promptly disclosed the existence of the tumor data (look here). In comments made to Wall Street analysts following the FDA panel vote, CEO Jack Lief insisted the info was handled correctly. An FDA decision is expected later this month.

Now, a petition has begun circulating the Internet ,in which the FDA is being asked to override the panel vote and approve the diet pill. The basic case is that the FDA staff made some fundamental mistakes in their analysis. In the FDA briefing documents, the petition contends, an FDA reviewer made “a highly damaging, but incorrect, statement” that “an excess number of malignant tumors developed in female rats with (Lorqess) at doses within seven-fold of the proposed clinical dose of 10mg BID.” In other words, the FDA analysis overstated the case and confused some of the panelists, who were not experts in such matters.


For instance, the petition argues that of the nine panelists who voted ‘no,’ only two did not cite tumors in rats as their main concern. “This suggests seven panelists that voted no might have voted yes if the FDA had provided a toxicology or a carcinogenic expert as support for any concerns the panelists might have had regarding the relevance to human subjects. It is clear that these panelists were confused or uncertain what the rat data showed, and therefore voted no, not based on scientific evidence but rather the fear of uncertainty.

And then there’s this closing appeal to FDA officials:


“We believe that the long term effects of this event could result in irreparable damage to the biotechnology and pharmaceutical industry as a whole. The dramatic elevation of concern over rat cancer…has prompted class action lawuits against Arena Pharmaceuticals. Clearly these data were adjusted to show significance in cancer occurrence where none existed. If all pharmaceutical and research firms were to release all toxicological results from their pre-clinical or animal studies to the investing community, equity markets in that industry might cease to exist…”

“The pendulum has swung too far at the FDA if they influence Advisory Committees to vote no for a drug that poses very little risk to the public at large, and certainly less than currently available therapies, and where there is a demonstrable clinical benefit in terms of additional weight loss and reduction in cardiovascular risk factors. This is particularly true if the methodology underlying that influence is unscientific and based upon assumptions that are contrary to accepted scientific knowledge.”


The people who initiated the petition do not reveal their identity and instead preferred to be called ‘Concerned Citizen,’ and they argue that by approving the Lorqess pill, the agency would promote public health, saving untold dollars from the nation’s health costs. Beyond such concerns, however, it is unclear whether the petitioners are tied to Arena or are simply investors who were angered by the FDA review.

In any event, their belief that releasing all toxicology data from pre-clinical or animal studies may fatally damage equity markets may be construed as rather sweeping, if not dramatic. Proper disclosure - and proper analysis - remain desirable. The real issue, of course, was whether the rat data was not only disclosed as it should have been, but scrutinized correctly by the FDA staff.

Diet pills, though, are a whole other animal, you’ll pardon the pun. For more than a decade, as you may recall, various diet drugs have been linked to safety issues, most notably the fen-phen weight-loss cocktail, half of which was withdrawn in 1997 over serious links to heart and lung conditions. Given the current environment in which safety is a prime concern, one should not be surprised if the FDA errs on the side of caution. Whether the equity markets then collapse also remains to be seen.

[Kursziel1000]

Antwort auf Beitrag Nr.: 40.270.435 von fisci am 05.10.10 22:56:24

habe ich heute schon gepostet
05.10.10 15:31:07

[Kursziel1000]

[Kursziel1000]

Arena and Eisai Announce Upcoming Lorcaserin Presentations at Obesity 2010

Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) and Eisai Inc. announced today upcoming lorcaserin presentations at Obesity 2010, the 28th Annual Scientific Meeting of The Obesity Society, in San Diego, California.Lorcaserin, which Arena discovered and developed, is intended for weight management, including weight loss and maintenance of weight loss , in patients who are obese (Body Mass Index, or BMI, >30) or patients who are overweight (BMI >27) and have at least one weight-related co-morbid condition.

"Obesity 2010 is an excellent scientific forum to present results from our recently completed clinical study evaluating the effects of lorcaserin on appetite, energy intake and energy expenditure," stated William R. Shanahan, M.D., Arena's Senior Vice President and Chief Medical Officer. "We look forward to presenting at this event, and to lorcaserin's October 22nd PDUFA date."

The meeting schedule includes presentations of a lorcaserin mechanism of action study conducted by Drs. Eric Ravussin, Leanne Redman, Corby Martin and Steven Smith at the Pennington Biomedical Research Center in Baton Rouge, Louisiana.

Saturday, October 9, 2010

* Oral Abstract Presentation: Lorcaserin, a Novel 5-HT2C Receptor Agonist, Causes Weight Loss Without Stimulating Energy Expenditure
* Session Time: 4:45 p.m. - 6:15 p.m. Pacific Time (PT)

Sunday, October 10, 2010

* Poster Presentation: Lorcaserin, a Selective 5-HT2C Receptor Agonist, Reduces Energy Intake and Appetite
* Session Time: The poster will be on display from 9:30 a.m. to 1:45 p.m. PT and from 3:15 p.m. to 6:30 p.m. PT. Presenters will be available to discuss the poster from 12:30 p.m. to 1:30 p.m. PT.

About Lorcaserin

Lorcaserin is a new chemical entity that is believed to act as a selective serotonin 2C receptor agonist. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area believed to be involved in the control of appetite and metabolism. Arena has patents that cover lorcaserin in the United States 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 Arena Pharmaceuticals

Arena is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs that target G protein-coupled receptors, an important class of validated drug targets, in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases. Arena's most advanced drug candidate, lorcaserin, is intended for weight management and has completed a pivotal Phase 3 clinical trial program. Arena has filed an NDA for lorcaserin with the FDA, and the FDA has assigned a PDUFA date of October 22, 2010, for review of the application. Arena's wholly owned subsidiary, Arena Pharmaceuticals GmbH, has granted Eisai Inc. exclusive rights to market and distribute lorcaserin in the United States.

Arena Pharmaceuticals(R) and Arena(R) are registered service marks of the company.

About Eisai Inc.

Eisai Inc. was established in 1995 and is ranked among the top-20 U.S. pharmaceutical companies (based on retail sales). The company began marketing its first product in the United States in 1997 and has rapidly grown to become a fully integrated pharmaceutical business with fiscal year 2009 (year ended March 31, 2010) sales of approximately $3.9 billion. Eisai's areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd.

Eisai has a global product creation organization that includes U.S.-based R&D facilities in Maryland, Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina. The company's areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs. For more information about Eisai, please visit www.eisai.com.

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 advancement, therapeutic indication and use, safety, efficacy, tolerability, mechanism of action and regulatory review and approval of lorcaserin; how lorcaserin is believed to act; lorcaserin's patent coverage; and Arena's focus, goals, strategy, research and development 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, the risk that regulatory authorities may not find data from Arena's clinical trials and other studies sufficient for regulatory approval; the timing of any regulatory review and approval is uncertain; Arena's ability to obtain and defend its patents; risks related to commercializing new products; the timing, success and cost of Arena's research and development programs; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; clinical trials and other studies may not proceed at the time or in the manner Arena or others expect or at all; Arena's ability to obtain adequate funds; the timing and receipt of payments and fees, if any, from Eisai and Arena's collaborators; and satisfactory resolution of pending and any future litigation or other disagreements with others. 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.

Contacts: Arena Pharmaceuticals, Inc.



Investor Inquiries:


Media Inquiries: Russo Partners


Cindy McGee


David Schull


[e-mail]


[e-mail]


858.453.7200, ext. 1479


858.717.2310



Contacts: Eisai Inc.



Investor Inquiries:


Media Inquiries:


Dave Melin


Lynn Kenney


[e-mail]


[e-mail]


908.255.6378


201.746.2294

[derneureiche]

Mark Jewell, AP Business Writer, On Saturday October 23, 2010, 1:40 pm EDT

Arena Pharmaceuticals Inc. on Saturday said the Food and Drug Administration rejected the company's application for lorcaserin, one of three drugs seeking to become the first new FDA-approved preion weight loss drug in more than a decade.

The federal agency's rejection came after an FDA panel of experts on Sept. 16 recommended against approving lorcaserin in a 9-5 vote. Panelists raised concerns about tumors seen in rats in early stage testing, one of the factors that Arena Pharmaceuticals said the FDA had cited in a letter responding to the company's application.

After last month's FDA panel vote, shares of Arena plunged nearly 47 percent, to $1.99. San Diego-based Arena currently has no drugs on the U.S. market.

A group of Arena investors later launched a campaign arguing that the FDA panel's review had relied on faulty scientific data. On Friday, as the full FDA's review was expected to conclude, shares of Arena rose nearly 12 percent to close at $1.63.

Arena said on Saturday that the FDA determined "that it cannot approve the application in its present form."

In addition to citing safety concerns about tumors, the FDA's letter said the agency found that lorcaserin's weight loss efficacy "in overweight and obese individuals without type 2 diabetes is marginal," Arena said.

Arena said the letter stated that the FDA may require additional clinical studies if the company can't provide further evidence to address the concern about tumors.

The company plans to hold a conference call on Monday to discuss the FDA's rejection. Arena President and CEO Jack Lief said in a news release that his company plans to request a meeting with the FDA "to obtain further clarity on the approval path and timeline."

Lorcaserin's backers have argued it offers a safer way to shed pounds than older medications linked to dangerous side effects. Notable among them was Wyeth's diet pill combination fen-phen, which was pulled from the market in 1997 because of links to heart valve disease.

Lorcaserin is part of a new wave of weight loss drugs from several small drugmakers seeking FDA approval.

However, in July, the same panel that recommended against lorcaserin also voted against approval for Vivus Inc.'s Qnexa after studies showed signs of heart palpitation and suicidal thoughts. Orexigen Therapeutics is scheduled to have its own drug reviewed at a meeting in December.

Both of those drugs showed greater weight loss than lorcaserin, but the drug was favored by analysts because of its perceived safety.

[JimmySpoon]

Tja, das war es dann wohl...

Hab hier ne Stange Geld verloren !!!

Mal schaun, wieviel Cents ich für meine Teile am Montag noch bekomme !!!

In den USA-Foren wird nur noch hinterfragt, wann Arna BK sein wird !!!

Pump and Dump und morgen gibt es den finalen K.O. !!!

Was ein wertvoller Sonntag !

[doppelkeks]

Antwort auf Beitrag Nr.: 40.380.559 von JimmySpoon am 24.10.10 15:20:01

Mal unter der Annahme, Postings hier würden irgendwie die Welt bewegen...
Jimmy,
dann würde ja jemand, der noch Teile besitzt und überzeugt ist, dass sie morgen wegen "schlechter Nachrichten" tief stürzen könnten -- der würde sich ja hüten am Vorabend in den Foren solche Stimmung zu verbreiten, ne?

Was du über die US Foren schreibst, kann ich so nicht sehen, da wo ich lese.

[JimmySpoon]

Antwort auf Beitrag Nr.: 40.381.155 von doppelkeks am 24.10.10 20:06:35

Ich weiß ja nicht welche Interpretation du aus den Weekend Neuigkeiten ziehst:

Fakt ist aber: FDA hat die Zulassung ebenfalls verweigert !

Arna hat leider keine weiteren Wirkstoffe in Phase 2 oder 3 (mir jedenfalls nicht bekannt)!
Zweifelhaft ob das Produkt jetzt überhaupt weiterverfolgt wird (hoffe dort
auf nachhaltige Infos aus dem Conference-Call) !
Wichtig wäre, dass Esai als Partner erhalten bleibt !

Wenn nicht haben wir hier 2-3 Jahre ne Leiche liegen!
Ist bei Biotechs nix neues...

P.S.
Meine Postings werden den Kurs ganz sicher nicht in die ein oder andere Richtung lenken,
dafür sorgt der Markt !

[JimmySpoon]

Antwort auf Beitrag Nr.: 40.381.711 von JimmySpoon am 25.10.10 06:51:38

Nachtrag:
Wenn Du die Ablehnung nicht als schlechte Neuigkeit wertest,
dann gehen die Biotech-Uhren ab sofort anders...

Ob Forbes oder New York Times Artikel,
dass liesst sich nunmal grauenvoll !!!

...schaun wir mal was die MM´s heute morgen für ein Bid/Ask stellen !!!

[doppelkeks]

Antwort auf Beitrag Nr.: 40.381.728 von JimmySpoon am 25.10.10 07:03:17

Der response letter ist ganz genau das was ich erwartet habe... "kommt wieder, wenn ihr noch ein paar Ratten umgebracht habt"... geht also in die Verlängerung, ist aber keine endgültige Ablehnung. Und sehr stark verlängern wird sich die Prozedur nach den Vorgaben nicht. Die Chance auf Zulassung ist weiterhin da.
Mal sehen was der Markt meint.

[Gustl24]

Antwort auf Beitrag Nr.: 40.382.083 von doppelkeks am 25.10.10 09:21:20

der FDA- letter sagt mir, dass es auf jahre hier keine chance auf approval geben wird...
ein paar extrem erfolgreiche "laborversuche" werden hieran nichts ändern...

...However, in July, the same panel that recommended against lorcaserin also voted against approval for Vivus Inc.'s Qnexa after studies showed signs of heart palpitation and suicidal thoughts. Orexigen Therapeutics is scheduled to have its own drug reviewed at a meeting in December...

sollte das orexigen meeting positiv ausfallen, was ich jedoch bezweifle,
könnten arena hiervon mit einem kleinen rebound profitieren...

wenn dieser ganze "sektor" abschlägige decisions bekommt, dann gute nacht...
deckel drauf, kiste zu...irgendwann dilution, RS und reset

[Fruehrentner]

Lorcaserin Phase 3 Clinical Trial in Patients with Type 2 Diabetes Shows Statistically Significant Weight Loss
09 Nov 2010

Arena Pharmaceuticals and Eisai reported today that top-line results from the one-year lorcaserin BLOOM-DM trial demonstrate statistically significant weight loss in obese and overweight patients with type 2 diabetes

SAN DIEGO, CA, USA and WOODCLIFF LAKE, NJ, USA | November 9, 2010 |

Arena Pharmaceuticals, Inc. (Nasdaq: ARNA - News) and Eisai Inc. reported today that top-line results from the one-year lorcaserin BLOOM-DM trial demonstrate statistically significant weight loss in obese and overweight patients with type 2 diabetes. In this trial, lorcaserin met all three co-primary efficacy endpoints. In addition, as described below, lorcaserin patients taking lorcaserin 10 mg twice daily (BID) achieved statistically significant improvements in multiple secondary endpoints, including HbA1c, as compared to patients randomized to placebo.

The BLOOM-DM study evaluated 604 obese and overweight patients with type 2 diabetes. Patients were randomized to lorcaserin 10 mg BID (N=256), lorcaserin 10 mg dosed once daily (QD) (N=95) or placebo (N=253). To expedite enrollment, randomization to the lorcaserin 10 mg QD dose was discontinued after approximately 300 patients were enrolled in the trial.

The three primary efficacy endpoints at Week 52 were as follows: the proportion of patients who lose at least 5% of their baseline body weight; change from baseline in body weight; and the proportion of patients who lose at least 10% of their baseline body weight. Using Modified Intent-to-Treat Last Observation Carried Forward (MITT-LOCF) analysis, lorcaserin 10 mg BID met the three primary efficacy endpoints by producing statistically significant weight loss compared to placebo (p<0.0001). At Week 52, 37.5% of patients treated with lorcaserin 10 mg BID achieved at least 5% weight loss, more than double the 16.1% of patients taking placebo. Patients treated with lorcaserin 10 mg BID achieved mean weight loss of 4.5% (4.7 kg), compared to 1.5% (1.6 kg) for placebo. Also, at Week 52, 16.3% of lorcaserin 10 mg BID patients achieved at least 10% weight loss, compared to 4.4% of patients taking placebo.

"We look forward to reviewing the BLOOM-DM data with the FDA as the efficacy results are aligned with the agency's categorical benchmark for weight management," said Jack Lief, Arena's President and Chief Executive Officer.

BLOOM-DM also evaluated multiple secondary endpoints at Week 52. Five families of endpoints have been or are being evaluated: glycemic, lipid, blood pressure, body composition, and Quality of Life (QOL). Data from the first three families are available, and analysis of body composition and QOL are pending. Within the glycemic, lipid and blood pressure families, lorcaserin patients achieved statistically significant improvements relative to placebo in HbA1c and fasting glucose. Lorcaserin 10 mg BID patients achieved a 0.9% reduction in HbA1c, compared to a 0.4% reduction for the placebo group (p<0.0001). At Week 52, changes with lorcaserin treatment relative to placebo for fasting insulin, triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, and systolic and diastolic blood pressure were not statistically significant.

BLOOM-DM Safety Results

The most frequent adverse events occurring in greater than or equal to 10% of patients (excluding hypoglycemia) and the proportion of patients affected for lorcaserin 10 mg BID and placebo, respectively, were as follows: headache (14.5%, 7.1%), upper respiratory infection (13.7%, 14.7%), back pain (11.7%, 7.9%) and nasopharyngitis (11.3%, 9.9%). Headache and hypoglycemia were the only adverse events that exceeded the placebo rate by greater than 4% of patients. Adverse events of "hypoglycemia," which included asymptomatic low blood glucose measurements and symptomatic events, were reported by 29.3% and 21.0% of lorcaserin 10 mg BID and placebo patients, respectively; however, no events of severe hypoglycemia were reported in either treatment group. Serious adverse events were infrequent. Discontinuations for adverse events were 8.6% for lorcaserin 10 mg BID patients and 4.3% for placebo patients.

Echocardiograms were performed at baseline and at Weeks 24 and 52. At Week 24, 2.5% of lorcaserin 10 mg BID patients and 1.9% of placebo patients had new valvulopathy (based on FDA criteria), and at Week 52, 2.9% of lorcaserin 10 mg BID patients and 0.5% of placebo patients had new valvulopathy. BLOOM-DM was not powered to detect meaningful differences in the incidence of valvulopathy.

Baseline Patient Characteristics

BLOOM-DM evaluated obese and overweight patients with type 2 diabetes treated with one or more oral agents. At baseline, patients had an average Body Mass Index (BMI) of 36, weight of 228 pounds (103.6 kg), age of 53 years, and HbA1c of approximately 8%. Proportions of Caucasian, African American and Hispanic patients were 61%, 21% and 14%, respectively, and 54% of patients were female.

About Lorcaserin



Lorcaserin is intended for weight management, including weight loss and maintenance of weight loss, in patients who are obese (BMI >30) or patients who are overweight (BMI >27) and have at least one weight-related co-morbid condition. Lorcaserin is a new chemical entity that is believed to act as a selective serotonin 2C receptor agonist. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area believed to be involved in the control of appetite and metabolism. Arena has patents that cover lorcaserin in the United States and other jurisdictions that in most cases are capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity Arena might obtain.

Arena submitted a New Drug Application for lorcaserin to the FDA in December 2009, and the FDA issued a Complete Response Letter (CRL) in October 2010. In the CRL, the FDA outlined non-clinical and clinical reasons for its decision and provided recommendations relating to addressing such issues.

Phase 3 Program Overview

The lorcaserin Phase 3 program consists of three double-blind, randomized, placebo-controlled trials, BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management), BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management) and BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus), and enrolled approximately 7,800 patients. BLOOM and BLOSSOM evaluated lorcaserin versus placebo in patients who are obese or patients who are overweight and have at least one weight-related co-morbid condition. BLOOM evaluated 3,182 patients over a two-year treatment period and BLOSSOM evaluated 4,008 patients over a one-year treatment period. BLOOM-DM evaluated 604 patients over a one-year treatment period in obese and overweight patients with type 2 diabetes that is managed with one or more oral anti-hyperglycemic agents. The trials included a standardized program of moderate diet and exercise guidance.

About the FDA Draft Guidance

The FDA draft guidance document "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 that target G protein-coupled receptors, an important class of validated drug targets, in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases. Arena's most advanced drug candidate, lorcaserin, is intended for weight management. Arena's wholly owned subsidiary, Arena Pharmaceuticals GmbH, has granted Eisai Inc. exclusive rights to market and distribute lorcaserin in the United States, following FDA approval of the New Drug Application for lorcaserin.

Arena Pharmaceuticals(R) and Arena(R) are registered service marks of the company.

About Eisai Inc.

Eisai Inc. was established in 1995 and is ranked among the top-20 US pharmaceutical companies (based on retail sales). The company began marketing its first product in the United States in 1997 and has rapidly grown to become a fully integrated pharmaceutical business with fiscal year 2009 (year ended March 31, 2010) sales of approximately $3.9 billion. Eisai's areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the US pharmaceutical operation of Eisai Co., Ltd.

Eisai has a global product creation organization that includes US-based R&D facilities in Maryland, Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina. The company's areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs. For more information about Eisai, please visit www.eisai.com.

SOURCE: Arena Pharmaceuticals, Inc.

[Karl79]

Der Wochenausklang war doch überaus erfreulich ...
Alles wartet auf die bevorstehenden News.
Auch charttechnsich hellt es sich hier zunehmend auf:

[Karl79]

.... und doch gibt es News:

"....last week Arena announced the initiation of dosing in a phase 1 clinical trial of APD 811 drug. This is a novel oral drug candidate discovered by Arena which is used to target prostacyclin receptor for the treatment of pulmonary arterial hypertension, or PAH....."
http://www.savvystockpicks.com/stock-updates/2010121192-aren…

Von der Zielstellung dieser Phase 1 -Indikation habe ich aber keine Ahnung ...

[derneureiche]

ich schau mir den wert nur noch von der seite an.
chancen-risiko verhältnis hat sich mit der FDA verweigerung extrem verschlechtert.
ich habe meine position direkt danach aufgelöst (SL).
lasse das geld in anderen werten arbeiten.:o)
ich sehe hier kurz und mittelfristig nicht wiklich eine verbesserung.
kann sein das durch gezocke der wert auch mal wieder raufhüpft, aber als investment macht das nur sinn, wenn es eine realistisch chance für ne positive FDA gibt.

euch allen viel glück

[Karl79]

Antwort auf Beitrag Nr.: 40.733.361 von derneureiche am 18.12.10 18:31:35

..Recht hast du .... musste hier nochmals nachlesen:
....." Das Kombipräparat Contrave (Bupropion / Naltrexon) ist das letzte von drei neuen Gewichtsreduktionsmedikamenten, das dieses Jahr durch die Food and Drug Administration (FDA) geprüft wurde. Die beiden vorherigen Kandidaten, Qnexa (Phentermin / Topiramat) und Lorqess (Lorcaserin), wurden beide von der FDA aufgrund von Sicherheitsbedenken zurückgewiesen.

Contrave hatte mehr Glück. Bei der gestrigen Sitzung der beratenden Kommission stimmten 13 von 20 Mitgliedern für die Einführung des neuen Medikaments. Das Kombipräparat aus Bupropion und Naltrexon scheint vor allem mit den relativ bescheidenen Nebenwirkungen gepunktet zu haben. Dieser Umstand ist bemerkenswert, da die gewichtsreduzierenden Eigenschaften deutlich hinter denen von Qnexa und Lorqess zurückliegen. ...."

http://www.inar.de/blog/medizin/20101210/die-neue-diaetpille…

Ich hatte die Diskussion anders in Erinnerung.
Ablehnung bedeutet nicht automatisch Ausschluss, aber wirft so ein Investment klar zurück. Der vergangene Kursrückschlag seit Oktober zeigte dies.
... Aber die Hoffnung lebt, wie der Kurs im Dezember zeigt. ... auch durch neue Nachrichten (siehe Phase 1 - Meldung oben)

[printguru]

Das sieht mir aber stark nach Ausbruch aus.

Denke heute werden wir die 3$ Marke zurückerobern.

lg Printi

[Karl79]

... die von Dir erhofften 3,- $ sind doch in weite Ferne gerückt.
Denke aber auch hier noch an krasse Vola ... und

.... so ein bissel Hoffnung gebe ich der Lorcaserin noch ...
No Risk --> no Fun



Ich wünsche Euch allen ein erfolgreiches- und gesundes Jahr 2011.

[Travis_Bickle]

weiß wer ob hier was im gange ist?

[straumen]

Antwort auf Beitrag Nr.: 42.547.501 von Travis_Bickle am 04.01.12 09:49:21

Arena Submits Response to FDA Complete Response Letter for Lorcaserin
Arena to Host Conference Call Today at 5:30 p.m. Eastern Time --

Hop oder Top - wir werden sehen.

Gruß

[abramovitsch]

Was für eine Pressekonferenz steht da an? Über was wird geredet/diskutiert?

[straumen]

Antwort auf Beitrag Nr.: 42.548.384 von abramovitsch am 04.01.12 12:25:25

...guckst Du hier:

http://www.marketwatch.com/story/arena-submits-response-to-f…

Gruß

[abramovitsch]

Zitat von straumen: ...guckst Du hier:

http://www.marketwatch.com/story/arena-submits-response-to-f…

Gruß

Danke ;-)