Human Genome Sciences, Tradingchance - 500 Beiträge pro Seite (Seite 4)

[crivit]

Human Genome Sciences CEO On CNBC (HGSI)
Posted on 01/12/10 at 1:51pm by Bud Fox

Human Genome Sciences (NASDAQ: HGSI) was one of the hottest stocks of 2009, appreciating nearly 1500% during the last year. The reason for the incredible run in HGSI is a very promising lupus drug called Benlysta.

Tom Watkins, Human Genome Sciences (HGSI) CEO, just appeared on CNBC to talk about Benlysta and his company's prospects in 2010. Watkins said that there has not been a new lupus drug brought to market in the last 50 years, but that Benlysta could change that this year. Analysts have speculated that with the development of Benlysta, Human Genome Sciences (HGSI) may be close to a solution in the fight against the disease. Lupus is a chronic autoimmune connective tissue disease that can affect any part of the body. As occurs in other autoimmune diseases, the immune system attacks the body’s cells and tissue, resulting in inflammation and tissue damage.

Watkins indicated that he is hopeful that an application for Benlysta will be filed with the FDA in the first half of this year. He also said that it is conceivable that the drug could be brought to market by late 2010 if the FDA fast tracks Benlysta's approval process. Although Watkins refused to discuss the price point for the drug, there is speculation that treatment may command $30,000 per patient.

Human Genome Sciences (HGSI) has partnered with GlaxoSmithKline (NYSE: GSK) to distribute Benlysta upon FDA approval. Shares of Human Genome Sciences are down 5.45% to $28.77 today on the Nasdaq exchange.

http://www.benzinga.com/media/cnbc/85075/human-genome-scienc…

[againstfotsch]

Dahin wird es mittelfristig gehen - 40$

Human Genome Sciences overweight
13.01.2010 - 09:19

Rating-Update:

New York (aktiencheck.de AG) - Steven Harr, Analyst von Morgan Stanley, stuft die Aktie von Human Genome Sciences (ISIN US4449031081/ WKN 889323) unverändert mit "overweight" ein. Das Kursziel werde bei 40,00 USD gesehen. (13.01.2010/ac/a/u) Analyse-Datum: 13.01.2010

Quelle: Finanzen.net

[againstfotsch]

Human Genome Sciences neues Kursziel
15.01.2010 - 09:25

Zürich (aktiencheck.de AG) - Maged Shenouda, Analystin der UBS, stuft die Aktie von Human Genome Sciences (ISIN US4449031081/ WKN 889323) unverändert mit "buy" ein.

Human Genome Sciences plane einen Zulassungsantrag für Benlysta im zweiten Quartal 2010 einzureichen. Falls ein beschleunigtes Verfahren genehmigt werde, könnte es Ende 2010/Anfang 2010 zur Erteilung der Zulassung kommen.

Benlysta sei wahrscheinlich seit mehr als 50 Jahren das erste neu zugelassene Präparat gegen Lupus. Ein starker Vermarktungsbeginn sei zu erwarten, wobei die Konzentration vor allem auf moderaten bis schweren Krankheitsverläufen liegen dürfte. Von in 2011 erwarteten Umsätzen von 0,4 Mrd. USD werde bis 2014 ein Anstieg auf 2,5 Mrd. USD geschätzt.

Die Aussichten des Albuferon-Geschäfts seien weiterhin sehr unsicher. Allerdings wachse das Vertrauen in die übrigen Pipelinekandidaten in frühen Entwicklungsstadien.

Das Kursziel werde von 35,00 auf 37,00 USD heraufgesetzt.

Vor diesem Hintergrund bleiben die Analysten der UBS bei ihrer Empfehlung die Aktie von Human Genome Sciences zu kaufen. (Analyse vom 14.01.10) (14.01.2010/ac/a/a)Analyse-Datum: 14.01.2010

Quelle: Finanzen.net

[crivit]

ISt ein bisschen spät aber:

Rating-Update 27.01.10:

Toronto (aktiencheck.de AG) - Die Analysten von RBC Capital Markets stufen die Aktie von Human Genome Sciences (ISIN US4449031081 / WKN 889323 ) in einer Ersteinschätzung mit dem Rating "outperform" ein.
Das Kursziel werde bei 38 USD gesehen.

[crivit]

Human Genome Sciences Names Scott Habig Vice President, Sales
Press Release Source: Human Genome Sciences, Inc. On Monday February 1, 2010, 7:00 am EST

ROCKVILLE, Md.--(BUSINESS WIRE)--Human Genome Sciences, Inc. (Nasdaq: HGSI - News) today announced that Scott Habig has joined the Company as Vice President, Sales, reporting to Kevin P. McRaith, Vice President, Sales and Marketing, HGS. Mr. Habig was most recently Vice President, Sales, at Centocor Ortho Biotech, a subsidiary of Johnson & Johnson.

“Scott Habig is exemplary of the top leadership talent with which we are building up our commercial organization. He brings to HGS more than 25 years of experience as a leader in the sales and marketing of biological and pharmaceutical products for the treatment of autoimmune and infectious diseases,” said Barry A. Labinger, Executive Vice President and Chief Commercial Officer. “We are pleased to have Scott join our commercial team and expect him to play a central role in building and leading a world class sales organization to launch our lead products, BENLYSTA for systemic lupus and ZALBIN for hepatitis C, along with our partners.” Both BENLYSTA™ (belimumab) and ZALBIN™ (albinterferon alfa-2b) have the potential to receive regulatory clearance in the United States as soon as late 2010.

During his nine years with the Centocor and Centocor Ortho Biotech subsidiaries of Johnson & Johnson, Mr. Habig held a number of key leadership positions, including Vice President, Sales and Marketing. He developed and led the execution of sales and marketing strategy that established REMICADE (infliximab) as a leading product for the treatment of autoimmune diseases including Crohn’s disease, rheumatoid arthritis, psoriasis and ulcerative colitis. He also managed a team of more than 600 sales and marketing employees. Prior to joining Centocor in 2000, Mr. Habig served as Vice President, Marketing, at Ethicon Endo Surgery. He began his career as a Sales Representative at Janssen Pharmaceutica, Inc., where he advanced through a series of sales and product management positions of increasing responsibility during a 14-year tenure. Mr. Habig received his Bachelor of Arts degree in mass media communications from the University of Akron, Ohio.

http://finance.yahoo.com/news/Human-Genome-Sciences-Names-bw…

[againstfotsch]

Hallo,

nach ein paar Tagen und Wochen der Erholung könnte es weiter gehen Richtung 40$...

Ich glaube immernoch an ein Übernahmeangebot von Glaxo, was meint ihr?

Gruß
af

[crivit]

Antwort auf Beitrag Nr.: 38.936.115 von againstfotsch am 12.02.10 17:25:58

Sieht seehhr gut aus.
Ein großer wird kommen, sehe ich genau so!

[crivit]

Antwort auf Beitrag Nr.: 38.936.390 von crivit am 12.02.10 17:57:20

Jetzt geht es an die 29$

[crivit]

Fidelity Contrafund - Fidelity Contrafund

Von 2,037,252 auf 7,860,104 aufgestockt.

http://www.mffais.com/mffais-history-94249-hgsi

http://www.mffais.com/hgsi

[crivit]

Antwort auf Beitrag Nr.: 38.936.390 von crivit am 12.02.10 17:57:20

Ist das schööönnn.

[HAVANNA-CLUB]

Antwort auf Beitrag Nr.: 39.035.889 von crivit am 01.03.10 19:54:26

Jetzt kann HGSI sich frei nach oben entfalten

[Bachalor]

Antwort auf Beitrag Nr.: 38.937.611 von crivit am 12.02.10 20:25:16

welche 29

[crivit]

Antwort auf Beitrag Nr.: 39.036.682 von Bachalor am 01.03.10 21:45:12

Yip, jetzt haben wir sie wieder.

[crivit]

Human Genome Sciences Announces Fourth-Quarter and Full-Year 2009 Financial Results and Key Developments
Press Release Source: Human Genome Sciences, Inc. On Tuesday March 2, 2010, 4:01 pm

- Positive results for BENLYSTA™ pivotal Phase 3 trials announced in July and November 2009; marketing applications in United States and Europe expected second quarter 2010 -

- Marketing applications for ZALBIN™ submitted in U.S. and Europe in fourth quarter 2009; BLA in U.S. accepted as filed by FDA with PDUFA date of October 4, 2010 -

- 2009 revenue exceeded $275 million; included $180 million from deliveries of raxibacumab to U.S. Strategic National Stockpile -

- HGS ended 2009 with $1.2 billion in cash and investments, including net proceeds from successful public offerings of HGSI common stock completed in August and December 2009 -


http://finance.yahoo.com/news/Human-Genome-Sciences-bw-39158…

[crivit]

Antwort auf Beitrag Nr.: 38.936.390 von crivit am 12.02.10 17:57:20

Und weiter Richtung NORDEN.

[againstfotsch]

Antwort auf Beitrag Nr.: 39.071.002 von crivit am 05.03.10 17:00:11

Hab zwar die Hälfte bei 20€ verkauft, bin aber mei WaMu eingestiegen, sieht auch gut aus

Bei 40€ kannst auch mal die Hälfte versilbern, Crivit

Schönes Wochenende
af

[againstfotsch]

Antwort auf Beitrag Nr.: 39.072.844 von againstfotsch am 05.03.10 19:48:44

wollte eigentlich 40$ schreiben, aber ist auch schon egal bei Human

[crivit]

Antwort auf Beitrag Nr.: 39.072.864 von againstfotsch am 05.03.10 19:51:11

40€ ist gut, aber erst beim Buyout!

[crivit]

[againstfotsch]

Antwort auf Beitrag Nr.: 39.106.561 von crivit am 10.03.10 17:45:28

hab dir eine BM geschickt
mfg

[crivit]

Human Genome Sciences Announces Interim Results of Phase 2b Monthly-Dosing Trial of ZALBIN in Patients with Chronic Hepatitis C
Press Release Source: Human Genome Sciences, Inc. On Wednesday March 24, 2010, 7:00 am

http://finance.yahoo.com/news/Human-Genome-Sciences-bw-13834…

[crivit]

Meldung von Heute passt mir nicht!
So fetten Gewinn abgesichert, kleine Posi bleibt drin.
Danke HGSI

[ambestenreichheiraten]

Antwort auf Beitrag Nr.: 39.367.986 von crivit am 20.04.10 15:35:36

....so hab mich auch verabschiedet...
EK 4,86 Euro VK 20,755 im Schnitt....war ja gar nicht so schlecht...

und meistens wenn ich draussen bin drehts wieder nuff

Euch noch gute Gewinne...ich streich die Segel

[zwitscherton]

Antwort auf Beitrag Nr.: 39.368.370 von ambestenreichheiraten am 20.04.10 16:16:35

Es kann ja nicht immer alles klappen.
Glaxo ist überhaupt nicht betroffen.
Ich denke das Approval wird trotzdem kommen.



GLTA

[Expertchen007]

Antwort auf Beitrag Nr.: 39.368.370 von ambestenreichheiraten am 20.04.10 16:16:35

EK 4,86 Euro VK 20,755 im Schnitt....war ja gar nicht so schlecht...

sauber...so macht Börse Spaß - Glückwusch

[zwitscherton]

Antwort auf Beitrag Nr.: 39.374.420 von Expertchen007 am 21.04.10 12:51:25

[urlWhy HGSI Is a Buy, Even After the Benlysta Data]http://www.minyanville.com/businessmarkets/articles/human-genome-sciences-benlysta-lupus-belimumab/4/20/2010/id/27891[/url]

[crivit]

Antwort auf Beitrag Nr.: 39.369.525 von zwitscherton am 20.04.10 18:16:22

Hoffe es obwohl ich nur noch mit kleiner Stückzahl dabei bin.
Bei einem EK von 0,55€ und 0,66€ wurde ich einfach schwach.

GLTA

[zwitscherton]

Antwort auf Beitrag Nr.: 39.394.315 von crivit am 23.04.10 20:41:42

Durchaus nachvollziehbar.

[HAVANNA-CLUB]

Wieso geht es jetzt so runter ?

[zwitscherton]

Antwort auf Beitrag Nr.: 39.471.268 von HAVANNA-CLUB am 06.05.10 17:50:07

weil die biotechs so eng mit den europäschen schuldenmacherstaaten verflochten sind.

die börse reagiert stets logisch und rational.

[HAVANNA-CLUB]

Wie tief meint ihr wird HGSI noch gehen ?

[HAVANNA-CLUB]

17.06.2010 10:30
Human Genome Sciences and GlaxoSmithKline Announce Full Presentation at EULAR of BLISS-76 Phase 3 Study Results for BENLYSTA® in Systemic Lupus Erythematosus

Human Genome Sciences, Inc. (Nasdaq: HGSI) and GlaxoSmithKline PLC (GSK) today announced the full presentation of results from BLISS-76, one of two pivotal Phase 3 trials of BENLYSTA® (belimumab) in seropositive patients with systemic lupus erythematosus (SLE). The results will be presented today in Rome at the 2010 Congress of the European League Against Rheumatism (EULAR).

"The BLISS-76 Phase 3 results presented at EULAR extend the findings of previous studies and reinforce our belief that belimumab, assuming regulatory approval, could deliver a significant therapeutic option for seropositive patients with systemic lupus," said David C. Stump, M.D., Executive Vice President, Research and Development, HGS. "In both of its pivotal Phase 3 trials in these patients, belimumab 10 mg/kg met its primary endpoint. The efficacy of treatment with belimumab plus standard of care compared with placebo plus standard of care was superior in both studies, with overall adverse event rates for belimumab comparable to placebo."

Carlo Russo, M.D., Senior Vice President, Biopharm Development, GSK, said, "Belimumab is the first medicine developed specifically for lupus that has reached this late stage of clinical development with positive results. The BLISS-76 results presented at EULAR, taken together with the results of BLISS-52, reinforce our belief that belimumab may play an important role for patients living with lupus."

Belimumab is an investigational drug and the first in a new class of drugs called BLyS-specific inhibitors. It is being developed by HGS and GSK under a co-development and commercialization agreement entered into in 2006. GSK submitted a Marketing Authorization Application to the European Medicines Agency (EMA) on June 4, 2010, seeking approval to market belimumab in Europe for treatment of autoantibody-positive patients with SLE. On June 10, 2010, HGS announced submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration seeking approval to market belimumab in the United States. No new drug for lupus has been approved by regulatory authorities in more than 50 years.

BLISS-76 PATIENT RESPONSE RATES (SRI)

The primary efficacy endpoint of BLISS-76 was the patient response rate at Week 52 as measured by the SLE Responder Index (SRI), which defines patient response by an improvement in SELENA SLEDAI score of 4 points or greater, with no clinically significant BILAG worsening, and no clinically significant worsening in Physician's Global Assessment.

* Week 52 (Primary Endpoint). Based on intention-to-treat (ITT) analysis, belimumab 10 mg/kg met its primary endpoint of superiority versus placebo at Week 52. A statistically significant improvement was shown in patient response rate for belimumab 10 mg/kg plus standard of care, vs. placebo plus standard of care, as measured by SRI at Week 52: 43.2% for 10 mg/kg belimumab, 40.6% for 1 mg/kg belimumab, and 33.5% for placebo (p=0.017 and p=0.089 for 10 mg/kg and 1 mg/kg belimumab, respectively vs. placebo).
* Week 76 (Major Secondary Endpoint). At Week 76, belimumab plus standard of care showed higher response rates compared with placebo plus standard of care as measured by SRI; however, this major secondary endpoint did not reach statistical significance: 38.5% for 10 mg/kg belimumab, 39.1% for 1 mg/kg belimumab, and 32.4% for placebo (p=0.13 and p=0.11 for 10 mg/kg and 1 mg/kg belimumab, respectively vs. placebo).
* Post hoc exploratory analyses at Weeks 52 and 76 evaluated SRI response using greater SELENA SLEDAI reductions (-5, -6, or -7 or more points) than the 4-point reduction used for the primary endpoint. These results along with the pre-specified 4-point reduction are provided below. Using these higher SELENA SLEDAI thresholds, a greater treatment effect was observed, with significant improvements in SRI response for the 10 mg/kg treatment group at both Week 52 and Week 76 (p<0.05 vs. placebo).

SRI Rate at Week 52 SRI Rate at Week 76

SELENA
SLEDAI


Placebo
N=275


1 mg/kg
N=271


10 mg/kg
N=273


Placebo
N=275


1 mg/kg
N=271


10 mg/kg
N=273

=4-point
reduction
33.5% 40.6% 43.2%* 32.4% 39.1% 38.5%
=5-point
reduction 20.4% 31.0%** 32.6%*** 21.8% 28.4% 30.8%*
=6-point
reduction 18.9% 28.8%** 30.8%** 20.4% 26.9% 28.9%*

=7-point
reduction
N=649
13.4% 19.4% 21.3%* 13.9% 21.7%* 21.8%*


* p<0.05 ** p<0.01 *** p<0.001

"Belimumab met the primary endpoint in both BLISS-76 and BLISS-52. The totality of Phase 3 data suggests that belimumab added to standard care offered improved clinical benefit versus standard of care alone, and was generally well tolerated in these studies," said Ronald F. van Vollenhoven, M.D., Associate Professor of Rheumatology, Karolinska Institute, and Chief, Clinical Trial Unit, Karolinska University Hospital, Stockholm, Sweden. "The clinical design innovations in these Phase 3 studies may also encourage the development of future medicines for lupus."

KEY BLISS-76 STUDY FINDINGS PRESENTED AT EULAR ALSO INCLUDED:

Disease Activity

* At Week 52, the mean percent improvement in SELENA SLEDAI score was 36.0% for belimumab 10 mg/kg, 33.9% for belimumab 1 mg/kg, and 26% for placebo (p=0.0077 and p=0.040 for 10 mg/kg and 1 mg/kg belimumab, respectively vs. placebo). At Week 76, the mean percent improvement in SELENA SLEDAI score was 37.0% for belimumab 10 mg/kg, 36.1% for belimumab 1 mg/kg, and 27.8% for placebo (p=0.014 and p=0.027 for 10mg/kg belimumab and 1 mg/kg belimumab, respectively vs. placebo).
* The proportion of patients with a reduction in SELENA SLEDAI score of at least 4 points by Week 52, a major secondary endpoint, was 46.9% for belimumab 10 mg/kg, 42.8% for belimumab 1 mg/kg, and 35.6% for placebo (p=0.0062 and p=0.087 for belimumab 10 mg/kg and 1 mg/kg, respectively vs. placebo). At Week 76, the proportion of patients with a reduction in SELENA SLEDAI score from baseline of at least 4 points was 41.4% for belimumab 10 mg/kg, 42.1% for belimumab 1 mg/kg, and 33.8% for placebo (p=0.066 and p=0.049 for belimumab 10 mg/kg and 1 mg/kg, respectively vs. placebo).
* The risk of severe SLE disease flares (SFI) was reduced over 76 weeks by 23% in the 10 mg/kg belimumab treatment group and by 34% in the 1 mg/kg belimumab treatment group vs. placebo (p=0.13 and p=0.023 for 10 mg/kg and 1 mg/kg belimumab, respectively). From Weeks 24-76, the risk of severe SLE disease flares was reduced by 30% in the 10 mg/kg belimumab treatment group and by 45% in the 1 mg/kg belimumab treatment group vs. placebo (p=0.10 and p=0.009 for 10 mg/kg and 1 mg/kg belimumab, respectively).
* From Weeks 24-76, the risk of all SLE disease flares was significantly reduced in the belimumab 10 mg/kg treatment group, with risk reduction of 22% for 10 mg/kg belimumab and 16% for 1 mg/kg belimumab (p=0.016 and p=0.098 for 10 mg/kg and 1 mg/kg belimumab, respectively). Over 76 weeks from study initiation, however, the risk of all SLE disease flares (SFI) was not statistically different between the belimumab and placebo treatment groups.

Steroid Use

* At entry into the BLISS-76 study, approximately 46% of patients were receiving steroids at a prednisone-equivalent dose of at least 7.5 mg per day. Among these patients, the percentage of patients who had their average steroid dose reduced from baseline to 7.5 mg per day or less by Week 76 was 25.8% for belimumab 10 mg/kg, 27.7% for belimumab 1 mg/kg, and 17.5%% for placebo (p=0.15 and p=0.046 for belimumab 10 mg/kg and 1 mg/kg, respectively, vs. placebo). One of the BLISS-76 study's major secondary endpoints was the percentage of these patients who - during Weeks 40-52 - had their average steroid dose reduced by at least 25% from baseline to 7.5 mg per day or less. These percentages were: 16.7% for belimumab 10 mg/kg, 19.2% for belimumab 1 mg/kg, and 12.7% for placebo, and were not statistically significant vs. placebo.
* Among patients who were receiving =7.5 mg per day of prednisone at baseline (N=443), the percentage of patients who had their average steroid dose increased to >7.5 mg per day by Week 76 was 11.8% for belimumab 10 mg/kg, 13.5% for belimumab 1 mg/kg, and 18.1% for placebo (p=0.17 and p=0.33 for belimumab 10 mg/kg and 1 mg/kg, respectively, vs. placebo).

Fatigue

* Numerically improved fatigue scores were observed in the belimumab treatment groups vs. the placebo group within 8-12 weeks, and the 1 mg/kg belimumab treatment group achieved statistically significant improvement of fatigue by Week 52, which was maintained at Week 76 (FACIT-Fatigue Scale; p<0.05 vs. the placebo group). Mean absolute FACIT-Fatigue improvement from baseline at Week 76 was 5.0 for belimumab 10 mg/kg, 5.2 for belimumab 1 mg/kg, and 3.2 for placebo (p=0.12 and p=0.036 for belimumab 10 mg/kg and 1 mg/kg, respectively, vs. placebo).

Biomarker Data

* Among patients who were positive for anti-double-stranded DNA autoantibodies (anti-dsDNA) at baseline, a significantly greater median percent reduction in anti-dsDNA was observed among patients in the belimumab treatment groups vs. the placebo group, with reductions observed by Week 8 that were sustained or increased through Week 76. At Week 76, the median percent reduction in anti-dsDNA was 49.5% for belimumab 10 mg/kg, 43.3% for belimumab 1 mg/kg, and 9.7% for placebo (p<0.0001 for belimumab 10 mg/kg and 1 mg/kg, vs. placebo).
* Among patients with low C4 complement at baseline, a significantly greater median percent increase was observed among patients in the belimumab treatment groups vs. the placebo group, with increases observed by Weeks 4-8 that were sustained or increased through Week 76. At Week 76, the median percent increase in C4 complement was 51.9% for belimumab 10 mg/kg, 38.5% for belimumab 1 mg/kg, and 16.7% for placebo (p<0.0001 and p=0.0002 for belimumab 10 mg/kg and 1 mg/kg, respectively, vs. placebo).

Safety

* In BLISS-76 through 76 weeks, belimumab was generally well tolerated, with rates of adverse events overall, serious and/or severe adverse events, all infections, serious and/or severe infections, and discontinuations due to adverse events comparable between treatment groups receiving belimumab plus standard of care and the treatment group receiving placebo plus standard of care. Serious and/or severe adverse events were reported in 29.0% of patients on belimumab and 26.2% of patients on placebo. Infections were reported in 74.3% of patients on belimumab and 69.1% of patients on placebo. Serious and/or severe infections were reported in 7.7% of patients on belimumab and 8.4% of patients on placebo. Serious and/or severe infusion reactions were reported in 1.1% of patients on belimumab and 0.7% of patients on placebo. Discontinuations due to adverse events were 7.5% in the belimumab treatment groups and 8.4% in the placebo treatment group. A total of seven malignancies were reported in BLISS-76: 2, 4, and 1 in the belimumab 10 mg/kg, belimumab 1 mg/kg and placebo groups, respectively. A total of three deaths were reported in the study: 1, 2, and 0 in the belimumab 10 mg/kg, belimumab 1 mg/kg and placebo groups, respectively.

About the Belimumab Phase 3 Development Program

The Phase 3 development program for belimumab included two double-blind, placebo-controlled, multi-center Phase 3 superiority trials - BLISS-52 and BLISS-76 - to evaluate the efficacy and safety of belimumab plus standard of care, versus placebo plus standard of care, in seropositive (HEp-2 ANA = 1:80 and/or anti-dsDNA = 30 IU/mL) patients with SLE. Both BLISS-52 and BLISS-76 have now been completed. This is the largest clinical trial program ever conducted in lupus patients. BLISS-52 randomized and treated 865 patients at 90 clinical sites in 13 countries, primarily in Asia, South America and Eastern Europe. BLISS-76 randomized and treated 819 patients at 136 clinical sites in 19 countries, primarily in North America and Europe.

The design of the two trials was similar, but the duration of therapy in the two studies was different - 52 weeks for BLISS-52 and 76 weeks for BLISS-76. The data from the BLISS-76 Phase 3 study were analyzed after 52 weeks in accord with the study protocol, in support of the BLA and MAA submissions. The BLISS-76 study then continued for an additional 24 weeks through the full 76-week treatment period, with the objective of generating additional information about belimumab based on a variety of secondary endpoints. HGS designed the Phase 3 program for belimumab in collaboration with GSK and leading international SLE experts, and the program is being conducted under a Special Protocol Assessment agreement with FDA.

EULAR PRESENTATION OF KEY PHASE 2 FIVE-YEAR CONTINUATION DATA

The results through five years from a long-term Phase 2 continuation trial of belimumab will be presented at EULAR on Saturday, June 19, by W. Winn Chatham, M.D., Professor of Medicine, Division of Clinical Immunology and Rheumatology, University of Alabama School of Medicine, Birmingham. "The evidence of durability of belimumab's clinical effect over the course of five years in a long-term Phase 2 continuation study, together with the favorable safety profile observed in the study, suggests that belimumab may have potential for chronic use in the treatment of patients with seropositive SLE," said Dr. Chatham.

The results showed that belimumab was associated with durable sustained improvement in disease activity across multiple clinical measures, decreased frequency of disease flares, and sustained reductions in autoantibody levels in seropositive patients with SLE. (All patients remaining on study after Week 52 received belimumab.) The data to be presented from Week 52 to Week 256 in seropositive patients with SLE who were treated with belimumab from initiation of the Phase 2 study include the following trends:

* An increase from 46% to 59% in the SRI response rate selected as the primary efficacy endpoint of the Phase 3 trials (post hoc; intention-to-treat analysis).
* A decrease from 62% to 22% in the overall frequency of SLE disease flares, as measured by the SELENA SLEDAI Flare Index.
* A decrease from 23% to 11% in the frequency of patients experiencing a new BILAG A flare (which would indicate a severe flare of lupus disease activity) or more than one new BILAG B flare (which would indicate a moderate flare of disease activity).
* An increase from 33% to 41% from Weeks 52-76 in mean percent improvement in PGA score, which was sustained from Weeks 76-256.

The biomarker data to be presented at EULAR from the Phase 2 continuation study through five years includes sustained reductions in a number of autoantibodies from Week 52 to Week 256 in seropositive patients who were treated with belimumab from initiation of the Phase 2 study. The median percent reductions from baseline among patients who were positive for the autoantibodies at baseline included:

* Reduction in anti-dsDNA of 29.4% at Week 52 and 63.0% at Week 256.
* Reduction in anti-Smith of 29.0% at Week 52 and 51.5% at Week 256.
* Reduction in anti-cardiolipin IgG of 13.8% at Week 52 and 37.3% at Week 256.

The five-year Phase 2 continuation data to be presented at EULAR show belimumab was generally well tolerated in patients with SLE. By Week 256, overall belimumab exposure was 1,394 patient years. The incidence rates per 100 patients in all adverse event categories, including serious adverse events, overall adverse events, and serious infections, were similar for belimumab and placebo during the 52-week double-blind period, and remained the same or decreased over five years of continuous treatment. The overall incidence of adverse events (in general and by system organ class), serious adverse events, infections, malignancies and laboratory abnormalities decreased or stabilized over time from Week 52 to Week 256.

About the Phase 2 Study of BENLYSTA in SLE

The primary objectives of the Phase 2 study were to evaluate the efficacy and safety of belimumab (BENLYSTA) plus standard of care, versus placebo plus standard of care. A total of 449 patients with active SLE were randomized to receive one of three different doses of belimumab (1, 4 or 10 mg/kg) or placebo administered intravenously over a 52-week treatment period, in addition to standard-of-care therapy. At the end of 52 weeks, 345 patients chose to participate in an optional 24-week extension phase of the study, during which all patients received belimumab. At Week 76, 296 patients chose to remain on belimumab treatment in an open-label long-term continuation phase of the Phase 2 trial, in which all patients are receiving 10 mg/kg belimumab.

POSTER PRESENTATIONS AT EULAR OF DATA FROM BLISS-52 PHASE 3 STUDY

A separate press release also issued today highlights additional data to be presented at EULAR on Saturday, June 19, from the BLISS-52 Phase 3 trial of belimumab in patients with systemic lupus.

ABOUT BELIMUMAB

Belimumab is an investigational human monoclonal antibody drug that specifically recognizes and inhibits the biological activity of B-lymphocyte stimulator, or BLyS. BLyS is a naturally occurring protein discovered by HGS that is required for the development of B-lymphocyte cells into mature plasma B cells. Plasma B cells produce antibodies, the body's first line of defense against infection. In lupus and certain other autoimmune diseases, elevated levels of BLyS are believed to contribute to the production of autoantibodies - antibodies that attack and destroy the body's own healthy tissues. The presence of autoantibodies appears to correlate with disease severity. Preclinical and clinical studies suggest that belimumab can reduce autoantibody levels in SLE. The results of two pivotal Phase 3 trials, BLISS-52 and BLISS-76, suggest that belimumab can reduce SLE disease activity.

ABOUT SYSTEMIC LUPUS ERYTHEMATOSUS

Systemic lupus erythematosus (SLE) is a chronic, life-threatening autoimmune disease. Approximately five million people worldwide, including approximately 1.5 million in the United States, suffer from various forms of lupus, including SLE. Lupus can occur at any age, but appears mostly in young people ages 15 to 45. About 90 percent of those diagnosed with lupus are women. African-American women are about three times more likely to develop lupus, and it is also more common in Hispanic, Asian and American Indian women. Symptoms may include extreme fatigue, painful and swollen joints, unexplained fever, skin rash and kidney problems. Lupus can lead to arthritis, kidney failure, heart and lung inflammation, central nervous system abnormalities, inflammation of the blood vessels and blood disorders. No new drug for lupus has been approved by regulatory authorities in more than 50 years. For more information on lupus, visit the Lupus Foundation of America at www.lupus.org, the Lupus Research Institute at www.lupusresearchinstitute.org, the National Institute of Arthritis and Musculoskeletal and Skin Diseases at www.niams.nih.gov, or Lupus Europe at www.elef.rheumanet.org.

ABOUT THE COLLABORATION WITH GSK

In August 2006, HGS and GSK entered into a definitive co-development and co-commercialization agreement under which HGS has responsibility for conducting the belimumab Phase 3 trials, with assistance from GSK. The companies will share equally in Phase 3/4 development costs, sales and marketing expenses, and profits of any product commercialized under the current agreement.

ABOUT GLAXOSMITHKLINE

GSK Biopharm R&D is employing novel approaches to harness the therapeutic potential of biopharmaceuticals for the benefit of patients with serious autoimmune disease.

GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.

http://www.finanznachrichten.de/nachrichten-2010-06/17179370…

[HAVANNA-CLUB]

Human Genome Sciences "market outperform," target price raised
06/28/10 - JMP Securities


NEW YORK, June 28 (newratings.com) - Analysts at JMP Securities reiterate their "market outperform" rating on Human Genome Sciences Inc (HGSI). The target price has been raised from $34 to $35.

http://www.newratings.com/en/main/company_headline.m?id=2077…

[HAVANNA-CLUB]

Antwort auf Beitrag Nr.: 39.765.226 von HAVANNA-CLUB am 01.07.10 17:56:19

Na dann, auf auf HGSI. Es fehlen ja nur noch ca. 13,50$

[lukola]

Test

[Fruehrentner]

Wann stehen hier eigentlich die nächsten planmäßigen News an?

[superemc]

Antwort auf Beitrag Nr.: 40.390.070 von Fruehrentner am 26.10.10 11:38:19

Morgen 12.11. und am 16.11. wird es spannend...

The U.S. Food and Drug Administration advisory panel meets Nov. 16 and will vote whether or not to recommend Benlysta's approval as a treatment for lupus, an autoimmune disease that has gone 50 years without a new, effective therapy for affected patients.

The FDA is expected to post online its own review of Benlysta on Friday, Nov. 12, in advance of the FDA panel meeting.

[Fruehrentner]

Antwort auf Beitrag Nr.: 40.506.602 von superemc am 11.11.10 21:59:16

Ok danke.

Dann wirds spannend!

[againstfotsch]

FDA stellt Nutzen von Lupus-Arzneikandidat Benlysta in Frage
12.11.2010 - 15:41

WASHINGTON (Dow Jones)--Die US-Gesundheitsbehörde FDA stellt den Nutzen des von der US-Biopharmagesellschaft Human Genome Sciences und der GlaxoSmithKline entwickelten Medikaments Benlysta in Frage. Das Mittel soll zur Behandlung der Autoimmunerkrankung Lupus eingesetzt werden. Die Behörde hatte im Sommer die Prüfung im beschleunigten Zulassungsverfahren beschlossen.

Der FDA zufolge geht der Einsatz offenbar mit einer höheren Sterblichkeitsrate und ernsten Nebenwirkungen einher. Dazu zählten schwere Infektionen und psychische Beeinträchtigungen, darunter auch Selbstmorde.

Die FDA stellte den Bericht zu Benlysta am Freitag im Vorfeld eines Ausschusstreffens in der kommenden Woche vor. Ein Fachgremium soll am Dienstag über eine mögliche Empfehlung des Mittels beraten. Analysten gehen davon aus, dass Benlysta Jahresumsätze von mehr als 1 Mrd USD erzielen könnte.

[againstfotsch]

Sieht nicht gut aus!
Ich denke Human Genome wird zum Nachbessern gezwungen...

Bin nicht mehr investiert, war von 0,5€ bis 20€ dabei, das reicht ;-)

Dienstag wird jedoch sehr spannend, von -50% bis +50% ist alles möglich!

Viel Glück an alle Aktionäre.
af

[zwitscherton]

Antwort auf Beitrag Nr.: 40.513.168 von againstfotsch am 12.11.10 16:52:03

www.blogtalkradio.com

Original Air Date: November 12, 2010

[urlHuman Genome Sciences Lupus Drug FDA Program Schedule Assuming the Worst Market Manipulation?]http://www.blogtalkradio.com/stock-radio-show/2010/11/12/human-genome-sciences-lupus-drug-fda-program-sched.mp3?localembed=download[/url]

Dauer ca. 50 min.

[KillingJoke]

Antwort auf Beitrag Nr.: 40.513.168 von againstfotsch am 12.11.10 16:52:03

"Ein Fachgremium soll am Dienstag über eine mögliche Empfehlung des Mittels beraten."
Immer wieder spannend, diese FDA Advisory Panel Vor-Entscheidungen,
selbst wenn man wie ich nicht investiert ist und sich die
Sache von aussen ansehen darf.

Der Handel wird bei solchen Beratungen ausgesetzt.

Zum Warmlesen vielleicht noch dieses:
http://www.reuters.com/article/idUSN1526214520101116
Der Artikel fasst schön die Bewegungen der letzten Tage zusammen.
Mit wenigen Zahlen wird schnell klar, warum die Entscheidung über Benlysta
so entscheidend für HGSI sein wird.

[againstfotsch]

Human Genome Sciences overweight
16.11.2010 - 12:04



Rating-Update:

London (aktiencheck.de AG) - Jim Birchenough, Ryan Martins und Charles J. Whitesell, Analysten von Barclays Capital, stufen die Aktie von Human Genome Sciences (ISIN US4449031081/ WKN 889323) weiterhin mit "overweight" ein. Das Kursziel werde bei 40 USD gesehen. (Analyse vom 15.11.2010) (16.11.2010/ac/a/u)

Offenlegung von möglichen Interessenskonflikten: Mögliche Interessenskonflikte können Sie auf der Site des Erstellers/ der Quelle der Analyse einsehen.


Quelle: Finanzen.net

[againstfotsch]

Bin wirklich sehr gespannt wie das Fachgremium entscheidet!

Wann kommt das Ergebnis?

gruß
af

[zwitscherton]

Antwort auf Beitrag Nr.: 40.532.024 von againstfotsch am 16.11.10 17:49:30

Adam Feuerstein berichtet live von der Sitzung:

http://www.thestreet.com/_yahoo/story/10921534/1/human-genom…

[zwitscherton]

Antwort auf Beitrag Nr.: 40.532.314 von zwitscherton am 16.11.10 18:15:22

Ist allerdings grad Mittagspause

LUNCH BREAK!!!!

[zwitscherton]

Antwort auf Beitrag Nr.: 40.532.328 von zwitscherton am 16.11.10 18:16:39

adam feuerstein:
more comments from ISI Group's Mark Schoenebaum (He's a big-time HGSI bull, by the way)

"The panel just finished asking the FDA questions. We took away a few observations that we interpreted as POSITIVE. Some of these are complex, so just email back with ANY questions/comments. (If you want more details, “Question & Answer” section below the summary text).

"1. STEROID SPARING ISSUE. FDA agreed with HGSI that “there was a higher number of Benlysta patients who achieved steroid reductions” but the way we calculated statistical significance may have been different. The FDA seemed to us to minimize the differences between HGSI’s claim that the steroid reduction was statistically significant and the FDA’s claim that it generally wasn’t.

"2. “MEDICATION FAILURE” ISSUE. The FDA said that they believe the “medication failures” SHOULD be counted as treatment failures, and that the only reason they raised the issues is to get the panel’s opinion. The panelist who asked about this seemed to agree with FDA. Most of the “medication failures” were also SRI4 non-responders, which is why the FDA thinks its reasonable to count them in primary endpoint. This basically negates the most important statistical efficacy concern that the FDA wrote about it its briefing document."

[zwitscherton]

Antwort auf Beitrag Nr.: 40.532.463 von zwitscherton am 16.11.10 18:29:29

adam feuerstein:

i'm always sensitive to identify the panel member(s) who are taking the lead prosecutorial role at these panels. usually, you get one or two people who sound skeptical, raise difficult questions, etc.

not so today. this doesn't mean that everyone votes for benlysta or even that the panel ends up positive, but there will need to be radical shift in sentiment this afternoon for HGSI to lose this one.

just my 2 cents.

[againstfotsch]

Die Nachricht wird eh nach 20 Uhr bzw. sogar erst nach Handelsschluss in Ammiland rauskommen...

Ich hatte mal 2000 Stück von den Dingern, zum Glück bin ich raus, das würden meine Nerven nicht aushalten ;-)

af

[zwitscherton]

Antwort auf Beitrag Nr.: 40.532.864 von againstfotsch am 16.11.10 19:05:45

Im Moment werden Patienten und Mitglieder der Lupus Foundation angehört.

Das kann einen schon betroffen machen.

Wenn wir Investoren verlieren ist halt nur ein bissl Kohle weg.

Das ist überhaupt kein vergleich ...

[zwitscherton]

Antwort auf Beitrag Nr.: 40.533.250 von zwitscherton am 16.11.10 19:50:26

Im Moment siehts so aus, als wird Benlysta durchfallen.

Wegen Nicht-Erwiesener-Wirksamkeit

[zwitscherton]

Antwort auf Beitrag Nr.: 40.534.216 von zwitscherton am 16.11.10 21:54:42

1. Frage zur Wirksamkeit anscheinend doch POSITIV entschieden.

Mit 10 zu 5.

[zwitscherton]

Antwort auf Beitrag Nr.: 40.534.522 von zwitscherton am 16.11.10 22:35:52

They're done. Schon 10x spannender als jeder Krimi dieses Hearing ...

4. (VOTING QUESTION) Considering the totality of the data, has Benlysta at a dose of 10 mg/kg at 2-week intervals for the first 3 doses and 4-week intervals thereafter demonstrated substantial evidence of efficacy for reducing disease activity in adult patients with active, autoantibody-positive, lupus who are receiving standard therapy?

A. If not, what further efficacy data should be obtained?

10 yes 5 no

5. (VOTING QUESTION) Is the safety profile of Benlysta sufficient for approval for reducing disease activity in adult patients with active autoantibody-positive, lupus who are receiving standard therapy?

A. If not, what further efficacy data should be obtained?
14 yes 1 no




adam feuerstein:
last question:

6. (VOTING QUESTION) Do the efficacy and safety data provide substantial evidence to support approval of Benlysta at a dose of 10 mg/kg at 2-week intervals for the first 3 doses and 4-week intervals thereafter demonstrated substantial evidence of efficacy for reducing disease activity in adult patients with active, autoantibody-positive, lupus who are receiving standard therapy?

13 yes 2 no
Tuesday November 16, 2010 4:44 adam feuerstein
4:44


adam feuerstein:
the FDA panel recommends benlysta's approval.
Tuesday November 16, 2010 4:44 adam feuerstein
4:45


adam feuerstein:
everyone B-R-E-A-T-H

[superemc]

Antwort auf Beitrag Nr.: 40.534.609 von zwitscherton am 16.11.10 22:50:32

schade, jetzt müsste man noch kaufen können...morgen früh wird der kurs wahrscheinlich durch die Decke gehen...

war würdest du empfehlen ?

[zwitscherton]

Antwort auf Beitrag Nr.: 40.534.668 von superemc am 16.11.10 23:01:41

Falls die FDA am 9.Dez. auch noch das Approval für Benlysta vergeben sollte, wird HGSI vermutlich bzw. möglicherweise ein Übernahmekandidat durch einen der Majors.

Eventuell könnte dann sogar ein Bieterkampf drohen.

All das wäre schon sehr positiv für den Kurs.

Aber wir können alle nicht in die Zukunft sehen.

Daher gebe ich auch keine Empfehlungen ab.

Das Chance / Risiko Verhältnis muß jeder für sich selbst abschätzen.

[zwitscherton]

Antwort auf Beitrag Nr.: 40.534.754 von zwitscherton am 16.11.10 23:26:52

BTW:

Beim Verfolgen des Live-Blog von Adam Feuerstein bzw. den Aussagen der Lupus-Patienten vor dem Panel ist mir noch mal klar geworden, was für ein grausame Krankheit das ist.

Falls es zum Approval kommen sollte, werd ich jedenfalls einen kleinen Teil des Gewinns an die Lupus-Foundation überweisen.

Wäre extrem anständig, wenn sich dann auch noch weitere Anteilseigner dazu entschließen könnten.

[KillingJoke]

Antwort auf Beitrag Nr.: 40.534.668 von superemc am 16.11.10 23:01:41

Nach dem Voting wurde in den USA auch wieder gehandelt.

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

Letzter Kurs 28,60 USD
Höchster 30,02 USD, Niedrigster: 27,80 USD

EUR/USD aktuell knapp 1,35.

Viele kaufen leider immer noch die Aktien in Deutschland statt in USA.
Berücksichtigt die US-Kurse vom Vorabend und zahlt bei aller Euphorie
nicht zu viel.


Gruss
KJ

[superemc]

13:2 ist ja ein eindeutiges Votum. Habe glesen, dass die FDA in der Regel den Empfehlungen des AUsschusses folgt...wie seht ihr die Chancen, dass die FDA am 09.12. das endgültige GO gibt ???

[zwitscherton]

Antwort auf Beitrag Nr.: 40.535.811 von superemc am 17.11.10 09:39:30

Das schlechteste Votum war 10 zu 5 zur Efficacy. Immerhin noch 2/3 Mehrheit.
Zeigt aber IMHO doch Kritikpunkte an. Als Dr.Blumental gestern lange und negativ sprach, dachte ich schon das wärs gewesen. Zum Glück waren nicht alle Panel-Member Ihrer Meinung.

Die FDA ist auch in der Letzten Zeit ziemlich rigide mit der Vergabe von NDAs.

Hoffe trotzdem auf einen Erfolg - und bleibe somit am Ball

GLTA !!!

[zwitscherton]

Antwort auf Beitrag Nr.: 40.536.962 von zwitscherton am 17.11.10 12:09:35

BTW

Heute ist wieder ein Panel-Hearing diesmal zu Provenge von DNDN.
Wenn ich's richtig verstanden hab, gibts dazu auch wieder ein Live-Blog von Adam Feuerstein.
Werd ich wahrscheinlich auch mal wieder reinschauen.

Der hat seinen Job gestern echt saugut gemacht.

[superemc]

Antwort auf Beitrag Nr.: 40.537.027 von zwitscherton am 17.11.10 12:17:34

wow,,,kurs stürzt gerade dramtisch von seinem Hoch ab...

Hoch 22 aktuell 19..warum ?

[zwitscherton]

Antwort auf Beitrag Nr.: 40.537.315 von superemc am 17.11.10 12:50:51

Das ist neu (für mich): FDA Panel empfiehlt das Approval - und zwei "Häuser" stufen die Aktie herunter.

http://www.thestreet.com/story/10924920/2/human-genome-hit-b…

[zwitscherton]

Antwort auf Beitrag Nr.: 40.539.051 von zwitscherton am 17.11.10 16:20:13

Ein Upgrade gabs auch noch. Allerdings schon gestern vor dem Panel-Votum.

http://www.aktiencheck.de/analysen/Artikel-Human_Genome_Scie…

[zwitscherton]

Antwort auf Beitrag Nr.: 40.539.084 von zwitscherton am 17.11.10 16:23:23

Immerhin kann anscheinend Glaxo von dem Votum profitieren ....

http://www.bloomberg.com/news/2010-11-17/glaxo-rises-after-f…

[againstfotsch]

Der Umsatz in Ammiland ist schon der Hammer, aber der Kursverlauf stimmt mich skeptisch.

Wollte eigentlich gleich heute früh rein zu 22€

Bin mal gespannt was sich noch bis zum 9.Dez tut, bis dahin halte ich die Füße still!

af

[Jano57]

Und täglich grüsst das Murmeltier

Das erinnert sehr stark an die Zeit, kurz bevor die Daten für Phase 3 veröffentlicht wurden

[zwitscherton]

Es entsteht der Eindruck, daß Glaxo der Gewinner des ganzen Procedere sein sollte

[urlGSK lupus drug wins US advisory approval]http://www.ft.com/cms/s/0/945ab1b0-f299-11df-8020-00144feab49a.html?referrer_id=yahoofinance&ft_ref=yahoo1&segid=03058#axzz15dCGw7vn[/url]

[zwitscherton]

Antwort auf Beitrag Nr.: 40.545.090 von zwitscherton am 18.11.10 12:18:30

Aber auch Glaxo kriegt Postwendend zum 17. Nov. von den "Analysten" auf die Mutze ...

[urlGlaxoSmithKline sell]http://www.finanzen.net/analyse/GlaxoSmithKline_sell-Soci_t_G_n_rale_Group_S_A__SG__385061[/url]

[zwitscherton]

Antwort auf Beitrag Nr.: 40.545.254 von zwitscherton am 18.11.10 12:36:27

Wo Schatten ist, ist auch Licht. Benlysta könne die Einnahmenrückgänge ausgleichen.

[urlGlaxoSmithKline buy]http://www.finanzen.net/analyse/GlaxoSmithKline_buy-UBS_AG_385150
[/url]


Ein Beraterausschuss der US-Gesundheitsbehörde FDA habe sich für eine Zulassung von Benlysta, einem Medikament zur Behandlung der Autoimmunerkrankung Lupus, ausgesprochen.

Es werde nun von einer 95%igen Zulassungswahrscheinlichkeit ausgegangen. Bis 2015 könnte Benlysta einen Umsatzbeitrag von 1,3 Mrd. GBP leisten. Bislang seien die Erlöse auf 1,1 Mrd. GBP geschätzt worden. GlaxoSmithKline könne damit die durch Generika ausgelösten Einnahmenrückgänge von Advair ausgleichen.

[againstfotsch]

Human Genome Sciences hold
18.11.2010 - 14:08



New York (aktiencheck.de AG) - Yaron Werber, Analyst der Citigroup, stuft die Aktie von Human Genome Sciences (ISIN US4449031081/ WKN 889323) von "buy" auf "hold" zurück.

Ein Beraterausschuss der FDA habe sich für eine Zulassung von Benlysta ausgesprochen. Das Mittel zur Therapie von Lupus dürfte jedoch nur mit spürbaren Einschränkungen zugelassen werden. Rheumatologen hätten auch schon zwiespältige Gefühle zum Ausdruck gebracht.

Die Markteinführung des Mittels könnte entgegen der früheren Erwartung statt im ersten nun im zweiten Quartal 2011 erfolgen. Angesichts des nur kleinen Nutzens sehe man das langfristige Umsatzpotenzial mit Sorge. Das Mittel könnte die Hälfte des adressierbaren Marktes verlieren. Afroamerikaner und Patienten mit Nierenleiden könnten von der Anwendung ausgeschlossen werden.

Die Prognose zum Spitzenumsatz in 2015 sei von 2,6 auf 1,6 Mrd. USD reduziert worden. Das Kursziel werde von 35,00 auf 30,00 USD zurückgesetzt.

Vor diesem Hintergrund empfehlen die Analysten der Citigroup die Aktie von Human Genome Sciences nunmehr zu halten. (Analyse vom 17.11.10) (17.11.2010/ac/a/a)

Offenlegung von möglichen Interessenskonflikten: Mögliche Interessenskonflikte können Sie auf der Site des Erstellers/ der Quelle der Analyse einsehen.


Quelle: Finanzen.net

[Fruehrentner]

Steht nicht heute die FDA Priority Review Designation für BENLYSTA (belimumab) an?

[Dr.Goldmann]

Antwort auf Beitrag Nr.: 40.678.210 von Fruehrentner am 09.12.10 09:50:38

Leider nein . Die FDA hat noch zusätzliche Unterlagen angefordert. Der neue Termin ist auf den 10.03.2011 verlegt worden.

[Fruehrentner]

Zitat von Dr.Goldmann: Leider nein . Die FDA hat noch zusätzliche Unterlagen angefordert. Der neue Termin ist auf den 10.03.2011 verlegt worden.

Ist es eigentlich bei dem Termin am 10.03.2011 geblieben?

[Dr.Goldmann]

Antwort auf Beitrag Nr.: 41.035.143 von Fruehrentner am 14.02.11 14:08:24

So weit ich weiss bleibt es bei diesem Termin. Heute präsentiert das Senior Management-Team einen Überblick über das Unternehmen, vieleicht erfahren wir dort etwas neues. Ich hoffe das die Aktie ihren Weg macht

[Fruehrentner]

Also morgen, am 10.03., ist der große Tag für das FDA priority review für BENLYSTA:

BENLYSTA (belimumab) has met the primary efficacy endpoint in two pivotal Phase 3 trials, as specified by Special Protocol Assessment agreement with FDA [3-16, 34]. The efficacy of treatment with BENLYSTA plus standard of care was superior to placebo plus standard of care in both BLISS-52 and BLISS-76, and was generally well tolerated. In June 2010, HGS and GSK submitted regulatory applications seeking approval to market BENLYSTA in the United States and Europe [17-18]. In November 2010, an FDA Advisory Committee voted 13-2 to recommend approval [19-20].

The FDA requested some additional information following the Advisory Committee, which has been submitted, and has extended the Prescription Drug User Fee Act (PDUFA) target date for priority review of the BENLYSTA application from December 9, 2010 to March 10, 2011. If approved, BENLYSTA would be the first new approved drug for lupus in more than 50 years.

[Jano57]

Der große Tag war gestern!!!

FDA approves Benlysta to treat lupus

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/uc…

Bin mal auf den Eröffnungskurs morgen gespannt

Tippe mal auf 38 Dollar

[Jano57]

Antwort auf Beitrag Nr.: 41.174.577 von Jano57 am 10.03.11 00:06:54

sorry, meinte natürlich den Eröffnungskurs HEUTE

[zwitscherton]

Antwort auf Beitrag Nr.: 41.174.582 von Jano57 am 10.03.11 00:08:44

Die Amies sind da etwas härter mit den Bewertungen, z.B.:

I agree approval is NOT guaranteed! FDA says no this week. The surprising thing to me is how certain the longs are regarding the FDA.
Full disclosure: I have jul 11 puts on this overhyped n overpriced company


You really believe FDA makes decisions based on which side of the bed they wake up? Out goes all the science and facts. In comes all the whims and fancies. Sorry to dissapoint you, that's not how it's done zenbuddha. Now go and meditate and search for the truth a bit harder:-)

Und so weiter und so fort - wir werden sehn.

[Fruehrentner]

HUMAN GENOME SCIENCES AND GLAXOSMITHKLINE ANNOUNCE FDA APPROVAL OF BENLYSTA® (BELIMUMAB) FOR TREATMENT OF SYSTEMIC LUPUS ERYTHEMATOSUS

First new approved drug for systemic lupus in more than 50 years
To be available to physicians and patients before the end of March


http://www.hgsi.com/latest/human-genome-sciences-and-glaxosm…

[zwitscherton]

Antwort auf Beitrag Nr.: 41.175.878 von Fruehrentner am 10.03.11 10:02:03

Sounds very well ...

[zwitscherton]

Antwort auf Beitrag Nr.: 41.177.062 von zwitscherton am 10.03.11 12:32:16

http://seekingalpha.com/article/257554-new-lupus-drug-drug-t…

[Fruehrentner]

GSK, HGS Benlysta get European approval

Published 15 July 2011

GlaxoSmithKline (GSK) and Human Genome Sciences (HGS) have received the European Commission (EC) approval to market Benlysta (belimumab) 10mg/kg.

The approval for Benlysta was granted as an additional therapy for the adult patients suffering from active autoantibody-positive systemic lupus erythematosus (SLE) with high degree of disease activity.

Benlysta is under development by GSK and HGS as per a co-development deal signed between the companies in 2006.

GSK European Medical Affairs senior VP Tony Hoos said the European approval of Benlysta represents a significant milestone, and they are very pleased to be able to provide physicians an additional therapeutic option for treating appropriate patients with this chronic disease.

[againstfotsch]

zum Glück bin ich bei 20€ raus!

Benlysta ist doch zugelassen, da müssten doch bald Gewinne sprudeln...

af

[SLGramann]

Meiner Meinung nach war die Prügel zu heftig. Das hat HGS nun wieder auf ein Niveau gebracht, wo man meiner Meinung nach mehr Wert bekommt, als man gibt, wenn man kauft.
Danach habe ich gehandelt.

[Icanfly]

Wieso stürzt die heute ab??

[Icanfly]

Antwort auf Beitrag Nr.: 41.995.879 von Icanfly am 24.08.11 14:44:09

Schon gefunden. Die Bennlysta Verkäufe im Juli waren wohl nicht so gut

[SLGramann]

Langfristig ist es eben die Frage, ob folgende Aussage des Unternehmens aus dem GB 2010 berechtigt ist oder nicht:

The approval of BENLYSTA opens the door to a promising
future for our Company. Based on the opportunities we
now have in hand and our expectation that decisions will
be reached on European and other regulatory approvals
in the second half of 2011, we believe that HGS will
achieve sustainable multi-billion dollar revenues by 2015.



Bisher hat der Markt diese Sichtweise geteilt und den Kurs in die Stratosphäre geschossen (zu schnell und zu weit).
Jetzt herrschen große Zweifel und Skeptiker gehen von einem Umsatzvolumen von wenigen 100 Millionen Dollar aus.

Mir kommt es jedenfalls so vor, als herrsche jetzt zu viel Pessimismus wo bis vor kurzem zu viel Euphorie war...

Wir werden sehen, wie sich die Benlysta-Verkäufe entwickeln. Für ein Urteil sollte man m.E. aber schon noch das Jahr 2012 abwarten.

[SLGramann]

Antwort auf Beitrag Nr.: 42.012.090 von SLGramann am 28.08.11 10:12:26

Hier mal ein gutes Beispiel für eine sehr skeptische Sichtweise:


Human Genome Sciences (Nasdaq: HGSI) has a market cap of $2.4 billion. Its main asset is Benlysta, a newly approved lupus drug. Because HGS shares half of their gross profit from Benlysta with partner GSK, it is more appropriate to think about the “Benlysta market cap” of roughly $5 billion. WK sales data last month suggest monthly sales of $5 million for this asset. At a run rate of $60 million annually, this is a product trading at 83x sales. Even if the run rate increases substantially from here, as it did with the Remicade in its early years, this early base is much lower than expectations.

My modeling suggests a global peak sales estimate of $750 million, with fair value for HGS at $7 per share, or 40% downside. I think my peak sales and value estimates are generous to HGS. This product is simply not efficacious enough. Drugs like Remicade, Enbrel, Humira are “night and day” differences for their patients. Benlysta is much more like Provenge, where the medical community is skeptical of relevant efficacy as the data sets for both drugs suggest a modest benefit. Physicians will use their discretion as to which patients may benefit most from Benlysta.

Lupus is a highly symptomatic disease where unless a flare is prevented or the severity lessened, patients and physicians aren’t served. Benlysta doesn’t seem to do either, instead it seems to provide a very small benefit in a highly variable disease. Lofty sales estimates rely on Benlysta patients remaining on Benlysta, an unlikely to occur scenario as the large patient copay and insurance pressures limit “perpetual” revenue drugs from patients who are not clearly benefitting. I could see revenue for Benlysta peak soon and then begin to decline sequentially as patient time on drug shrinks.

Benlysta is also a very expensive product. In the new healthcare and macroeconomic environment, new drugs are being shunned, especially if they do not provide meaningful improvements over old standards. Expensive and new drugs are even more carefully scrutinized. My thesis is that when HGSI reports Q3 and Q4 earnings, the share price will nose dive just as Dendreon’s (DNDN) share price did. Reality is quickly setting in for HGS longs, mostly growth-oriented mutual funds who have just completed large purchases above $25 per share in Q2 2011.

I suspect these investors will exit as quickly as they entered, as the current $12 and declining share price creates a panic.

Disclosure: I am short HGSI.

[Icanfly]

Klingt nicht ganz unschlüssig.Allerdingd besteht die HGSI Pipeline nicht nur aus Benlysta.

[SLGramann]

A new lupus treatment developed by Human Genome Sciences Inc. is receiving a lukewarm reception from doctors so far, with demand for the drug shaping up to be much softer than expected, according to a Citi analyst.

Analyst Dr. Yaron Werber lowered his price target on the Rockville, Md., company's stock to $15 from $26 and also trimmed sales expectations for the drug over the next couple years.

Human Genome Sciences shares closed at $13.41 on Tuesday.

The treatment, Benlysta, is an injectable drug designed to relieve flare-ups and pain caused by lupus, a potentially fatal ailment in which the body attacks its own tissue and organs. Human Genome Sciences spent 15 years developing the drug and is marketing it with British drugmaker GlaxoSmithKline PLC.

It became the first new drug to treat lupus in more than 50 years when the Food and Drug Administration approved it in March. European Union and Canadian regulators approved the drug in July. Analysts have estimated that sales of the drug could exceed $3 billion within five years.

Werber said in a research note late Tuesday that those who are supposed to promote the drug's merits to a broader base of rheumatologists are much less enthusiastic about Benlysta than expected.

"While docs are happy that Benlysta is now available, they are clearly looking for better options down the line," Werber said in the note.

The analyst also noted that Benlysta may face competition in the next few years from other drugs in late-stage clinical development, and those potential treatments have the advantage of learning from Benlysta's trial-design shortcomings.

Werber also lowered his Benlysta sales estimates for the third quarter and 2011 and 2012.


---------------

Die Frage bleibt: Wird Benlysta ein Blockbuster oder nicht? Falls nicht, muss HGS nachlegen, um die gegenwärtige Marktkapitalisierung zu rechtfertigen. Ich denke aber immer noch, dass die Wahrheit irgendwo in der Mitte zwischen 700 und 3.000 Mio. Umsatz liegen wird.

[SLGramann]

Interessanter Artikel bei Minyanville:



Human Genome Sciences Slowly Building a Blockbuster
Brett Chase SEP 08, 2011 1:00 PM

Human Genome Sciences Slowly Building a Blockbuster

The ramp-up for sales of lupus drug Benlysta may take some time but CFO Southwell sees no real impediment to reaching blockbuster status.




Human Genome Sciences (HGSI) has lost 40% of its market value since the end of July -- a large drop for a company that hasn’t disclosed any significantly bad news.

Early sales results of the company’s recently introduced lupus drug Benlysta are generally in line with analyst expectations, though some of those analysts have lowered their near-term sales estimates. There’s been no real negative catalyst for the drug yet there’s still a nagging question about whether Benlysta is going to fall flat.

One analyst calls the sell-off a “Provenge contagion,” a reference to the problems rival biotech company Dendreon (DNDN) has had selling its prostate cancer vaccine. (Dendreon is holding a call Thursday afternoon to discuss restructuring plans in the wake of disappointing Provenge sales.)

Benlysta is a much different drug than Provenge. The treatment, co-developed with UK-based GlaxoSmithKline (GSK) was the first new lupus treatment in 50 years to be approved in the US. Analysts view it as potentially a product with $4 billion in annual sales.

But those sales have yet to ramp up. The company reported Benlysta revenue of just under $8 million in the second quarter and analysts expect those sales to increase to about $24 million in the July to September period.

Part of the problem with investor confidence may be that Human Genome can’t really articulate when those sales will spike.

“What is difficult to predict is the uptake to that peak,” Chief Financial Officer David Southwell told a group of investors in New York this morning.

Southwell, speaking at the Robert W. Baird investor conference, admitted that the company is still working to get doctors on board with the drug. Ninety percent of the doctors targeted by the company as potential customers have indicated an intent to prescribe Benlysta, but only 20% of those physicians have ordered the drug as of mid-August, he said. Asked if he was still confident in $4 billion in peak sales, he said he was.

“We have certainly not seen a waning interest in the drug,” Southwell said. “The percentage of the accounts ordering has been growing steadily.”

Some doctors have hesitated to order the drug based on fear of delayed payments from insurers -- a trend these physicians experienced following launches of other biotech drugs, Southwell said.

But Southwell insisted insurers are covering the drug, and about 90% of patients are seeing benefit verifications from their insurance companies within two to three days, he says.

“We’re not seeing any real payer headwinds,” he said.

Fifty-seven percent of lupus patients are covered by commercial insurers, while 18% are covered by Medicare and 16% are in Medicaid plans. Three percent of patients pay for their drugs themselves and 6% are dependent on other sources.

Benlysta is a secondary drug and its initial market is about 200,000 Americans with moderate to severe lupus. The drug was launched last month in Germany and Canada. In the US, Human Genome charges about $35,000 on average per patient a year. The drug is marketed to rheumatologists.

Southwell says the company just received FDA approval of some marketing material it will use to reach out directly to patients. He says the ads will appear primarily in women’s magazines and on the Web.

Shares of the company were up less than 1% to $12.04 in midday trading Thursday. The stock traded above $21 a share at the end of July.

Several analysts predict the stock will regain its mojo.

Among them is BMO Capital Markets analyst Jim Birchenough, who just initiated coverage with a buy rating and a 12-month price target of $28 a share. Birchenough is on the high end of peak sales estimates for Benlysta, predicting the drug will top $5 billion.

He blames the stock’s recent sell-off is all due to Dendreon’s implosion. (See Dendreon’s Stock Plunges on Low Provenge Sales.)

RBC Capital Markets analyst Michael Yee also recommends buying the stock. Benlysta usage will double or triple in the year, the analyst predicts. Yee has a $25 price target on the shares.

Finally, Robert W. Baird analyst Christopher Raymond (who used the Provenge contagion phrase) recommends Human Genome and has a $27 price target. He sees enthusiasm for the drug among specialist doctors and doesn’t see insurance reimbursement as a major problem based on early indications.

Twitter: @brettchase


http://www.minyanville.com/businessmarkets/articles/human-ge…






Sowohl die peak sales wie auch die Umsätze für das laufende Quartal werden immer noch sehr optimistisch eingeschätzt.
Bin sehr gespannt, was dann wirklich gemeldet wird. 24 Millionen hieße durchschnittlich 2 Millionen / Woche Umsatz. Im Juni waren erst eine Millionen / Woche. Ich denke, dass der Kurs sehr deutlich steigen wird, wenn die 24 Millionen erreicht oder sogar getopt werden sollten.

[againstfotsch]

geht ganz schön hoch heute!
gibts news?
hab nichts gefunden...

[SLGramann]

Antwort auf Beitrag Nr.: 42.227.240 von againstfotsch am 18.10.11 17:39:50

Gerüchte...

October 18, 2011 8:11 AM EDT
Shares of Human Genome Sciences (Nasdaq: HGSI) are up nearly 7 percent in pre-market action Tuesday amid chatter out of the UK's Mail.

Rumors suggest GlaxoSmithKline (NYSE: GSK) could bid as much as $25 per share in cash for Human Genome. The article points out the two companies already partner for Benlysta.

With Human Genome shares last trading around $12, the rumored price would indicate a more than 100 percent premium.

Notably, shares of Human Genome Sciences have fallen nearly 50 percent over the last two months.

---------

Kann alles quatsch sein. Nur spricht eben einiges dafür, dass HGSI zu billig ist, auch wenn man bei Benlysta einige Fragezeichen machen muss.

[boersenarzt]

Antwort auf Beitrag Nr.: 42.062.466 von SLGramann am 08.09.11 21:18:48

Fürchte eher Totalabsturz.
Benlysta kommt niemals in die Billionen---alles sehr wacklige ,spekulative Annahmen---immerhin die Blase platzt ja schon ne Weile-
Schau mer mal, was Q3 heute bringt.

[againstfotsch]

Verlust in Q3 zwar reduziert aber Umsatz sehr mies!
Kann sich wahrscheinlich niemand leisten das neue Medikament...

Unter 1€ steig ich wieder ein - und über 20€ aus, hat schon mal geklappt ;-)

af

[SLGramann]

Antwort auf Beitrag Nr.: 42.256.765 von boersenarzt am 25.10.11 19:33:56

BENLYSTA gross sales for the third quarter totaled $21.3 million before gross-to-net adjustments of $2.5 million. Net sales of BENLYSTA for the quarter totaled $18.8 million, compared with $7.8 million in the second quarter. During the third quarter, BENLYSTA average weekly gross sales for the last four weeks of September were $2.0 million, compared with $1.7 million and $1.4 million for the preceding four-week periods, respectively.


Also, Analystenerwartungen klar verfehlt. Die Entwicklung geht zwar aufwärts, verläuft aber recht zäh. Ob Benlysta je ein Blockbuster werden wird, steht wohl in Frage.

[Fruehrentner]

Human Genome Sciences, GSK commence Benlysta trial in SLE patients

16 December 2011

Human Genome Sciences and GlaxoSmithKline (GSK) have commenced the dosing in BLISS-SC, a Phase 3 trial intended to assess the efficacy, safety and tolerability of Benlysta (belimumab) in systemic lupus erythematosus (SLE) patients.

Belimumab belongs to a class of drugs known as BLyS-specific inhibitors.

The multi-center, international, randomized, double-blind, placebo-controlled, 52-week study will investigate use of belimumab administered subcutaneously (SC) once-weekly to autoantibody-positive adults with active systemic lupus erythematosus (SLE).

The primary efficacy endpoint of BLISS-SC is response rate at Week 52, as measured by the SLE Responder Index (SRI).

The company is likely to announce the initial results in the second half of 2014.

Once the data of the study receives approval by regulatory authorities, belimumab could be made available in a subcutaneous formulation.

[SLGramann]

Antwort auf Beitrag Nr.: 42.261.563 von SLGramann am 26.10.11 18:07:29

Wie gehabt, zäh aufwärts.

BENLYSTA gross sales totaled $29.1 million in the fourth quarter of 2011. After gross-to-net adjustments of $3.4 million, net sales of BENLYSTA in the fourth quarter totaled $25.7 million.

[Biohero]

HGSI hat ein Übernahmee angebot für 13$ pro Aktie von GSK heute erhalten . Aktie explodiert gerade ...
http://finance.yahoo.com/news/human-genome-sciences-announce…

[Fruehrentner]

Antwort auf Beitrag Nr.: 43.059.494 von Biohero am 19.04.12 11:31:19

[Dr.Goldmann]

Antwort auf Beitrag Nr.: 43.061.709 von Fruehrentner am 19.04.12 17:04:49

Das warten hat sich gelohnt.Abwarten undsehen was noch kopmmt.

[againstfotsch]

das ding ist doch locker 20$ wert!

[Dr.Goldmann]

Antwort auf Beitrag Nr.: 43.062.201 von againstfotsch am 19.04.12 18:32:11

Schau dir mal die Pipline von HGSI an, da liegst du gut mit deinen 20 Dollar

[Fruehrentner]

Belimumab und Fampridin

IQWiG: Zusatznutzen nicht belegt

Berlin - Das Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) hat heute zwei Dossierbewertungen von neuen Arzneimitteln vorgelegt, die zu dem Ergebnis kommen, dass ein Zusatznutzen nicht belegt ist. Dabei handelt es sich um Belimumab (Benlysta® von GSK) gegen Lupus und das MS-Medikament Fampridin (Fampyra® von Biogen Idec).

http://www.deutsche-apotheker-zeitung.de/pharmazie/news/2012…

[happymuck]

Wir werden wohl verkaufen müssen, nicht das durch die Übernahme noch eine US-Steuer droht, den Wert würde ich locker auf 20 Dollar schätzen.