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Celgene Receives Fast Track Status From FDA for REVIMID(TM) in Myelodysplastic Syndromes
via COMTEX
April 15, 2003
WARREN, N.J., Apr 15, 2003 /PRNewswire-FirstCall via COMTEX/ --
Celgene Corporation (Nasdaq: CELG) announced today that REVIMID(TM) (CC-5013) received fast track designation from the U.S. Food and Drug Administration (FDA) for the treatment of myelodysplastic syndromes (MDS). The FDA grants fast track designation to compounds that may provide a significant improvement in the safety or effectiveness of the treatment for a serious or life-threatening disease. Compounds that receive the designation are also eligible for priority review, which provides for a six-month review of a new drug application by the FDA.
`We are very encouraged by the emerging data on REVIMID as a potential therapy for MDS patients, and based on the data, we are moving REVIMID through the clinical and regulatory development process as quickly as possible to help alleviate the unmet medical needs of MDS patients,`said Sol J. Barer, Ph.D., President and Chief Operating Officer of Celgene Corporation. `We look forward to presenting updated data from our Phase I/II trial of REVIMID in MDS at the International MDS Symposium that will be held May 15-18, 2003 in Paris, France.`
About Myelodysplastic Syndromes
Myelodysplastic syndromes (MDS) are a group of hematologic conditions that affect approximately 50,000 people in the United States. The five types of MDS are refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in formation, and chronic myelomonocytic leukemia. Myelodysplastic syndromes occur when blood cells remain in an immature or `blast`stage within the bone marrow and never develop into mature cells capable of performing their necessary functions. Eventually, the bone marrow becomes filled with blast cells until there is no room for normal cells to develop. According to the American Cancer Society 14,000 new cases of MDS are diagnosed each year in the United States, with survival rates ranging from six months to five years for the different types of MDS.
REVIMID (CC-5013) is not approved by the FDA and is currently being evaluated in clinical trials for efficacy and safety for future regulatory applications.
Celgene Corporation, headquartered in Warren, New Jersey, is an independent biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company`s website at www.celgene.com.
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company`s control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company`s filings with the Securities and Exchange Commission such as 10K, 10Q and 8K reports.
SOURCE Celgene Corporation
Robert J. Hugin, Senior VP and CFO, Celgene Corporation, +1-732-271-4102
http://www.celgene.com
Copyright (C) 2003 PR Newswire. All rights reserved.
JS200
via COMTEX
April 15, 2003
WARREN, N.J., Apr 15, 2003 /PRNewswire-FirstCall via COMTEX/ --
Celgene Corporation (Nasdaq: CELG) announced today that REVIMID(TM) (CC-5013) received fast track designation from the U.S. Food and Drug Administration (FDA) for the treatment of myelodysplastic syndromes (MDS). The FDA grants fast track designation to compounds that may provide a significant improvement in the safety or effectiveness of the treatment for a serious or life-threatening disease. Compounds that receive the designation are also eligible for priority review, which provides for a six-month review of a new drug application by the FDA.
`We are very encouraged by the emerging data on REVIMID as a potential therapy for MDS patients, and based on the data, we are moving REVIMID through the clinical and regulatory development process as quickly as possible to help alleviate the unmet medical needs of MDS patients,`said Sol J. Barer, Ph.D., President and Chief Operating Officer of Celgene Corporation. `We look forward to presenting updated data from our Phase I/II trial of REVIMID in MDS at the International MDS Symposium that will be held May 15-18, 2003 in Paris, France.`
About Myelodysplastic Syndromes
Myelodysplastic syndromes (MDS) are a group of hematologic conditions that affect approximately 50,000 people in the United States. The five types of MDS are refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in formation, and chronic myelomonocytic leukemia. Myelodysplastic syndromes occur when blood cells remain in an immature or `blast`stage within the bone marrow and never develop into mature cells capable of performing their necessary functions. Eventually, the bone marrow becomes filled with blast cells until there is no room for normal cells to develop. According to the American Cancer Society 14,000 new cases of MDS are diagnosed each year in the United States, with survival rates ranging from six months to five years for the different types of MDS.
REVIMID (CC-5013) is not approved by the FDA and is currently being evaluated in clinical trials for efficacy and safety for future regulatory applications.
Celgene Corporation, headquartered in Warren, New Jersey, is an independent biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company`s website at www.celgene.com.
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company`s control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company`s filings with the Securities and Exchange Commission such as 10K, 10Q and 8K reports.
SOURCE Celgene Corporation
Robert J. Hugin, Senior VP and CFO, Celgene Corporation, +1-732-271-4102
http://www.celgene.com
Copyright (C) 2003 PR Newswire. All rights reserved.
JS200
04/15/2003 (07:44 ET) Celgene Receives Fast Track Status From FDA for REVIMID(TM) in Myelodysplastic Syndromes - PR Newswire
04/15/2003 (06:34 ET) Celgene to promote Glaxo`s mulitple myeloma drug - Datamonitor
04/14/2003 (08:15 ET) GlaxoSmithKline`s Alkeran myeloma treatment to be marketed in US by Celgene - AFX News Europe
04/14/2003 (08:15 ET) GlaxoSmithKline`s Alkeran myeloma treatment to be marketed in US by Celgene - AFX News UK
04/14/2003 (08:14 ET) GlaxoSmithKline`s Alkeran myeloma treatment to be marketed in US by Celgene - AFX News Asia
04/14/2003 (07:30 ET) Celgene Signs Strategic Agreement With GlaxoSmithKline to Distribute and Promote ALKERAN(R) (melphalan) - PR Newswire
04/11/2003 (08:55 ET) RATING(o): USB Piper Sets CELG Rating @ Outperform - Knobias
04/10/2003 (10:44 ET) SECTOR(HCR): Biotechs Help Push Sector Lower - Knobias
04/09/2003 (08:00 ET) Celgene to Dominate the Multiple Myeloma Drug Market Through 2011 - PR Newswire
04/08/2003 (07:32 ET) CONF: CELG To Present At Mattison Healthcare Conference @ 10:30 ET - Knobias
04/07/2003 (11:37 ET) VOLUME(-): CELG Volume 32% > 20-adsv, Stock -9.06% - Knobias
04/04/2003 (17:00 ET) Celgene Will Present at Gerard Klauer Mattison Healthcare Conference - PR Newswire
04/03/2003 (09:53 ET) RATING(1): Bear Stearns Initiates CELG Rating @ Peer Perform - Knobias
04/03/2003 (09:51 ET) 52W HIGH: New 52-Wk High for CELG @ $28.420 up1.07% - Knobias
04/03/2003 (07:20 ET) Celgene granted patent covering p38 and JNK pathways - Datamonitor
04/02/2003 (13:42 ET) 52W HIGH: New 52-Wk High for CELG @ $27.970 up4.37% - Knobias
04/02/2003 (07:52 ET) Celgene Strengthens Broad Intellectual Property Estate for Kinase Program With U.S. Patent Covering P38 and JNK Pathways - PR Newswire
04/01/2003 (06:00 ET) EntreMed and Celgene End Standstill Period and Move Towards Strategic Partnership - PR Newswire
03/31/2003 (17:38 ET) New 10-K just released for CELG - Edgar
03/28/2003 (06:16 ET) MEDIA: Today`s Wall Street Journal Mentions CELG - Knobias
03/27/2003 (11:56 ET) VOLUME(+): CELG Volume 20% > 20-adsv, Stock +3.95% - Knobias
03/27/2003 (11:46 ET) 52W HIGH: New 52-Wk High for CELG @ $27.280 up4.68% - Knobias
03/26/2003 (17:02 ET) CONF: CELG To Present At BOA Healthcare Conference @ 19:50 ET - Knobias
03/24/2003 (08:36 ET) Celgene plans further investigation of Thalomid after positive clinical data - Datamonitor
03/24/2003 (08:19 ET) Celgene Will Present at Banc of America Healthcare Conference - PR Newswire
JS200
04/15/2003 (06:34 ET) Celgene to promote Glaxo`s mulitple myeloma drug - Datamonitor
04/14/2003 (08:15 ET) GlaxoSmithKline`s Alkeran myeloma treatment to be marketed in US by Celgene - AFX News Europe
04/14/2003 (08:15 ET) GlaxoSmithKline`s Alkeran myeloma treatment to be marketed in US by Celgene - AFX News UK
04/14/2003 (08:14 ET) GlaxoSmithKline`s Alkeran myeloma treatment to be marketed in US by Celgene - AFX News Asia
04/14/2003 (07:30 ET) Celgene Signs Strategic Agreement With GlaxoSmithKline to Distribute and Promote ALKERAN(R) (melphalan) - PR Newswire
04/11/2003 (08:55 ET) RATING(o): USB Piper Sets CELG Rating @ Outperform - Knobias
04/10/2003 (10:44 ET) SECTOR(HCR): Biotechs Help Push Sector Lower - Knobias
04/09/2003 (08:00 ET) Celgene to Dominate the Multiple Myeloma Drug Market Through 2011 - PR Newswire
04/08/2003 (07:32 ET) CONF: CELG To Present At Mattison Healthcare Conference @ 10:30 ET - Knobias
04/07/2003 (11:37 ET) VOLUME(-): CELG Volume 32% > 20-adsv, Stock -9.06% - Knobias
04/04/2003 (17:00 ET) Celgene Will Present at Gerard Klauer Mattison Healthcare Conference - PR Newswire
04/03/2003 (09:53 ET) RATING(1): Bear Stearns Initiates CELG Rating @ Peer Perform - Knobias
04/03/2003 (09:51 ET) 52W HIGH: New 52-Wk High for CELG @ $28.420 up1.07% - Knobias
04/03/2003 (07:20 ET) Celgene granted patent covering p38 and JNK pathways - Datamonitor
04/02/2003 (13:42 ET) 52W HIGH: New 52-Wk High for CELG @ $27.970 up4.37% - Knobias
04/02/2003 (07:52 ET) Celgene Strengthens Broad Intellectual Property Estate for Kinase Program With U.S. Patent Covering P38 and JNK Pathways - PR Newswire
04/01/2003 (06:00 ET) EntreMed and Celgene End Standstill Period and Move Towards Strategic Partnership - PR Newswire
03/31/2003 (17:38 ET) New 10-K just released for CELG - Edgar
03/28/2003 (06:16 ET) MEDIA: Today`s Wall Street Journal Mentions CELG - Knobias
03/27/2003 (11:56 ET) VOLUME(+): CELG Volume 20% > 20-adsv, Stock +3.95% - Knobias
03/27/2003 (11:46 ET) 52W HIGH: New 52-Wk High for CELG @ $27.280 up4.68% - Knobias
03/26/2003 (17:02 ET) CONF: CELG To Present At BOA Healthcare Conference @ 19:50 ET - Knobias
03/24/2003 (08:36 ET) Celgene plans further investigation of Thalomid after positive clinical data - Datamonitor
03/24/2003 (08:19 ET) Celgene Will Present at Banc of America Healthcare Conference - PR Newswire
JS200
Von Gestern
CELG
CELGENE CORP
25.550
+0.360 +1.43%
Daily Commentary
WAIT
Our system recommends WAIT as of today. Previous SELL recommendation was made on 4/8/2003 (6) days ago, when the stock price was 26.300. Since then the stock fell -2.85% .
Today the stock closed higher, at its high (sign of strength) with a lower high and a lower low. The volume is high. The security price is trending sideways.
Candlestick Analysis
Today’s Candlestick Patterns:
White Candlestick
Today a White Candlestick formed. Buyers were in control but the buying pressure was not very strong.
Stock Quote
Last 25.550
Previous Close 25.190
Change +0.360
% Change +1.43%
Volume 1,425,678
Stock Activity
Open 25.160
Day`s High 25.550
Day`s Low 24.720
52 Week High 28.560
52 Week Low 11.500
Stock Price History
3 Month % Change 5.19
6 Month % Change 53.90
12 Month % Change 8.77
Stock Statistics
50 Day Close MA 24.151
200 Day Close MA 20.600
65 Day Volume MA 1,033,766
JS200
CELG
CELGENE CORP
25.550
+0.360 +1.43%
Daily Commentary
WAIT
Our system recommends WAIT as of today. Previous SELL recommendation was made on 4/8/2003 (6) days ago, when the stock price was 26.300. Since then the stock fell -2.85% .
Today the stock closed higher, at its high (sign of strength) with a lower high and a lower low. The volume is high. The security price is trending sideways.
Candlestick Analysis
Today’s Candlestick Patterns:
White Candlestick
Today a White Candlestick formed. Buyers were in control but the buying pressure was not very strong.
Stock Quote
Last 25.550
Previous Close 25.190
Change +0.360
% Change +1.43%
Volume 1,425,678
Stock Activity
Open 25.160
Day`s High 25.550
Day`s Low 24.720
52 Week High 28.560
52 Week Low 11.500
Stock Price History
3 Month % Change 5.19
6 Month % Change 53.90
12 Month % Change 8.77
Stock Statistics
50 Day Close MA 24.151
200 Day Close MA 20.600
65 Day Volume MA 1,033,766
JS200
CELG`s REVIMID Gets Fast Track Designation From FDA
Tuesday , April 15, 2003 08:57 ET
Celgene Corporation (NasdaqNM: CELG) announced that REVIMID(TM) (CC-5013) received fast track designation from the FDA for the treatment of myelodysplastic syndromes (MDS).
The FDA grants fast track designation to compounds that may provide a significant improvement in the safety or effectiveness of the treatment for a serious or life-threatening disease.
Compounds that receive the designation are also eligible for priority review, which provides for a six-month review of a new drug application by the FDA.
JS200
Tuesday , April 15, 2003 08:57 ET
Celgene Corporation (NasdaqNM: CELG) announced that REVIMID(TM) (CC-5013) received fast track designation from the FDA for the treatment of myelodysplastic syndromes (MDS).
The FDA grants fast track designation to compounds that may provide a significant improvement in the safety or effectiveness of the treatment for a serious or life-threatening disease.
Compounds that receive the designation are also eligible for priority review, which provides for a six-month review of a new drug application by the FDA.
JS200
Trading Spotlight
oha, bist du nicht dieser LAMP-freak?
muss ich mir jetzt sorgen machen, hehe..
muss ich mir jetzt sorgen machen, hehe..
@ARRO
Ich habe mit Lamp genug Lehrgeld bezahlt, aber mit Celgene habe ich bis jetzt immer gutes Geld verdient.
Lamp-Freak ?????
Warum ??????
Weil ich versucht habe ein maximum von Informationen zu sammeln???????
Weil ich persönlich heute noch an das Produkt glaube?????
Ist das schlecht, wenn man sich die Mühe macht um Recherschen aufzustellen??????
Ich wusste nicht, dass dieses ein schlechtes Licht ins Board bringt, wenn man nur offizielle Nachrichten und Informationen ins Board stellt!!!!
JS200
Ich habe mit Lamp genug Lehrgeld bezahlt, aber mit Celgene habe ich bis jetzt immer gutes Geld verdient.
Lamp-Freak ?????
Warum ??????
Weil ich versucht habe ein maximum von Informationen zu sammeln???????
Weil ich persönlich heute noch an das Produkt glaube?????
Ist das schlecht, wenn man sich die Mühe macht um Recherschen aufzustellen??????
Ich wusste nicht, dass dieses ein schlechtes Licht ins Board bringt, wenn man nur offizielle Nachrichten und Informationen ins Board stellt!!!!
JS200
@MR. ARRO
Sieht nicht berauschend aus, was du von dir gibst:
Thread Postings Ansicht Autor Datum
kreuzzug im namen der freiheit + demokratie 8 Mr.Arrogance 11.02.03 19:32:02
"Saddam Hussein ist die Wurzel allen Übels!" 5 Mr.Arrogance 07.02.03 16:56:34
rumsfeld-deutschland oder wann schlägt der schurkenstaat zurück? 9 Mr.Arrogance 07.02.03 13:39:32
15.07.02 kaufe CELG 3 Mr.Arrogance 20.08.02 17:40:23
EMC - Kauf nach "Downgrade" Limit $6,70 3 Mr.Arrogance 20.08.02 17:31:04
APHT interessant trotz hohem risiko! 4 Mr.Arrogance 23.07.02 21:17:25
WM des Grauens: Völlers `Germanaccio` vs 11 Cowboys 5 Mr.Arrogance 21.06.02 16:34:27
ONXX, was ist hier im busch? 8 Mr.Arrogance 16.05.02 17:32:20
CTXS eindeutiges kaufsignal! 1 Mr.Arrogance 26.04.02 00:41:57
wen kauft Schering? ILXO,ONXX,TTP... 17 Mr.Arrogance 24.04.02 21:57:16
JS200
Sieht nicht berauschend aus, was du von dir gibst:
Thread Postings Ansicht Autor Datum
kreuzzug im namen der freiheit + demokratie 8 Mr.Arrogance 11.02.03 19:32:02
"Saddam Hussein ist die Wurzel allen Übels!" 5 Mr.Arrogance 07.02.03 16:56:34
rumsfeld-deutschland oder wann schlägt der schurkenstaat zurück? 9 Mr.Arrogance 07.02.03 13:39:32
15.07.02 kaufe CELG 3 Mr.Arrogance 20.08.02 17:40:23
EMC - Kauf nach "Downgrade" Limit $6,70 3 Mr.Arrogance 20.08.02 17:31:04
APHT interessant trotz hohem risiko! 4 Mr.Arrogance 23.07.02 21:17:25
WM des Grauens: Völlers `Germanaccio` vs 11 Cowboys 5 Mr.Arrogance 21.06.02 16:34:27
ONXX, was ist hier im busch? 8 Mr.Arrogance 16.05.02 17:32:20
CTXS eindeutiges kaufsignal! 1 Mr.Arrogance 26.04.02 00:41:57
wen kauft Schering? ILXO,ONXX,TTP... 17 Mr.Arrogance 24.04.02 21:57:16
JS200
nana burschi, wer wird denn gleich so aufbrausen...
das du nun in CELG investiert hast, sehe ich nicht mal als fehler. weil du ja gleich mal mit dem schäufelchen im userprofil gebuddelt hast, wirst du ja feststellen, daß ich seit dem 15.07.02 investiert bin, auch wenn du dies nicht berauschend findest, hehe...
du bist halt ein bisschen später dran.
mein kleines spässchen bezog sich darauf, daß es oft ein warnsignal ist, wenn sich diejenigen, die sonst begeistert in otc-buden investieren, plötzlich auf deinen wert stürzen.
aber keine angst, sehe weiterhin langfristig grosses potential bei CELG.
mr.A
das du nun in CELG investiert hast, sehe ich nicht mal als fehler. weil du ja gleich mal mit dem schäufelchen im userprofil gebuddelt hast, wirst du ja feststellen, daß ich seit dem 15.07.02 investiert bin, auch wenn du dies nicht berauschend findest, hehe...
du bist halt ein bisschen später dran.
mein kleines spässchen bezog sich darauf, daß es oft ein warnsignal ist, wenn sich diejenigen, die sonst begeistert in otc-buden investieren, plötzlich auf deinen wert stürzen.
aber keine angst, sehe weiterhin langfristig grosses potential bei CELG.
mr.A
Dear Subscriber,
In today`s issue of the Daily Update, we help you take the temperature of healthcare giant Johnson & Johnson (JNJ QUOTE / RESEARCH) as it faces heated competition on several fronts. Also, Alexander Ljubimow explains why MGI Pharma (MOGN QUOTE / RESEARCH) may be the biotechnology company to own right now, and Lipper gives its latest take on equity funds. To help you make even more informed investment decisions, we`re spotlighting research on International Business Machines (IBM QUOTE / RESEARCH), Qualcomm (QCOM QUOTE / RESEARCH), and top pharmaceuticals companies. Finally, see why U.S. Bancorp Piper Jaffray initiated coverage of Celgene (CELG QUOTE / RESEARCH) at Outperform. You`ll have to register for their free research trial here if you haven`t already.
JS200
In today`s issue of the Daily Update, we help you take the temperature of healthcare giant Johnson & Johnson (JNJ QUOTE / RESEARCH) as it faces heated competition on several fronts. Also, Alexander Ljubimow explains why MGI Pharma (MOGN QUOTE / RESEARCH) may be the biotechnology company to own right now, and Lipper gives its latest take on equity funds. To help you make even more informed investment decisions, we`re spotlighting research on International Business Machines (IBM QUOTE / RESEARCH), Qualcomm (QCOM QUOTE / RESEARCH), and top pharmaceuticals companies. Finally, see why U.S. Bancorp Piper Jaffray initiated coverage of Celgene (CELG QUOTE / RESEARCH) at Outperform. You`ll have to register for their free research trial here if you haven`t already.
JS200
04/15/2003 (14:08 ET) RATING(=): Wells Fargo Reiterates CELG Rating @ Buy - Knobias
04/15/2003 (12:42 ET) Celgene receives Fast Track status from FDA for Revimid in myelodysplastic syndromes - Datamonitor
04/15/2003 (08:57 ET) CELG`s REVIMID Gets Fast Track Designation From FDA - Knobias
04/15/2003 (07:44 ET) Celgene Receives Fast Track Status From FDA for REVIMID(TM) in Myelodysplastic Syndromes - PR Newswire
04/15/2003 (06:34 ET) Celgene to promote Glaxo`s mulitple myeloma drug - Datamonitor
JS200
04/15/2003 (12:42 ET) Celgene receives Fast Track status from FDA for Revimid in myelodysplastic syndromes - Datamonitor
04/15/2003 (08:57 ET) CELG`s REVIMID Gets Fast Track Designation From FDA - Knobias
04/15/2003 (07:44 ET) Celgene Receives Fast Track Status From FDA for REVIMID(TM) in Myelodysplastic Syndromes - PR Newswire
04/15/2003 (06:34 ET) Celgene to promote Glaxo`s mulitple myeloma drug - Datamonitor
JS200
RATING(=): Wells Fargo Reiterates CELG Rating @ Buy
Tuesday , April 15, 2003 14:08 ET
Issuer: Celgene Corporation (NasdaqNM: CELG)
Analyst Firm: Wells Fargo Van Kasper & Co.
Ratings Action: REITERATION
Current Rating: Buy
Target Price: $28.00
This rating information was reported by Briefing.com.
JS200
Tuesday , April 15, 2003 14:08 ET
Issuer: Celgene Corporation (NasdaqNM: CELG)
Analyst Firm: Wells Fargo Van Kasper & Co.
Ratings Action: REITERATION
Current Rating: Buy
Target Price: $28.00
This rating information was reported by Briefing.com.
JS200
Celgene Corporation Will Announce First Quarter Financial Results on April 24, 2003
via COMTEX
April 18, 2003
WARREN, N.J., Apr 18, 2003 (BUSINESS WIRE) --
Celgene Corporation (NASDAQ:CELG) will announce its first quarter financial results on Thursday, April 24, 2003 by press release before the market opens. Celgene`s management will host a conference call and live audio webcast at 9:00 AM ET to fully discuss the financial results and other business results.
The webcast will be available in the investor relations section of the Company`s website at www.celgene.com and will be archived for two weeks. An audio replay of the conference call will be available from noon ET, April 24, 2003 until midnight ET, April 27, 2003. To access the replay, please dial 1-800-633-8284 and enter Reservation Number 21141535.
The webcast is also being distributed over CCBN`s Investor Distribution Network to both institutional and individual investors. Individual investors can listen to the call through CCBN`s individual investor center at www.companyboardroom.com or by visiting any of the investor sites in CCBN`s Individual Investor Network. Institutional investors can access the call via CCBN`s password-protected event management site, StreetEvents (www.streetevents.com).
Celgene Corporation, headquartered in Warren, New Jersey, is an independent biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for treatment of cancer and inflammatory diseases.
Celgene Corporation Robert J. Hugin, 732/271-4102
http://www.businesswire.com
Today`s News On The Net - Business Wire`s full file on the Internet with Hyperlinks to your home page.
Copyright (C) 2003 Business Wire. All rights reserved.
JS200
via COMTEX
April 18, 2003
WARREN, N.J., Apr 18, 2003 (BUSINESS WIRE) --
Celgene Corporation (NASDAQ:CELG) will announce its first quarter financial results on Thursday, April 24, 2003 by press release before the market opens. Celgene`s management will host a conference call and live audio webcast at 9:00 AM ET to fully discuss the financial results and other business results.
The webcast will be available in the investor relations section of the Company`s website at www.celgene.com and will be archived for two weeks. An audio replay of the conference call will be available from noon ET, April 24, 2003 until midnight ET, April 27, 2003. To access the replay, please dial 1-800-633-8284 and enter Reservation Number 21141535.
The webcast is also being distributed over CCBN`s Investor Distribution Network to both institutional and individual investors. Individual investors can listen to the call through CCBN`s individual investor center at www.companyboardroom.com or by visiting any of the investor sites in CCBN`s Individual Investor Network. Institutional investors can access the call via CCBN`s password-protected event management site, StreetEvents (www.streetevents.com).
Celgene Corporation, headquartered in Warren, New Jersey, is an independent biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for treatment of cancer and inflammatory diseases.
Celgene Corporation Robert J. Hugin, 732/271-4102
http://www.businesswire.com
Today`s News On The Net - Business Wire`s full file on the Internet with Hyperlinks to your home page.
Copyright (C) 2003 Business Wire. All rights reserved.
JS200
NASDAQ Hosts 6th Life Sciences Forum
via COMTEX
April 22, 2003
LONDON, Apr 22, 2003 /PRNewswire-FirstCall via COMTEX/ --
The Nasdaq Stock Market, Inc. (NASDAQ)(R), will host its 6th Life Science Forum in London and Zurich during the week of April 28th. Presentations will be made by the senior management of 14 biotechnology, pharmaceutical and life science companies, including 10 NASDAQ-100(R) companies. These presentations will be webcast live on Wednesday, April 30 and Thursday May 1, between 0900 - 1730 (BST).
Details of how to access the webcasts live on these dates or afterwards in archived form can be found at NASDAQ`s Institutional Investor Center at http://investors.nasdaq.com/. The site, which was launched in February 2003, provides the institutional investment community with access to information on NASDAQ-listed companies including: company presentations, exclusive video interviews with CEOs and CFOs, company background details and links to various company and market information sites. Since launch, it has generated approximately one million hits.
The companies participating at the NASDAQ Life Science Forum are: AdvancePCS (Nasdaq: ADVP); Affymetrix, Inc (Nasdaq: AFFX); Amgen (Nasdaq: AMGN); Biomet, Inc (Nasdaq: BMET); Celgene Corp. (Nasdaq: CELG); Cephalon, Inc (Nasdaq: CEPH); Chiron Corp. (Nasdaq: CHIR); DENTSPLY International, Inc (Nasdaq: XRAY); Express Scripts, Inc (Nasdaq: ESRX); First Health Group Corp. (Nasdaq: FHCC); Gilead Sciences, Inc (Nasdaq: GILD); Human Genome Sciences, Inc. (Nasdaq: HGSI); Protein Design Labs, Inc (Nasdaq: PDLI); Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX).
David Weild IV, Vice Chairman, NASDAQ, commented, `This year is the 50th anniversary of Watson and Crick`s discovery of the double helix. The next 50 will be the `Golden Age`of Life Sciences -- an era where advances in the quality of healthcare will likely exceed those made in all of recorded history. NASDAQ gave birth to the world`s first public life sciences company and today, more than 95% of all life sciences companies in the United States make their home on The NASDAQ Stock Market. Assisting our issuers in raising their profile with institutional investors worldwide is a prime focus for NASDAQ -- and is particularly appropriate in this `essential`sector of the world`s economy.`
Weild continued, `Our Institutional Investor program has been running successfully for over six years and is strongly supported both by our leading companies and the analyst and investment community internationally. Through new initiatives such as the Institutional Investor Center, we provide our companies with higher visibility internationally than any other US market.`
The 2003 NASDAQ Institutional Investor program continues with the Retailing and Technology Conference in London and Milan on 24-26 June, the 10th Asian Investors Conference in Tokyo and Singapore on 9-12 September and the 11th Technology Conference in London and Frankfurt on 4-7 November 2003.
About NASDAQ
NASDAQ (OTC Bulletin Board: NDAQ) is the world`s largest electronic stock market. With approximately 3,600 companies, NASDAQ lists more companies and trades more shares per day than any other U.S. market. It is home to category-defining companies that are leaders across all areas of business including technology, retail, communications, financial services, media and biotechnology industries. For more information about NASDAQ, visit the NASDAQ Web site at www.NASDAQ.com or the NASDAQ Newsroom(SM) at www.NASDAQnews.com
SOURCE Nasdaq Stock Market, Inc.
Media, Fiona MacRae, +44 0 20 7825 5506 or Non-Media, Alex Ferrari, +44 0 20 7825 5538, both of The Nasdaq Stock Market, Inc.
http://www.nasdaqnews.com
Copyright (C) 2003 PR Newswire. All rights reserved.
JS200
via COMTEX
April 22, 2003
LONDON, Apr 22, 2003 /PRNewswire-FirstCall via COMTEX/ --
The Nasdaq Stock Market, Inc. (NASDAQ)(R), will host its 6th Life Science Forum in London and Zurich during the week of April 28th. Presentations will be made by the senior management of 14 biotechnology, pharmaceutical and life science companies, including 10 NASDAQ-100(R) companies. These presentations will be webcast live on Wednesday, April 30 and Thursday May 1, between 0900 - 1730 (BST).
Details of how to access the webcasts live on these dates or afterwards in archived form can be found at NASDAQ`s Institutional Investor Center at http://investors.nasdaq.com/. The site, which was launched in February 2003, provides the institutional investment community with access to information on NASDAQ-listed companies including: company presentations, exclusive video interviews with CEOs and CFOs, company background details and links to various company and market information sites. Since launch, it has generated approximately one million hits.
The companies participating at the NASDAQ Life Science Forum are: AdvancePCS (Nasdaq: ADVP); Affymetrix, Inc (Nasdaq: AFFX); Amgen (Nasdaq: AMGN); Biomet, Inc (Nasdaq: BMET); Celgene Corp. (Nasdaq: CELG); Cephalon, Inc (Nasdaq: CEPH); Chiron Corp. (Nasdaq: CHIR); DENTSPLY International, Inc (Nasdaq: XRAY); Express Scripts, Inc (Nasdaq: ESRX); First Health Group Corp. (Nasdaq: FHCC); Gilead Sciences, Inc (Nasdaq: GILD); Human Genome Sciences, Inc. (Nasdaq: HGSI); Protein Design Labs, Inc (Nasdaq: PDLI); Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX).
David Weild IV, Vice Chairman, NASDAQ, commented, `This year is the 50th anniversary of Watson and Crick`s discovery of the double helix. The next 50 will be the `Golden Age`of Life Sciences -- an era where advances in the quality of healthcare will likely exceed those made in all of recorded history. NASDAQ gave birth to the world`s first public life sciences company and today, more than 95% of all life sciences companies in the United States make their home on The NASDAQ Stock Market. Assisting our issuers in raising their profile with institutional investors worldwide is a prime focus for NASDAQ -- and is particularly appropriate in this `essential`sector of the world`s economy.`
Weild continued, `Our Institutional Investor program has been running successfully for over six years and is strongly supported both by our leading companies and the analyst and investment community internationally. Through new initiatives such as the Institutional Investor Center, we provide our companies with higher visibility internationally than any other US market.`
The 2003 NASDAQ Institutional Investor program continues with the Retailing and Technology Conference in London and Milan on 24-26 June, the 10th Asian Investors Conference in Tokyo and Singapore on 9-12 September and the 11th Technology Conference in London and Frankfurt on 4-7 November 2003.
About NASDAQ
NASDAQ (OTC Bulletin Board: NDAQ) is the world`s largest electronic stock market. With approximately 3,600 companies, NASDAQ lists more companies and trades more shares per day than any other U.S. market. It is home to category-defining companies that are leaders across all areas of business including technology, retail, communications, financial services, media and biotechnology industries. For more information about NASDAQ, visit the NASDAQ Web site at www.NASDAQ.com or the NASDAQ Newsroom(SM) at www.NASDAQnews.com
SOURCE Nasdaq Stock Market, Inc.
Media, Fiona MacRae, +44 0 20 7825 5506 or Non-Media, Alex Ferrari, +44 0 20 7825 5538, both of The Nasdaq Stock Market, Inc.
http://www.nasdaqnews.com
Copyright (C) 2003 PR Newswire. All rights reserved.
JS200
Biotechs Well Ahead of Big Pharma in The Development of Map Kinase-Based Therapeutics
via COMTEX
April 23, 2003
WALTHAM, Apr 23, 2003 /PRNewswire via COMTEX/ --
Decision Resources, one of the world`s leading research and advisory firms for pharmaceutical and health care issues, announced today that several biotechnology companies are at the forefront of the quest to bring mitogen-activated protein (MAP) kinase pathway-based therapeutics to market, and will do so ahead of most big pharmaceutical companies. According to a new Pathways and Processes report entitled MAP Kinase Pathway Modulators: Emerging Therapeutic Opportunities, MAP kinase- based therapeutics have blockbuster potential in the rheumatoid arthritis, Crohn`s disease, ischemic stroke, Parkinson`s disease, and prostate cancer drug markets.
`The recent acquisition of Scios by Johnson &Johnson for approximately $2.4 billion underscores the clinical and commercial value of MAP kinase pathway-modulating therapeutics perceived by pharmaceutical companies. This deal also exemplifies the need of pharmaceutical companies to fill their clinical pipelines and to protect their indication-specific franchises,`said Sylvia Marecki Ph.D., analyst at Decision Resources. `Biotechs like Scios, Vertex, Celgene, and Cephalon hold strong positions in this field, and partnerships between pharmaceutical companies (including Novartis, Lundbeck, Serono, and Kissei) and biotechs demonstrate that the potential of MAP kinase- based therapeutics to bolster clinical pipelines has not gone unnoticed.`
MAP Kinase Pathway -- Facts
The (MAP kinase) signal transduction pathway has tremendous physiological, clinical, and commercial importance because this pathway is critical for cellular responses to external stimuli such as cytokines, stress, and growth factors. Aberrant activation of this pathway is implicated in the pathogenesis of many diseases, which fall into a broad range of therapeutic areas including immune and inflammatory diseases, cardiovascular diseases, central nervous system disorders, and cancer.
Pathways and Processes
MAP Kinase Pathway Modulators: Emerging Therapeutic Opportunities is a report from Pathways and Processes, a new advisory service that focuses on cellular and molecular pathways. The reports provide insight into cutting-edge developments relating to drug targets with the potential to significantly change treatment practice and impact multiple pharmaceutical markets.
About Decision Resources
Decision Resources, Inc. is a world leader in research publications, advisory services, and consulting designed to help clients shape strategy, allocate resources, and master their chosen markets. The company has provided strategic information services for 30 years, assessing international pharmaceutical and health care industry trends. Visit Decision Resources at www.decisionresources.com.
All company, brand, or product names contained in this document may be trademarks or registered trademarks of their respective holders.
For more information, contact: Elizabeth Marshall Decision Resources 781-296-2563 emarshall@dresources.com
SOURCE Decision Resources, Inc.
Elizabeth Marshall of Decision Resources, +1-781-296-2563, emarshall@dresources.com
http://www.decisionresources.com
Copyright (C) 2003 PR Newswire. All rights reserved.
JS200
via COMTEX
April 23, 2003
WALTHAM, Apr 23, 2003 /PRNewswire via COMTEX/ --
Decision Resources, one of the world`s leading research and advisory firms for pharmaceutical and health care issues, announced today that several biotechnology companies are at the forefront of the quest to bring mitogen-activated protein (MAP) kinase pathway-based therapeutics to market, and will do so ahead of most big pharmaceutical companies. According to a new Pathways and Processes report entitled MAP Kinase Pathway Modulators: Emerging Therapeutic Opportunities, MAP kinase- based therapeutics have blockbuster potential in the rheumatoid arthritis, Crohn`s disease, ischemic stroke, Parkinson`s disease, and prostate cancer drug markets.
`The recent acquisition of Scios by Johnson &Johnson for approximately $2.4 billion underscores the clinical and commercial value of MAP kinase pathway-modulating therapeutics perceived by pharmaceutical companies. This deal also exemplifies the need of pharmaceutical companies to fill their clinical pipelines and to protect their indication-specific franchises,`said Sylvia Marecki Ph.D., analyst at Decision Resources. `Biotechs like Scios, Vertex, Celgene, and Cephalon hold strong positions in this field, and partnerships between pharmaceutical companies (including Novartis, Lundbeck, Serono, and Kissei) and biotechs demonstrate that the potential of MAP kinase- based therapeutics to bolster clinical pipelines has not gone unnoticed.`
MAP Kinase Pathway -- Facts
The (MAP kinase) signal transduction pathway has tremendous physiological, clinical, and commercial importance because this pathway is critical for cellular responses to external stimuli such as cytokines, stress, and growth factors. Aberrant activation of this pathway is implicated in the pathogenesis of many diseases, which fall into a broad range of therapeutic areas including immune and inflammatory diseases, cardiovascular diseases, central nervous system disorders, and cancer.
Pathways and Processes
MAP Kinase Pathway Modulators: Emerging Therapeutic Opportunities is a report from Pathways and Processes, a new advisory service that focuses on cellular and molecular pathways. The reports provide insight into cutting-edge developments relating to drug targets with the potential to significantly change treatment practice and impact multiple pharmaceutical markets.
About Decision Resources
Decision Resources, Inc. is a world leader in research publications, advisory services, and consulting designed to help clients shape strategy, allocate resources, and master their chosen markets. The company has provided strategic information services for 30 years, assessing international pharmaceutical and health care industry trends. Visit Decision Resources at www.decisionresources.com.
All company, brand, or product names contained in this document may be trademarks or registered trademarks of their respective holders.
For more information, contact: Elizabeth Marshall Decision Resources 781-296-2563 emarshall@dresources.com
SOURCE Decision Resources, Inc.
Elizabeth Marshall of Decision Resources, +1-781-296-2563, emarshall@dresources.com
http://www.decisionresources.com
Copyright (C) 2003 PR Newswire. All rights reserved.
JS200
Celgene vermeldet starke Zahlen q1 und hebt Ausblicke an!
Starke Zahlen q1 vermeldet und Ausblicke angehoben!
Na dann, auf geht es!
Na dann, auf geht es!
Celgene (WKN: 881244, US: CELG) präsentiert aufgrund einer stärkeren Nachfrage nach dem umsatzstärksten Medikament Thalomid einen Gewinn nach einem Verlust im Vorjahr. Thalomid dient der Behandlung von Krebs. Der Gewinn lag bei $952,000 oder einem Cent je Aktie nach $823,000 oder einem Cent im Vorjahr. Der Umsatz wuchs um 60% auf $49.1 Millionen. Im Gesamtjahr will das Unternehmen ein EPS (Gewinn je Aktie) zwischen 5 und 10 Cents erwirtschaften. Die Umsätze mit Thalomid sollen höher als ursprünglich erwartet ausfallen.
RAiDAR alerts Learn More About RAiDAR-LT
04/24/2003 (09:55 ET) ERN(+): CELG/Q1 1c vs (1c); Beats Q Est; Provides Guidance - Knobias
04/24/2003 (07:38 ET) Celgene Corporation Announces First Quarter 2003 Results - PR Newswire
04/24/2003 (06:32 ET) ERN/CALL: CELG To Hold Q1 Conf Call @ 9:00 ET Today - Knobias
04/23/2003 (13:00 ET) ERN/RLS(X): CELG To Release Q1 Results Apr 24 [BMO] - Knobias
04/23/2003 (11:21 ET) SECTOR(HCR): Biotechs Lead Sector, Bolstered by ENMD - Knobias
04/23/2003 (08:01 ET) Biotechs Well Ahead of Big Pharma in The Development of Map Kinase-Based Therapeutics - PR Newswire
04/22/2003 (10:01 ET) NASDAQ Hosts 6th Life Sciences Forum - PR Newswire
04/18/2003 (16:03 ET) New 10-K/A just released for CELG - Edgar
04/18/2003 (08:00 ET) Celgene Corporation Will Announce First Quarter Financial Results on April 24, 2003 - Business Wire
04/15/2003 (14:08 ET) RATING(=): Wells Fargo Reiterates CELG Rating @ Buy - Knobias
04/15/2003 (12:42 ET) Celgene receives Fast Track status from FDA for Revimid in myelodysplastic syndromes - Datamonitor
04/15/2003 (08:57 ET) CELG`s REVIMID Gets Fast Track Designation From FDA - Knobias
04/15/2003 (07:44 ET) Celgene Receives Fast Track Status From FDA for REVIMID(TM) in Myelodysplastic Syndromes - PR Newswire
04/15/2003 (06:34 ET) Celgene to promote Glaxo`s mulitple myeloma drug - Datamonitor
04/14/2003 (08:15 ET) GlaxoSmithKline`s Alkeran myeloma treatment to be marketed in US by Celgene - AFX News Europe
04/14/2003 (08:15 ET) GlaxoSmithKline`s Alkeran myeloma treatment to be marketed in US by Celgene - AFX News UK
04/14/2003 (08:14 ET) GlaxoSmithKline`s Alkeran myeloma treatment to be marketed in US by Celgene - AFX News Asia
04/14/2003 (07:30 ET) Celgene Signs Strategic Agreement With GlaxoSmithKline to Distribute and Promote ALKERAN(R) (melphalan) - PR Newswire
04/11/2003 (08:55 ET) RATING(o): USB Piper Sets CELG Rating @ Outperform - Knobias
04/10/2003 (10:44 ET) SECTOR(HCR): Biotechs Help Push Sector Lower - Knobias
04/09/2003 (08:00 ET) Celgene to Dominate the Multiple Myeloma Drug Market Through 2011 - PR Newswire
04/08/2003 (07:32 ET) CONF: CELG To Present At Mattison Healthcare Conference @ 10:30 ET - Knobias
04/07/2003 (11:37 ET) VOLUME(-): CELG Volume 32% > 20-adsv, Stock -9.06% - Knobias
04/04/2003 (17:00 ET) Celgene Will Present at Gerard Klauer Mattison Healthcare Conference - PR Newswire
04/03/2003 (09:53 ET) RATING(1): Bear Stearns Initiates CELG Rating @ Peer Perform - Knobias
JS200
04/24/2003 (09:55 ET) ERN(+): CELG/Q1 1c vs (1c); Beats Q Est; Provides Guidance - Knobias
04/24/2003 (07:38 ET) Celgene Corporation Announces First Quarter 2003 Results - PR Newswire
04/24/2003 (06:32 ET) ERN/CALL: CELG To Hold Q1 Conf Call @ 9:00 ET Today - Knobias
04/23/2003 (13:00 ET) ERN/RLS(X): CELG To Release Q1 Results Apr 24 [BMO] - Knobias
04/23/2003 (11:21 ET) SECTOR(HCR): Biotechs Lead Sector, Bolstered by ENMD - Knobias
04/23/2003 (08:01 ET) Biotechs Well Ahead of Big Pharma in The Development of Map Kinase-Based Therapeutics - PR Newswire
04/22/2003 (10:01 ET) NASDAQ Hosts 6th Life Sciences Forum - PR Newswire
04/18/2003 (16:03 ET) New 10-K/A just released for CELG - Edgar
04/18/2003 (08:00 ET) Celgene Corporation Will Announce First Quarter Financial Results on April 24, 2003 - Business Wire
04/15/2003 (14:08 ET) RATING(=): Wells Fargo Reiterates CELG Rating @ Buy - Knobias
04/15/2003 (12:42 ET) Celgene receives Fast Track status from FDA for Revimid in myelodysplastic syndromes - Datamonitor
04/15/2003 (08:57 ET) CELG`s REVIMID Gets Fast Track Designation From FDA - Knobias
04/15/2003 (07:44 ET) Celgene Receives Fast Track Status From FDA for REVIMID(TM) in Myelodysplastic Syndromes - PR Newswire
04/15/2003 (06:34 ET) Celgene to promote Glaxo`s mulitple myeloma drug - Datamonitor
04/14/2003 (08:15 ET) GlaxoSmithKline`s Alkeran myeloma treatment to be marketed in US by Celgene - AFX News Europe
04/14/2003 (08:15 ET) GlaxoSmithKline`s Alkeran myeloma treatment to be marketed in US by Celgene - AFX News UK
04/14/2003 (08:14 ET) GlaxoSmithKline`s Alkeran myeloma treatment to be marketed in US by Celgene - AFX News Asia
04/14/2003 (07:30 ET) Celgene Signs Strategic Agreement With GlaxoSmithKline to Distribute and Promote ALKERAN(R) (melphalan) - PR Newswire
04/11/2003 (08:55 ET) RATING(o): USB Piper Sets CELG Rating @ Outperform - Knobias
04/10/2003 (10:44 ET) SECTOR(HCR): Biotechs Help Push Sector Lower - Knobias
04/09/2003 (08:00 ET) Celgene to Dominate the Multiple Myeloma Drug Market Through 2011 - PR Newswire
04/08/2003 (07:32 ET) CONF: CELG To Present At Mattison Healthcare Conference @ 10:30 ET - Knobias
04/07/2003 (11:37 ET) VOLUME(-): CELG Volume 32% > 20-adsv, Stock -9.06% - Knobias
04/04/2003 (17:00 ET) Celgene Will Present at Gerard Klauer Mattison Healthcare Conference - PR Newswire
04/03/2003 (09:53 ET) RATING(1): Bear Stearns Initiates CELG Rating @ Peer Perform - Knobias
JS200
Celgene Broadens S.T.E.P.S.(R) Intellectual Property Estate With Issuance of Two Fundamental U.S. Patents
via COMTEX
May 13, 2003
WARREN, N.J., May 13, 2003 /PRNewswire-FirstCall via COMTEX/ --
Celgene Corporation (Nasdaq: CELG) announced today that its intellectual property estate for the Company`s unique distribution program expanded with two additional U.S. patents that issued today. The Celgene patent portfolio covers managed distribution programs for products or drugs that are either teratogens (causing birth defects) or have other adverse effects that require contraindication for certain patients. The Company`s two previously issued patents cover distribution programs that register pharmacists, patients and physicians. The newly issued patents, U.S. Patents 6,561,976 and 6,561,977, expand the scope of coverage to include distribution programs that do not require the type of registrations described in the prior patents.
`We are very proud of S.T.E.P.S. and the high standard of controlled pharmaceutical distribution it offers our industry. These new patents broaden our existing intellectual property estate to include controlled distribution programs that do not require pharmacist, patient and physician registration,` said Sol J. Barer, Ph.D., President and Chief Operating Officer of Celgene Corporation. `Furthermore, the issuance of these patents supports our strategy to vigorously protect and safeguard our THALOMID franchise.`
Celgene developed S.T.E.P.S.(R) (System for Thalidomide Education and Prescribing Safety), the first program in this proprietary type of managed drug distribution, to support the distribution of THALOMID(R) (thalidomide). THALOMID, approved for the acute treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence, potentially causes severe birth defects or death to an unborn baby. THALOMID is not indicated as monotherapy for ENL treatment in the presence of moderate to severe neuritis.
S.T.E.P.S., the first FDA-approved managed distribution program, serves as a blueprint for the appropriate distribution of pharmaceutical products that offer important therapeutic benefits but have serious side effects. Celgene has effectively implemented S.T.E.P.S. since the launch of THALOMID in 1998 and during the past five years approximately 79,000 patients, 14,900 prescribers and 24,400 pharmacists have been successfully registered in S.T.E.P.S. to fill over 418,000 prescriptions for THALOMID. S.T.E.P.S. incorporates state-of-the-art technology to ensure that THALOMID is appropriately distributed and to improve patient care, permit real-time interventions and maximize compliance. For more information on S.T.E.P.S., please visit the Celgene website at www.celgene.com.
Safety Notice
If thalidomide is taken during pregnancy, it can cause severe birth defects or death to an unborn baby. Thalidomide should never be used by women who are pregnant or who could become pregnant while taking the drug. Even a single dose, one capsule (50 mg, 100 mg and 200 mg), taken by a pregnant woman can cause severe birth defects. Because thalidomide is present in the semen of male patients, males receiving thalidomide must always use a latex condom during sexual contact with women of childbearing potential even if he has undergone a successful vasectomy. Thalidomide can only be marketed under a special restricted distribution program. This program is called the `System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.(R)). Under this program, only registered prescribers and pharmacists may dispense the drug. In addition, patients must be advised of, agree to and comply with the requirements of S.T.E.P.S.
Thalidomide is known to cause nerve damage that may be permanent. Peripheral neuropathy is a common, potentially severe, side effect of treatment with thalidomide that may be irreversible. Decreased white blood cell counts, including neutropenia, have been reported in the clinical use of thalidomide. In placebo controlled clinical trials of HIV-seropositive patient populations, there have been reports of increased plasma HIV RNA levels associated with thalidomide therapy. The most common adverse events observed in clinical use in ENL and HIV-seropositive patient populations are rash, maculo-papular rash, drowsiness/somnolence, peripheral neuropathy, dizziness/orthostatic hypotension, neutropenia, and increased HIV-viral load. Patients should be advised about these associated adverse events and routinely monitored by a physician during treatment with thalidomide.
THALOMID (thalidomide), manufactured by Celgene Corporation, received U.S. Food and Drug Administration (FDA) clearance on July 16, 1998 for the acute treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence. THALOMID is not indicated as monotherapy for ENL treatment in the presence of moderate to severe neuritis.
Celgene Corporation, headquartered in Warren, New Jersey, is an integrated biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company`s website at www.celgene.com.
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company`s control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company`s filings with the Securities and Exchange Commission such as 10K, 10Q and 8K reports.
SOURCE Celgene Corporation
Robert J. Hugin, Senior VP and CFO of Celgene Corporation, +1-732-271-4102
http://www.celgene.com
Copyright (C) 2003 PR Newswire. All rights reserved.
JS200
via COMTEX
May 13, 2003
WARREN, N.J., May 13, 2003 /PRNewswire-FirstCall via COMTEX/ --
Celgene Corporation (Nasdaq: CELG) announced today that its intellectual property estate for the Company`s unique distribution program expanded with two additional U.S. patents that issued today. The Celgene patent portfolio covers managed distribution programs for products or drugs that are either teratogens (causing birth defects) or have other adverse effects that require contraindication for certain patients. The Company`s two previously issued patents cover distribution programs that register pharmacists, patients and physicians. The newly issued patents, U.S. Patents 6,561,976 and 6,561,977, expand the scope of coverage to include distribution programs that do not require the type of registrations described in the prior patents.
`We are very proud of S.T.E.P.S. and the high standard of controlled pharmaceutical distribution it offers our industry. These new patents broaden our existing intellectual property estate to include controlled distribution programs that do not require pharmacist, patient and physician registration,` said Sol J. Barer, Ph.D., President and Chief Operating Officer of Celgene Corporation. `Furthermore, the issuance of these patents supports our strategy to vigorously protect and safeguard our THALOMID franchise.`
Celgene developed S.T.E.P.S.(R) (System for Thalidomide Education and Prescribing Safety), the first program in this proprietary type of managed drug distribution, to support the distribution of THALOMID(R) (thalidomide). THALOMID, approved for the acute treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence, potentially causes severe birth defects or death to an unborn baby. THALOMID is not indicated as monotherapy for ENL treatment in the presence of moderate to severe neuritis.
S.T.E.P.S., the first FDA-approved managed distribution program, serves as a blueprint for the appropriate distribution of pharmaceutical products that offer important therapeutic benefits but have serious side effects. Celgene has effectively implemented S.T.E.P.S. since the launch of THALOMID in 1998 and during the past five years approximately 79,000 patients, 14,900 prescribers and 24,400 pharmacists have been successfully registered in S.T.E.P.S. to fill over 418,000 prescriptions for THALOMID. S.T.E.P.S. incorporates state-of-the-art technology to ensure that THALOMID is appropriately distributed and to improve patient care, permit real-time interventions and maximize compliance. For more information on S.T.E.P.S., please visit the Celgene website at www.celgene.com.
Safety Notice
If thalidomide is taken during pregnancy, it can cause severe birth defects or death to an unborn baby. Thalidomide should never be used by women who are pregnant or who could become pregnant while taking the drug. Even a single dose, one capsule (50 mg, 100 mg and 200 mg), taken by a pregnant woman can cause severe birth defects. Because thalidomide is present in the semen of male patients, males receiving thalidomide must always use a latex condom during sexual contact with women of childbearing potential even if he has undergone a successful vasectomy. Thalidomide can only be marketed under a special restricted distribution program. This program is called the `System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.(R)). Under this program, only registered prescribers and pharmacists may dispense the drug. In addition, patients must be advised of, agree to and comply with the requirements of S.T.E.P.S.
Thalidomide is known to cause nerve damage that may be permanent. Peripheral neuropathy is a common, potentially severe, side effect of treatment with thalidomide that may be irreversible. Decreased white blood cell counts, including neutropenia, have been reported in the clinical use of thalidomide. In placebo controlled clinical trials of HIV-seropositive patient populations, there have been reports of increased plasma HIV RNA levels associated with thalidomide therapy. The most common adverse events observed in clinical use in ENL and HIV-seropositive patient populations are rash, maculo-papular rash, drowsiness/somnolence, peripheral neuropathy, dizziness/orthostatic hypotension, neutropenia, and increased HIV-viral load. Patients should be advised about these associated adverse events and routinely monitored by a physician during treatment with thalidomide.
THALOMID (thalidomide), manufactured by Celgene Corporation, received U.S. Food and Drug Administration (FDA) clearance on July 16, 1998 for the acute treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence. THALOMID is not indicated as monotherapy for ENL treatment in the presence of moderate to severe neuritis.
Celgene Corporation, headquartered in Warren, New Jersey, is an integrated biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company`s website at www.celgene.com.
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company`s control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company`s filings with the Securities and Exchange Commission such as 10K, 10Q and 8K reports.
SOURCE Celgene Corporation
Robert J. Hugin, Senior VP and CFO of Celgene Corporation, +1-732-271-4102
http://www.celgene.com
Copyright (C) 2003 PR Newswire. All rights reserved.
JS200
Last Trade: 28.830 Change: 0.730 (+2.598%)
Previous Close: 28.100 Volume: 1,120,600
Bid: 28.870 Ask: 29.080
Today`s Open: 28.140 # of Trades: 3,876
JS200
Previous Close: 28.100 Volume: 1,120,600
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JS200
Wyeth Research, AEterna Laboratories, Antigenics, and Celgene All to Introduce Novel Therapies to Expand Renal Cancer Drug Market
via COMTEX
May 19, 2003
WALTHAM, Mass., May 19, 2003 /PRNewswire via COMTEX/ --
Decision Resources, Inc., one of the world`s leading research and advisory firms focusing on pharmaceutical and health care issues, finds that Wyeth Research, AEterna Laboratories, and Celegne are all launching second-line therapies in the seven major pharmaceutical markets (United States, France, Germany, Italy, Spain, United Kingdom, and Japan) that will expand the renal cell carcinoma (RCC) drug market. Antigenics will launch a first-line treatment in the seven major markets by 2008. The introduction of these new therapies is expected to offer better toxicity profiles and greater survival benefit for stage IV RCC, according to a new Pharmacor study from Decision Resources entitled Renal Cell Carcinoma.
`We expect agents from Wyeth, AEterna, and Celegene to launch in 2005/2006 and offer alternatives to conventional second-line treatments, with equal or better toxicity profiles,`said Mohamed Muhsin, analyst at Decision Resources. `AEterna`s drug, Neovastat, and Wyeth`s drug, CCI-779, along with Antigenics` Oncophage will penetrate the first-line market in the second half our study period between 2008 and 2012.`
Disease Background -- Renal Cell Carcinoma
Renal cell carcinoma is a specific type of kidney cancer that originates in the renal tubules. RCC accounts for 85% of all kidney cancers: approximately 25,000 incident cases are diagnosed each year in the United States, where RCC accounts for 3% of all cancer cases and approximately 1.5% of cancer deaths.
About Pharmacor from Decision Resources
Pharmacor is a unique family of studies based on primary and secondary research conducted by Decision Resources`on-staff experts. Each comprehensive study assesses a host of market-impacting factors and analyzes the commercial outlook for drugs in research and development. Cardium, Cognos, Immune and Inflammatory Disorders, Infectious Disease, Metabolic Disorders, Psychiatric Disorders, and Onkos concentrate on specific therapeutic areas. Mosaic covers high-interest disease states. Renal Cell Carcinoma is an Onkos study.
About Decision Resources
Decision Resources, Inc. is a world leader in research publications, advisory services, and consulting designed to help clients shape strategy, allocate resources, and master their chosen markets. The company has provided strategic information services for 30 years, assessing international pharmaceutical and health care industry trends. Visit Decision Resources at www.decisionresources.com.
All company, brand, or product names contained in this document may be trademarks or registered trademarks of their respective holders.
SOURCE Decision Resources, Inc.
Elizabeth Marshall of Decision Resources, Inc., +1-781-296-2563, emarshall@dresources.com
http://www.decisionresources.com
JS200
via COMTEX
May 19, 2003
WALTHAM, Mass., May 19, 2003 /PRNewswire via COMTEX/ --
Decision Resources, Inc., one of the world`s leading research and advisory firms focusing on pharmaceutical and health care issues, finds that Wyeth Research, AEterna Laboratories, and Celegne are all launching second-line therapies in the seven major pharmaceutical markets (United States, France, Germany, Italy, Spain, United Kingdom, and Japan) that will expand the renal cell carcinoma (RCC) drug market. Antigenics will launch a first-line treatment in the seven major markets by 2008. The introduction of these new therapies is expected to offer better toxicity profiles and greater survival benefit for stage IV RCC, according to a new Pharmacor study from Decision Resources entitled Renal Cell Carcinoma.
`We expect agents from Wyeth, AEterna, and Celegene to launch in 2005/2006 and offer alternatives to conventional second-line treatments, with equal or better toxicity profiles,`said Mohamed Muhsin, analyst at Decision Resources. `AEterna`s drug, Neovastat, and Wyeth`s drug, CCI-779, along with Antigenics` Oncophage will penetrate the first-line market in the second half our study period between 2008 and 2012.`
Disease Background -- Renal Cell Carcinoma
Renal cell carcinoma is a specific type of kidney cancer that originates in the renal tubules. RCC accounts for 85% of all kidney cancers: approximately 25,000 incident cases are diagnosed each year in the United States, where RCC accounts for 3% of all cancer cases and approximately 1.5% of cancer deaths.
About Pharmacor from Decision Resources
Pharmacor is a unique family of studies based on primary and secondary research conducted by Decision Resources`on-staff experts. Each comprehensive study assesses a host of market-impacting factors and analyzes the commercial outlook for drugs in research and development. Cardium, Cognos, Immune and Inflammatory Disorders, Infectious Disease, Metabolic Disorders, Psychiatric Disorders, and Onkos concentrate on specific therapeutic areas. Mosaic covers high-interest disease states. Renal Cell Carcinoma is an Onkos study.
About Decision Resources
Decision Resources, Inc. is a world leader in research publications, advisory services, and consulting designed to help clients shape strategy, allocate resources, and master their chosen markets. The company has provided strategic information services for 30 years, assessing international pharmaceutical and health care industry trends. Visit Decision Resources at www.decisionresources.com.
All company, brand, or product names contained in this document may be trademarks or registered trademarks of their respective holders.
SOURCE Decision Resources, Inc.
Elizabeth Marshall of Decision Resources, Inc., +1-781-296-2563, emarshall@dresources.com
http://www.decisionresources.com
JS200
RAiDAR alerts Learn More About RAiDAR-LT
05/19/2003 (15:57 ET) RATING(=): USB Piper Reiterates CELG Rating @ Outperform - Knobias
05/19/2003 (10:32 ET) SECTOR(HCR): Biotechs Fairing Well Today, Led by DNA - Knobias
05/19/2003 (09:56 ET) 52W HIGH: New 52-Wk High for CELG @ $32.493 up3.22% - Knobias
05/19/2003 (08:02 ET) Wyeth Research, AEterna Laboratories, Antigenics, and Celgene All to Introduce Novel Therapies to Expand Renal Cancer Drug Market - PR Newswire
05/15/2003 (17:28 ET) New 10-Q just released for CELG - Edgar
05/15/2003 (09:48 ET) 52W HIGH: New 52-Wk High for CELG @ $32.250 up8.08% - Knobias
05/15/2003 (08:40 ET) New REVIMID(TM) Clinical Data Shows Potential as Novel Approach to Treating Myelodysplastic Syndromes (MDS) - PR Newswire
05/14/2003 (13:06 ET) 52W HIGH: New 52-Wk High for CELG @ $30.240 up4.89% - Knobias
05/14/2003 (10:56 ET) VOLUME(+): CELG Volume 12% > 20-adsv, Stock +1.98% - Knobias
05/14/2003 (09:39 ET) RATING(=): Adams Harkness Reiterates CELG Rating @ Strong Buy - Knobias
05/13/2003 (07:38 ET) Celgene Broadens S.T.E.P.S.(R) Intellectual Property Estate With Issuance of Two Fundamental U.S. Patents - PR Newswire
05/06/2003 (14:24 ET) SECTOR(HCR): Biotechs Remain Red for Most of Day - Knobias
05/06/2003 (11:56 ET) 52W HIGH: New 52-Wk High for CELG @ $30.150 up9.08% - Knobias
05/01/2003 (16:02 ET) CONF: CELG To Present At NASDAQ Life Sciences Conference @ 18:35 ET - Knobias
05/01/2003 (07:15 ET) DEF 14A: CELG Vote; Directors; Auditor; Stock Op Plan - Knobias
04/30/2003 (16:04 ET) New DEF 14A just released for CELG - Edgar
04/24/2003 (09:55 ET) ERN(+): CELG/Q1 1c vs (1c); Beats Q Est; Provides Guidance - Knobias
04/24/2003 (07:38 ET) Celgene Corporation Announces First Quarter 2003 Results - PR Newswire
04/24/2003 (06:32 ET) ERN/CALL: CELG To Hold Q1 Conf Call @ 9:00 ET Today - Knobias
04/23/2003 (13:00 ET) ERN/RLS(X): CELG To Release Q1 Results Apr 24 [BMO] - Knobias
04/23/2003 (11:21 ET) SECTOR(HCR): Biotechs Lead Sector, Bolstered by ENMD - Knobias
04/23/2003 (08:01 ET) Biotechs Well Ahead of Big Pharma in The Development of Map Kinase-Based Therapeutics - PR Newswire
04/22/2003 (10:01 ET) NASDAQ Hosts 6th Life Sciences Forum - PR Newswire
JS200
05/19/2003 (15:57 ET) RATING(=): USB Piper Reiterates CELG Rating @ Outperform - Knobias
05/19/2003 (10:32 ET) SECTOR(HCR): Biotechs Fairing Well Today, Led by DNA - Knobias
05/19/2003 (09:56 ET) 52W HIGH: New 52-Wk High for CELG @ $32.493 up3.22% - Knobias
05/19/2003 (08:02 ET) Wyeth Research, AEterna Laboratories, Antigenics, and Celgene All to Introduce Novel Therapies to Expand Renal Cancer Drug Market - PR Newswire
05/15/2003 (17:28 ET) New 10-Q just released for CELG - Edgar
05/15/2003 (09:48 ET) 52W HIGH: New 52-Wk High for CELG @ $32.250 up8.08% - Knobias
05/15/2003 (08:40 ET) New REVIMID(TM) Clinical Data Shows Potential as Novel Approach to Treating Myelodysplastic Syndromes (MDS) - PR Newswire
05/14/2003 (13:06 ET) 52W HIGH: New 52-Wk High for CELG @ $30.240 up4.89% - Knobias
05/14/2003 (10:56 ET) VOLUME(+): CELG Volume 12% > 20-adsv, Stock +1.98% - Knobias
05/14/2003 (09:39 ET) RATING(=): Adams Harkness Reiterates CELG Rating @ Strong Buy - Knobias
05/13/2003 (07:38 ET) Celgene Broadens S.T.E.P.S.(R) Intellectual Property Estate With Issuance of Two Fundamental U.S. Patents - PR Newswire
05/06/2003 (14:24 ET) SECTOR(HCR): Biotechs Remain Red for Most of Day - Knobias
05/06/2003 (11:56 ET) 52W HIGH: New 52-Wk High for CELG @ $30.150 up9.08% - Knobias
05/01/2003 (16:02 ET) CONF: CELG To Present At NASDAQ Life Sciences Conference @ 18:35 ET - Knobias
05/01/2003 (07:15 ET) DEF 14A: CELG Vote; Directors; Auditor; Stock Op Plan - Knobias
04/30/2003 (16:04 ET) New DEF 14A just released for CELG - Edgar
04/24/2003 (09:55 ET) ERN(+): CELG/Q1 1c vs (1c); Beats Q Est; Provides Guidance - Knobias
04/24/2003 (07:38 ET) Celgene Corporation Announces First Quarter 2003 Results - PR Newswire
04/24/2003 (06:32 ET) ERN/CALL: CELG To Hold Q1 Conf Call @ 9:00 ET Today - Knobias
04/23/2003 (13:00 ET) ERN/RLS(X): CELG To Release Q1 Results Apr 24 [BMO] - Knobias
04/23/2003 (11:21 ET) SECTOR(HCR): Biotechs Lead Sector, Bolstered by ENMD - Knobias
04/23/2003 (08:01 ET) Biotechs Well Ahead of Big Pharma in The Development of Map Kinase-Based Therapeutics - PR Newswire
04/22/2003 (10:01 ET) NASDAQ Hosts 6th Life Sciences Forum - PR Newswire
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Celgene JNK Intellectual Property Estate Broadened With Tufts University Agreement
via COMTEX
May 21, 2003
WARREN, N.J., May 21, 2003 /PRNewswire-FirstCall via COMTEX/ --
Celgene Corporation (Nasdaq: CELG) announced today that its extensive patent portfolio for the Company`s broad JNK (c-Jun N-terminal Kinase) inhibitor program has been further strengthened with three issued European patents and a pending U.S. patent application licensed from Tufts University. The patents and application cover methods for treating and preventing insulin resistance and related disorders such as diabetes and obesity.
Insulin, a hormone produced by the pancreas, regulates the transport of sugar from the blood to cells. Insulin resistance occurs when insulin can no longer control how the body processes sugar or when cells are unable to respond to insulin, and as a result, the pancreas compensates by releasing more insulin into the blood. The higher-than-normal levels of blood sugar can lead to type II diabetes, obesity, abnormal cholesterol and triglyceride levels, and high blood pressure, which are all risk factors for heart disease and stroke. The American Association of Clinical Endocrinologists estimates that insulin resistance affects one in three Americans. Insulin resistant people are at a dramatically higher risk to develop obesity and type II diabetes, which affect 250 million and 150 million people worldwide, respectively, than non-insulin resistant people.
Celgene has a major drug discovery program focused on developing novel small molecule therapies to modulate the JNK signaling pathway. These efforts have resulted in the successful development of multiple series of proprietary JNK inhibitors. The lead Celgene JNK inhibitor, CC-401, successfully completed a Phase I, double-blind, placebo controlled, ascending single intravenous dose study in healthy human volunteers. In addition, Celgene has advanced several JNK drug leads to testing in in vivo models of diabetes, stroke, rheumatoid arthritis, organ transplantation, asthma and cancer. The compounds have demonstrated significant activity in each preclinical disease model and were well tolerated in these studies. In a mouse model of diabetes and obesity, an orally administered JNK inhibitor lowered blood glucose levels, decreased urine output and slowed body weight gain. The compound also appeared to improve the viability of the islet cells of the pancreas responsible for insulin secretion. Celgene expects to advance the development of CC-401 and additional novel JNK inhibitors in a broad range of chronic and acute diseases including diabetes and obesity.
`Data has recently emerged on the central role of the JNK pathway in insulin resistance and the subsequent onset and progression of diabetes and obesity,`said Sol J. Barer, Ph.D., President and Chief Operating Officer of Celgene Corporation. `Our strategic licensing agreement with Tufts University strengthens our already extensive JNK intellectual property estate. We look forward to realizing the full potential of our broad pipeline of JNK inhibitors as potential therapies for insulin resistance and other metabolic disorders.`
The JNK gene regulation pathway has been shown to play an essential role in the onset and progression of a variety of important human diseases that involve inflammation, cell death, ischemia reperfusion injury and cellular proliferation. Over-activation of the JNK pathway increases expression of a broad set of genes, including tumor necrosis factor-alpha, interleukin-2 and gamma interferon, which are believed to be important mechanisms in autoimmune, inflammatory, cardiovascular, metabolic and neurological diseases as well as cancer.
Celgene has a dominant and expanding intellectual property estate covering the JNK pathway and JNK genes, JNK polypeptides and proteins, expression systems for protein production, JNK screening technology, JNK targets and therapeutic uses of molecules modulating JNK activity. This patent estate comprises one pending and twelve issued U.S. patents and eight foreign patents through licenses with the University of California, the University of Massachusetts, Tufts University and patents held by Celgene. The Company`s comprehensive JNK patent portfolio is expected to expand further as Celgene has various pending U.S. and foreign patent applications. Celgene has not licensed any rights to its JNK program to date, retaining exclusive worldwide rights for all disease indications.
Celgene Corporation, headquartered in Warren, New Jersey, is an integrated biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company`s website at www.celgene.com.
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company`s control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company`s filings with the Securities and Exchange Commission such as 10K, 10Q and 8K reports.
SOURCE Celgene Corporation
Robert J. Hugin, Senior VP and CFO, of Celgene Corporation, +1-732-271-4102
http://www.celgene.com
Copyright (C) 2003 PR Newswire. All rights reserved.
JS200
via COMTEX
May 21, 2003
WARREN, N.J., May 21, 2003 /PRNewswire-FirstCall via COMTEX/ --
Celgene Corporation (Nasdaq: CELG) announced today that its extensive patent portfolio for the Company`s broad JNK (c-Jun N-terminal Kinase) inhibitor program has been further strengthened with three issued European patents and a pending U.S. patent application licensed from Tufts University. The patents and application cover methods for treating and preventing insulin resistance and related disorders such as diabetes and obesity.
Insulin, a hormone produced by the pancreas, regulates the transport of sugar from the blood to cells. Insulin resistance occurs when insulin can no longer control how the body processes sugar or when cells are unable to respond to insulin, and as a result, the pancreas compensates by releasing more insulin into the blood. The higher-than-normal levels of blood sugar can lead to type II diabetes, obesity, abnormal cholesterol and triglyceride levels, and high blood pressure, which are all risk factors for heart disease and stroke. The American Association of Clinical Endocrinologists estimates that insulin resistance affects one in three Americans. Insulin resistant people are at a dramatically higher risk to develop obesity and type II diabetes, which affect 250 million and 150 million people worldwide, respectively, than non-insulin resistant people.
Celgene has a major drug discovery program focused on developing novel small molecule therapies to modulate the JNK signaling pathway. These efforts have resulted in the successful development of multiple series of proprietary JNK inhibitors. The lead Celgene JNK inhibitor, CC-401, successfully completed a Phase I, double-blind, placebo controlled, ascending single intravenous dose study in healthy human volunteers. In addition, Celgene has advanced several JNK drug leads to testing in in vivo models of diabetes, stroke, rheumatoid arthritis, organ transplantation, asthma and cancer. The compounds have demonstrated significant activity in each preclinical disease model and were well tolerated in these studies. In a mouse model of diabetes and obesity, an orally administered JNK inhibitor lowered blood glucose levels, decreased urine output and slowed body weight gain. The compound also appeared to improve the viability of the islet cells of the pancreas responsible for insulin secretion. Celgene expects to advance the development of CC-401 and additional novel JNK inhibitors in a broad range of chronic and acute diseases including diabetes and obesity.
`Data has recently emerged on the central role of the JNK pathway in insulin resistance and the subsequent onset and progression of diabetes and obesity,`said Sol J. Barer, Ph.D., President and Chief Operating Officer of Celgene Corporation. `Our strategic licensing agreement with Tufts University strengthens our already extensive JNK intellectual property estate. We look forward to realizing the full potential of our broad pipeline of JNK inhibitors as potential therapies for insulin resistance and other metabolic disorders.`
The JNK gene regulation pathway has been shown to play an essential role in the onset and progression of a variety of important human diseases that involve inflammation, cell death, ischemia reperfusion injury and cellular proliferation. Over-activation of the JNK pathway increases expression of a broad set of genes, including tumor necrosis factor-alpha, interleukin-2 and gamma interferon, which are believed to be important mechanisms in autoimmune, inflammatory, cardiovascular, metabolic and neurological diseases as well as cancer.
Celgene has a dominant and expanding intellectual property estate covering the JNK pathway and JNK genes, JNK polypeptides and proteins, expression systems for protein production, JNK screening technology, JNK targets and therapeutic uses of molecules modulating JNK activity. This patent estate comprises one pending and twelve issued U.S. patents and eight foreign patents through licenses with the University of California, the University of Massachusetts, Tufts University and patents held by Celgene. The Company`s comprehensive JNK patent portfolio is expected to expand further as Celgene has various pending U.S. and foreign patent applications. Celgene has not licensed any rights to its JNK program to date, retaining exclusive worldwide rights for all disease indications.
Celgene Corporation, headquartered in Warren, New Jersey, is an integrated biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company`s website at www.celgene.com.
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company`s control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company`s filings with the Securities and Exchange Commission such as 10K, 10Q and 8K reports.
SOURCE Celgene Corporation
Robert J. Hugin, Senior VP and CFO, of Celgene Corporation, +1-732-271-4102
http://www.celgene.com
Copyright (C) 2003 PR Newswire. All rights reserved.
JS200
Data on THALOMID(R) in Every Stage of Multiple Myeloma to be Presented at Ninth International Myeloma Workshop
via COMTEX
May 22, 2003
WARREN, N.J., May 22, 2003 /PRNewswire-FirstCall via COMTEX/ --
Celgene Corporation (Nasdaq: CELG) announced today that clinical investigators from leading cancer research centers around the world will present data from clinical trials of THALOMID(R) (thalidomide) at the Ninth International Myeloma Workshop in Salamanca, Spain from May 23-27, 2003. The investigators will discuss data on THALOMID in all stages of multiple myeloma including smoldering or indolent, newly diagnosed, relapsed or refractory, salvage and as induction therapy before a stem cell transplant. Sixty-nine abstracts focus on THALOMID or the IMiDs and will be presented during the general sessions and during a Celgene-sponsored Focused Symposium held on Friday, May 23, 2003.
The following abstracts will be highlights of the general sessions and the Celgene Focused Symposium:
* Friday, May 23 at 11:00 a.m. Thalidomide in Newly Diagnosed Patients: Overview of Smoldering/Indolent Data Dr. S. Vincent Rajkumar Mayo Clinic * Friday, May 23 at 11:30 a.m. Role of Immunomodulatory Drugs in Multiple Myeloma Dr. Kenneth Anderson Dana-Farber Cancer Institute * Saturday, May 24 Poster Session Thalidomide-Dexamethasone as Primary Therapy for Multiple Myeloma of High Tumor Mass Dr. Donna Weber M.D. Anderson Cancer Center * Saturday, May 24 Poster Session Thalidomide and Oral Melphalan Compared to Thalidomide Alone in Patients with Advanced Multiple Myeloma Dr. Massimo Offidani Regional Hospital of Turrets, Italy * Saturday, May 24 Poster Session Low-dose Thalidomide and Dexamethasone in Multiple Myeloma Patients Dr. A. Palumbo University of Turin, Italy * Saturday, May 24 Poster Session Long-term Treatment with Low-dose Thalidomide in Refractory Multiple Myeloma: Preliminary Results Dr. A. Alegre Hospital Universitario de la Princesa, Spain * Saturday, May 24 Poster Session Maintenance or Salvage Therapy with Thalidomide Following Autologous Hematopoietic Progenitor Cell Transplantation for Multiple Myeloma Dr. S. Lonial Winship Cancer Institute * Tuesday, May 27 at 8:20 a.m. Results of Thalidomide and IMiDs in Multiple Myeloma Dr. Meletios A. Dimopoulos University of Athens School of Medicine, Greece
Safety Notice
If thalidomide is taken during pregnancy, it can cause severe birth defects or death to an unborn baby. Thalidomide should never be used by women who are pregnant or who could become pregnant while taking the drug. Even a single dose, one capsule (50 mg, 100 mg and 200 mg), taken by a pregnant woman can cause severe birth defects. Because thalidomide is present in the semen of male patients, males receiving thalidomide must always use a latex condom during sexual contact with women of childbearing potential even if he has undergone a successful vasectomy. Thalidomide can only be marketed under a special restricted distribution program. This program is called the `System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.(R)). Under this program, only registered prescribers and pharmacists may dispense the drug. In addition, patients must be advised of, agree to and comply with the requirements of S.T.E.P.S.
Thalidomide is known to cause nerve damage that may be permanent. Peripheral neuropathy is a common, potentially severe, side effect of treatment with thalidomide that may be irreversible. Decreased white blood cell counts, including neutropenia, have been reported in the clinical use of thalidomide. In placebo controlled clinical trials of HIV-seropositive patient populations, there have been reports of increased plasma HIV RNA levels associated with thalidomide therapy. The most common adverse events observed in clinical use in ENL and HIV-seropositive patient populations are rash, maculo-papular rash, drowsiness/somnolence, peripheral neuropathy, dizziness/orthostatic hypotension, neutropenia, and increased HIV-viral load. Patients should be advised about these associated adverse events and routinely monitored by a physician during treatment with thalidomide.
THALOMID (thalidomide), manufactured by Celgene Corporation, received U.S. Food and Drug Administration (FDA) clearance on July 16, 1998 for the acute treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence. THALOMID is not indicated as monotherapy for ENL treatment in the presence of moderate to severe neuritis.
Celgene Corporation, headquartered in Warren, New Jersey, is an integrated biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company`s website at www.celgene.com.
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company`s control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company`s filings with the Securities and Exchange Commission such as 10K, 10Q and 8K reports.
SOURCE Celgene Corporation
Robert J. Hugin, Senior VP and CFO of Celgene Corporation, +1-732-271-4102
http://www.celgene.com
Copyright (C) 2003 PR Newswire. All rights reserved.
JS200
via COMTEX
May 22, 2003
WARREN, N.J., May 22, 2003 /PRNewswire-FirstCall via COMTEX/ --
Celgene Corporation (Nasdaq: CELG) announced today that clinical investigators from leading cancer research centers around the world will present data from clinical trials of THALOMID(R) (thalidomide) at the Ninth International Myeloma Workshop in Salamanca, Spain from May 23-27, 2003. The investigators will discuss data on THALOMID in all stages of multiple myeloma including smoldering or indolent, newly diagnosed, relapsed or refractory, salvage and as induction therapy before a stem cell transplant. Sixty-nine abstracts focus on THALOMID or the IMiDs and will be presented during the general sessions and during a Celgene-sponsored Focused Symposium held on Friday, May 23, 2003.
The following abstracts will be highlights of the general sessions and the Celgene Focused Symposium:
* Friday, May 23 at 11:00 a.m. Thalidomide in Newly Diagnosed Patients: Overview of Smoldering/Indolent Data Dr. S. Vincent Rajkumar Mayo Clinic * Friday, May 23 at 11:30 a.m. Role of Immunomodulatory Drugs in Multiple Myeloma Dr. Kenneth Anderson Dana-Farber Cancer Institute * Saturday, May 24 Poster Session Thalidomide-Dexamethasone as Primary Therapy for Multiple Myeloma of High Tumor Mass Dr. Donna Weber M.D. Anderson Cancer Center * Saturday, May 24 Poster Session Thalidomide and Oral Melphalan Compared to Thalidomide Alone in Patients with Advanced Multiple Myeloma Dr. Massimo Offidani Regional Hospital of Turrets, Italy * Saturday, May 24 Poster Session Low-dose Thalidomide and Dexamethasone in Multiple Myeloma Patients Dr. A. Palumbo University of Turin, Italy * Saturday, May 24 Poster Session Long-term Treatment with Low-dose Thalidomide in Refractory Multiple Myeloma: Preliminary Results Dr. A. Alegre Hospital Universitario de la Princesa, Spain * Saturday, May 24 Poster Session Maintenance or Salvage Therapy with Thalidomide Following Autologous Hematopoietic Progenitor Cell Transplantation for Multiple Myeloma Dr. S. Lonial Winship Cancer Institute * Tuesday, May 27 at 8:20 a.m. Results of Thalidomide and IMiDs in Multiple Myeloma Dr. Meletios A. Dimopoulos University of Athens School of Medicine, Greece
Safety Notice
If thalidomide is taken during pregnancy, it can cause severe birth defects or death to an unborn baby. Thalidomide should never be used by women who are pregnant or who could become pregnant while taking the drug. Even a single dose, one capsule (50 mg, 100 mg and 200 mg), taken by a pregnant woman can cause severe birth defects. Because thalidomide is present in the semen of male patients, males receiving thalidomide must always use a latex condom during sexual contact with women of childbearing potential even if he has undergone a successful vasectomy. Thalidomide can only be marketed under a special restricted distribution program. This program is called the `System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.(R)). Under this program, only registered prescribers and pharmacists may dispense the drug. In addition, patients must be advised of, agree to and comply with the requirements of S.T.E.P.S.
Thalidomide is known to cause nerve damage that may be permanent. Peripheral neuropathy is a common, potentially severe, side effect of treatment with thalidomide that may be irreversible. Decreased white blood cell counts, including neutropenia, have been reported in the clinical use of thalidomide. In placebo controlled clinical trials of HIV-seropositive patient populations, there have been reports of increased plasma HIV RNA levels associated with thalidomide therapy. The most common adverse events observed in clinical use in ENL and HIV-seropositive patient populations are rash, maculo-papular rash, drowsiness/somnolence, peripheral neuropathy, dizziness/orthostatic hypotension, neutropenia, and increased HIV-viral load. Patients should be advised about these associated adverse events and routinely monitored by a physician during treatment with thalidomide.
THALOMID (thalidomide), manufactured by Celgene Corporation, received U.S. Food and Drug Administration (FDA) clearance on July 16, 1998 for the acute treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence. THALOMID is not indicated as monotherapy for ENL treatment in the presence of moderate to severe neuritis.
Celgene Corporation, headquartered in Warren, New Jersey, is an integrated biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company`s website at www.celgene.com.
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company`s control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company`s filings with the Securities and Exchange Commission such as 10K, 10Q and 8K reports.
SOURCE Celgene Corporation
Robert J. Hugin, Senior VP and CFO of Celgene Corporation, +1-732-271-4102
http://www.celgene.com
Copyright (C) 2003 PR Newswire. All rights reserved.
JS200
da schau man sich doch mal den umsatz und den kurs an der nasdaq an
usd 35,39!!!
usd 35,39!!!
Mein Kursziel kommt immer näher !!!!!
hihihihihi
JS200
hihihihihi
JS200
MOVER(+): CELG Shares Spike After Rumor of AMGN Merger
Tuesday , May 27, 2003 13:13 ET
Shares of Celgene Corporation (NasdaqNM: CELG) are spiking higher in the session at this time. Traders have been speculating about a possible merger between CELG and Amgen Inc. (NasdaqNM: AMGN). Shares of AMGN are trading higher in the session as well.
JS200
Tuesday , May 27, 2003 13:13 ET
Shares of Celgene Corporation (NasdaqNM: CELG) are spiking higher in the session at this time. Traders have been speculating about a possible merger between CELG and Amgen Inc. (NasdaqNM: AMGN). Shares of AMGN are trading higher in the session as well.
JS200
RAiDAR alerts Learn More About RAiDAR-LT
05/27/2003 (13:13 ET) MOVER(+): CELG Shares Spike After Rumor of AMGN Merger - Knobias
05/27/2003 (13:11 ET) VOLUME(+): CELG Volume 61% > 20-adsv, Stock +14.79% - Knobias
05/27/2003 (12:56 ET) 52W HIGH: New 52-Wk High for CELG @ $34.030 up9.42% - Knobias
05/22/2003 (12:12 ET) RATING(1): JMP Sec Initiates CELG Rating @ Mkt Outperform - Knobias
05/22/2003 (07:30 ET) Data on THALOMID(R) in Every Stage of Multiple Myeloma to be Presented at Ninth International Myeloma Workshop - PR Newswire
05/21/2003 (09:20 ET) SECTOR(HCR): Morgan Stanley Cuts Biotech Sector - Knobias
05/21/2003 (07:37 ET) Celgene JNK Intellectual Property Estate Broadened With Tufts University Agreement - PR Newswire
05/19/2003 (15:57 ET) RATING(=): USB Piper Reiterates CELG Rating @ Outperform - Knobias
05/19/2003 (10:32 ET) SECTOR(HCR): Biotechs Fairing Well Today, Led by DNA - Knobias
05/19/2003 (09:56 ET) 52W HIGH: New 52-Wk High for CELG @ $32.493 up3.22% - Knobias
05/19/2003 (08:02 ET) Wyeth Research, AEterna Laboratories, Antigenics, and Celgene All to Introduce Novel Therapies to Expand Renal Cancer Drug Market - PR Newswire
05/15/2003 (17:28 ET) New 10-Q just released for CELG - Edgar
05/15/2003 (09:48 ET) 52W HIGH: New 52-Wk High for CELG @ $32.250 up8.08% - Knobias
05/15/2003 (08:40 ET) New REVIMID(TM) Clinical Data Shows Potential as Novel Approach to Treating Myelodysplastic Syndromes (MDS) - PR Newswire
05/14/2003 (13:06 ET) 52W HIGH: New 52-Wk High for CELG @ $30.240 up4.89% - Knobias
05/14/2003 (10:56 ET) VOLUME(+): CELG Volume 12% > 20-adsv, Stock +1.98% - Knobias
05/14/2003 (09:39 ET) RATING(=): Adams Harkness Reiterates CELG Rating @ Strong Buy - Knobias
05/13/2003 (07:38 ET) Celgene Broadens S.T.E.P.S.(R) Intellectual Property Estate With Issuance of Two Fundamental U.S. Patents - PR Newswire
05/06/2003 (14:24 ET) SECTOR(HCR): Biotechs Remain Red for Most of Day - Knobias
05/06/2003 (11:56 ET) 52W HIGH: New 52-Wk High for CELG @ $30.150 up9.08% - Knobias
05/01/2003 (16:02 ET) CONF: CELG To Present At NASDAQ Life Sciences Conference @ 18:35 ET - Knobias
05/01/2003 (07:15 ET) DEF 14A: CELG Vote; Directors; Auditor; Stock Op Plan - Knobias
04/30/2003 (16:04 ET) New DEF 14A just released for CELG - Edgar
JS200
05/27/2003 (13:13 ET) MOVER(+): CELG Shares Spike After Rumor of AMGN Merger - Knobias
05/27/2003 (13:11 ET) VOLUME(+): CELG Volume 61% > 20-adsv, Stock +14.79% - Knobias
05/27/2003 (12:56 ET) 52W HIGH: New 52-Wk High for CELG @ $34.030 up9.42% - Knobias
05/22/2003 (12:12 ET) RATING(1): JMP Sec Initiates CELG Rating @ Mkt Outperform - Knobias
05/22/2003 (07:30 ET) Data on THALOMID(R) in Every Stage of Multiple Myeloma to be Presented at Ninth International Myeloma Workshop - PR Newswire
05/21/2003 (09:20 ET) SECTOR(HCR): Morgan Stanley Cuts Biotech Sector - Knobias
05/21/2003 (07:37 ET) Celgene JNK Intellectual Property Estate Broadened With Tufts University Agreement - PR Newswire
05/19/2003 (15:57 ET) RATING(=): USB Piper Reiterates CELG Rating @ Outperform - Knobias
05/19/2003 (10:32 ET) SECTOR(HCR): Biotechs Fairing Well Today, Led by DNA - Knobias
05/19/2003 (09:56 ET) 52W HIGH: New 52-Wk High for CELG @ $32.493 up3.22% - Knobias
05/19/2003 (08:02 ET) Wyeth Research, AEterna Laboratories, Antigenics, and Celgene All to Introduce Novel Therapies to Expand Renal Cancer Drug Market - PR Newswire
05/15/2003 (17:28 ET) New 10-Q just released for CELG - Edgar
05/15/2003 (09:48 ET) 52W HIGH: New 52-Wk High for CELG @ $32.250 up8.08% - Knobias
05/15/2003 (08:40 ET) New REVIMID(TM) Clinical Data Shows Potential as Novel Approach to Treating Myelodysplastic Syndromes (MDS) - PR Newswire
05/14/2003 (13:06 ET) 52W HIGH: New 52-Wk High for CELG @ $30.240 up4.89% - Knobias
05/14/2003 (10:56 ET) VOLUME(+): CELG Volume 12% > 20-adsv, Stock +1.98% - Knobias
05/14/2003 (09:39 ET) RATING(=): Adams Harkness Reiterates CELG Rating @ Strong Buy - Knobias
05/13/2003 (07:38 ET) Celgene Broadens S.T.E.P.S.(R) Intellectual Property Estate With Issuance of Two Fundamental U.S. Patents - PR Newswire
05/06/2003 (14:24 ET) SECTOR(HCR): Biotechs Remain Red for Most of Day - Knobias
05/06/2003 (11:56 ET) 52W HIGH: New 52-Wk High for CELG @ $30.150 up9.08% - Knobias
05/01/2003 (16:02 ET) CONF: CELG To Present At NASDAQ Life Sciences Conference @ 18:35 ET - Knobias
05/01/2003 (07:15 ET) DEF 14A: CELG Vote; Directors; Auditor; Stock Op Plan - Knobias
04/30/2003 (16:04 ET) New DEF 14A just released for CELG - Edgar
JS200
THALOMID(R) Evaluated in Every Stage of Multiple Myeloma Presented at Ninth International Myeloma Workshop
via COMTEX
May 28, 2003
SALAMANCA, Spain, May 28, 2003 /PRNewswire-FirstCall via COMTEX/ --
Celgene Corporation (Nasdaq: CELG) -- Clinical investigators from leading cancer research centers around the world presented data from sixty-nine clinical trials of THALOMID(R) (thalidomide) and REVIMID(TM) (CC-5013) in multiple myeloma at the Ninth International Myeloma Workshop. The investigators discussed their evaluations of THALOMID as both a single agent and in combination therapy in every stage of multiple myeloma.
`The MMRF is committed to accelerating the search for medically meaningful therapies that target the cause of multiple myeloma rather than managing its symptoms,`said Kathy Giusti, president, Multiple Myeloma Research Foundation (MMRF) and a myeloma patient.
Thalidomide Plus Dexamethasone as Primary Therapy for Multiple Myeloma of
High Tumor Mass
Dr. Donna Weber from M.D. Anderson Cancer Center initiated a Phase II trial of thalidomide in combination with dexamethasone in 17 newly diagnosed multiple myeloma patients with high tumor mass (Hgb lesser than or equal to 8.5 gm/dl or calcium > 11.5 mg/dl). Patients received 150-200 mg/day of thalidomide and 20 mg/m2 of dexamethasone on days 1-4, 9-12 and 17-20. Results were compared with those observed in 50 matched patients with high tumor mass who received high-dose cyclophosphamide with VAD (HCVAD) by continuous infusion through a central venous catheter. With both treatment regimens, early deaths occurred in six percent of patients. All patients who received HCVAD therapy experienced grade four neutropenia, which required hospitalization in 20 percent of patients, and 70 percent of patients experienced grades three or four thromocytopenia. Patients who received thalidomide plus dexamethasone combination therapy did not experience grade three or four neutropenia or thrombocytopenia. Three patients who received thalidomide plus dexamethasone therapy required hospitalization for nonneutropenic infections. Response rates for each regimen were similar: 71 percent of patients who received thalidomide plus dexamethasone therapy responded to treatment compared to 67 percent of patients who received HCVAD therapy. Two patients in each group experienced a complete response to therapy.
Thalidomide in Newly Diagnosed Patients with Smoldering/Indolent Multiple
Myeloma
Dr. S. Vincent Rajkumar of the Mayo Clinic conducted a Phase II clinical trial of thalidomide monotherapy in 31 patients with asymptomatic multiple myeloma. The current standard of care for patients with smoldering multiple myeloma is to delay therapy until symptomatic disease occurs. Dr. Rajkumar initiated this Phase II trial to investigate if thalidomide may be effective in delaying progression from asymptomatic to symptomatic multiple myeloma. Thirty-two patients were initiated at a thalidomide dose of 200 mg/day and escalated to 800 mg/day as tolerated. If necessary, the daily thalidomide dose was lower than 200 mg/day to minimize toxicity. Of 29 evaluable patients, ten patients (34 percent) experienced at least a 50 percent reduction in serum and urine monoclonal protein. Nineteen patients (66 percent) experienced at least a 25 percent reduction in serum and urine monoclonal protein. Kaplan-Meier estimates of progression free survival are 80 percent for year one and 63 percent for year two. Grade three and four toxicities included neuropathy, deep vein thrombosis, hearing loss, weakness, sinus bradycardia and edema. Grade one and two neuropathy, sedation and constipation were also observed.
Thalidomide Plus Dexamethasone Versus Conventional Chemotherapy in
Advanced Multiple Myeloma
Clinical investigators conducted a case-matched control analysis to compare response rate and clinical outcome of thalidomide plus dexamethasone combination therapy versus conventional chemotherapy in patients with advanced multiple myeloma. A group of 120 patients who had relapsed or were refractory to chemotherapy were administered 100 mg/day of thalidomide plus 40 mg of dexamethasone days one through four of each month. The investigators compared the clinical outcome of these 120 patients to a control group of 120 relapsed or refractory patients treated with conventional chemotherapy who were matched for serum levels and the clinical stage of their multiple myeloma. In patients who had previously received one line of chemotherapy, 56 percent of patients in the thalidomide plus dexamethasone arm achieved a greater than 50 percent reduction in myeloma protein levels compared to 46 percent of patients in the conventional chemotherapy arm. The probability of progression free survival for three years was 38 percent after thalidomide plus dexamethasone therapy and six percent after conventional chemotherapy (p<0.0024). In patients who had received two or more lines of chemotherapy, 46 percent of patients in the thalidomide plus dexamethasone arm achieved a greater than 50 percent reduction in myeloma protein levels compared to 42 percent of patients in the conventional chemotherapy arm. The probability of progression free survival for three years was 11 percent after thalidomide plus dexamethasone therapy and three percent after conventional chemotherapy (p<0.23). Constipation, sedation, confusion, tingling and numbness and tremors were the most commonly observed adverse events. Most adverse events were grade one with twelve and four percent of patients experiencing grade two and three side effects, respectively. Eighteen percent of patients required dose reduction, mostly due to neurologic toxicity.
Thalidomide Plus Melphalan Versus Thalidomide Alone in Multiple Myeloma
Patients
Dr. Massimo Offidani of the Regional Hospital of Turrets, Italy initiated a trial of thalidomide versus thalidomide plus oral melphalan in multiple myeloma patients. Twenty-three patients received thalidomide monotherapy of 100 mg/day that was escalated weekly by 100 mg increments until a maximum tolerated dose of 600 mg. Twenty-seven patients received thalidomide and melphalan combination therapy of the same thalidomide regimen plus 0.20 mg/kg/day of melphalan everyday for four days every 28 days. Sixty-three percent of patients in the thalidomide plus melphalan arm achieved a greater than 50 percent reduction in paraprotein levels compared to 26 percent of patients in the thalidomide alone arm who achieved the same paraprotein reduction (p=0.009). Four patients (15 percent) in the combination therapy arm achieved a greater than 75 percent reduction in paraprotein levels compared to one patient (four percent) in the thalidomide monotherapy arm. Progression free survival at two years was significantly higher for the thalidomide plus melphalan arm compared to the thalidomide monotherapy arm (61 percent vs. 45 percent, p=0.0356). The most common side effected attributable to thalidomide were constipation, somnolence, asthenia and peripheral neuropathy.
Safety Notice
If thalidomide is taken during pregnancy, it can cause severe birth defects or death to an unborn baby. Thalidomide should never be used by women who are pregnant or who could become pregnant while taking the drug. Even a single dose, one capsule (50 mg, 100 mg and 200 mg), taken by a pregnant woman can cause severe birth defects. Because thalidomide is present in the semen of male patients, males receiving thalidomide must always use a latex condom during sexual contact with women of childbearing potential even if he has undergone a successful vasectomy. Thalidomide can only be marketed under a special restricted distribution program. This program is called the `System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.(R)). Under this program, only registered prescribers and pharmacists may dispense the drug. In addition, patients must be advised of, agree to and comply with the requirements of S.T.E.P.S.
Thalidomide is known to cause nerve damage that may be permanent. Peripheral neuropathy is a common, potentially severe, side effect of treatment with thalidomide that may be irreversible. Decreased white blood cell counts, including neutropenia, have been reported in the clinical use of thalidomide. In placebo controlled clinical trials of HIV-seropositive patient populations, there have been reports of increased plasma HIV RNA levels associated with thalidomide therapy. The most common adverse events observed in clinical use in ENL and HIV-seropositive patient populations are rash, maculo-papular rash, drowsiness/somnolence, peripheral neuropathy, dizziness/orthostatic hypotension, neutropenia, and increased HIV-viral load. Patients should be advised about these associated adverse events and routinely monitored by a physician during treatment with thalidomide.
THALOMID (thalidomide), manufactured by Celgene Corporation, received U.S. Food and Drug Administration (FDA) clearance on July 16, 1998 for the acute treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence. THALOMID is not indicated as monotherapy for ENL treatment in the presence of moderate to severe neuritis.
Celgene Corporation, headquartered in Warren, New Jersey, is an integrated biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company`s website at www.celgene.com.
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company`s control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company`s filings with the Securities and Exchange Commission such as 10K, 10Q and 8K reports.
SOURCE Celgene Corporation
Robert J. Hugin, Senior VP and CFO of Celgene Corporation, +1-732-271-4102
http://www.celgene.com
Copyright (C) 2003 PR Newswire. All rights reserved.
JS200
via COMTEX
May 28, 2003
SALAMANCA, Spain, May 28, 2003 /PRNewswire-FirstCall via COMTEX/ --
Celgene Corporation (Nasdaq: CELG) -- Clinical investigators from leading cancer research centers around the world presented data from sixty-nine clinical trials of THALOMID(R) (thalidomide) and REVIMID(TM) (CC-5013) in multiple myeloma at the Ninth International Myeloma Workshop. The investigators discussed their evaluations of THALOMID as both a single agent and in combination therapy in every stage of multiple myeloma.
`The MMRF is committed to accelerating the search for medically meaningful therapies that target the cause of multiple myeloma rather than managing its symptoms,`said Kathy Giusti, president, Multiple Myeloma Research Foundation (MMRF) and a myeloma patient.
Thalidomide Plus Dexamethasone as Primary Therapy for Multiple Myeloma of
High Tumor Mass
Dr. Donna Weber from M.D. Anderson Cancer Center initiated a Phase II trial of thalidomide in combination with dexamethasone in 17 newly diagnosed multiple myeloma patients with high tumor mass (Hgb lesser than or equal to 8.5 gm/dl or calcium > 11.5 mg/dl). Patients received 150-200 mg/day of thalidomide and 20 mg/m2 of dexamethasone on days 1-4, 9-12 and 17-20. Results were compared with those observed in 50 matched patients with high tumor mass who received high-dose cyclophosphamide with VAD (HCVAD) by continuous infusion through a central venous catheter. With both treatment regimens, early deaths occurred in six percent of patients. All patients who received HCVAD therapy experienced grade four neutropenia, which required hospitalization in 20 percent of patients, and 70 percent of patients experienced grades three or four thromocytopenia. Patients who received thalidomide plus dexamethasone combination therapy did not experience grade three or four neutropenia or thrombocytopenia. Three patients who received thalidomide plus dexamethasone therapy required hospitalization for nonneutropenic infections. Response rates for each regimen were similar: 71 percent of patients who received thalidomide plus dexamethasone therapy responded to treatment compared to 67 percent of patients who received HCVAD therapy. Two patients in each group experienced a complete response to therapy.
Thalidomide in Newly Diagnosed Patients with Smoldering/Indolent Multiple
Myeloma
Dr. S. Vincent Rajkumar of the Mayo Clinic conducted a Phase II clinical trial of thalidomide monotherapy in 31 patients with asymptomatic multiple myeloma. The current standard of care for patients with smoldering multiple myeloma is to delay therapy until symptomatic disease occurs. Dr. Rajkumar initiated this Phase II trial to investigate if thalidomide may be effective in delaying progression from asymptomatic to symptomatic multiple myeloma. Thirty-two patients were initiated at a thalidomide dose of 200 mg/day and escalated to 800 mg/day as tolerated. If necessary, the daily thalidomide dose was lower than 200 mg/day to minimize toxicity. Of 29 evaluable patients, ten patients (34 percent) experienced at least a 50 percent reduction in serum and urine monoclonal protein. Nineteen patients (66 percent) experienced at least a 25 percent reduction in serum and urine monoclonal protein. Kaplan-Meier estimates of progression free survival are 80 percent for year one and 63 percent for year two. Grade three and four toxicities included neuropathy, deep vein thrombosis, hearing loss, weakness, sinus bradycardia and edema. Grade one and two neuropathy, sedation and constipation were also observed.
Thalidomide Plus Dexamethasone Versus Conventional Chemotherapy in
Advanced Multiple Myeloma
Clinical investigators conducted a case-matched control analysis to compare response rate and clinical outcome of thalidomide plus dexamethasone combination therapy versus conventional chemotherapy in patients with advanced multiple myeloma. A group of 120 patients who had relapsed or were refractory to chemotherapy were administered 100 mg/day of thalidomide plus 40 mg of dexamethasone days one through four of each month. The investigators compared the clinical outcome of these 120 patients to a control group of 120 relapsed or refractory patients treated with conventional chemotherapy who were matched for serum levels and the clinical stage of their multiple myeloma. In patients who had previously received one line of chemotherapy, 56 percent of patients in the thalidomide plus dexamethasone arm achieved a greater than 50 percent reduction in myeloma protein levels compared to 46 percent of patients in the conventional chemotherapy arm. The probability of progression free survival for three years was 38 percent after thalidomide plus dexamethasone therapy and six percent after conventional chemotherapy (p<0.0024). In patients who had received two or more lines of chemotherapy, 46 percent of patients in the thalidomide plus dexamethasone arm achieved a greater than 50 percent reduction in myeloma protein levels compared to 42 percent of patients in the conventional chemotherapy arm. The probability of progression free survival for three years was 11 percent after thalidomide plus dexamethasone therapy and three percent after conventional chemotherapy (p<0.23). Constipation, sedation, confusion, tingling and numbness and tremors were the most commonly observed adverse events. Most adverse events were grade one with twelve and four percent of patients experiencing grade two and three side effects, respectively. Eighteen percent of patients required dose reduction, mostly due to neurologic toxicity.
Thalidomide Plus Melphalan Versus Thalidomide Alone in Multiple Myeloma
Patients
Dr. Massimo Offidani of the Regional Hospital of Turrets, Italy initiated a trial of thalidomide versus thalidomide plus oral melphalan in multiple myeloma patients. Twenty-three patients received thalidomide monotherapy of 100 mg/day that was escalated weekly by 100 mg increments until a maximum tolerated dose of 600 mg. Twenty-seven patients received thalidomide and melphalan combination therapy of the same thalidomide regimen plus 0.20 mg/kg/day of melphalan everyday for four days every 28 days. Sixty-three percent of patients in the thalidomide plus melphalan arm achieved a greater than 50 percent reduction in paraprotein levels compared to 26 percent of patients in the thalidomide alone arm who achieved the same paraprotein reduction (p=0.009). Four patients (15 percent) in the combination therapy arm achieved a greater than 75 percent reduction in paraprotein levels compared to one patient (four percent) in the thalidomide monotherapy arm. Progression free survival at two years was significantly higher for the thalidomide plus melphalan arm compared to the thalidomide monotherapy arm (61 percent vs. 45 percent, p=0.0356). The most common side effected attributable to thalidomide were constipation, somnolence, asthenia and peripheral neuropathy.
Safety Notice
If thalidomide is taken during pregnancy, it can cause severe birth defects or death to an unborn baby. Thalidomide should never be used by women who are pregnant or who could become pregnant while taking the drug. Even a single dose, one capsule (50 mg, 100 mg and 200 mg), taken by a pregnant woman can cause severe birth defects. Because thalidomide is present in the semen of male patients, males receiving thalidomide must always use a latex condom during sexual contact with women of childbearing potential even if he has undergone a successful vasectomy. Thalidomide can only be marketed under a special restricted distribution program. This program is called the `System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.(R)). Under this program, only registered prescribers and pharmacists may dispense the drug. In addition, patients must be advised of, agree to and comply with the requirements of S.T.E.P.S.
Thalidomide is known to cause nerve damage that may be permanent. Peripheral neuropathy is a common, potentially severe, side effect of treatment with thalidomide that may be irreversible. Decreased white blood cell counts, including neutropenia, have been reported in the clinical use of thalidomide. In placebo controlled clinical trials of HIV-seropositive patient populations, there have been reports of increased plasma HIV RNA levels associated with thalidomide therapy. The most common adverse events observed in clinical use in ENL and HIV-seropositive patient populations are rash, maculo-papular rash, drowsiness/somnolence, peripheral neuropathy, dizziness/orthostatic hypotension, neutropenia, and increased HIV-viral load. Patients should be advised about these associated adverse events and routinely monitored by a physician during treatment with thalidomide.
THALOMID (thalidomide), manufactured by Celgene Corporation, received U.S. Food and Drug Administration (FDA) clearance on July 16, 1998 for the acute treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence. THALOMID is not indicated as monotherapy for ENL treatment in the presence of moderate to severe neuritis.
Celgene Corporation, headquartered in Warren, New Jersey, is an integrated biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company`s website at www.celgene.com.
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company`s control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company`s filings with the Securities and Exchange Commission such as 10K, 10Q and 8K reports.
SOURCE Celgene Corporation
Robert J. Hugin, Senior VP and CFO of Celgene Corporation, +1-732-271-4102
http://www.celgene.com
Copyright (C) 2003 PR Newswire. All rights reserved.
JS200
kann mir einmal einer sagen, warum die jetzt eine wandelanleihe in höhe non 300 mio usd begeben wollen?
eigentlich haben die doch cash genug, oder?
aber vielleicht haben die ja großes vor, übernahme o. ä.?
eigentlich haben die doch cash genug, oder?
aber vielleicht haben die ja großes vor, übernahme o. ä.?
RAiDAR alerts Learn More About RAiDAR-LT
05/29/2003 (16:12 ET) Schaeffer`s Market Observation Features BBH, GILD, ICOS, CELG - PR Newswire
05/29/2003 (16:08 ET) Schaeffer`s Market Observation Features BBH, GILD, ICOS, CELG - PR Newswire
05/29/2003 (16:05 ET) Schaeffer`s Market Observation Features BBH, GILD, ICOS, CELG - PR Newswire
05/29/2003 (16:04 ET) Schaeffer`s Market Observation Features BBH, GILD, ICOS, CELG - PR Newswire
05/29/2003 (16:04 ET) Schaeffer`s Market Observation Features BBH, GILD, ICOS, CELG - PR Newswire
05/29/2003 (10:41 ET) MOVER(-): CELG Offers $325M of Convertable Notes - Knobias
05/29/2003 (10:07 ET) VOLUME(-): CELG Volume 6% > 20-adsv, Stock -3.10% - Knobias
05/29/2003 (08:30 ET) Celgene Corporation Announces Pricing of $325 Million Convertible Note Offering - PR Newswire
05/28/2003 (20:14 ET) Ventura County Star, Calif., Business Briefs Column - Knight Ridder
05/28/2003 (16:01 ET) Celgene Corporation Announces Proposed $300 Million Convertible Notes Offering - PR Newswire
05/28/2003 (13:31 ET) CELG: Short Interest UP 11.6% to 6.2M in May 2003 - Knobias
05/28/2003 (09:29 ET) MORNING UPDATE: Man Securities Issues Alerts AMGN, CELG, COST, MIMS, And TOL - PR Newswire
05/28/2003 (08:34 ET) THALOMID(R) Evaluated in Every Stage of Multiple Myeloma Presented at Ninth International Myeloma Workshop - PR Newswire
05/28/2003 (07:32 ET) CONF: CELG To Present At FBR Tech & Growth Conference @ 09:20 ET - Knobias
05/27/2003 (13:13 ET) MOVER(+): CELG Shares Spike After Rumor of AMGN Merger - Knobias
05/27/2003 (13:11 ET) VOLUME(+): CELG Volume 61% > 20-adsv, Stock +14.79% - Knobias
05/27/2003 (12:56 ET) 52W HIGH: New 52-Wk High for CELG @ $34.030 up9.42% - Knobias
05/22/2003 (12:12 ET) RATING(1): JMP Sec Initiates CELG Rating @ Mkt Outperform - Knobias
05/22/2003 (07:30 ET) Data on THALOMID(R) in Every Stage of Multiple Myeloma to be Presented at Ninth International Myeloma Workshop - PR Newswire
05/21/2003 (09:20 ET) SECTOR(HCR): Morgan Stanley Cuts Biotech Sector - Knobias
05/21/2003 (07:37 ET) Celgene JNK Intellectual Property Estate Broadened With Tufts University Agreement - PR Newswire
05/19/2003 (15:57 ET) RATING(=): USB Piper Reiterates CELG Rating @ Outperform - Knobias
05/19/2003 (10:32 ET) SECTOR(HCR): Biotechs Fairing Well Today, Led by DNA - Knobias
05/19/2003 (09:56 ET) 52W HIGH: New 52-Wk High for CELG @ $32.493 up3.22% - Knobias
05/19/2003 (08:02 ET) Wyeth Research, AEterna Laboratories, Antigenics, and Celgene All to Introduce Novel Therapies to Expand Renal Cancer Drug Market - PR Newswire
JS200
05/29/2003 (16:12 ET) Schaeffer`s Market Observation Features BBH, GILD, ICOS, CELG - PR Newswire
05/29/2003 (16:08 ET) Schaeffer`s Market Observation Features BBH, GILD, ICOS, CELG - PR Newswire
05/29/2003 (16:05 ET) Schaeffer`s Market Observation Features BBH, GILD, ICOS, CELG - PR Newswire
05/29/2003 (16:04 ET) Schaeffer`s Market Observation Features BBH, GILD, ICOS, CELG - PR Newswire
05/29/2003 (16:04 ET) Schaeffer`s Market Observation Features BBH, GILD, ICOS, CELG - PR Newswire
05/29/2003 (10:41 ET) MOVER(-): CELG Offers $325M of Convertable Notes - Knobias
05/29/2003 (10:07 ET) VOLUME(-): CELG Volume 6% > 20-adsv, Stock -3.10% - Knobias
05/29/2003 (08:30 ET) Celgene Corporation Announces Pricing of $325 Million Convertible Note Offering - PR Newswire
05/28/2003 (20:14 ET) Ventura County Star, Calif., Business Briefs Column - Knight Ridder
05/28/2003 (16:01 ET) Celgene Corporation Announces Proposed $300 Million Convertible Notes Offering - PR Newswire
05/28/2003 (13:31 ET) CELG: Short Interest UP 11.6% to 6.2M in May 2003 - Knobias
05/28/2003 (09:29 ET) MORNING UPDATE: Man Securities Issues Alerts AMGN, CELG, COST, MIMS, And TOL - PR Newswire
05/28/2003 (08:34 ET) THALOMID(R) Evaluated in Every Stage of Multiple Myeloma Presented at Ninth International Myeloma Workshop - PR Newswire
05/28/2003 (07:32 ET) CONF: CELG To Present At FBR Tech & Growth Conference @ 09:20 ET - Knobias
05/27/2003 (13:13 ET) MOVER(+): CELG Shares Spike After Rumor of AMGN Merger - Knobias
05/27/2003 (13:11 ET) VOLUME(+): CELG Volume 61% > 20-adsv, Stock +14.79% - Knobias
05/27/2003 (12:56 ET) 52W HIGH: New 52-Wk High for CELG @ $34.030 up9.42% - Knobias
05/22/2003 (12:12 ET) RATING(1): JMP Sec Initiates CELG Rating @ Mkt Outperform - Knobias
05/22/2003 (07:30 ET) Data on THALOMID(R) in Every Stage of Multiple Myeloma to be Presented at Ninth International Myeloma Workshop - PR Newswire
05/21/2003 (09:20 ET) SECTOR(HCR): Morgan Stanley Cuts Biotech Sector - Knobias
05/21/2003 (07:37 ET) Celgene JNK Intellectual Property Estate Broadened With Tufts University Agreement - PR Newswire
05/19/2003 (15:57 ET) RATING(=): USB Piper Reiterates CELG Rating @ Outperform - Knobias
05/19/2003 (10:32 ET) SECTOR(HCR): Biotechs Fairing Well Today, Led by DNA - Knobias
05/19/2003 (09:56 ET) 52W HIGH: New 52-Wk High for CELG @ $32.493 up3.22% - Knobias
05/19/2003 (08:02 ET) Wyeth Research, AEterna Laboratories, Antigenics, and Celgene All to Introduce Novel Therapies to Expand Renal Cancer Drug Market - PR Newswire
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MOVER(-): CELG Offers $325M of Convertable Notes
Thursday , May 29, 2003 10:41 ET
Celgene Corporation (NasdaqNM: CELG) announced that it agreed to privately place $325 million aggregate principal amount of Convertible Notes due 2008 with an interest rate of 1.75% per annum. These Notes will be convertible into CELG common stock at a conversion price of $48.45 per share, a premium of 50% over its closing price of $32.30 on 05/28/03. Celgene expects to use the net proceeds of the offering for general corporate purposes.
JS200
Thursday , May 29, 2003 10:41 ET
Celgene Corporation (NasdaqNM: CELG) announced that it agreed to privately place $325 million aggregate principal amount of Convertible Notes due 2008 with an interest rate of 1.75% per annum. These Notes will be convertible into CELG common stock at a conversion price of $48.45 per share, a premium of 50% over its closing price of $32.30 on 05/28/03. Celgene expects to use the net proceeds of the offering for general corporate purposes.
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Ventura County Star, Calif., Business Briefs Column
Wednesday, May 28, 2003 20:14 ET
May 28, 2003 (Ventura County Star - Knight Ridder/Tribune Business News via COMTEX) -- COMPUTER SOFTWARE FIRM HITS NEW HIGH: Shares of Carpinteria-based QAD Inc. (Nasdaq: QADI) hit a 52-week high of $9.18 during trading Tuesday, closing at $8.65 with an 80-cent gain on more than seven times the normal volume.
The biotech sector saw a broad rally on speculation about potential merger and licensing agreements. TheStreet.com reported that one of the stocks was Celgene, which closed up $2.37 at $33.47 on speculation Amgen Inc. (Nasdaq: AMGN) might have its eye on the company.
The Thousand Oaks biotech company closed higher by $1.77 to $63.65.
ECOLA FEATURED ON THE HISTORY CHANNEL: Ecola Termite Services is going to be featured on the History Channel on Tuesday. The title of the program is Modern Marvels "Exterminators Then and Now."
Owned by Susan Fries, Ecola is known for alternatives for fumigation. The feature goes into detail on the Electro Gun and Heat process.
The company, with various locations including Simi Valley and Ventura, serves Los Angeles, Ventura, Santa Barbara, Riverside, San Diego, Orange and parts of San Bernardino and San Luis Obispo counties.
For more details about the company, call (800) 332-2847 or visit www.ecolatermite.com.
VETERINARY HOSPITAL RECEIVES RECOGNITION: Rancho Sequoia Veterinary Hospital has been honored by the American Animal Hospital Association for its 25-year commitment to excellence in small-animal care. The hospital was recognized on March 24 at AAHA`s 70th annual meeting in Phoenix.
Rancho Sequoia Veterinary Hospital has been an AAHA hospital member since 1978. The hospital has undergone regular evaluations by AAHA practice consultants, who visit hospitals to ensure compliance with AAHA standards in many areas of practice, from surgery to diagnostic imaging.
KANAGLEKAR OFFERS HAIR REMOVAL ALTERNATIVE: Swati Kanaglekar, a California licensed cosmetologist, is offering eyebrows and face threading. Threading is a traditional method used in the East to remove facial hair with a 100 percent cotton thread. The process does not involve chemicals.
Besides threading, Kanaglekar also specializes in Japanese-style hair straightening, color correction, hair coloring, highlighting and styles. She works at Salon 3835 in the North Ranch Mall, Westlake Village.
For more details, call Kanaglekar at 320-2568.
PRINTING FIRM EARNS AWARDS FOR CALENDAR: Ventura Printing`s 2003 12-Designer Desk Calendar won the highest award in four different categories at the National Calendar Marketing Association`s annual contest in Naperville, Ill.
The company`s calendar, Expressing Thanks, won awards for Most Original Desk Calendar, Most Creative Marketing Application, Best Contemporary Art and Best Graphic Design.
For the past 10 years, Ventura Printing has invited 12 artists and agencies to submit an image based on their chosen theme and then combine them, highlighting one artist each month. This year`s theme pointed out the need for businesspeople to take the time to say thanks more often.
The contributing artists this year were Zest.net, Shirley Howell Design, The Agency, Wolf Design, Ideocore, SB Artworks, Keating Lang, Idea Engineering, Channel Islands Design, Walters Group, 451 Media and InFocus Advertising.
The Ventura County Star publishes information on business openings, relocations and companies offering new products or services. Mail typed submissions to the business desk at the Ventura County Star, P.O. Box 6711, Ventura, CA 93006, fax to 650-2950 or e-mail to mdelatorre@insidevc.com. Please include contact name, address and telephone number. Call 645-1049 with questions.
To see more of the Ventura County Star, or to subscribe to the newspaper, go
to http://www.insidevc.com
(c) 2003, Ventura County Star, Calif. Distributed by Knight Ridder/Tribune
Business News.
JS200
Wednesday, May 28, 2003 20:14 ET
May 28, 2003 (Ventura County Star - Knight Ridder/Tribune Business News via COMTEX) -- COMPUTER SOFTWARE FIRM HITS NEW HIGH: Shares of Carpinteria-based QAD Inc. (Nasdaq: QADI) hit a 52-week high of $9.18 during trading Tuesday, closing at $8.65 with an 80-cent gain on more than seven times the normal volume.
The biotech sector saw a broad rally on speculation about potential merger and licensing agreements. TheStreet.com reported that one of the stocks was Celgene, which closed up $2.37 at $33.47 on speculation Amgen Inc. (Nasdaq: AMGN) might have its eye on the company.
The Thousand Oaks biotech company closed higher by $1.77 to $63.65.
ECOLA FEATURED ON THE HISTORY CHANNEL: Ecola Termite Services is going to be featured on the History Channel on Tuesday. The title of the program is Modern Marvels "Exterminators Then and Now."
Owned by Susan Fries, Ecola is known for alternatives for fumigation. The feature goes into detail on the Electro Gun and Heat process.
The company, with various locations including Simi Valley and Ventura, serves Los Angeles, Ventura, Santa Barbara, Riverside, San Diego, Orange and parts of San Bernardino and San Luis Obispo counties.
For more details about the company, call (800) 332-2847 or visit www.ecolatermite.com.
VETERINARY HOSPITAL RECEIVES RECOGNITION: Rancho Sequoia Veterinary Hospital has been honored by the American Animal Hospital Association for its 25-year commitment to excellence in small-animal care. The hospital was recognized on March 24 at AAHA`s 70th annual meeting in Phoenix.
Rancho Sequoia Veterinary Hospital has been an AAHA hospital member since 1978. The hospital has undergone regular evaluations by AAHA practice consultants, who visit hospitals to ensure compliance with AAHA standards in many areas of practice, from surgery to diagnostic imaging.
KANAGLEKAR OFFERS HAIR REMOVAL ALTERNATIVE: Swati Kanaglekar, a California licensed cosmetologist, is offering eyebrows and face threading. Threading is a traditional method used in the East to remove facial hair with a 100 percent cotton thread. The process does not involve chemicals.
Besides threading, Kanaglekar also specializes in Japanese-style hair straightening, color correction, hair coloring, highlighting and styles. She works at Salon 3835 in the North Ranch Mall, Westlake Village.
For more details, call Kanaglekar at 320-2568.
PRINTING FIRM EARNS AWARDS FOR CALENDAR: Ventura Printing`s 2003 12-Designer Desk Calendar won the highest award in four different categories at the National Calendar Marketing Association`s annual contest in Naperville, Ill.
The company`s calendar, Expressing Thanks, won awards for Most Original Desk Calendar, Most Creative Marketing Application, Best Contemporary Art and Best Graphic Design.
For the past 10 years, Ventura Printing has invited 12 artists and agencies to submit an image based on their chosen theme and then combine them, highlighting one artist each month. This year`s theme pointed out the need for businesspeople to take the time to say thanks more often.
The contributing artists this year were Zest.net, Shirley Howell Design, The Agency, Wolf Design, Ideocore, SB Artworks, Keating Lang, Idea Engineering, Channel Islands Design, Walters Group, 451 Media and InFocus Advertising.
The Ventura County Star publishes information on business openings, relocations and companies offering new products or services. Mail typed submissions to the business desk at the Ventura County Star, P.O. Box 6711, Ventura, CA 93006, fax to 650-2950 or e-mail to mdelatorre@insidevc.com. Please include contact name, address and telephone number. Call 645-1049 with questions.
To see more of the Ventura County Star, or to subscribe to the newspaper, go
to http://www.insidevc.com
(c) 2003, Ventura County Star, Calif. Distributed by Knight Ridder/Tribune
Business News.
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Initial Purchaser Exercises Option to Purchase an Additional $75 Million of the $325 Million of 1.75% Convertible Notes
via COMTEX
May 30, 2003
WARREN, N.J., May 30, 2003 /PRNewswire-FirstCall via COMTEX/ --
Celgene Corporation (Nasdaq: CELG) announced today that the initial purchaser of $325 million of its 1.75% Convertible Notes due 2008 has elected to exercise its option to purchase an additional $75 million principal amount of such Notes. As a result, the final aggregate principal amount of the offering of the Notes will be $400 million. These Notes will be convertible into Celgene Corporation common stock at a conversion price of $48.45 per share (reflecting a premium of 50%, relative to the NASDAQ closing price for Celgene common stock of $32.30 on May 28, 2003). The placement of the Notes is expected to close on June 3, 2003.
As previously announced, Celgene expects to use the net proceeds of the offering for general corporate purposes. The offering is being made by means of an offering memorandum to qualified institutional buyers pursuant to Rule 144A of the Securities Act of 1933, as amended.
The Notes and the common stock issuable upon conversion of the Notes have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws, and unless so registered, may not be offered or sold in the United States, except pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended, and applicable state securities laws.
This press release shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy the Notes. This press release is being issued pursuant to and in accordance with Rule 135c under the Securities Act of 1933, as amended.
Celgene Corporation, headquartered in Warren, New Jersey, is an integrated biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company`s website at www.celgene.com.
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company`s control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company`s filings with the Securities and Exchange Commission such as 10K, 10Q and 8K reports.
SOURCE Celgene Corporation
Robert J. Hugin, Senior VP and CFO of Celgene Corporation, +1-732-271-4102
http://www.celgene.com
Copyright (C) 2003 PR Newswire. All rights reserved.
JS200
via COMTEX
May 30, 2003
WARREN, N.J., May 30, 2003 /PRNewswire-FirstCall via COMTEX/ --
Celgene Corporation (Nasdaq: CELG) announced today that the initial purchaser of $325 million of its 1.75% Convertible Notes due 2008 has elected to exercise its option to purchase an additional $75 million principal amount of such Notes. As a result, the final aggregate principal amount of the offering of the Notes will be $400 million. These Notes will be convertible into Celgene Corporation common stock at a conversion price of $48.45 per share (reflecting a premium of 50%, relative to the NASDAQ closing price for Celgene common stock of $32.30 on May 28, 2003). The placement of the Notes is expected to close on June 3, 2003.
As previously announced, Celgene expects to use the net proceeds of the offering for general corporate purposes. The offering is being made by means of an offering memorandum to qualified institutional buyers pursuant to Rule 144A of the Securities Act of 1933, as amended.
The Notes and the common stock issuable upon conversion of the Notes have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws, and unless so registered, may not be offered or sold in the United States, except pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended, and applicable state securities laws.
This press release shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy the Notes. This press release is being issued pursuant to and in accordance with Rule 135c under the Securities Act of 1933, as amended.
Celgene Corporation, headquartered in Warren, New Jersey, is an integrated biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company`s website at www.celgene.com.
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company`s control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company`s filings with the Securities and Exchange Commission such as 10K, 10Q and 8K reports.
SOURCE Celgene Corporation
Robert J. Hugin, Senior VP and CFO of Celgene Corporation, +1-732-271-4102
http://www.celgene.com
Copyright (C) 2003 PR Newswire. All rights reserved.
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RAiDAR alerts Learn More About RAiDAR-LT
05/30/2003 (14:39 ET) Initial Purchaser Exercises Option to Purchase an Additional $75 Million of the $325 Million of 1.75% Convertible Notes - PR Newswire
05/30/2003 (08:57 ET) RATING(1): Caris & Co Initiates CELG Rating @ Above Average - Knobias
05/30/2003 (08:50 ET) PREMKT: CELG Reports on Study of Ritalin vs Concerta - Knobias
05/30/2003 (07:45 ET) Study Shows Ritalin(R) LA Provides Statistically Greater ADHD Symptom Management Over Concerta(R) Across the School Day - PR Newswire
05/30/2003 (07:30 ET) Clinical Data on THALOMID(R) and REVIMID(TM) in Hematologic and Solid Tumor Cancers to be Presented at the American Society of Clinical Oncology - PR Newswire
05/30/2003 (06:36 ET) MEDIA: Today`s Wall Street Journal Mentions CELG - Knobias
05/29/2003 (16:12 ET) Schaeffer`s Market Observation Features BBH, GILD, ICOS, CELG - PR Newswire
05/29/2003 (16:08 ET) Schaeffer`s Market Observation Features BBH, GILD, ICOS, CELG - PR Newswire
05/29/2003 (16:05 ET) Schaeffer`s Market Observation Features BBH, GILD, ICOS, CELG - PR Newswire
05/29/2003 (16:04 ET) Schaeffer`s Market Observation Features BBH, GILD, ICOS, CELG - PR Newswire
05/29/2003 (16:04 ET) Schaeffer`s Market Observation Features BBH, GILD, ICOS, CELG - PR Newswire
05/29/2003 (10:41 ET) MOVER(-): CELG Offers $325M of Convertable Notes - Knobias
05/29/2003 (10:07 ET) VOLUME(-): CELG Volume 6% > 20-adsv, Stock -3.10% - Knobias
05/29/2003 (08:30 ET) Celgene Corporation Announces Pricing of $325 Million Convertible Note Offering - PR Newswire
05/28/2003 (20:14 ET) Ventura County Star, Calif., Business Briefs Column - Knight Ridder
05/28/2003 (16:01 ET) Celgene Corporation Announces Proposed $300 Million Convertible Notes Offering - PR Newswire
05/28/2003 (13:31 ET) CELG: Short Interest UP 11.6% to 6.2M in May 2003 - Knobias
05/28/2003 (09:29 ET) MORNING UPDATE: Man Securities Issues Alerts AMGN, CELG, COST, MIMS, And TOL - PR Newswire
05/28/2003 (08:34 ET) THALOMID(R) Evaluated in Every Stage of Multiple Myeloma Presented at Ninth International Myeloma Workshop - PR Newswire
05/28/2003 (07:32 ET) CONF: CELG To Present At FBR Tech & Growth Conference @ 09:20 ET - Knobias
05/27/2003 (13:13 ET) MOVER(+): CELG Shares Spike After Rumor of AMGN Merger - Knobias
05/27/2003 (13:11 ET) VOLUME(+): CELG Volume 61% > 20-adsv, Stock +14.79% - Knobias
05/27/2003 (12:56 ET) 52W HIGH: New 52-Wk High for CELG @ $34.030 up9.42% - Knobias
05/22/2003 (12:12 ET) RATING(1): JMP Sec Initiates CELG Rating @ Mkt Outperform - Knobias
05/22/2003 (07:30 ET) Data on THALOMID(R) in Every Stage of Multiple Myeloma to be Presented at Ninth International Myeloma Workshop - PR Newswire
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05/30/2003 (14:39 ET) Initial Purchaser Exercises Option to Purchase an Additional $75 Million of the $325 Million of 1.75% Convertible Notes - PR Newswire
05/30/2003 (08:57 ET) RATING(1): Caris & Co Initiates CELG Rating @ Above Average - Knobias
05/30/2003 (08:50 ET) PREMKT: CELG Reports on Study of Ritalin vs Concerta - Knobias
05/30/2003 (07:45 ET) Study Shows Ritalin(R) LA Provides Statistically Greater ADHD Symptom Management Over Concerta(R) Across the School Day - PR Newswire
05/30/2003 (07:30 ET) Clinical Data on THALOMID(R) and REVIMID(TM) in Hematologic and Solid Tumor Cancers to be Presented at the American Society of Clinical Oncology - PR Newswire
05/30/2003 (06:36 ET) MEDIA: Today`s Wall Street Journal Mentions CELG - Knobias
05/29/2003 (16:12 ET) Schaeffer`s Market Observation Features BBH, GILD, ICOS, CELG - PR Newswire
05/29/2003 (16:08 ET) Schaeffer`s Market Observation Features BBH, GILD, ICOS, CELG - PR Newswire
05/29/2003 (16:05 ET) Schaeffer`s Market Observation Features BBH, GILD, ICOS, CELG - PR Newswire
05/29/2003 (16:04 ET) Schaeffer`s Market Observation Features BBH, GILD, ICOS, CELG - PR Newswire
05/29/2003 (16:04 ET) Schaeffer`s Market Observation Features BBH, GILD, ICOS, CELG - PR Newswire
05/29/2003 (10:41 ET) MOVER(-): CELG Offers $325M of Convertable Notes - Knobias
05/29/2003 (10:07 ET) VOLUME(-): CELG Volume 6% > 20-adsv, Stock -3.10% - Knobias
05/29/2003 (08:30 ET) Celgene Corporation Announces Pricing of $325 Million Convertible Note Offering - PR Newswire
05/28/2003 (20:14 ET) Ventura County Star, Calif., Business Briefs Column - Knight Ridder
05/28/2003 (16:01 ET) Celgene Corporation Announces Proposed $300 Million Convertible Notes Offering - PR Newswire
05/28/2003 (13:31 ET) CELG: Short Interest UP 11.6% to 6.2M in May 2003 - Knobias
05/28/2003 (09:29 ET) MORNING UPDATE: Man Securities Issues Alerts AMGN, CELG, COST, MIMS, And TOL - PR Newswire
05/28/2003 (08:34 ET) THALOMID(R) Evaluated in Every Stage of Multiple Myeloma Presented at Ninth International Myeloma Workshop - PR Newswire
05/28/2003 (07:32 ET) CONF: CELG To Present At FBR Tech & Growth Conference @ 09:20 ET - Knobias
05/27/2003 (13:13 ET) MOVER(+): CELG Shares Spike After Rumor of AMGN Merger - Knobias
05/27/2003 (13:11 ET) VOLUME(+): CELG Volume 61% > 20-adsv, Stock +14.79% - Knobias
05/27/2003 (12:56 ET) 52W HIGH: New 52-Wk High for CELG @ $34.030 up9.42% - Knobias
05/22/2003 (12:12 ET) RATING(1): JMP Sec Initiates CELG Rating @ Mkt Outperform - Knobias
05/22/2003 (07:30 ET) Data on THALOMID(R) in Every Stage of Multiple Myeloma to be Presented at Ninth International Myeloma Workshop - PR Newswire
JS200
Big surge as small companies` experiments advance - UPDATE 3
Thursday , June 05, 2003 17:54 ET
SAN FRANCISCO, Jun 05, 2003 (AFX-Asia via COMTEX) -- Shares of biotech stocks jumped late in the regular session Thursday, as several small companies at a conference in New York revealed encouraging test results on experimental drugs. The Amex Biotechnology Index gained nearly 6 percent to 490.78, and the Nasdaq Biotechnology Index also finished up 6 percent at 743.39 Drug stocks recovered from earlier weakness, with the Amex Pharmaceutical Index closing up nearly 2 percent at 326.85. At the Needham & Co. biotechnology conference, Neurocrine Biosciences leapt $5.15, or 10 percent, to close at $57.01 after it affirmed plans to seek approval next year for a new anti-insomia drug its developing with Pfizer . Pfizer shares closed higher by 35 cents at $32.75. Also Needham conference, Celgene Chief Executive John Jackson said he expects his company to post a profit of 5 to 10 cents in 2003. Celgene`s Revimid drug in development appears to have strong potential as a cancer treatment, Jackson added. Celgene shares moved up $2.30, or 7 percent, to close at $34.39. A mutual agreement announced late Wednesday sent shares of NPS Pharmaceuticals soaring and Enzon Pharmaceutical sinking after the companies said they were terminating NPS` planned acquisition of Enzon. As part of the agreement, NPS will pay a termination fee of 1.5 million shares of its common stock to Enzon. Shares of NPS climbed $5.21, or 22 percent, to $28.96, while shares of Enzon fell 70 cents, or 5 percent, to $14.30. Cytogen shares rocketed 95 cents, or 18 percent higher, to $6.11 after the Princeton, N.J.-based company said its Quadrament cancer fighter showed "significant decreases" in prostate specific antigen when used in combination with chemotherapy. Additional trials for Quadrament are underway, the company said. Targeted Genetics shares flew up $1.22, or 103 percent, to $2.41 after the biotech firm said Phase II study results of its treatment for cystic fibrosis, tgAAVCF, met its primary endpoint of demonstrating safety and tolerability. The Seattle-based company also said the positive trends were observed in lung function. Based on the results, the company plans to initiate a larger study in coming months. Guidant shares recovered from early losses to close up $1.12, or 3 percent, at $44 after the Indianapolis-based company said an arbitration panel entered a preliminary finding that the company`s stent system "infringe certain claims of the Palmaz/Schatz patents of Cordis Corp." Johnson & Johnson fell 4 percent to $52.02 after Morgan Stanley lowered its price target on the stock to $49 from $59 citing rising concerns over the company`s Procrit and Remicade franchises and execution issues regarding its drug-coated cardiovascular stent Cypher. Morgan said these issues will put pressure on Johnson & Johnson`s multiple and thus lowered its 2005 earnings-per-share estimate. This story was supplied by CBSMarketWatch. For further information see www.cbsmarketwatch.com.
Copyright 2003. AFX News Ltd. All rights reserved.
-0-
KEYWORD: United States of America
INDUSTRY KEYWORD: Health Care
SUBJECT CODE: Earnings
JS200
Thursday , June 05, 2003 17:54 ET
SAN FRANCISCO, Jun 05, 2003 (AFX-Asia via COMTEX) -- Shares of biotech stocks jumped late in the regular session Thursday, as several small companies at a conference in New York revealed encouraging test results on experimental drugs. The Amex Biotechnology Index gained nearly 6 percent to 490.78, and the Nasdaq Biotechnology Index also finished up 6 percent at 743.39 Drug stocks recovered from earlier weakness, with the Amex Pharmaceutical Index closing up nearly 2 percent at 326.85. At the Needham & Co. biotechnology conference, Neurocrine Biosciences leapt $5.15, or 10 percent, to close at $57.01 after it affirmed plans to seek approval next year for a new anti-insomia drug its developing with Pfizer . Pfizer shares closed higher by 35 cents at $32.75. Also Needham conference, Celgene Chief Executive John Jackson said he expects his company to post a profit of 5 to 10 cents in 2003. Celgene`s Revimid drug in development appears to have strong potential as a cancer treatment, Jackson added. Celgene shares moved up $2.30, or 7 percent, to close at $34.39. A mutual agreement announced late Wednesday sent shares of NPS Pharmaceuticals soaring and Enzon Pharmaceutical sinking after the companies said they were terminating NPS` planned acquisition of Enzon. As part of the agreement, NPS will pay a termination fee of 1.5 million shares of its common stock to Enzon. Shares of NPS climbed $5.21, or 22 percent, to $28.96, while shares of Enzon fell 70 cents, or 5 percent, to $14.30. Cytogen shares rocketed 95 cents, or 18 percent higher, to $6.11 after the Princeton, N.J.-based company said its Quadrament cancer fighter showed "significant decreases" in prostate specific antigen when used in combination with chemotherapy. Additional trials for Quadrament are underway, the company said. Targeted Genetics shares flew up $1.22, or 103 percent, to $2.41 after the biotech firm said Phase II study results of its treatment for cystic fibrosis, tgAAVCF, met its primary endpoint of demonstrating safety and tolerability. The Seattle-based company also said the positive trends were observed in lung function. Based on the results, the company plans to initiate a larger study in coming months. Guidant shares recovered from early losses to close up $1.12, or 3 percent, at $44 after the Indianapolis-based company said an arbitration panel entered a preliminary finding that the company`s stent system "infringe certain claims of the Palmaz/Schatz patents of Cordis Corp." Johnson & Johnson fell 4 percent to $52.02 after Morgan Stanley lowered its price target on the stock to $49 from $59 citing rising concerns over the company`s Procrit and Remicade franchises and execution issues regarding its drug-coated cardiovascular stent Cypher. Morgan said these issues will put pressure on Johnson & Johnson`s multiple and thus lowered its 2005 earnings-per-share estimate. This story was supplied by CBSMarketWatch. For further information see www.cbsmarketwatch.com.
Copyright 2003. AFX News Ltd. All rights reserved.
-0-
KEYWORD: United States of America
INDUSTRY KEYWORD: Health Care
SUBJECT CODE: Earnings
JS200
RAiDAR alerts Learn More About RAiDAR-LT
06/05/2003 (17:54 ET) Big surge as small companies` experiments advance - UPDATE 3 - AFX News Asia
06/05/2003 (17:54 ET) Big surge as small companies` experiments advance - UPDATE 3 - AFX News Europe
06/05/2003 (17:54 ET) Big surge as small companies` experiments advance - UPDATE 3 - AFX News UK
06/05/2003 (17:40 ET) Big surge as small companies` experiments advance - UPDATE 2 - AFX News Asia
06/05/2003 (17:40 ET) Big surge as small companies` experiments advance - UPDATE 2 - AFX News Europe
06/05/2003 (17:40 ET) Big surge as small companies` experiments advance - UPDATE 2 - AFX News UK
06/05/2003 (16:18 ET) Celgene CEO affirms profit target, sees hopes for drug - UPDATE 1 - AFX News Asia
06/05/2003 (16:18 ET) Celgene CEO affirms profit target, sees hopes for drug - UPDATE 1 - AFX News Europe
06/05/2003 (16:18 ET) Celgene CEO affirms profit target, sees hopes for drug - UPDATE 1 - AFX News UK
06/05/2003 (14:00 ET) 8-K: CELG Repeats 3 Press Releases; Convertible Notes - Knobias
06/05/2003 (13:47 ET) Celgene CEO affirms profit target, sees hopes for drug - AFX News Asia
06/05/2003 (13:47 ET) Celgene CEO affirms profit target, sees hopes for drug - AFX News Europe
06/05/2003 (13:47 ET) Celgene CEO affirms profit target, sees hopes for drug - AFX News UK
06/05/2003 (12:37 ET) New 8-K just released for CELG - Edgar
06/05/2003 (11:02 ET) CONF: CELG To Present At Needham Biotech Conference @ 14:00 ET - Knobias
06/05/2003 (08:18 ET) CELG CEO Appears on Bloomberg TV Today - Knobias
06/05/2003 (07:32 ET) CONF: CELG To Present At JMP Securities Conference @ 10:15 ET - Knobias
06/05/2003 (07:30 ET) Celgene Corporation Announces the Appointment of Mr. Francis Brown As Senior Vice President of Sales and Marketing - PR Newswire
06/04/2003 (12:32 ET) CONF: CELG To Present At UBS Pharmaceutical Conference @ 15:30 ET - Knobias
06/04/2003 (09:14 ET) PRMKT: CELG Repots Clinical Data Presented on THALOMID - Knobias
06/04/2003 (07:30 ET) New Data from Clinical Trials of THALOMID(R) in Broad Range Of Solid Tumor Cancers Presented at ASCO - PR Newswire
06/03/2003 (07:53 ET) IMiDs(TM) Multiple Mechanism of Action Demonstrate Potential Activity In Solid Tumors - PR Newswire
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06/05/2003 (17:54 ET) Big surge as small companies` experiments advance - UPDATE 3 - AFX News Asia
06/05/2003 (17:54 ET) Big surge as small companies` experiments advance - UPDATE 3 - AFX News Europe
06/05/2003 (17:54 ET) Big surge as small companies` experiments advance - UPDATE 3 - AFX News UK
06/05/2003 (17:40 ET) Big surge as small companies` experiments advance - UPDATE 2 - AFX News Asia
06/05/2003 (17:40 ET) Big surge as small companies` experiments advance - UPDATE 2 - AFX News Europe
06/05/2003 (17:40 ET) Big surge as small companies` experiments advance - UPDATE 2 - AFX News UK
06/05/2003 (16:18 ET) Celgene CEO affirms profit target, sees hopes for drug - UPDATE 1 - AFX News Asia
06/05/2003 (16:18 ET) Celgene CEO affirms profit target, sees hopes for drug - UPDATE 1 - AFX News Europe
06/05/2003 (16:18 ET) Celgene CEO affirms profit target, sees hopes for drug - UPDATE 1 - AFX News UK
06/05/2003 (14:00 ET) 8-K: CELG Repeats 3 Press Releases; Convertible Notes - Knobias
06/05/2003 (13:47 ET) Celgene CEO affirms profit target, sees hopes for drug - AFX News Asia
06/05/2003 (13:47 ET) Celgene CEO affirms profit target, sees hopes for drug - AFX News Europe
06/05/2003 (13:47 ET) Celgene CEO affirms profit target, sees hopes for drug - AFX News UK
06/05/2003 (12:37 ET) New 8-K just released for CELG - Edgar
06/05/2003 (11:02 ET) CONF: CELG To Present At Needham Biotech Conference @ 14:00 ET - Knobias
06/05/2003 (08:18 ET) CELG CEO Appears on Bloomberg TV Today - Knobias
06/05/2003 (07:32 ET) CONF: CELG To Present At JMP Securities Conference @ 10:15 ET - Knobias
06/05/2003 (07:30 ET) Celgene Corporation Announces the Appointment of Mr. Francis Brown As Senior Vice President of Sales and Marketing - PR Newswire
06/04/2003 (12:32 ET) CONF: CELG To Present At UBS Pharmaceutical Conference @ 15:30 ET - Knobias
06/04/2003 (09:14 ET) PRMKT: CELG Repots Clinical Data Presented on THALOMID - Knobias
06/04/2003 (07:30 ET) New Data from Clinical Trials of THALOMID(R) in Broad Range Of Solid Tumor Cancers Presented at ASCO - PR Newswire
06/03/2003 (07:53 ET) IMiDs(TM) Multiple Mechanism of Action Demonstrate Potential Activity In Solid Tumors - PR Newswire
JS200
RAiDAR alerts Learn More About RAiDAR-LT
06/10/2003 (10:02 ET) DEF 14A: CELG Vote; Directors; Auditor; Stock Op Plan - Knobias
06/09/2003 (13:53 ET) SECTOR(HCR): First Albany Comments on Biotech Industry - Knobias
06/09/2003 (12:03 ET) SECTOR(HCR): Biotechs Down; OXGN, ENMD, GERN, PPHM Up - Knobias
06/06/2003 (16:43 ET) StockPickReport.Com: StockPickReport.Com announces Stock Evaluation Ratings for Delta Air Lines Inc, Best Buy Co Inc, Celgene , Cadence Design Systems, Nisource Inc - M2 Communications
06/06/2003 (11:02 ET) StockPickReport.Com: StockPickReport.Com announces Stock Evaluation Ratings for Delta Air Lines Inc, Best Buy Co Inc, Celgene , Cadence Design Systems, Nisource Inc - M2 Communications
06/06/2003 (09:57 ET) 52W HIGH: New 52-Wk High for CELG @ $36.110 up5.00% - Knobias
06/05/2003 (17:54 ET) Big surge as small companies` experiments advance - UPDATE 3 - AFX News Asia
06/05/2003 (17:54 ET) Big surge as small companies` experiments advance - UPDATE 3 - AFX News Europe
06/05/2003 (17:54 ET) Big surge as small companies` experiments advance - UPDATE 3 - AFX News UK
06/05/2003 (17:40 ET) Big surge as small companies` experiments advance - UPDATE 2 - AFX News Asia
06/05/2003 (17:40 ET) Big surge as small companies` experiments advance - UPDATE 2 - AFX News Europe
06/05/2003 (17:40 ET) Big surge as small companies` experiments advance - UPDATE 2 - AFX News UK
06/05/2003 (16:18 ET) Celgene CEO affirms profit target, sees hopes for drug - UPDATE 1 - AFX News Asia
06/05/2003 (16:18 ET) Celgene CEO affirms profit target, sees hopes for drug - UPDATE 1 - AFX News Europe
06/05/2003 (16:18 ET) Celgene CEO affirms profit target, sees hopes for drug - UPDATE 1 - AFX News UK
06/05/2003 (14:00 ET) 8-K: CELG Repeats 3 Press Releases; Convertible Notes - Knobias
06/05/2003 (13:47 ET) Celgene CEO affirms profit target, sees hopes for drug - AFX News Asia
06/05/2003 (13:47 ET) Celgene CEO affirms profit target, sees hopes for drug - AFX News Europe
06/05/2003 (13:47 ET) Celgene CEO affirms profit target, sees hopes for drug - AFX News UK
06/05/2003 (12:37 ET) New 8-K just released for CELG - Edgar
06/05/2003 (11:02 ET) CONF: CELG To Present At Needham Biotech Conference @ 14:00 ET - Knobias
06/05/2003 (08:18 ET) CELG CEO Appears on Bloomberg TV Today - Knobias
06/05/2003 (07:32 ET) CONF: CELG To Present At JMP Securities Conference @ 10:15 ET - Knobias
06/05/2003 (07:30 ET) Celgene Corporation Announces the Appointment of Mr. Francis Brown As Senior Vice President of Sales and Marketing - PR Newswire
06/04/2003 (12:32 ET) CONF: CELG To Present At UBS Pharmaceutical Conference @ 15:30 ET - Knobias
JS200
06/10/2003 (10:02 ET) DEF 14A: CELG Vote; Directors; Auditor; Stock Op Plan - Knobias
06/09/2003 (13:53 ET) SECTOR(HCR): First Albany Comments on Biotech Industry - Knobias
06/09/2003 (12:03 ET) SECTOR(HCR): Biotechs Down; OXGN, ENMD, GERN, PPHM Up - Knobias
06/06/2003 (16:43 ET) StockPickReport.Com: StockPickReport.Com announces Stock Evaluation Ratings for Delta Air Lines Inc, Best Buy Co Inc, Celgene , Cadence Design Systems, Nisource Inc - M2 Communications
06/06/2003 (11:02 ET) StockPickReport.Com: StockPickReport.Com announces Stock Evaluation Ratings for Delta Air Lines Inc, Best Buy Co Inc, Celgene , Cadence Design Systems, Nisource Inc - M2 Communications
06/06/2003 (09:57 ET) 52W HIGH: New 52-Wk High for CELG @ $36.110 up5.00% - Knobias
06/05/2003 (17:54 ET) Big surge as small companies` experiments advance - UPDATE 3 - AFX News Asia
06/05/2003 (17:54 ET) Big surge as small companies` experiments advance - UPDATE 3 - AFX News Europe
06/05/2003 (17:54 ET) Big surge as small companies` experiments advance - UPDATE 3 - AFX News UK
06/05/2003 (17:40 ET) Big surge as small companies` experiments advance - UPDATE 2 - AFX News Asia
06/05/2003 (17:40 ET) Big surge as small companies` experiments advance - UPDATE 2 - AFX News Europe
06/05/2003 (17:40 ET) Big surge as small companies` experiments advance - UPDATE 2 - AFX News UK
06/05/2003 (16:18 ET) Celgene CEO affirms profit target, sees hopes for drug - UPDATE 1 - AFX News Asia
06/05/2003 (16:18 ET) Celgene CEO affirms profit target, sees hopes for drug - UPDATE 1 - AFX News Europe
06/05/2003 (16:18 ET) Celgene CEO affirms profit target, sees hopes for drug - UPDATE 1 - AFX News UK
06/05/2003 (14:00 ET) 8-K: CELG Repeats 3 Press Releases; Convertible Notes - Knobias
06/05/2003 (13:47 ET) Celgene CEO affirms profit target, sees hopes for drug - AFX News Asia
06/05/2003 (13:47 ET) Celgene CEO affirms profit target, sees hopes for drug - AFX News Europe
06/05/2003 (13:47 ET) Celgene CEO affirms profit target, sees hopes for drug - AFX News UK
06/05/2003 (12:37 ET) New 8-K just released for CELG - Edgar
06/05/2003 (11:02 ET) CONF: CELG To Present At Needham Biotech Conference @ 14:00 ET - Knobias
06/05/2003 (08:18 ET) CELG CEO Appears on Bloomberg TV Today - Knobias
06/05/2003 (07:32 ET) CONF: CELG To Present At JMP Securities Conference @ 10:15 ET - Knobias
06/05/2003 (07:30 ET) Celgene Corporation Announces the Appointment of Mr. Francis Brown As Senior Vice President of Sales and Marketing - PR Newswire
06/04/2003 (12:32 ET) CONF: CELG To Present At UBS Pharmaceutical Conference @ 15:30 ET - Knobias
JS200
OSI Pharmaceuticals Recovers Full Rights to Market Gelclair-TM- in the Oncology Setting in North America
via COMTEX
June 13, 2003
MELVILLE, N.Y., Jun 13, 2003 (BUSINESS WIRE) --
OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today that it has entered into an agreement with Celgene Corporation by which OSI will recover full rights to market and promote Gelclair(TM) in the oncology setting in North America. Gelclair(TM) is a bioadherent oral gel that provides relief for the treatment of pain associated with oral mucositis, a debilitating side effect often seen in cancer patients undergoing radiation treatment or chemotherapy. Previously, Gelclair(TM) was marketed to oncologists for their cancer patients under a co-promotion agreement between Celgene and Cell Pathways, Inc. Gelclair(TM) was added to OSI`s oncology portfolio as part of the Company`s recent acquisition of Cell Pathways. Financial terms of the agreement have not been disclosed.
`Today`s transaction allows us to focus the sales and marketing effort around Gelclair(TM) within OSI,`stated Colin Goddard, Ph.D., Chief Executive Officer of the Company. `We believe Gelclair(TM) can help address a major unmet need for cancer patients who have to suffer the painful consequences of oral mucositis and can become a valuable niche product for OSI.`
About Gelclair(TM)
Gelclair(TM) provides a protective adherent barrier over the surface of the mouth and throat, thereby shielding and soothing the exposed and sensitized nerves. Gelclair(TM) contains several mucoadherent and lubricating agents including polyvinylpyrrolidone (PVP) and sodium hyaluronate (HA), a viscous fluid that occurs naturally in the body. Gelclair(TM) is a device cleared for sale by the FDA through a 510(k) application.
Gelclair(TM) is indicated for the management and relief of pain. It works by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. These indications include oral mucositis/stomatitis (which may be caused by chemotherapy and/or radiotherapy), irritation due to oral surgery and traumatic ulcers caused by braces, ill-fitting dentures or disease. Gelclair(TM) is also indicated for treatment of diffuse aphthous ulcers. Gelclair(TM) is also being sold to dental care providers through an agreement with the John O. Butler Company which OSI intends to retain.
It is estimated that approximately 300,000 cancer patients in the U.S. suffer from oral mucositis associated with cancer treatment. OSI believes that Gelclair(TM) could be widely used by oncology patients suffering from chemotherapy or radiotherapy induced mucositis, as well as any other patient with oral mucosal lesions. The safety profile of Gelclair(TM) includes rare reports of allergic reaction, therefore the administration of Gelclair(TM) is contraindicated in any patient with a known history of hypersensitivity to any of its ingredients.
OSI Pharmaceuticals is a leading biotechnology company focused on the discovery, development and commercialization of high-quality, next-generation oncology products that both extend and improve the quality-of-life for cancer patients worldwide. OSI has a balanced pipeline of oncology drug candidates that includes both next-generation cytotoxic agents and novel mechanism-based, gene-targeted therapeutics focused in the areas of signal transduction and apoptosis. OSI`s most advanced drug candidate, Tarceva(TM) (erlotinib HCl), a small-molecule inhibitor of the HER1 gene, is currently in Phase III clinical trials for lung and pancreatic cancers. OSI has a commercial presence in the U.S. oncology market where it exclusively markets Novantrone(R) (mitoxantrone concentrate for injection) for approved oncology indications.
This news release contains forward-looking statements. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. Factors that might cause such a difference include, among others, the completion of clinical trials, the FDA review process and other governmental regulation, pharmaceutical collaborators`ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, the ability to effectively market products and other factors described in OSI Pharmaceuticals`filings with the Securities and Exchange Commission.
SOURCE: OSI Pharmaceuticals, Inc.
OSI Pharmaceuticals, Inc. Kathy Galante Director Investor &Public Relations 631/962-2000 or Burns McClellan Jonathan M. Nugent (Investors) Kathy Jones, Ph.D. (Media) 212/213-0006
http://www.businesswire.com
Today`s News On The Net - Business Wire`s full file on the Internet with Hyperlinks to your home page.
Copyright (C) 2003 Business Wire. All rights reserved.
JS200
via COMTEX
June 13, 2003
MELVILLE, N.Y., Jun 13, 2003 (BUSINESS WIRE) --
OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today that it has entered into an agreement with Celgene Corporation by which OSI will recover full rights to market and promote Gelclair(TM) in the oncology setting in North America. Gelclair(TM) is a bioadherent oral gel that provides relief for the treatment of pain associated with oral mucositis, a debilitating side effect often seen in cancer patients undergoing radiation treatment or chemotherapy. Previously, Gelclair(TM) was marketed to oncologists for their cancer patients under a co-promotion agreement between Celgene and Cell Pathways, Inc. Gelclair(TM) was added to OSI`s oncology portfolio as part of the Company`s recent acquisition of Cell Pathways. Financial terms of the agreement have not been disclosed.
`Today`s transaction allows us to focus the sales and marketing effort around Gelclair(TM) within OSI,`stated Colin Goddard, Ph.D., Chief Executive Officer of the Company. `We believe Gelclair(TM) can help address a major unmet need for cancer patients who have to suffer the painful consequences of oral mucositis and can become a valuable niche product for OSI.`
About Gelclair(TM)
Gelclair(TM) provides a protective adherent barrier over the surface of the mouth and throat, thereby shielding and soothing the exposed and sensitized nerves. Gelclair(TM) contains several mucoadherent and lubricating agents including polyvinylpyrrolidone (PVP) and sodium hyaluronate (HA), a viscous fluid that occurs naturally in the body. Gelclair(TM) is a device cleared for sale by the FDA through a 510(k) application.
Gelclair(TM) is indicated for the management and relief of pain. It works by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. These indications include oral mucositis/stomatitis (which may be caused by chemotherapy and/or radiotherapy), irritation due to oral surgery and traumatic ulcers caused by braces, ill-fitting dentures or disease. Gelclair(TM) is also indicated for treatment of diffuse aphthous ulcers. Gelclair(TM) is also being sold to dental care providers through an agreement with the John O. Butler Company which OSI intends to retain.
It is estimated that approximately 300,000 cancer patients in the U.S. suffer from oral mucositis associated with cancer treatment. OSI believes that Gelclair(TM) could be widely used by oncology patients suffering from chemotherapy or radiotherapy induced mucositis, as well as any other patient with oral mucosal lesions. The safety profile of Gelclair(TM) includes rare reports of allergic reaction, therefore the administration of Gelclair(TM) is contraindicated in any patient with a known history of hypersensitivity to any of its ingredients.
OSI Pharmaceuticals is a leading biotechnology company focused on the discovery, development and commercialization of high-quality, next-generation oncology products that both extend and improve the quality-of-life for cancer patients worldwide. OSI has a balanced pipeline of oncology drug candidates that includes both next-generation cytotoxic agents and novel mechanism-based, gene-targeted therapeutics focused in the areas of signal transduction and apoptosis. OSI`s most advanced drug candidate, Tarceva(TM) (erlotinib HCl), a small-molecule inhibitor of the HER1 gene, is currently in Phase III clinical trials for lung and pancreatic cancers. OSI has a commercial presence in the U.S. oncology market where it exclusively markets Novantrone(R) (mitoxantrone concentrate for injection) for approved oncology indications.
This news release contains forward-looking statements. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. Factors that might cause such a difference include, among others, the completion of clinical trials, the FDA review process and other governmental regulation, pharmaceutical collaborators`ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, the ability to effectively market products and other factors described in OSI Pharmaceuticals`filings with the Securities and Exchange Commission.
SOURCE: OSI Pharmaceuticals, Inc.
OSI Pharmaceuticals, Inc. Kathy Galante Director Investor &Public Relations 631/962-2000 or Burns McClellan Jonathan M. Nugent (Investors) Kathy Jones, Ph.D. (Media) 212/213-0006
http://www.businesswire.com
Today`s News On The Net - Business Wire`s full file on the Internet with Hyperlinks to your home page.
Copyright (C) 2003 Business Wire. All rights reserved.
JS200
Der Aktionär Nr. 27 vom 25.6.2003:
Biotechs vor neuen Höhen
Übernahme in der Luft?
Laut "Global Biotech Investing" sollten sich Anleger einige Aktien von Celgene ins Depot legen: Zahlreiche Studien haben die Wirksamkeit des Präparats Thalomid in Kombination mit Chemo- und Immuntherapie erneut unter Beweis gestellt. Das Medikament, das besser unter dem Namen Contergan bekannt ist, wird wegen seiner Vergangenheit heute nur noch unter strengsten Kontrollen verabreicht. Nächstes Jahr wird die Zulassung bei der Behandlung von Knochenkrebs erwartet. Die eigentliche Fantasie liegt im Produktportfolio des Unternehmens. So ist Revimid eine weniger toxische Variante zur Behandlung von verschiedenen Leukämiearten und Hautkrebs, das in Kombination mit Velcade, einem jüngst zugelassenen Krebsmedikament von Millenium Pharma, beachtliche Resultate erzielt. Amgen soll deshalb bereits seine Übernahme-Fühler ausgestreckt haben. Mit Umsätzen durch Thalomid in Höhe von 170 bis 180 Millionen US-Dollar wird Celgene im laufenden Jahr schwarze Zahlen schreiben. Bis zum Jahr 2005 soll sich der Umsatz auf rund 450 Millionen US-Dollar erhöhen.
Gruß
Honorar
Biotechs vor neuen Höhen
Übernahme in der Luft?
Laut "Global Biotech Investing" sollten sich Anleger einige Aktien von Celgene ins Depot legen: Zahlreiche Studien haben die Wirksamkeit des Präparats Thalomid in Kombination mit Chemo- und Immuntherapie erneut unter Beweis gestellt. Das Medikament, das besser unter dem Namen Contergan bekannt ist, wird wegen seiner Vergangenheit heute nur noch unter strengsten Kontrollen verabreicht. Nächstes Jahr wird die Zulassung bei der Behandlung von Knochenkrebs erwartet. Die eigentliche Fantasie liegt im Produktportfolio des Unternehmens. So ist Revimid eine weniger toxische Variante zur Behandlung von verschiedenen Leukämiearten und Hautkrebs, das in Kombination mit Velcade, einem jüngst zugelassenen Krebsmedikament von Millenium Pharma, beachtliche Resultate erzielt. Amgen soll deshalb bereits seine Übernahme-Fühler ausgestreckt haben. Mit Umsätzen durch Thalomid in Höhe von 170 bis 180 Millionen US-Dollar wird Celgene im laufenden Jahr schwarze Zahlen schreiben. Bis zum Jahr 2005 soll sich der Umsatz auf rund 450 Millionen US-Dollar erhöhen.
Gruß
Honorar
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Celgene Says New Trial of Attention Deficit Drug Starts
By Meredith Derby
Staff Reporter
07/02/2003 03:20 PM EDT
Celgene (CELG:Nasdaq - news - commentary - research - analysis) said Wednesday that a Phase III clinical trial to evaluate the safety and efficacy of its adult attention deficit disorder/attention deficit hyperactivity disorder drug, Focalin LA, has been initiated.
Celgene, based in Warren, N.J., said that Novartis Pharmaceuticals (NVS:NYSE - news - commentary - research - analysis), which currently has marketing rights to the drug in the U.S., will carry out the multicenter trial. In the trial, Focalin LA will be administered once a day to adult patients with ADD/ADHD.
Recently, shares of Celgene were up 1.3% at $39.90. Novartis was falling 0.6% at $39.05.
Focalin is a refined form of Ritalin, which has been approved by the Food and Drug Administration for the treatment of ADD/ADHD in children and adolescents. Focalin LA is an extended release version of Focalin.
Celgene licensed the worldwide rights, excluding Canada, to Focalin and Focalin LA to Novartis in 2000 in exchange for milestone payments and royalties on Focalin and the Ritalin family of drugs, including Ritalin, Ritalin LA, Ritalin SR and eventually Focalin LA.
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Stock News : Biotech/Pharmaceuticals
Celgene Says New Trial of Attention Deficit Drug Starts
By Meredith Derby
Staff Reporter
07/02/2003 03:20 PM EDT
Celgene (CELG:Nasdaq - news - commentary - research - analysis) said Wednesday that a Phase III clinical trial to evaluate the safety and efficacy of its adult attention deficit disorder/attention deficit hyperactivity disorder drug, Focalin LA, has been initiated.
Celgene, based in Warren, N.J., said that Novartis Pharmaceuticals (NVS:NYSE - news - commentary - research - analysis), which currently has marketing rights to the drug in the U.S., will carry out the multicenter trial. In the trial, Focalin LA will be administered once a day to adult patients with ADD/ADHD.
Recently, shares of Celgene were up 1.3% at $39.90. Novartis was falling 0.6% at $39.05.
Focalin is a refined form of Ritalin, which has been approved by the Food and Drug Administration for the treatment of ADD/ADHD in children and adolescents. Focalin LA is an extended release version of Focalin.
Celgene licensed the worldwide rights, excluding Canada, to Focalin and Focalin LA to Novartis in 2000 in exchange for milestone payments and royalties on Focalin and the Ritalin family of drugs, including Ritalin, Ritalin LA, Ritalin SR and eventually Focalin LA.
Auf Deutsch
Anführungsstrich-Search Site rückte Nachrichtenwahlen Suchströmende Anführungsstrich-Analyst Actions Latest Stories Tech Stocks Markets Commentary Personal Finance Portfolio Therapy Company vor und handeln Probetätigkeitsalarme ZukunftRealMoney frei PLUS den kurzen Berater der sichere Plan der Abwehr das handelnde Buchumkehrreporttelekommunikationsanschlußes Reporttsc-SchwätzchenCramer tägliche Schwingen des RadioCramer`s die Aktientsc-Konferenzen TechrandChartman`s oberen außer ProduktTheStreet des Geldes jetzt der Kalenderströmenanführungsstriche des professionellen der Ansichteinkommenreports Investmentfondssuchers ökonomischem der Börseaussicht FREI finanziellem Führer FREI Müssen-Eigener Vorrat-Freier Versuch der Übereinkunft! WahlcQuiz-VorratcNachrichten: Biotech/Pharmaceuticals Celgene sagt, daß neuer Versuch der Aufmerksamkeitsdefizit-Drogeanfänge durch Personalreporter 07/02/2003 Meredith Derby 03:20 P.M. EDT Celgene (CELG:Nasdaq - Nachrichten - Kommentar - Forschung - Analyse) Mittwoch sagte, den ein klinischer Versuch der Phase III zum Auswerten der Sicherheit und der Wirksamkeit seiner Defizithyperaktivität-Störungdroge des Erwachsenaufmerksamkeitsdefizits disorder/attention, LA Focalin, eingeleitet worden ist. Celgene, gegründet in Warren, New Jersey, sagte, daß pharmazeutische Produkte Novartis (NVS:NYSE - Nachrichten - Kommentar - Forschung - Analyse), die z.Z. Marketing-Rechte zur Droge in den VEREINIGTEN STAATEN hat, den Multicenterversuch durchführen. Im Versuch wird LA Focalin einmal täglich zu den Erwachsenpatienten mit ADD/ADHD ausgeübt. Vor kurzem waren Anteile von Celgene herauf 1,3% bei $39,90. Novartis war fallendes 0,6% bei $39,05. Focalin ist eine raffinierte Form von Ritalin, das durch die Nahrung und die Drogeleitung für die Behandlung von ADD/ADHD in den Kindern und in den Jugendlichen genehmigt worden ist. LA Focalin ist eine ausgedehnte Freigabeversion von Focalin. Celgene genehmigte die weltweiten Rechte, ausschließlich Kanadas, zum LA Focalin und Focalin zu Novartis 2000 gegen Meilensteinzahlungen und -abgaben auf Focalin und der Familie Ritalin der Drogen, einschließlich des LA Ritalin, Ritalin, des SR Ritalin und schließlich des LA Focalin.
Anführungsstrich-Search Site rückte Nachrichtenwahlen Suchströmende Anführungsstrich-Analyst Actions Latest Stories Tech Stocks Markets Commentary Personal Finance Portfolio Therapy Company vor und handeln Probetätigkeitsalarme ZukunftRealMoney frei PLUS den kurzen Berater der sichere Plan der Abwehr das handelnde Buchumkehrreporttelekommunikationsanschlußes Reporttsc-SchwätzchenCramer tägliche Schwingen des RadioCramer`s die Aktientsc-Konferenzen TechrandChartman`s oberen außer ProduktTheStreet des Geldes jetzt der Kalenderströmenanführungsstriche des professionellen der Ansichteinkommenreports Investmentfondssuchers ökonomischem der Börseaussicht FREI finanziellem Führer FREI Müssen-Eigener Vorrat-Freier Versuch der Übereinkunft! WahlcQuiz-VorratcNachrichten: Biotech/Pharmaceuticals Celgene sagt, daß neuer Versuch der Aufmerksamkeitsdefizit-Drogeanfänge durch Personalreporter 07/02/2003 Meredith Derby 03:20 P.M. EDT Celgene (CELG:Nasdaq - Nachrichten - Kommentar - Forschung - Analyse) Mittwoch sagte, den ein klinischer Versuch der Phase III zum Auswerten der Sicherheit und der Wirksamkeit seiner Defizithyperaktivität-Störungdroge des Erwachsenaufmerksamkeitsdefizits disorder/attention, LA Focalin, eingeleitet worden ist. Celgene, gegründet in Warren, New Jersey, sagte, daß pharmazeutische Produkte Novartis (NVS:NYSE - Nachrichten - Kommentar - Forschung - Analyse), die z.Z. Marketing-Rechte zur Droge in den VEREINIGTEN STAATEN hat, den Multicenterversuch durchführen. Im Versuch wird LA Focalin einmal täglich zu den Erwachsenpatienten mit ADD/ADHD ausgeübt. Vor kurzem waren Anteile von Celgene herauf 1,3% bei $39,90. Novartis war fallendes 0,6% bei $39,05. Focalin ist eine raffinierte Form von Ritalin, das durch die Nahrung und die Drogeleitung für die Behandlung von ADD/ADHD in den Kindern und in den Jugendlichen genehmigt worden ist. LA Focalin ist eine ausgedehnte Freigabeversion von Focalin. Celgene genehmigte die weltweiten Rechte, ausschließlich Kanadas, zum LA Focalin und Focalin zu Novartis 2000 gegen Meilensteinzahlungen und -abgaben auf Focalin und der Familie Ritalin der Drogen, einschließlich des LA Ritalin, Ritalin, des SR Ritalin und schließlich des LA Focalin.
Celgene sagt neuen Versuch der Aufmerksamkeitsdefizit-Drogeanfänge
Durch Meredith Derby
PersonalcReporter
07/02/2003 03:20 P.M. EDT
Celgene ( CELG :Nasdaq - Nachrichten - Kommentar - Forschung - Analyse) sagte Mittwoch, den ein klinischer Versuch der Phase III zum Auswerten der Sicherheit und der Wirksamkeit seiner Defizithyperaktivität-Störungdroge des Erwachsenaufmerksamkeitsdefizits disorder/attention, LA Focalin, eingeleitet worden ist.
Celgene, gegründet in Warren, New Jersey, sagte, daß pharmazeutische Produkte Novartis ( NVS :NYSE - Nachrichten - Kommentar - Forschung - Analyse) , die z.Z. Marketing-Rechte zur Droge in den VEREINIGTEN STAATEN hat, den Multicenterversuch durchführen. Im Versuch wird LA Focalin einmal täglich zu den Erwachsenpatienten mit ADD/ADHD ausgeübt.
Vor kurzem waren Anteile von Celgene herauf 1,3% bei $39,90. Novartis war fallendes 0,6% bei $39,05.
Focalin ist eine raffinierte Form von Ritalin, das durch die Nahrung und die Drogeleitung für die Behandlung von ADD/ADHD in den Kindern und in den Jugendlichen genehmigt worden ist. LA Focalin ist eine ausgedehnte Freigabeversion von Focalin.
Celgene genehmigte die weltweiten Rechte, ausschließlich Kanadas, zum LA Focalin und Focalin zu Novartis 2000 gegen Meilensteinzahlungen und -abgaben auf Focalin und der Familie Ritalin der Drogen, einschließlich des LA Ritalin, Ritalin, des SR Ritalin und schließlich des LA Focalin.
Durch Meredith Derby
PersonalcReporter
07/02/2003 03:20 P.M. EDT
Celgene ( CELG :Nasdaq - Nachrichten - Kommentar - Forschung - Analyse) sagte Mittwoch, den ein klinischer Versuch der Phase III zum Auswerten der Sicherheit und der Wirksamkeit seiner Defizithyperaktivität-Störungdroge des Erwachsenaufmerksamkeitsdefizits disorder/attention, LA Focalin, eingeleitet worden ist.
Celgene, gegründet in Warren, New Jersey, sagte, daß pharmazeutische Produkte Novartis ( NVS :NYSE - Nachrichten - Kommentar - Forschung - Analyse) , die z.Z. Marketing-Rechte zur Droge in den VEREINIGTEN STAATEN hat, den Multicenterversuch durchführen. Im Versuch wird LA Focalin einmal täglich zu den Erwachsenpatienten mit ADD/ADHD ausgeübt.
Vor kurzem waren Anteile von Celgene herauf 1,3% bei $39,90. Novartis war fallendes 0,6% bei $39,05.
Focalin ist eine raffinierte Form von Ritalin, das durch die Nahrung und die Drogeleitung für die Behandlung von ADD/ADHD in den Kindern und in den Jugendlichen genehmigt worden ist. LA Focalin ist eine ausgedehnte Freigabeversion von Focalin.
Celgene genehmigte die weltweiten Rechte, ausschließlich Kanadas, zum LA Focalin und Focalin zu Novartis 2000 gegen Meilensteinzahlungen und -abgaben auf Focalin und der Familie Ritalin der Drogen, einschließlich des LA Ritalin, Ritalin, des SR Ritalin und schließlich des LA Focalin.
Celgene Corporation Announces New Additions to Senior Management Team
via COMTEX
July 8, 2003
WARREN, N.J., Jul 8, 2003 /PRNewswire-FirstCall via COMTEX/ --
Celgene Corporation (Nasdaq: CELG) announced today the appointment of Graham Burton, M.D., Ph.D. as Senior Vice President of Regulatory Affairs, Pharmacovigilence and Project Management and Michael Vander Zwan, Ph.D. as Vice President of Quality Assurance and Compliance.
Dr. Burton joins Celgene with over 15 years of strong global regulatory relationships. During his career at Johnson &Johnson, Dr. Burton held key senior management positions in international regulatory development, strategic partnering with marketing and clinical development and the successful completion of leading global New Drug Applications. His most recent position was as Senior Vice President, Global Regulatory Affairs &Quality Assurance at Johnson &Johnson Pharmaceutical Research &Development, L.L.C. In his new role at Celgene, Dr. Burton will foster strong relationships with Global Regulatory agencies and manage the Celgene Drug Safety Pharmacovigilence Worldwide department. He will report to Celgene President and Chief Operating Officer, Sol J. Barer, Ph.D. and will be a member of the Company`s Senior Management Team.
Dr. Vander Zwan has over 25 years of pharmaceutical experience and most recently was Vice President, Compliance and Quality Management of Pharmacia where he developed and implemented a global compliance management function. Dr. Vander Zwan began his career as a senior research chemist at Merck and Co., Inc. before holding senior quality management positions at Merck, Hoffman-La Roche and Pharmacia. He has worked closely with the Regulatory function to ensure full compliance and successful completion of numerous FDA submissions. Dr. Vander Zwan will also be a member of the Celgene Senior Management Team and report to Sol J. Barer, Ph.D.
`Graham and Michael bring strategic regulatory and quality assurance expertise from working relationships with global regulatory agencies and will be instrumental in the continuing global development of THALOMID, REVIMID, ACTIMID, the SelCIDs and our extensive product pipeline,`stated Sol J. Barer, Ph.D. President and Chief Operating Officer of Celgene Corporation. `We look forward to their important contribution to the growth of Celgene.`
Celgene Corporation, headquartered in Warren, New Jersey, is an integrated biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company`s website at www.celgene.com.
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company`s control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company`s filings with the Securities and Exchange Commission such as 10K, 10Q and 8K reports.
SOURCE Celgene Corporation
Robert J. Hugin, Senior VP and CFO, Celgene Corporation +1-732-271-4102
http://www.celgene.com
Copyright (C) 2003 PR Newswire. All rights reserved.
JS200
via COMTEX
July 8, 2003
WARREN, N.J., Jul 8, 2003 /PRNewswire-FirstCall via COMTEX/ --
Celgene Corporation (Nasdaq: CELG) announced today the appointment of Graham Burton, M.D., Ph.D. as Senior Vice President of Regulatory Affairs, Pharmacovigilence and Project Management and Michael Vander Zwan, Ph.D. as Vice President of Quality Assurance and Compliance.
Dr. Burton joins Celgene with over 15 years of strong global regulatory relationships. During his career at Johnson &Johnson, Dr. Burton held key senior management positions in international regulatory development, strategic partnering with marketing and clinical development and the successful completion of leading global New Drug Applications. His most recent position was as Senior Vice President, Global Regulatory Affairs &Quality Assurance at Johnson &Johnson Pharmaceutical Research &Development, L.L.C. In his new role at Celgene, Dr. Burton will foster strong relationships with Global Regulatory agencies and manage the Celgene Drug Safety Pharmacovigilence Worldwide department. He will report to Celgene President and Chief Operating Officer, Sol J. Barer, Ph.D. and will be a member of the Company`s Senior Management Team.
Dr. Vander Zwan has over 25 years of pharmaceutical experience and most recently was Vice President, Compliance and Quality Management of Pharmacia where he developed and implemented a global compliance management function. Dr. Vander Zwan began his career as a senior research chemist at Merck and Co., Inc. before holding senior quality management positions at Merck, Hoffman-La Roche and Pharmacia. He has worked closely with the Regulatory function to ensure full compliance and successful completion of numerous FDA submissions. Dr. Vander Zwan will also be a member of the Celgene Senior Management Team and report to Sol J. Barer, Ph.D.
`Graham and Michael bring strategic regulatory and quality assurance expertise from working relationships with global regulatory agencies and will be instrumental in the continuing global development of THALOMID, REVIMID, ACTIMID, the SelCIDs and our extensive product pipeline,`stated Sol J. Barer, Ph.D. President and Chief Operating Officer of Celgene Corporation. `We look forward to their important contribution to the growth of Celgene.`
Celgene Corporation, headquartered in Warren, New Jersey, is an integrated biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company`s website at www.celgene.com.
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company`s control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company`s filings with the Securities and Exchange Commission such as 10K, 10Q and 8K reports.
SOURCE Celgene Corporation
Robert J. Hugin, Senior VP and CFO, Celgene Corporation +1-732-271-4102
http://www.celgene.com
Copyright (C) 2003 PR Newswire. All rights reserved.
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RAiDAR alerts Learn More About RAiDAR-LT
07/08/2003 (16:22 ET) CLOSER(+): Last 90 Min, CELG Jumps +1.24%; Vol +55% - Knobias
07/08/2003 (12:23 ET) JP Morgan Affirms Strong Sales Growth for Cancer Drugs - Knobias
07/08/2003 (09:50 ET) Celgene Corporation Announces New Additions to Senior Management Team - PR Newswire
07/08/2003 (07:30 ET) Celgene Corporation Announces New Additions to Senior Management Team - PR Newswire
07/02/2003 (12:49 ET) Goldman Maintains Neutral View on Biotech Industry - Knobias
07/02/2003 (09:04 ET) NVS to Conduct Safety & Efficacy Trial on Focalin - Knobias
07/02/2003 (07:59 ET) Focalin(TM) LA Pivotal Clinical Trial Initiated in Adults With ADD/ADHD - PR Newswire
07/01/2003 (15:57 ET) SECTOR(HCR): FDA Says It`s Committed to Enforcements - Knobias
07/01/2003 (11:49 ET) SECTOR(HCR): Biotechs Down, Led by MLNM - Knobias
07/01/2003 (09:02 ET) CONF: CELG To Present At Anti-Cancer Drug Conference @ 11:50 ET - Knobias
JS200
07/08/2003 (16:22 ET) CLOSER(+): Last 90 Min, CELG Jumps +1.24%; Vol +55% - Knobias
07/08/2003 (12:23 ET) JP Morgan Affirms Strong Sales Growth for Cancer Drugs - Knobias
07/08/2003 (09:50 ET) Celgene Corporation Announces New Additions to Senior Management Team - PR Newswire
07/08/2003 (07:30 ET) Celgene Corporation Announces New Additions to Senior Management Team - PR Newswire
07/02/2003 (12:49 ET) Goldman Maintains Neutral View on Biotech Industry - Knobias
07/02/2003 (09:04 ET) NVS to Conduct Safety & Efficacy Trial on Focalin - Knobias
07/02/2003 (07:59 ET) Focalin(TM) LA Pivotal Clinical Trial Initiated in Adults With ADD/ADHD - PR Newswire
07/01/2003 (15:57 ET) SECTOR(HCR): FDA Says It`s Committed to Enforcements - Knobias
07/01/2003 (11:49 ET) SECTOR(HCR): Biotechs Down, Led by MLNM - Knobias
07/01/2003 (09:02 ET) CONF: CELG To Present At Anti-Cancer Drug Conference @ 11:50 ET - Knobias
JS200
CBI`s 4th Annual Phase IV Clinical Trials
via COMTEX
July 17, 2003
WOBURN, Mass., Jul 17, 2003 /PRNewswire via COMTEX/ --
Phase IV clinical trials are an important tool used by the pharmaceutical industry to speed the approval process, position products against competitors and test for new indications or marketing data. Attend the premier event for Phase IV executives to network and learn key strategies for initiating and implementing Phase IV clinical trials. Managing Phase IV studies is quite different from managing earlier phase clinical trials. Challenges include hundreds, if not thousands of investigative sites, sites with little or no clinical trial experience, sales and marketing involvement, etc. CBI`s 4th Annual Phase IV Clinical Trials conference is an exclusive event that is dedicated to the design, development and management of Phase IV studies. At this event you hear perspectives from 10 leading pharmaceutical executives, as well as specific case studies of actual Phase IV projects.
Topics include: * Current regulatory climate for conducting Phase IV studies * Advantages of Phase IV studies in pharmacovigilance and risk management * Strategies for disseminating Phase IV study results * The role of Investigator-Initiated Research in post-marketing studies * And much more!
Executives from Abbott Laboratories, AstraZeneca LP, Bayer, Boehringer- Ingelheim Pharmaceuticals, Celgene Corporation, Dr. Reddy`s Laboratories, Endo Pharmaceuticals, Gilead Sciences, LLC, Janssen Pharmaceutica, Inc., Pfizer Inc., Wyeth and other industry leaders come together to share their experiences at CBI`s 4th Annual Phase IV Clinical Trials conference on September 22-23, 2003 at the Crowne Plaza Philadelphia in Philadelphia, PA.
Register today for this opportunity to network with your colleagues and clients and discuss crucial information they have learned from their experiences.
For more information on this event or to register, contact CBI Registration at 800-817-8601 Fax 781-939-2490 Email cbireg@cbinet.com. Please visit our website at www.cbinet.com/events/HB328/index.html
SOURCE The Center for Business Intelligence (CBI)
CBI Registration, +1-800-817-8601, cbireg@cbinet.com
http://www.cbinet.com
Copyright (C) 2003 PR Newswire. All rights reserved.
JS200
via COMTEX
July 17, 2003
WOBURN, Mass., Jul 17, 2003 /PRNewswire via COMTEX/ --
Phase IV clinical trials are an important tool used by the pharmaceutical industry to speed the approval process, position products against competitors and test for new indications or marketing data. Attend the premier event for Phase IV executives to network and learn key strategies for initiating and implementing Phase IV clinical trials. Managing Phase IV studies is quite different from managing earlier phase clinical trials. Challenges include hundreds, if not thousands of investigative sites, sites with little or no clinical trial experience, sales and marketing involvement, etc. CBI`s 4th Annual Phase IV Clinical Trials conference is an exclusive event that is dedicated to the design, development and management of Phase IV studies. At this event you hear perspectives from 10 leading pharmaceutical executives, as well as specific case studies of actual Phase IV projects.
Topics include: * Current regulatory climate for conducting Phase IV studies * Advantages of Phase IV studies in pharmacovigilance and risk management * Strategies for disseminating Phase IV study results * The role of Investigator-Initiated Research in post-marketing studies * And much more!
Executives from Abbott Laboratories, AstraZeneca LP, Bayer, Boehringer- Ingelheim Pharmaceuticals, Celgene Corporation, Dr. Reddy`s Laboratories, Endo Pharmaceuticals, Gilead Sciences, LLC, Janssen Pharmaceutica, Inc., Pfizer Inc., Wyeth and other industry leaders come together to share their experiences at CBI`s 4th Annual Phase IV Clinical Trials conference on September 22-23, 2003 at the Crowne Plaza Philadelphia in Philadelphia, PA.
Register today for this opportunity to network with your colleagues and clients and discuss crucial information they have learned from their experiences.
For more information on this event or to register, contact CBI Registration at 800-817-8601 Fax 781-939-2490 Email cbireg@cbinet.com. Please visit our website at www.cbinet.com/events/HB328/index.html
SOURCE The Center for Business Intelligence (CBI)
CBI Registration, +1-800-817-8601, cbireg@cbinet.com
http://www.cbinet.com
Copyright (C) 2003 PR Newswire. All rights reserved.
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Celgene Corporation to Announce Second Quarter and Six Months Financial and Operational Results on July 24, 2003
via COMTEX
July 18, 2003
WARREN, N.J., Jul 18, 2003 /PRNewswire-FirstCall via COMTEX/ --
Celgene Corporation (Nasdaq: CELG) will announce second quarter and six month financial and operational results on Thursday, July 24, 2003. Celgene`s management team will host a conference call and live audio webcast at 9:00 AM EDT to discuss the financial and operational results. The webcast will be available to in the investor relations section of the Company`s website at www.celgene.com and will be archived for two weeks.
Celgene Corporation, headquartered in Warren, New Jersey, is an integrated biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company`s website at www.celgene.com.
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company`s control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company`s filings with the Securities and Exchange Commission such as 10K, 10Q and 8K reports.
SOURCE Celgene Corporation
Robert J. Hugin, Senior VP and CFO of Celgene Corporation, +1-732-271-4102
http://www.celgene.com
Copyright (C) 2003 PR Newswire. All rights reserved.
JS200
via COMTEX
July 18, 2003
WARREN, N.J., Jul 18, 2003 /PRNewswire-FirstCall via COMTEX/ --
Celgene Corporation (Nasdaq: CELG) will announce second quarter and six month financial and operational results on Thursday, July 24, 2003. Celgene`s management team will host a conference call and live audio webcast at 9:00 AM EDT to discuss the financial and operational results. The webcast will be available to in the investor relations section of the Company`s website at www.celgene.com and will be archived for two weeks.
Celgene Corporation, headquartered in Warren, New Jersey, is an integrated biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company`s website at www.celgene.com.
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company`s control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company`s filings with the Securities and Exchange Commission such as 10K, 10Q and 8K reports.
SOURCE Celgene Corporation
Robert J. Hugin, Senior VP and CFO of Celgene Corporation, +1-732-271-4102
http://www.celgene.com
Copyright (C) 2003 PR Newswire. All rights reserved.
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Pharmacopeia Achieves Research Milestone in Collaboration With Celgene
via COMTEX
July 22, 2003
PRINCETON, N.J., Jul 22, 2003 /PRNewswire-FirstCall via COMTEX/ --
Pharmacopeia, Inc. (Nasdaq: PCOP) today announced that a research milestone has been reached in its collaboration with Celgene Corporation.
In the collaboration, Pharmacopeia scientists discovered lead compounds from Pharmacopeia`s proprietary compound collection active against Celgene`s inflammation related kinase target. The milestone was triggered by Celgene`s acceptance of the compounds identified from the collaboration and its decision to advance the compounds into a joint optimization program. Based on the achievement of this milestone, Celgene has made a cash payment to Pharmacopeia. Pharmacopeia will be entitled to additional milestone payments as this program progresses through pre-clinical and clinical development and onto the market. Pharmacopeia is also entitled to royalties on commercial sales of any products emanating from this collaboration.
`We are delighted to be able to deliver lead compounds to Celgene,`said Joseph A. Mollica, PhD, Chairman, President and Chief Executive Officer, `in what is a competitive field, with many research groups in biopharmaceutical companies committing resources to the kinase area.`
`We have greatly benefited from accessing Pharmacopeia`s extensive compound library and HTS capability to generate novel pharmacophores to enhance our intellectual property with one of our important kinase targets,` said Alan J. Lewis, PhD, President of the Celgene Research Division, San Diego.
Pharmacopeia (www.pharmacopeia.com) is a leader in enabling science and technology that accelerates and improves the drug discovery and chemical development processes. Pharmacopeia`s Drug Discovery business integrates proprietary small molecule combinatorial and medicinal chemistry, high- throughput screening, in-vitro pharmacology, computational methods and informatics to discover and optimize lead compounds. Pharmacopeia`s software subsidiary, Accelrys, develops and commercializes molecular modeling and simulation software for the life sciences and materials research markets, cheminformatics and decision support systems, and bioinformatics tools including gene sequence analysis. Pharmacopeia is headquartered in Princeton, New Jersey.
When used anywhere in this document, the words `expects,``believes,` `anticipates,``estimates`and similar expressions are intended to identify forward-looking statements. Forward-looking statements herein may include statements addressing future financial and operating results of Pharmacopeia. Pharmacopeia has based these forward-looking statements on its current expectations about future events. Such statements are subject to risks and uncertainties including, but not limited to, the successful implementation of Pharmacopeia`s strategic plans, the acceptance of new products, the obsolescence of existing products, the resolution of existing and potential future patent issues, additional competition, changes in economic conditions, and other risks described in documents Pharmacopeia has filed with the Securities and Exchange Commission, including its most recent report on Form 10-K and subsequent reports on Form 10-Q. All forward-looking statements in this document are qualified entirely by the cautionary statements included in this document and such filings. These risks and uncertainties could cause actual results to differ materially from results expressed or implied by forward-looking statements contained in this document. These forward-looking statements speak only as of the date of this document. Pharmacopeia disclaims any undertaking to publicly update or revise any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.
Contact: Simon M. Tomlinson, Ph.D. Senior Vice President of Business Development (609) 452-3600 irreq@pharmacop.com
SOURCE Pharmacopeia, Inc.
Simon M. Tomlinson, Ph.D., Senior Vice President of Business Development, Pharmacopeia, +1-609-452-3600 or irreq@pharmacop.com
http://www.pharmacopeia.com
Copyright (C) 2003 PR Newswire. All rights reserved.
JS200
via COMTEX
July 22, 2003
PRINCETON, N.J., Jul 22, 2003 /PRNewswire-FirstCall via COMTEX/ --
Pharmacopeia, Inc. (Nasdaq: PCOP) today announced that a research milestone has been reached in its collaboration with Celgene Corporation.
In the collaboration, Pharmacopeia scientists discovered lead compounds from Pharmacopeia`s proprietary compound collection active against Celgene`s inflammation related kinase target. The milestone was triggered by Celgene`s acceptance of the compounds identified from the collaboration and its decision to advance the compounds into a joint optimization program. Based on the achievement of this milestone, Celgene has made a cash payment to Pharmacopeia. Pharmacopeia will be entitled to additional milestone payments as this program progresses through pre-clinical and clinical development and onto the market. Pharmacopeia is also entitled to royalties on commercial sales of any products emanating from this collaboration.
`We are delighted to be able to deliver lead compounds to Celgene,`said Joseph A. Mollica, PhD, Chairman, President and Chief Executive Officer, `in what is a competitive field, with many research groups in biopharmaceutical companies committing resources to the kinase area.`
`We have greatly benefited from accessing Pharmacopeia`s extensive compound library and HTS capability to generate novel pharmacophores to enhance our intellectual property with one of our important kinase targets,` said Alan J. Lewis, PhD, President of the Celgene Research Division, San Diego.
Pharmacopeia (www.pharmacopeia.com) is a leader in enabling science and technology that accelerates and improves the drug discovery and chemical development processes. Pharmacopeia`s Drug Discovery business integrates proprietary small molecule combinatorial and medicinal chemistry, high- throughput screening, in-vitro pharmacology, computational methods and informatics to discover and optimize lead compounds. Pharmacopeia`s software subsidiary, Accelrys, develops and commercializes molecular modeling and simulation software for the life sciences and materials research markets, cheminformatics and decision support systems, and bioinformatics tools including gene sequence analysis. Pharmacopeia is headquartered in Princeton, New Jersey.
When used anywhere in this document, the words `expects,``believes,` `anticipates,``estimates`and similar expressions are intended to identify forward-looking statements. Forward-looking statements herein may include statements addressing future financial and operating results of Pharmacopeia. Pharmacopeia has based these forward-looking statements on its current expectations about future events. Such statements are subject to risks and uncertainties including, but not limited to, the successful implementation of Pharmacopeia`s strategic plans, the acceptance of new products, the obsolescence of existing products, the resolution of existing and potential future patent issues, additional competition, changes in economic conditions, and other risks described in documents Pharmacopeia has filed with the Securities and Exchange Commission, including its most recent report on Form 10-K and subsequent reports on Form 10-Q. All forward-looking statements in this document are qualified entirely by the cautionary statements included in this document and such filings. These risks and uncertainties could cause actual results to differ materially from results expressed or implied by forward-looking statements contained in this document. These forward-looking statements speak only as of the date of this document. Pharmacopeia disclaims any undertaking to publicly update or revise any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.
Contact: Simon M. Tomlinson, Ph.D. Senior Vice President of Business Development (609) 452-3600 irreq@pharmacop.com
SOURCE Pharmacopeia, Inc.
Simon M. Tomlinson, Ph.D., Senior Vice President of Business Development, Pharmacopeia, +1-609-452-3600 or irreq@pharmacop.com
http://www.pharmacopeia.com
Copyright (C) 2003 PR Newswire. All rights reserved.
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Celgene mit Hammerzahlen!!!
Celgene Corporation Reports Strong Operating Performance in Second Quarter as Total Sales Increase 100 Percent and Profits Rise
via COMTEX
July 24, 2003
WARREN, N.J., Jul 24, 2003 /PRNewswire-FirstCall via Comtex/ --
Celgene Corporation (Nasdaq: CELG) today announced earnings per diluted share of $0.03 driven by strong THALOMID(R) (thalidomide) and ALKERAN(R) (melphalan) Tablets and ALKERAN(R) (melphalan HCl) for Injection sales. THALOMID sales were approximately $54.8 million up 93.4 percent for the second quarter of 2003 compared to $28.3 million in the second quarter of 2002. Total revenue was $67.3 million, an increase of 100.1 percent over the prior-year quarter. Celgene posted net income of $2.9 million, or $0.03 per diluted share compared to a net loss of $1.7 million or ($0.02) per diluted share year-over-year.
THALOMID sales rose 20.2 percent quarter-over-quarter to $54.8 million from $45.6 million and total revenues, quarter-over-quarter, increased 37.0 percent to $67.3 million from $49.0 million. Additionally, to offer more convenience to patients and prescribers, Celgene launched new 100mg and 200mg strength capsules of THALOMID in March. We estimate that the launch of these new formulations contributed approximately $4.0 million in added revenue in the quarter. It is expected, with the multiple formulations of THALOMID, that retail pharmacies will maintain higher levels of inventory to support future sales.
THALOMID sales for the six-month period ended June 30, 2003 were $100.5 million compared to $54.5 million in 2002, a growth rate of approximately 84.0 percent year-over-year. Total revenue for the first half of 2003 was a record $116.3 million, an increase of 81.0 percent over the same period in 2002. Celgene posted net income for the first six months of 2003 of $3.8 million or $0.05 per diluted share, compared to a net loss of $2.5 million or ($0.03) per diluted share in the comparable 2002 period.
Celgene increased research and development expenditures to accelerate the regulatory programs for REVIMID in myelodysplastic syndromes and multiple myeloma. Celgene spent $30.5 million in the second quarter of 2003, representing an increase of 59.0 percent compared to the year ago quarter. Additionally, these research and development expenditures supported rapid clinical progress in multiple development programs for its THALOMID, REVIMID(TM), and ACTIMID(TM) products, as well as for its SelCID(TM) and JNK programs. Funding increases also enabled accelerated progress in a number of additional high potential preclinical and early clinical programs.
Including the $12 million Pharmion convertible notes investment, Celgene reported more than $662 million in cash, marketable securities and investments at the end of the second quarter.
`Increasing use of THALOMID in newly diagnosed multiple myeloma patients contributed to the continued strong results in the second quarter. In addition, its clinical investigation in a variety of cancers was reported by researchers in more than 150 studies presented at major international medical meetings,`said John W. Jackson, Chairman and Chief Executive Officer of Celgene Corporation. `This was a record quarter, in which we achieved stronger profits while also advancing key late stage portfolio products like REVIMID, supporting high potential pipeline programs from our drug discovery engine and further bolstering our strong financial position.`
2003 Full Year Financial Guidance Update
In light of the results of the first half of the year we are raising our guidance for 2003. Celgene is raising its THALOMID revenues targets to $200-210 million from prior guidance of $175-185 million. Our new target represents an increase of approximately 65 to 75 percent over 2002 THALOMID revenues. Based on sales trends, new data and significant milestones projected in 2004 and 2005, we maintain our guidance, for the Ritalin(R) product line, approximately $40 million and $60 million, respectively. We are adjusting our target for 2003 to approximately $15 million from the prior guidance of approximately $20 million. Celgene is targeting research and development expenses to increase approximately 40 to 45 percent to $120 to 130 million, to support multiple pivotal programs and an accelerated regulatory approval process for REVIMID. Our goal for full-year 2003 profitability has been raised to a range of $0.10 to $0.15 per diluted share from $0.05 to $0.10 per diluted share.
COMPANY HIGHLIGHTS Clinical, Regulatory and Drug Discovery Achievements * New clinical data presented at the Seventh International Symposium on Myelodysplastic Syndromes in Paris, shows that Celgene`s lead investigational IMiD, REVIMID, has potential activity in limiting the number of red cell transfusions in patients who rely on transfusions as a treatment option. In addition, REVIMID demonstrated significant cytogenic activity with a 100 percent complete response rate in a 5Q minus patient population, an important subset of MDS patients. * REVIMID received fast track designation from the U.S. Food and Drug Administration (FDA) for the treatment of MDS and multiple myeloma. The FDA grants fast track designation to compounds that may provide a significant improvement in the safety or effectiveness of the treatment for a serious or life-threatening disease. Compounds that receive the designation are also eligible for priority review, which provides for a six-month review by the FDA of a new drug application. * Celgene has also initiated several REVIMID Phase I trials in a range of solid tumors, based on new studies demonstrating that REVIMID has multiple novel mechanisms of activity with anti-cancer potential. * Clinical investigators from leading cancer centers presented promising data from more than 43 studies on THALOMID in hematologic and solid tumor cancers at the Annual Meeting of the American Society of Clinical Oncology (ASCO). Data was presented from clinical trials on THALOMID in combination with IL-2 in Metastatic Renal Cell Carcinoma, in combination with Paclitaxel and Estramustine in Androgen Independent Prostate Cancer and in combination with temozolomide in melanoma patients with measurable brain metastasis. * Clinical investigators presented data from 69 THALOMID and REVIMID clinical trials at the Ninth International Myeloma Workshop in Salamanca, Spain. The studies included clinical results for THALOMID used as both a single agent and in combination therapy in every stage of multiple myeloma. Highlights included new data on: thalidomide plus dexamethasone as primary therapy for multiple myeloma of high tumor mass, thalidomide in newly diagnosed patients with smoldering/indolent multiple myeloma, thalidomide plus dexamethasone versus conventional chemotherapy in advanced multiple myeloma and thalidomide plus melphalan versus thalidomide alone in multiple myeloma patients. * Celgene strengthened its extensive intellectual property estate for the Company`s JNK (c-Jun N-terminal Kinase) program by licensing three European patents and a pending U.S. patent from Tufts University. The patents and application cover methods for treating and preventing insulin resistance and related disorders such as diabetes and obesity. * A recent study presented at the NIMH 43rd Annual New Drug Evaluation Unit Meeting in Orlando, Florida demonstrated that Ritalin(R)LA licensed by Celgene to, and marketed by Novartis provides statistically greater symptom management compared to Concerta(R) in children with ADHD over the course of the school day. Corporate and Commercial Achievements * Celgene completed the placement of $400 million of 1.75 percent Convertible Notes due 2008 to qualified institutional buyers. The notes will be convertible into Celgene Corporation common stock at a conversion price of $48.45 per share (reflecting a 50 percent premium, based on the NASDAQ closing price for Celgene common stock of $32.30 on May 28, 2003.) The net proceeds of the offering will be used for Celgene general corporate purposes. * Celgene announced the appointments of Mr. Francis Brown as Senior Vice President of Sales and Marketing, who brings to Celgene over 20 years of experience in directing oncology and immunology sales and marketing for Pharmacia; Dr. Graham Burton as Senior Vice President of Regulatory Affairs, Pharmacovigilence and Project Management, with over 15 years of strong global regulatory relationships and a track record of approvals developed during his successful career at Johnson &Johnson; and Dr. Michael Vander Zwan as Vice President of Quality Assurance and Compliance, with more than 25 years of pharmaceutical experience including developing and implementing a global compliance management function at Pharmacia. * Celgene`s S.T.E.P.S.(R) intellectual property estate for THALOMID was broadened with the issuance of two fundamental U.S. Patents. The newly issued patents, U.S. Patents 6,561,976 and 6,561,977, expand the scope of coverage to include special pharmaceutical distribution programs that do not require the type of health professional or patient registrations described in prior patents. Celgene`s innovative S.T.E.P.S. includes managed distribution programs for products or drugs that are either teratogens (causing birth defects) or have other adverse effects that require contraindication for certain patients.
Celgene senior management will host a conference call to discuss the results and achievements of its second quarter operating and financial performance on July 24, 2003 at 9:00 a.m. EDT. The conference call will be available by webcast at www.celgene.com. An audio replay of the call will be available from noon EDT July 24, 2003 until midnight EDT July 27, 2003. To access the replay, dial 1-800-633-8284 and enter Reservation Number 21154924.
Celgene Corporation, headquartered in Warren, New Jersey, is an integrated biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company`s website at www.celgene.com.
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company`s control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company`s filings with the Securities and Exchange Commission such as 10K, 10Q and 8K reports.
Celgene Corporation Consolidated Financial Results (Unaudited) (In thousands, except per share data) Consolidated Statement of Operations Data Three Month Period Six Month Period Ended June 30, Ended June 30, 2003 2002 2003 2002 Product sales $ 62,497 $ 30,359 $ 108,301 $ 57,997 Collaborative agreement and other revenue 2,308 3,262 3,387 6,318 Royalty revenue 2,481 4,686 - Total revenue 67,286 33,621 116,374 64,315 Cost of goods sold 11,629 4,110 16,291 7,774 Research and development 30,517 19,222 55,238 36,746 Selling, general and administrative 25,905 18,397 49,278 34,695 Total costs and expenses 68,051 41,729 120,807 79,215 Operating loss (765) (8,108) (4,433) (14,900) Interest and other income, net 3,869 6,393 8,624 12,362 Income (loss) before tax 3,104 (1,715) 4,191 (2,538) Income tax 210 - 345 - Net income (loss) $ 2,894 $ (1,715) $ 3,846 $(2,538) Per common share-basic and diluted Net income(loss)-basic $ 0.04 $ (0.02) $ 0.05 $ (0.03) Net income(loss)-diluted $ 0.03 $ (0.02) $ 0.05 $ (0.03) Weighted average shares outstanding-basic 80,839 76,377 80,613 76,003 Weighted average shares outstanding-diluted 85,134 76,377 84,435 76,003 Consolidated Balance Sheet Data June 30, December 31, 2003 2002 Cash, cash equivalents &marketable securities $ 650,111 $ 261,182 Total assets 758,686 327,287 Convertible notes 400,000 - Stockholders`equity 292,663 276,698
SOURCE Celgene Corporation
Robert J. Hugin, Senior VP and CFO of Celgene Corporation, +1-732-271-4102
http://www.prnewswire.com
Copyright (C) 2003 PR Newswire. All rights reserved.
JS2090
via COMTEX
July 24, 2003
WARREN, N.J., Jul 24, 2003 /PRNewswire-FirstCall via Comtex/ --
Celgene Corporation (Nasdaq: CELG) today announced earnings per diluted share of $0.03 driven by strong THALOMID(R) (thalidomide) and ALKERAN(R) (melphalan) Tablets and ALKERAN(R) (melphalan HCl) for Injection sales. THALOMID sales were approximately $54.8 million up 93.4 percent for the second quarter of 2003 compared to $28.3 million in the second quarter of 2002. Total revenue was $67.3 million, an increase of 100.1 percent over the prior-year quarter. Celgene posted net income of $2.9 million, or $0.03 per diluted share compared to a net loss of $1.7 million or ($0.02) per diluted share year-over-year.
THALOMID sales rose 20.2 percent quarter-over-quarter to $54.8 million from $45.6 million and total revenues, quarter-over-quarter, increased 37.0 percent to $67.3 million from $49.0 million. Additionally, to offer more convenience to patients and prescribers, Celgene launched new 100mg and 200mg strength capsules of THALOMID in March. We estimate that the launch of these new formulations contributed approximately $4.0 million in added revenue in the quarter. It is expected, with the multiple formulations of THALOMID, that retail pharmacies will maintain higher levels of inventory to support future sales.
THALOMID sales for the six-month period ended June 30, 2003 were $100.5 million compared to $54.5 million in 2002, a growth rate of approximately 84.0 percent year-over-year. Total revenue for the first half of 2003 was a record $116.3 million, an increase of 81.0 percent over the same period in 2002. Celgene posted net income for the first six months of 2003 of $3.8 million or $0.05 per diluted share, compared to a net loss of $2.5 million or ($0.03) per diluted share in the comparable 2002 period.
Celgene increased research and development expenditures to accelerate the regulatory programs for REVIMID in myelodysplastic syndromes and multiple myeloma. Celgene spent $30.5 million in the second quarter of 2003, representing an increase of 59.0 percent compared to the year ago quarter. Additionally, these research and development expenditures supported rapid clinical progress in multiple development programs for its THALOMID, REVIMID(TM), and ACTIMID(TM) products, as well as for its SelCID(TM) and JNK programs. Funding increases also enabled accelerated progress in a number of additional high potential preclinical and early clinical programs.
Including the $12 million Pharmion convertible notes investment, Celgene reported more than $662 million in cash, marketable securities and investments at the end of the second quarter.
`Increasing use of THALOMID in newly diagnosed multiple myeloma patients contributed to the continued strong results in the second quarter. In addition, its clinical investigation in a variety of cancers was reported by researchers in more than 150 studies presented at major international medical meetings,`said John W. Jackson, Chairman and Chief Executive Officer of Celgene Corporation. `This was a record quarter, in which we achieved stronger profits while also advancing key late stage portfolio products like REVIMID, supporting high potential pipeline programs from our drug discovery engine and further bolstering our strong financial position.`
2003 Full Year Financial Guidance Update
In light of the results of the first half of the year we are raising our guidance for 2003. Celgene is raising its THALOMID revenues targets to $200-210 million from prior guidance of $175-185 million. Our new target represents an increase of approximately 65 to 75 percent over 2002 THALOMID revenues. Based on sales trends, new data and significant milestones projected in 2004 and 2005, we maintain our guidance, for the Ritalin(R) product line, approximately $40 million and $60 million, respectively. We are adjusting our target for 2003 to approximately $15 million from the prior guidance of approximately $20 million. Celgene is targeting research and development expenses to increase approximately 40 to 45 percent to $120 to 130 million, to support multiple pivotal programs and an accelerated regulatory approval process for REVIMID. Our goal for full-year 2003 profitability has been raised to a range of $0.10 to $0.15 per diluted share from $0.05 to $0.10 per diluted share.
COMPANY HIGHLIGHTS Clinical, Regulatory and Drug Discovery Achievements * New clinical data presented at the Seventh International Symposium on Myelodysplastic Syndromes in Paris, shows that Celgene`s lead investigational IMiD, REVIMID, has potential activity in limiting the number of red cell transfusions in patients who rely on transfusions as a treatment option. In addition, REVIMID demonstrated significant cytogenic activity with a 100 percent complete response rate in a 5Q minus patient population, an important subset of MDS patients. * REVIMID received fast track designation from the U.S. Food and Drug Administration (FDA) for the treatment of MDS and multiple myeloma. The FDA grants fast track designation to compounds that may provide a significant improvement in the safety or effectiveness of the treatment for a serious or life-threatening disease. Compounds that receive the designation are also eligible for priority review, which provides for a six-month review by the FDA of a new drug application. * Celgene has also initiated several REVIMID Phase I trials in a range of solid tumors, based on new studies demonstrating that REVIMID has multiple novel mechanisms of activity with anti-cancer potential. * Clinical investigators from leading cancer centers presented promising data from more than 43 studies on THALOMID in hematologic and solid tumor cancers at the Annual Meeting of the American Society of Clinical Oncology (ASCO). Data was presented from clinical trials on THALOMID in combination with IL-2 in Metastatic Renal Cell Carcinoma, in combination with Paclitaxel and Estramustine in Androgen Independent Prostate Cancer and in combination with temozolomide in melanoma patients with measurable brain metastasis. * Clinical investigators presented data from 69 THALOMID and REVIMID clinical trials at the Ninth International Myeloma Workshop in Salamanca, Spain. The studies included clinical results for THALOMID used as both a single agent and in combination therapy in every stage of multiple myeloma. Highlights included new data on: thalidomide plus dexamethasone as primary therapy for multiple myeloma of high tumor mass, thalidomide in newly diagnosed patients with smoldering/indolent multiple myeloma, thalidomide plus dexamethasone versus conventional chemotherapy in advanced multiple myeloma and thalidomide plus melphalan versus thalidomide alone in multiple myeloma patients. * Celgene strengthened its extensive intellectual property estate for the Company`s JNK (c-Jun N-terminal Kinase) program by licensing three European patents and a pending U.S. patent from Tufts University. The patents and application cover methods for treating and preventing insulin resistance and related disorders such as diabetes and obesity. * A recent study presented at the NIMH 43rd Annual New Drug Evaluation Unit Meeting in Orlando, Florida demonstrated that Ritalin(R)LA licensed by Celgene to, and marketed by Novartis provides statistically greater symptom management compared to Concerta(R) in children with ADHD over the course of the school day. Corporate and Commercial Achievements * Celgene completed the placement of $400 million of 1.75 percent Convertible Notes due 2008 to qualified institutional buyers. The notes will be convertible into Celgene Corporation common stock at a conversion price of $48.45 per share (reflecting a 50 percent premium, based on the NASDAQ closing price for Celgene common stock of $32.30 on May 28, 2003.) The net proceeds of the offering will be used for Celgene general corporate purposes. * Celgene announced the appointments of Mr. Francis Brown as Senior Vice President of Sales and Marketing, who brings to Celgene over 20 years of experience in directing oncology and immunology sales and marketing for Pharmacia; Dr. Graham Burton as Senior Vice President of Regulatory Affairs, Pharmacovigilence and Project Management, with over 15 years of strong global regulatory relationships and a track record of approvals developed during his successful career at Johnson &Johnson; and Dr. Michael Vander Zwan as Vice President of Quality Assurance and Compliance, with more than 25 years of pharmaceutical experience including developing and implementing a global compliance management function at Pharmacia. * Celgene`s S.T.E.P.S.(R) intellectual property estate for THALOMID was broadened with the issuance of two fundamental U.S. Patents. The newly issued patents, U.S. Patents 6,561,976 and 6,561,977, expand the scope of coverage to include special pharmaceutical distribution programs that do not require the type of health professional or patient registrations described in prior patents. Celgene`s innovative S.T.E.P.S. includes managed distribution programs for products or drugs that are either teratogens (causing birth defects) or have other adverse effects that require contraindication for certain patients.
Celgene senior management will host a conference call to discuss the results and achievements of its second quarter operating and financial performance on July 24, 2003 at 9:00 a.m. EDT. The conference call will be available by webcast at www.celgene.com. An audio replay of the call will be available from noon EDT July 24, 2003 until midnight EDT July 27, 2003. To access the replay, dial 1-800-633-8284 and enter Reservation Number 21154924.
Celgene Corporation, headquartered in Warren, New Jersey, is an integrated biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company`s website at www.celgene.com.
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company`s control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company`s filings with the Securities and Exchange Commission such as 10K, 10Q and 8K reports.
Celgene Corporation Consolidated Financial Results (Unaudited) (In thousands, except per share data) Consolidated Statement of Operations Data Three Month Period Six Month Period Ended June 30, Ended June 30, 2003 2002 2003 2002 Product sales $ 62,497 $ 30,359 $ 108,301 $ 57,997 Collaborative agreement and other revenue 2,308 3,262 3,387 6,318 Royalty revenue 2,481 4,686 - Total revenue 67,286 33,621 116,374 64,315 Cost of goods sold 11,629 4,110 16,291 7,774 Research and development 30,517 19,222 55,238 36,746 Selling, general and administrative 25,905 18,397 49,278 34,695 Total costs and expenses 68,051 41,729 120,807 79,215 Operating loss (765) (8,108) (4,433) (14,900) Interest and other income, net 3,869 6,393 8,624 12,362 Income (loss) before tax 3,104 (1,715) 4,191 (2,538) Income tax 210 - 345 - Net income (loss) $ 2,894 $ (1,715) $ 3,846 $(2,538) Per common share-basic and diluted Net income(loss)-basic $ 0.04 $ (0.02) $ 0.05 $ (0.03) Net income(loss)-diluted $ 0.03 $ (0.02) $ 0.05 $ (0.03) Weighted average shares outstanding-basic 80,839 76,377 80,613 76,003 Weighted average shares outstanding-diluted 85,134 76,377 84,435 76,003 Consolidated Balance Sheet Data June 30, December 31, 2003 2002 Cash, cash equivalents &marketable securities $ 650,111 $ 261,182 Total assets 758,686 327,287 Convertible notes 400,000 - Stockholders`equity 292,663 276,698
SOURCE Celgene Corporation
Robert J. Hugin, Senior VP and CFO of Celgene Corporation, +1-732-271-4102
http://www.prnewswire.com
Copyright (C) 2003 PR Newswire. All rights reserved.
JS2090
Celgene strong buy geratet von Adams & Harkness & Hill
Quelle: www.aktiencheck.de
Quelle: www.aktiencheck.de
07/28/2003 (16:23 ET) CLOSER(+): Last 90 Min, CELG Jumps +1.84%; Vol +84% - Knobias
07/28/2003 (15:11 ET) VOLUME(+): CELG Volume 63% > 20-adsv, Stock +6.75% - Knobias
07/28/2003 (15:06 ET) 52W HIGH: New 52-Wk High for CELG @ $37.190 up7.30% - Knobias
07/28/2003 (14:00 ET) BIOTECHS: Industry Rallies on OXGN, HGSI, XOMA, IMCL - Knobias
07/25/2003 (15:37 ET) RATING(=): Morgan Stanley Reiterates CELG Rating @ Overweight - Knobias
JS200
07/28/2003 (15:11 ET) VOLUME(+): CELG Volume 63% > 20-adsv, Stock +6.75% - Knobias
07/28/2003 (15:06 ET) 52W HIGH: New 52-Wk High for CELG @ $37.190 up7.30% - Knobias
07/28/2003 (14:00 ET) BIOTECHS: Industry Rallies on OXGN, HGSI, XOMA, IMCL - Knobias
07/25/2003 (15:37 ET) RATING(=): Morgan Stanley Reiterates CELG Rating @ Overweight - Knobias
JS200
Wer will noch heute Celgene kaufen ?
Ich verkaufe.
Ich will dafür Sun Microsystems kaufen.
Ich verkaufe.
Ich will dafür Sun Microsystems kaufen.
Ich glaube, die Aktie von Celgene wird uns noch sehr viel Freude bereiten!
Mit Sicherheit
JS200
JS200
Wie hoch kann Celgene WKN 881244 noch wachsen ???????
Nach dem MACD scheint es gerade heute beginnen zu wachsen !!!!!
Nach dem RSI in New York scheint es aber schon genug überkauft zu sein !!!!!
Besser wäre heute 19.8.2003 noch warten mit den GEWINN-MITNAHMEN , nicht wahr ? nicht wahr ? nicht wahr ??????
Nach dem MACD scheint es gerade heute beginnen zu wachsen !!!!!
Nach dem RSI in New York scheint es aber schon genug überkauft zu sein !!!!!
Besser wäre heute 19.8.2003 noch warten mit den GEWINN-MITNAHMEN , nicht wahr ? nicht wahr ? nicht wahr ??????
Celg wird weiter steigen. Taschen sind voll! Das endet nicht nur bei 40 Dollar!
@OUKEJ
Setz ein Stopplos unter den Steigendenden Trend und ziehe diesen einfach nach.
Meiner steht 5% unter dieser Linie, zur Zeit bei 34 Dollar, ich bin bei 22,11 hinein
JS200
Setz ein Stopplos unter den Steigendenden Trend und ziehe diesen einfach nach.
Meiner steht 5% unter dieser Linie, zur Zeit bei 34 Dollar, ich bin bei 22,11 hinein
JS200
Celgene Corporation Will Present at Healthcare Conferences
via COMTEX
September 2, 2003
WARREN, N.J., Sep 2, 2003 /PRNewswire-FirstCall via COMTEX/ --
Celgene Corporation (Nasdaq: CELG) announced today that Celgene Senior Management will present a company overview at three major healthcare conferences. The presentations will be webcast live and will be available in the investor relations section of the Company`s website at http://www.celgene.com
John W. Jackson, Chairman and Chief Executive Officer will present at the Bear Stearns 16th Annual Healthcare Conference at 4:30 p.m. ET on Monday, September 8, from the Plaza Hotel in New York City.
Sol J. Barer, Ph.D., President and Chief Operating Officer will present at the NewsMakers in the Biotech Industry Conference at 9:30 a.m. ET on Thursday, September 4, 2003 from the Millennium Broadway Hotel in New York City.
Robert J. Hugin, Senior Vice President and Chief Financial Officer will present at the Thomas Weisel Partners Healthcare Conference at 8:35 a.m. ET on Friday, September 5, 2003 from the Four Seasons Hotel in Boston.
Celgene Corporation, headquartered in Warren, New Jersey, is an integrated biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company`s website at www.celgene.com.
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company`s control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company`s filings with the Securities and Exchange Commission such as 10K, 10Q and 8K reports.
SOURCE Celgene Corporation
Robert J. Hugin, Senior VP and CFO of Celgene Corporation, +1-732-271-4102
http://www.celgene.com
Copyright (C) 2003 PR Newswire. All rights reserved.
JS200
via COMTEX
September 2, 2003
WARREN, N.J., Sep 2, 2003 /PRNewswire-FirstCall via COMTEX/ --
Celgene Corporation (Nasdaq: CELG) announced today that Celgene Senior Management will present a company overview at three major healthcare conferences. The presentations will be webcast live and will be available in the investor relations section of the Company`s website at http://www.celgene.com
John W. Jackson, Chairman and Chief Executive Officer will present at the Bear Stearns 16th Annual Healthcare Conference at 4:30 p.m. ET on Monday, September 8, from the Plaza Hotel in New York City.
Sol J. Barer, Ph.D., President and Chief Operating Officer will present at the NewsMakers in the Biotech Industry Conference at 9:30 a.m. ET on Thursday, September 4, 2003 from the Millennium Broadway Hotel in New York City.
Robert J. Hugin, Senior Vice President and Chief Financial Officer will present at the Thomas Weisel Partners Healthcare Conference at 8:35 a.m. ET on Friday, September 5, 2003 from the Four Seasons Hotel in Boston.
Celgene Corporation, headquartered in Warren, New Jersey, is an integrated biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company`s website at www.celgene.com.
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company`s control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company`s filings with the Securities and Exchange Commission such as 10K, 10Q and 8K reports.
SOURCE Celgene Corporation
Robert J. Hugin, Senior VP and CFO of Celgene Corporation, +1-732-271-4102
http://www.celgene.com
Copyright (C) 2003 PR Newswire. All rights reserved.
JS200
Reise geht weiter, aktuell 41,50 USD neues Jahreshoch!
Sind immerhin 100 % seit Tread eröffnung
JS200
JS200
09/04/2003 (14:16 ET) 52W HIGH: New 52-Wk High for CELG @ $41.150 up2.72% - Knobias
09/04/2003 (11:51 ET) BTC: JMP Provides Fall Preview of Biotech Industry - Knobias
09/04/2003 (10:59 ET) New 4 just released for CELG - Edgar
09/04/2003 (09:41 ET) CONF: CELG To Present At Biotech Newsmakers Conference @ 09:30 ET - Knobias
09/03/2003 (12:15 ET) JP Morgan Sees CELG as Attractive Investment - Knobias
JS200
09/04/2003 (11:51 ET) BTC: JMP Provides Fall Preview of Biotech Industry - Knobias
09/04/2003 (10:59 ET) New 4 just released for CELG - Edgar
09/04/2003 (09:41 ET) CONF: CELG To Present At Biotech Newsmakers Conference @ 09:30 ET - Knobias
09/03/2003 (12:15 ET) JP Morgan Sees CELG as Attractive Investment - Knobias
JS200
SK 42,-- USD
MORNING UPDATE: Man Securities Issues Alerts for ORCL, MWD, ASML, IDTI, And CELG
via COMTEX
September 5, 2003
CHICAGO, Sep 5, 2003 /PRNewswire via COMTEX/ --
Man Securities issues the following Morning Update at 8:30 AM EDT with new PriceWatch Alerts for key stocks.
(Logo: http://www.newscom.com/cgi-bin/prnh/20020214/MANSECLOGO )
Before the open... PriceWatch Alerts for ORCL, MWD, ASML, IDTI, and CELG, Market Overview, Today`s Economic Calendar, and the Quote Of The Day.
QUOTE OF THE DAY
`Until employment growth returns materially, consumer spending is at risk.`
-- John Lonski, chief economist, Moody`s Investor Service New PriceWatch Alerts for ORCL, MWD, ASML, IDTI, and CELG... PRICEWATCH ALERTS - HIGH RETURN COVERED CALL OPTIONS ----------- -- Oracle Systems Corp. (Nasdaq: ORCL) Last Price 13.72 - DEC 12.50 CALL OPTION@ $1.75 -> 4.4 % Return assigned* -- Morgan Stanley Dean Witter &Co. (NYSE: MWD) Last Price 49.36 - JAN 45.00 CALL OPTION@ $6.50 -> 5 % Return assigned* -- ASML Holding N.V. (Nasdaq: ASML) Last Price 15.30 - OCT 15.00 CALL OPTION@ $1.25 -> 6.8 % Return assigned* -- Integrated Device Technology, Inc. (Nasdaq: IDTI) Last Price 14.57 - NOV 12.50 CALL OPTION@ $2.65 -> 4.9 % Return assigned* -- Celgene Corp. (Nasdaq: CELG) Last Price 42.00 - JAN 35.00 CALL OPTION@ $8.70 -> 5.1 % Return assigned*
* For our report, `5 Dividend Paying Stocks With Double Digit Returns`, go to: www.investorsobserver.com/5divsl
** For a FREE subscription to The Wall Street Journal, Investors Business Daily, or Financial Times go to www.InvestorsObserver.com/freenews
NOTE: All stocks and options shown are examples only. These are not recommendations to buy or sell any security.
MARKET OVERVIEW
Overseas markets seem to have retracted from a higher open. Currently just three of the 15 markets that we track are positive. The cumulative average return on the group now stands at a minus 0.321 percent. The Nikkei posted minimal gains overnight but exited the week higher by 2.97 percent and closed out the week firmly above the 10,500 level. The last time the Nikkei posted a weekly close above that level was July 12, 2002 at 10,601.50. Focusing north of the border, the Canadian jobless rate rose to 8.0 percent in August from the 7.8 percent posted in July while employment fell by 19,000 jobs. Following the hot/cold reports coming out of Germany of late, we have a positive one today. German industrial output rose 2.4 percent in July, reversing June`s 0.4 percent decline. Analysts were braced for an anemic 0.5 percent rise on the month. This report has sparked `hopes`that the German economy may shift into the growth column in the third quarter.
Before the market open today, August Non-Farm Payrolls figures are due out. The consensus of opinion currently forecasts a rise of 12,000 in non- farm payrolls on the heel of July`s shocking 44,000 loss. If correct, this rise will mark the first monthly increase since January. Of course, 12,000 is a drop in the bucket when monthly numbers in excess of plus 100,000 would be required to validate a `typical`economic recovery (not this apparent `atypical`economic recovery). The August Unemployment Rate is expected to hold at 6.2 percent, matching last month`s 6.2 percent rate.
Be prepared for the investing week ahead with Bernie Schaeffer`s FREE Monday Morning Outlook. For more details and to sign up, go to: http://www.investorsobserver.com/freemo.
TODAY`S ECONOMIC CALENDAR 8:30 a.m.: August Non-Farm Payrolls (seen as up by 12,000, last minus 44,000). 8:30 a.m.: August Unemployment Rate (expected at 6.2 percent, last 6.2 percent). 9:40 a.m.: August ECRI Inflation Gauge (last 115.4). 2:00 p.m.: August Treasury STRIPS.
Man Financial Inc is one of the world`s major futures and options brokers and has been recognized as a leading option order execution firm for individuals and institutions. Member CBOE/NASD/SIPC (CRD#6731). For more information and a free CD with educational tools to help you invest smarter, see http://www.mansecurities.com/mu.html." target="_blank" rel="nofollow ugc noopener">http://www.mansecurities.com/mu.html.
This Morning Update was prepared with data and information provided by:
InvestorsObserver.com - Better Strategies for Making Money -> For Investors With a Sense of Humor. Only $1 for your first month plus seven free bonuses worth over $420, see: www.investorsobserver.com/bm
Schaeffer`s Investment Research - Sign up for your FREE e-weekly, Monday Morning Outlook, Bernie Schaeffer`s look ahead at the markets. Sign Up Now http://www.schaeffersresearch.com/redirect.asp?CODE=GJ01A3&P…
PowerOptionsPlus - The Best Way To Find, Compare, Analyze, and Make Money On Options Investments. For a 14-Day FREE trial and 5 FREE bonuses go to: www.PowerOptionsPlus.com
All stocks and options shown are examples only. These are not recommendations to buy or sell any security and they do not represent in any way a positive or negative outlook for any security. Potential returns do not take into account your trade size, brokerage commissions or taxes which will affect actual investment returns. Stocks and options involve risk and are not suitable for all investors and investing in options carries substantial risk. Prior to buying or selling options, a person must receive a copy of Characteristics and Risks of Standardized Options available from Sharon at 800-837-6212 or at http://www.cboe.com/Resources/Intro.asp. Privacy policy available upon request.
SOURCE Man Securities
Michael Lavelle of Man Securities, +1-800-837-6212 /Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20020214/MANSECLOGO AP Archive: http://photoarchive.ap.org PRN Photo Desk, +1-888-776-6555 or +1-212-782-2840
http://www.mansecurities.com/mu.html
Copyright (C) 2003 PR Newswire. All rights reserved.
JS200
via COMTEX
September 5, 2003
CHICAGO, Sep 5, 2003 /PRNewswire via COMTEX/ --
Man Securities issues the following Morning Update at 8:30 AM EDT with new PriceWatch Alerts for key stocks.
(Logo: http://www.newscom.com/cgi-bin/prnh/20020214/MANSECLOGO )
Before the open... PriceWatch Alerts for ORCL, MWD, ASML, IDTI, and CELG, Market Overview, Today`s Economic Calendar, and the Quote Of The Day.
QUOTE OF THE DAY
`Until employment growth returns materially, consumer spending is at risk.`
-- John Lonski, chief economist, Moody`s Investor Service New PriceWatch Alerts for ORCL, MWD, ASML, IDTI, and CELG... PRICEWATCH ALERTS - HIGH RETURN COVERED CALL OPTIONS ----------- -- Oracle Systems Corp. (Nasdaq: ORCL) Last Price 13.72 - DEC 12.50 CALL OPTION@ $1.75 -> 4.4 % Return assigned* -- Morgan Stanley Dean Witter &Co. (NYSE: MWD) Last Price 49.36 - JAN 45.00 CALL OPTION@ $6.50 -> 5 % Return assigned* -- ASML Holding N.V. (Nasdaq: ASML) Last Price 15.30 - OCT 15.00 CALL OPTION@ $1.25 -> 6.8 % Return assigned* -- Integrated Device Technology, Inc. (Nasdaq: IDTI) Last Price 14.57 - NOV 12.50 CALL OPTION@ $2.65 -> 4.9 % Return assigned* -- Celgene Corp. (Nasdaq: CELG) Last Price 42.00 - JAN 35.00 CALL OPTION@ $8.70 -> 5.1 % Return assigned*
* For our report, `5 Dividend Paying Stocks With Double Digit Returns`, go to: www.investorsobserver.com/5divsl
** For a FREE subscription to The Wall Street Journal, Investors Business Daily, or Financial Times go to www.InvestorsObserver.com/freenews
NOTE: All stocks and options shown are examples only. These are not recommendations to buy or sell any security.
MARKET OVERVIEW
Overseas markets seem to have retracted from a higher open. Currently just three of the 15 markets that we track are positive. The cumulative average return on the group now stands at a minus 0.321 percent. The Nikkei posted minimal gains overnight but exited the week higher by 2.97 percent and closed out the week firmly above the 10,500 level. The last time the Nikkei posted a weekly close above that level was July 12, 2002 at 10,601.50. Focusing north of the border, the Canadian jobless rate rose to 8.0 percent in August from the 7.8 percent posted in July while employment fell by 19,000 jobs. Following the hot/cold reports coming out of Germany of late, we have a positive one today. German industrial output rose 2.4 percent in July, reversing June`s 0.4 percent decline. Analysts were braced for an anemic 0.5 percent rise on the month. This report has sparked `hopes`that the German economy may shift into the growth column in the third quarter.
Before the market open today, August Non-Farm Payrolls figures are due out. The consensus of opinion currently forecasts a rise of 12,000 in non- farm payrolls on the heel of July`s shocking 44,000 loss. If correct, this rise will mark the first monthly increase since January. Of course, 12,000 is a drop in the bucket when monthly numbers in excess of plus 100,000 would be required to validate a `typical`economic recovery (not this apparent `atypical`economic recovery). The August Unemployment Rate is expected to hold at 6.2 percent, matching last month`s 6.2 percent rate.
Be prepared for the investing week ahead with Bernie Schaeffer`s FREE Monday Morning Outlook. For more details and to sign up, go to: http://www.investorsobserver.com/freemo.
TODAY`S ECONOMIC CALENDAR 8:30 a.m.: August Non-Farm Payrolls (seen as up by 12,000, last minus 44,000). 8:30 a.m.: August Unemployment Rate (expected at 6.2 percent, last 6.2 percent). 9:40 a.m.: August ECRI Inflation Gauge (last 115.4). 2:00 p.m.: August Treasury STRIPS.
Man Financial Inc is one of the world`s major futures and options brokers and has been recognized as a leading option order execution firm for individuals and institutions. Member CBOE/NASD/SIPC (CRD#6731). For more information and a free CD with educational tools to help you invest smarter, see http://www.mansecurities.com/mu.html." target="_blank" rel="nofollow ugc noopener">http://www.mansecurities.com/mu.html.
This Morning Update was prepared with data and information provided by:
InvestorsObserver.com - Better Strategies for Making Money -> For Investors With a Sense of Humor. Only $1 for your first month plus seven free bonuses worth over $420, see: www.investorsobserver.com/bm
Schaeffer`s Investment Research - Sign up for your FREE e-weekly, Monday Morning Outlook, Bernie Schaeffer`s look ahead at the markets. Sign Up Now http://www.schaeffersresearch.com/redirect.asp?CODE=GJ01A3&P…
PowerOptionsPlus - The Best Way To Find, Compare, Analyze, and Make Money On Options Investments. For a 14-Day FREE trial and 5 FREE bonuses go to: www.PowerOptionsPlus.com
All stocks and options shown are examples only. These are not recommendations to buy or sell any security and they do not represent in any way a positive or negative outlook for any security. Potential returns do not take into account your trade size, brokerage commissions or taxes which will affect actual investment returns. Stocks and options involve risk and are not suitable for all investors and investing in options carries substantial risk. Prior to buying or selling options, a person must receive a copy of Characteristics and Risks of Standardized Options available from Sharon at 800-837-6212 or at http://www.cboe.com/Resources/Intro.asp. Privacy policy available upon request.
SOURCE Man Securities
Michael Lavelle of Man Securities, +1-800-837-6212 /Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20020214/MANSECLOGO AP Archive: http://photoarchive.ap.org PRN Photo Desk, +1-888-776-6555 or +1-212-782-2840
http://www.mansecurities.com/mu.html
Copyright (C) 2003 PR Newswire. All rights reserved.
JS200
MORNING UPDATE: Man Securities Issues Alerts for ORCL, MWD, ASML, IDTI, And CELG [INLINE]
via CDS
September 5, 2003
Man Securities issues the following Morning Update at 8:30 AM EDT with new PriceWatch Alerts for key stocks.
(Logo: http://www.newscom.com/cgi-bin/prnh/20020214/MANSECLOGO )
Before the open... PriceWatch Alerts for ORCL, MWD, ASML, IDTI, and CELG, Market Overview, Today`s Economic Calendar, and the Quote Of The Day.
QUOTE OF THE DAY
`Until employment growth returns materially, consumer spending is at risk.`
-- John Lonski, chief economist, Moody`s Investor Service
New PriceWatch Alerts for ORCL, MWD, ASML, IDTI, and CELG...
PRICEWATCH ALERTS - HIGH RETURN COVERED CALL OPTIONS -----------
-- Oracle Systems Corp. (Nasdaq: ORCL) Last Price 13.72 - DEC 12.50 CALL OPTION@ $1.75 -) 4.4 % Return assigned*
-- Morgan Stanley Dean Witter & Co. (NYSE: MWD) Last Price 49.36 - JAN 45.00 CALL OPTION@ $6.50 -) 5 % Return assigned*
-- ASML Holding N.V. (Nasdaq: ASML) Last Price 15.30 - OCT 15.00 CALL OPTION@ $1.25 -) 6.8 % Return assigned*
-- Integrated Device Technology, Inc. (Nasdaq: IDTI) Last Price 14.57 - NOV 12.50 CALL OPTION@ $2.65 -) 4.9 % Return assigned*
-- Celgene Corp. (Nasdaq: CELG) Last Price 42.00 - JAN 35.00 CALL OPTION@ $8.70 -) 5.1 % Return assigned*
* For our report, `5 Dividend Paying Stocks With Double Digit Returns`, go to: http://www.investorsobserver.com/5divsl
** For a FREE subscription to The Wall Street Journal, Investors Business Daily, or Financial Times go to http://www.InvestorsObserver.com/freenews
NOTE: All stocks and options shown are examples only. These are not recommendations to buy or sell any security.
MARKET OVERVIEW
Overseas markets seem to have retracted from a higher open. Currently just three of the 15 markets that we track are positive. The cumulative average return on the group now stands at a minus 0.321 percent. The Nikkei posted minimal gains overnight but exited the week higher by 2.97 percent and closed out the week firmly above the 10,500 level. The last time the Nikkei posted a weekly close above that level was July 12, 2002 at 10,601.50. Focusing north of the border, the Canadian jobless rate rose to 8.0 percent in August from the 7.8 percent posted in July while employment fell by 19,000 jobs. Following the hot/cold reports coming out of Germany of late, we have a positive one today. German industrial output rose 2.4 percent in July, reversing June`s 0.4 percent decline. Analysts were braced for an anemic 0.5 percent rise on the month. This report has sparked `hopes`that the German economy may shift into the growth column in the third quarter.
Before the market open today, August Non-Farm Payrolls figures are due out. The consensus of opinion currently forecasts a rise of 12,000 in non- farm payrolls on the heel of July`s shocking 44,000 loss. If correct, this rise will mark the first monthly increase since January. Of course, 12,000 is a drop in the bucket when monthly numbers in excess of plus 100,000 would be required to validate a `typical`economic recovery (not this apparent `atypical`economic recovery). The August Unemployment Rate is expected to hold at 6.2 percent, matching last month`s 6.2 percent rate.
Be prepared for the investing week ahead with Bernie Schaeffer`s FREE Monday Morning Outlook. For more details and to sign up, go to: http://www.investorsobserver.com/freemo.
TODAY`S ECONOMIC CALENDAR
8:30 a.m.: August Non-Farm Payrolls (seen as up by 12,000, last minus 44,000).
8:30 a.m.: August Unemployment Rate (expected at 6.2 percent, last 6.2 percent).
9:40 a.m.: August ECRI Inflation Gauge (last 115.4).
2:00 p.m.: August Treasury STRIPS.
Man Financial Inc is one of the world`s major futures and options brokers and has been recognized as a leading option order execution firm for individuals and institutions. Member CBOE/NASD/SIPC (CRD#6731). For more information and a free CD with educational tools to help you invest smarter, see http://www.mansecurities.com/mu.html.
This Morning Update was prepared with data and information provided by:
InvestorsObserver.com - Better Strategies for Making Money -) For Investors With a Sense of Humor. Only $1 for your first month plus seven free bonuses worth over $420, see: http://www.investorsobserver.com/bm
Schaeffer`s Investment Research - Sign up for your FREE e-weekly, Monday Morning Outlook, Bernie Schaeffer`s look ahead at the markets. Sign Up Now http://www.schaeffersresearch.com/redirect.asp?CODE=GJ01A3&P…
PowerOptionsPlus - The Best Way To Find, Compare, Analyze, and Make Money On Options Investments. For a 14-Day FREE trial and 5 FREE bonuses go to: http://www.PowerOptionsPlus.com
All stocks and options shown are examples only. These are not recommendations to buy or sell any security and they do not represent in any way a positive or negative outlook for any security. Potential returns do not take into account your trade size, brokerage commissions or taxes which will affect actual investment returns. Stocks and options involve risk and are not suitable for all investors and investing in options carries substantial risk. Prior to buying or selling options, a person must receive a copy of Characteristics and Risks of Standardized Options available from Sharon at 800-837-6212 or at http://www.cboe.com/Resources/Intro.asp. Privacy policy available upon request.
Print story
Current Quote
NSD: CELG
Biotech/Medical
Last: 44.420
Change: 2.420
Volume: 2,374,500
Day High: 44.670
Day Low: 41.840
First Alert News
Get real-time CELG release alerts by entering your email address below.
JS200
via CDS
September 5, 2003
Man Securities issues the following Morning Update at 8:30 AM EDT with new PriceWatch Alerts for key stocks.
(Logo: http://www.newscom.com/cgi-bin/prnh/20020214/MANSECLOGO )
Before the open... PriceWatch Alerts for ORCL, MWD, ASML, IDTI, and CELG, Market Overview, Today`s Economic Calendar, and the Quote Of The Day.
QUOTE OF THE DAY
`Until employment growth returns materially, consumer spending is at risk.`
-- John Lonski, chief economist, Moody`s Investor Service
New PriceWatch Alerts for ORCL, MWD, ASML, IDTI, and CELG...
PRICEWATCH ALERTS - HIGH RETURN COVERED CALL OPTIONS -----------
-- Oracle Systems Corp. (Nasdaq: ORCL) Last Price 13.72 - DEC 12.50 CALL OPTION@ $1.75 -) 4.4 % Return assigned*
-- Morgan Stanley Dean Witter & Co. (NYSE: MWD) Last Price 49.36 - JAN 45.00 CALL OPTION@ $6.50 -) 5 % Return assigned*
-- ASML Holding N.V. (Nasdaq: ASML) Last Price 15.30 - OCT 15.00 CALL OPTION@ $1.25 -) 6.8 % Return assigned*
-- Integrated Device Technology, Inc. (Nasdaq: IDTI) Last Price 14.57 - NOV 12.50 CALL OPTION@ $2.65 -) 4.9 % Return assigned*
-- Celgene Corp. (Nasdaq: CELG) Last Price 42.00 - JAN 35.00 CALL OPTION@ $8.70 -) 5.1 % Return assigned*
* For our report, `5 Dividend Paying Stocks With Double Digit Returns`, go to: http://www.investorsobserver.com/5divsl
** For a FREE subscription to The Wall Street Journal, Investors Business Daily, or Financial Times go to http://www.InvestorsObserver.com/freenews
NOTE: All stocks and options shown are examples only. These are not recommendations to buy or sell any security.
MARKET OVERVIEW
Overseas markets seem to have retracted from a higher open. Currently just three of the 15 markets that we track are positive. The cumulative average return on the group now stands at a minus 0.321 percent. The Nikkei posted minimal gains overnight but exited the week higher by 2.97 percent and closed out the week firmly above the 10,500 level. The last time the Nikkei posted a weekly close above that level was July 12, 2002 at 10,601.50. Focusing north of the border, the Canadian jobless rate rose to 8.0 percent in August from the 7.8 percent posted in July while employment fell by 19,000 jobs. Following the hot/cold reports coming out of Germany of late, we have a positive one today. German industrial output rose 2.4 percent in July, reversing June`s 0.4 percent decline. Analysts were braced for an anemic 0.5 percent rise on the month. This report has sparked `hopes`that the German economy may shift into the growth column in the third quarter.
Before the market open today, August Non-Farm Payrolls figures are due out. The consensus of opinion currently forecasts a rise of 12,000 in non- farm payrolls on the heel of July`s shocking 44,000 loss. If correct, this rise will mark the first monthly increase since January. Of course, 12,000 is a drop in the bucket when monthly numbers in excess of plus 100,000 would be required to validate a `typical`economic recovery (not this apparent `atypical`economic recovery). The August Unemployment Rate is expected to hold at 6.2 percent, matching last month`s 6.2 percent rate.
Be prepared for the investing week ahead with Bernie Schaeffer`s FREE Monday Morning Outlook. For more details and to sign up, go to: http://www.investorsobserver.com/freemo.
TODAY`S ECONOMIC CALENDAR
8:30 a.m.: August Non-Farm Payrolls (seen as up by 12,000, last minus 44,000).
8:30 a.m.: August Unemployment Rate (expected at 6.2 percent, last 6.2 percent).
9:40 a.m.: August ECRI Inflation Gauge (last 115.4).
2:00 p.m.: August Treasury STRIPS.
Man Financial Inc is one of the world`s major futures and options brokers and has been recognized as a leading option order execution firm for individuals and institutions. Member CBOE/NASD/SIPC (CRD#6731). For more information and a free CD with educational tools to help you invest smarter, see http://www.mansecurities.com/mu.html.
This Morning Update was prepared with data and information provided by:
InvestorsObserver.com - Better Strategies for Making Money -) For Investors With a Sense of Humor. Only $1 for your first month plus seven free bonuses worth over $420, see: http://www.investorsobserver.com/bm
Schaeffer`s Investment Research - Sign up for your FREE e-weekly, Monday Morning Outlook, Bernie Schaeffer`s look ahead at the markets. Sign Up Now http://www.schaeffersresearch.com/redirect.asp?CODE=GJ01A3&P…
PowerOptionsPlus - The Best Way To Find, Compare, Analyze, and Make Money On Options Investments. For a 14-Day FREE trial and 5 FREE bonuses go to: http://www.PowerOptionsPlus.com
All stocks and options shown are examples only. These are not recommendations to buy or sell any security and they do not represent in any way a positive or negative outlook for any security. Potential returns do not take into account your trade size, brokerage commissions or taxes which will affect actual investment returns. Stocks and options involve risk and are not suitable for all investors and investing in options carries substantial risk. Prior to buying or selling options, a person must receive a copy of Characteristics and Risks of Standardized Options available from Sharon at 800-837-6212 or at http://www.cboe.com/Resources/Intro.asp. Privacy policy available upon request.
Print story
Current Quote
NSD: CELG
Biotech/Medical
Last: 44.420
Change: 2.420
Volume: 2,374,500
Day High: 44.670
Day Low: 41.840
First Alert News
Get real-time CELG release alerts by entering your email address below.
JS200
Last Trade: 44.390 Change: 2.390 (+5.690%)
Previous Close: 42.000 Volume: 2,378,600
Bid: 44.390 Ask: 44.390
Today`s Open: 42.100 # of Trades: 4,848
09/05/2003 (11:16 ET) VOLUME(+): CELG Volume 11% > 20-adsv, Stock +4.76% - Knobias
09/05/2003 (10:42 ET) RATING(=): Leerink Swann Reiterates CELG Rating @ Outperform - Knobias
09/05/2003 (09:57 ET) 52W HIGH: New 52-Wk High for CELG @ $42.400 up0.95% - Knobias
09/05/2003 (09:20 ET) MORNING UPDATE: Man Securities Issues Alerts for ORCL, MWD, ASML, IDTI, And CELG - PR Newswire
09/05/2003 (08:02 ET) CONF: CELG To Present At Thomas Weisel Health Conference @ 08:35 ET - Knobias
JS200
Previous Close: 42.000 Volume: 2,378,600
Bid: 44.390 Ask: 44.390
Today`s Open: 42.100 # of Trades: 4,848
09/05/2003 (11:16 ET) VOLUME(+): CELG Volume 11% > 20-adsv, Stock +4.76% - Knobias
09/05/2003 (10:42 ET) RATING(=): Leerink Swann Reiterates CELG Rating @ Outperform - Knobias
09/05/2003 (09:57 ET) 52W HIGH: New 52-Wk High for CELG @ $42.400 up0.95% - Knobias
09/05/2003 (09:20 ET) MORNING UPDATE: Man Securities Issues Alerts for ORCL, MWD, ASML, IDTI, And CELG - PR Newswire
09/05/2003 (08:02 ET) CONF: CELG To Present At Thomas Weisel Health Conference @ 08:35 ET - Knobias
JS200
Last Trade: 45.096 Change: 3.096 (+7.371%)
Previous Close: 42.000 Volume: 2,938,200
Bid: 45.020 Ask: 45.100
Today`s Open: 42.100 # of Trades: 6,596
Day High: 45.100 Day Low: 41.840
52 Week High: 42.140 52 week Low: 14.850
Market Cap: 3.65B Avg Daily Vol: 1,051,315
EPS: -1.20 PE Ratio: -37.580
Dividend: N/A Yield: N/A
JS200
Previous Close: 42.000 Volume: 2,938,200
Bid: 45.020 Ask: 45.100
Today`s Open: 42.100 # of Trades: 6,596
Day High: 45.100 Day Low: 41.840
52 Week High: 42.140 52 week Low: 14.850
Market Cap: 3.65B Avg Daily Vol: 1,051,315
EPS: -1.20 PE Ratio: -37.580
Dividend: N/A Yield: N/A
JS200
Jetzt noch einmal so eine Woche, das wäre es! 
@HONORAR
Ich gehe eher von einem leicht fallenden Kurs aus
Mein Stopplos steht bei 43,00
JS200
Ich gehe eher von einem leicht fallenden Kurs aus
Mein Stopplos steht bei 43,00
JS200
@JS200
Gratuliere für den 100% Gewinn
Gratuliere für den 100% Gewinn
@OSKI
Hab schon mehrere für dieses Jahr
MLNM
EXEL
usw
JS200
Hab schon mehrere für dieses Jahr
MLNM
EXEL
usw
JS200
@OSKI
CARA mit fast 600% hatte ich vergessen, trotzdem sehr interessant, habe aber nur 400 % mitgenommen, leider.
JS200
CARA mit fast 600% hatte ich vergessen, trotzdem sehr interessant, habe aber nur 400 % mitgenommen, leider.
JS200
Ich habe auch irgendwie ein glückliches Händchen. Schaut mal auf PSI (Kaufkurs 1,21), Trinity Biotech (KK 0,91)
IM Internationalmedia (DK 1,35) die geht morgen durch die Decke! Da fängt es jetzt erst an!!!
Tja, dann bleiben da noch Celgene, Foundry, Itelligence und Varetis!!
Viel Erfolg!!!
IM Internationalmedia (DK 1,35) die geht morgen durch die Decke! Da fängt es jetzt erst an!!!
Tja, dann bleiben da noch Celgene, Foundry, Itelligence und Varetis!!
Viel Erfolg!!!
Celgene kennt kein halten mehr, neues Jahreshoch!!!
New Treatment Options Featured in NCCN Multiple Myeloma Clinical Practice Guidelines
via COMTEX
September 8, 2003
JENKINTOWN, Pa., Sep 8, 2003 (BUSINESS WIRE) --
The National Comprehensive Cancer Network, an alliance of nineteen of the world`s leading cancer centers, announces an update of the NCCN Multiple Myeloma Clinical Practice Guidelines. The NCCN`s panel of oncology experts has added bortezomib (Velcade(TM); Millennium Pharmaceuticals, Inc., Cambridge, MA) to its listing of chemotherapeutic agents that are considered appropriate for patients with progressive or refractory multiple myeloma who have previously been treated with conventional dose chemotherapy alone or followed by high dose chemotherapy and stem cell transplant. Bortezomib is the first in a new class of drugs (i.e., proteasome inhibitors) to be approved by the FDA. Another update is the inclusion of the combination of thalidomide (Thalomid(R); Celgene Corporation, Warren, NJ) and dexamethasone on the list of options for the primary treatment of disseminated disease. Thalidomide had previously been recommended as an approach to managing progressive or refractory multiple myeloma.
`NCCN Clinical Practice Guidelines in Oncology are widely recognized as the standard for clinical policy in oncology. Additionally, they are being used increasingly by managed care companies to help establish coverage policy,`said Rodger J. Winn, MD, Chair of the NCCN Guideline Steering Committee. `As such, the NCCN recognizes its responsibility to provide up-to-date information to inform decision-making. Thus, the NCCN Guidelines process is an ongoing, continual process.`
NCCN Clinical Practice Guidelines in Oncology are available free of charge on CD-ROM. These can be ordered from NCCN by calling 215-690-0300. The guidelines can also be found at www.nccn.org.
The National Comprehensive Cancer Network (NCCN), an alliance of 19 of the world`s leading cancer centers, is an authoritative source of information to help patients and health professionals make informed decisions about cancer care. Through the collective expertise of its member institutions, the NCCN develops, updates, and disseminates a complete library of clinical practice guidelines. These guidelines are the standard for clinical policy in oncology. NCCN`s complete spectrum of programs emphasizes improving the quality, effectiveness, and efficiency of oncology practice.
SOURCE: National Comprehensive Cancer Network (NCCN)
National Comprehensive Cancer Network (NCCN) Kim Schwalje, 215-690-0252 Schwalje@nccn.org
http://www.businesswire.com
Today`s News On The Net - Business Wire`s full file on the Internet with Hyperlinks to your home page.
Copyright (C) 2003 Business Wire. All rights reserved.
JS200
via COMTEX
September 8, 2003
JENKINTOWN, Pa., Sep 8, 2003 (BUSINESS WIRE) --
The National Comprehensive Cancer Network, an alliance of nineteen of the world`s leading cancer centers, announces an update of the NCCN Multiple Myeloma Clinical Practice Guidelines. The NCCN`s panel of oncology experts has added bortezomib (Velcade(TM); Millennium Pharmaceuticals, Inc., Cambridge, MA) to its listing of chemotherapeutic agents that are considered appropriate for patients with progressive or refractory multiple myeloma who have previously been treated with conventional dose chemotherapy alone or followed by high dose chemotherapy and stem cell transplant. Bortezomib is the first in a new class of drugs (i.e., proteasome inhibitors) to be approved by the FDA. Another update is the inclusion of the combination of thalidomide (Thalomid(R); Celgene Corporation, Warren, NJ) and dexamethasone on the list of options for the primary treatment of disseminated disease. Thalidomide had previously been recommended as an approach to managing progressive or refractory multiple myeloma.
`NCCN Clinical Practice Guidelines in Oncology are widely recognized as the standard for clinical policy in oncology. Additionally, they are being used increasingly by managed care companies to help establish coverage policy,`said Rodger J. Winn, MD, Chair of the NCCN Guideline Steering Committee. `As such, the NCCN recognizes its responsibility to provide up-to-date information to inform decision-making. Thus, the NCCN Guidelines process is an ongoing, continual process.`
NCCN Clinical Practice Guidelines in Oncology are available free of charge on CD-ROM. These can be ordered from NCCN by calling 215-690-0300. The guidelines can also be found at www.nccn.org.
The National Comprehensive Cancer Network (NCCN), an alliance of 19 of the world`s leading cancer centers, is an authoritative source of information to help patients and health professionals make informed decisions about cancer care. Through the collective expertise of its member institutions, the NCCN develops, updates, and disseminates a complete library of clinical practice guidelines. These guidelines are the standard for clinical policy in oncology. NCCN`s complete spectrum of programs emphasizes improving the quality, effectiveness, and efficiency of oncology practice.
SOURCE: National Comprehensive Cancer Network (NCCN)
National Comprehensive Cancer Network (NCCN) Kim Schwalje, 215-690-0252 Schwalje@nccn.org
http://www.businesswire.com
Today`s News On The Net - Business Wire`s full file on the Internet with Hyperlinks to your home page.
Copyright (C) 2003 Business Wire. All rights reserved.
JS200
Major Peer-Reviewed Journal Publication of a Clinical Study of THALOMID(R) Plus Temozolomide as Oral Regimen for Treating Patients with Advanced-Stage Metastatic Melanoma
via COMTEX
September 8, 2003
WARREN, N.J., Sep 8, 2003 /PRNewswire-FirstCall via COMTEX/ --
Celgene Corporation (Nasdaq: CELG) today announced the results of a clinical study using THALOMID(R) in combination with temozolomide as an oral regimen for metastatic melanoma, published in the September 1, 2003 issue of the Journal of Clinical Oncology (JCO). This clinical study investigated the combination of a low-dose daily schedule of temozolomide with THALOMID(R) (200 mg - 400 mg) in patients with advanced-stage metastatic melanoma. One (3%) patient had clinical complete response and five (13%) patients had surgical complete response made possible by the > 90% tumor regression of soft tissue, lymph node, and lung metastases that was achieved with treatment. Moreover, the study achieved an overall objective response rate of 32% and a median survival, in this advanced-stage patient population, of 9.5 months.
`This data enhances our knowledge of THALOMID(R) in combination with temozolomide for the treatment of metastatic melanoma,`said Dr. Sol J. Barer, Ph.D., President and Chief Operating Officer of Celgene Corporation. `It is still too early to be sure of any long-term clinical outcomes, but from the preliminary results we have seen in this Memorial Sloan-Kettering Cancer Center study, there is reason for further investigation of this oral combination regimen.`
The study`s daily regimen of concomitant temozolomide plus THALOMID(R) was administered to a total of 38 patients carried over from the phase I study who were treated at the same dose level used in the phase II study. Median age was 62 years (range, 21 to 83 years) and median Karnofsky performance status was 90%. Eleven patients were > or equal to 70 years of age. Twenty-seven patients had cutaneous melanoma, 9 patients had unknown primaries, and 1 patient each had melanoma of the vulva and of the rectum. One patient had stage IIIc disease with multiple in-transit metastases and the remaining patients all had stage IV disease. Hematologic toxicity associated with temozolomide led to dose delay in only 1 patient and discontinuation in only 2 patients. THALOMID(R)-associated neurotoxicity and rash led to discontinuation in several patients.
Hematologic toxicity consisted primarily of lymphopenia and leukopenia. Grade 3 lymphopenia developed in 14 (37%) patients. One patient had transient grade 4 leukopenia and neutropenia plus persistent grade 4 thrombocytopenia, which led to discontinuation. A second patient developed transient grade 4 neutropenia and discontinued because of a gastrointestinal bleed. The most frequent non-hematologic adverse events > or equal to grade 2 occurring in > or equal to 5% of patients included rash, constipation, vomiting, dizziness, dyspnea, fatigue, nausea, headache, and infection. Most non-hematologic adverse events were grade 2 and manageable. Furthermore, after a median follow-up of more than 24 months, brain metastases developed in nine (24%) patients, including in one patient who did not complete 1 cycle of therapy.
Study Details:
Patients with histologically confirmed advanced-stage metastatic melanoma were enrolled in an open-label, phase II study. The primary endpoint was response rate. Patients received temozolomide (75 mg/m2/day x 6 weeks with a 2-week rest between cycles) plus concomitant thalidomide (200 mg/day with dose escalation to 400 mg/day for patients < 70 years old or 100 mg/day with dose escalation to 250 mg/day for patients > or equal to 70 years old). Treatment was continued until unacceptable toxicity or disease progression occurred.
Thirty-eight patients (median age, 62 years) with stage IV (3 M1a, 8 M1b, and 26 M1c) or stage IIIc (1 patient) melanoma and a median of 4 metastatic sites were enrolled and received a median of 2 cycles of therapy. Twelve (32%) patients had an objective tumor response, including 1 with an ongoing complete response of 25+ months`duration and 11 with partial responses. Five patients achieving partial response with > 90% reduction of disease were converted to a complete response with surgery. Median survival was 9.5 months with a median follow-up among survivors of 24.3 months.
About Melanoma:
Melanoma is a very serious form of skin cancer. It begins in melanocytes- cells that make the skin pigment called melanin. Although melanoma accounts for only about 4% of all skin cancer cases, it causes most skin cancer-related deaths. The chance of developing melanoma increases with age, but it affects all age groups and is one of the most common cancers in young adults. The number of new melanomas diagnosed in the United States is increasing. Since 1973, the incidence rate for melanoma (the number of new melanomas diagnosed per 100,000 people each year) has more than doubled from 5.7 to 14.3. The American Cancer Society estimates that about 53,600 new melanomas will be diagnosed in the United States during 2002. About 7,400 people in the US are expected to die of melanomas during 2002.
Safety Notice:
If thalidomide is taken during pregnancy, it can cause severe birth defects or death to an unborn baby. Thalidomide should never be used by women who are pregnant or who could become pregnant while taking the drug. Even a single dose, one capsule (50 mg, 100 mg and 200 mg), taken by a pregnant woman can cause severe birth defects. Because thalidomide is present in the semen of male patients, males receiving thalidomide must always use a latex condom during sexual contact with women of childbearing potential even if he has undergone a successful vasectomy. Thalidomide can only be marketed under a special restricted distribution program. This program is called the `System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.(R)). Under this program, only registered prescribers and pharmacists may dispense the drug. In addition, patients must be advised of, agree to and comply with the requirements of S.T.E.P.S.
Thalidomide is known to cause nerve damage that may be permanent. Peripheral neuropathy is a common, potentially severe, side effect of treatment with thalidomide that may be irreversible. Decreased white blood cell counts, including neutropenia, have been reported in the clinical use of thalidomide. In placebo controlled clinical trials of HIV-seropositive patient populations, there have been reports of increased plasma HIV RNA levels associated with thalidomide therapy. The most common adverse events observed in clinical use in ENL and HIV-seropositive patient populations are rash, maculo-papular rash, drowsiness/somnolence, peripheral neuropathy, dizziness/orthostatic hypotension, neutropenia, and increased HIV-viral load. Patients should be advised about these associated adverse events and routinely monitored by a physician during treatment with thalidomide.
THALOMID(R) (thalidomide), manufactured by Celgene Corporation, received U.S. Food and Drug Administration (FDA) clearance on July 16, 1998 for the acute treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence. THALOMID(R) is not indicated as monotherapy for ENL treatment in the presence of moderate to severe neuritis.
Celgene Corporation, headquartered in Warren, New Jersey, is an integrated biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company`s website at www.celgene.com.
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company`s control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company`s filings with the Securities and Exchange Commission such as 10K, 10Q and 8K reports.
SOURCE Celgene Corporation
Robert J. Hugin, Senior Vice President &CFO of Celgene Corporation, +1-732-271-4102
http://www.celgene.com
Copyright (C) 2003 PR Newswire. All rights reserved.
JS200
via COMTEX
September 8, 2003
WARREN, N.J., Sep 8, 2003 /PRNewswire-FirstCall via COMTEX/ --
Celgene Corporation (Nasdaq: CELG) today announced the results of a clinical study using THALOMID(R) in combination with temozolomide as an oral regimen for metastatic melanoma, published in the September 1, 2003 issue of the Journal of Clinical Oncology (JCO). This clinical study investigated the combination of a low-dose daily schedule of temozolomide with THALOMID(R) (200 mg - 400 mg) in patients with advanced-stage metastatic melanoma. One (3%) patient had clinical complete response and five (13%) patients had surgical complete response made possible by the > 90% tumor regression of soft tissue, lymph node, and lung metastases that was achieved with treatment. Moreover, the study achieved an overall objective response rate of 32% and a median survival, in this advanced-stage patient population, of 9.5 months.
`This data enhances our knowledge of THALOMID(R) in combination with temozolomide for the treatment of metastatic melanoma,`said Dr. Sol J. Barer, Ph.D., President and Chief Operating Officer of Celgene Corporation. `It is still too early to be sure of any long-term clinical outcomes, but from the preliminary results we have seen in this Memorial Sloan-Kettering Cancer Center study, there is reason for further investigation of this oral combination regimen.`
The study`s daily regimen of concomitant temozolomide plus THALOMID(R) was administered to a total of 38 patients carried over from the phase I study who were treated at the same dose level used in the phase II study. Median age was 62 years (range, 21 to 83 years) and median Karnofsky performance status was 90%. Eleven patients were > or equal to 70 years of age. Twenty-seven patients had cutaneous melanoma, 9 patients had unknown primaries, and 1 patient each had melanoma of the vulva and of the rectum. One patient had stage IIIc disease with multiple in-transit metastases and the remaining patients all had stage IV disease. Hematologic toxicity associated with temozolomide led to dose delay in only 1 patient and discontinuation in only 2 patients. THALOMID(R)-associated neurotoxicity and rash led to discontinuation in several patients.
Hematologic toxicity consisted primarily of lymphopenia and leukopenia. Grade 3 lymphopenia developed in 14 (37%) patients. One patient had transient grade 4 leukopenia and neutropenia plus persistent grade 4 thrombocytopenia, which led to discontinuation. A second patient developed transient grade 4 neutropenia and discontinued because of a gastrointestinal bleed. The most frequent non-hematologic adverse events > or equal to grade 2 occurring in > or equal to 5% of patients included rash, constipation, vomiting, dizziness, dyspnea, fatigue, nausea, headache, and infection. Most non-hematologic adverse events were grade 2 and manageable. Furthermore, after a median follow-up of more than 24 months, brain metastases developed in nine (24%) patients, including in one patient who did not complete 1 cycle of therapy.
Study Details:
Patients with histologically confirmed advanced-stage metastatic melanoma were enrolled in an open-label, phase II study. The primary endpoint was response rate. Patients received temozolomide (75 mg/m2/day x 6 weeks with a 2-week rest between cycles) plus concomitant thalidomide (200 mg/day with dose escalation to 400 mg/day for patients < 70 years old or 100 mg/day with dose escalation to 250 mg/day for patients > or equal to 70 years old). Treatment was continued until unacceptable toxicity or disease progression occurred.
Thirty-eight patients (median age, 62 years) with stage IV (3 M1a, 8 M1b, and 26 M1c) or stage IIIc (1 patient) melanoma and a median of 4 metastatic sites were enrolled and received a median of 2 cycles of therapy. Twelve (32%) patients had an objective tumor response, including 1 with an ongoing complete response of 25+ months`duration and 11 with partial responses. Five patients achieving partial response with > 90% reduction of disease were converted to a complete response with surgery. Median survival was 9.5 months with a median follow-up among survivors of 24.3 months.
About Melanoma:
Melanoma is a very serious form of skin cancer. It begins in melanocytes- cells that make the skin pigment called melanin. Although melanoma accounts for only about 4% of all skin cancer cases, it causes most skin cancer-related deaths. The chance of developing melanoma increases with age, but it affects all age groups and is one of the most common cancers in young adults. The number of new melanomas diagnosed in the United States is increasing. Since 1973, the incidence rate for melanoma (the number of new melanomas diagnosed per 100,000 people each year) has more than doubled from 5.7 to 14.3. The American Cancer Society estimates that about 53,600 new melanomas will be diagnosed in the United States during 2002. About 7,400 people in the US are expected to die of melanomas during 2002.
Safety Notice:
If thalidomide is taken during pregnancy, it can cause severe birth defects or death to an unborn baby. Thalidomide should never be used by women who are pregnant or who could become pregnant while taking the drug. Even a single dose, one capsule (50 mg, 100 mg and 200 mg), taken by a pregnant woman can cause severe birth defects. Because thalidomide is present in the semen of male patients, males receiving thalidomide must always use a latex condom during sexual contact with women of childbearing potential even if he has undergone a successful vasectomy. Thalidomide can only be marketed under a special restricted distribution program. This program is called the `System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.(R)). Under this program, only registered prescribers and pharmacists may dispense the drug. In addition, patients must be advised of, agree to and comply with the requirements of S.T.E.P.S.
Thalidomide is known to cause nerve damage that may be permanent. Peripheral neuropathy is a common, potentially severe, side effect of treatment with thalidomide that may be irreversible. Decreased white blood cell counts, including neutropenia, have been reported in the clinical use of thalidomide. In placebo controlled clinical trials of HIV-seropositive patient populations, there have been reports of increased plasma HIV RNA levels associated with thalidomide therapy. The most common adverse events observed in clinical use in ENL and HIV-seropositive patient populations are rash, maculo-papular rash, drowsiness/somnolence, peripheral neuropathy, dizziness/orthostatic hypotension, neutropenia, and increased HIV-viral load. Patients should be advised about these associated adverse events and routinely monitored by a physician during treatment with thalidomide.
THALOMID(R) (thalidomide), manufactured by Celgene Corporation, received U.S. Food and Drug Administration (FDA) clearance on July 16, 1998 for the acute treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence. THALOMID(R) is not indicated as monotherapy for ENL treatment in the presence of moderate to severe neuritis.
Celgene Corporation, headquartered in Warren, New Jersey, is an integrated biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company`s website at www.celgene.com.
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company`s control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company`s filings with the Securities and Exchange Commission such as 10K, 10Q and 8K reports.
SOURCE Celgene Corporation
Robert J. Hugin, Senior Vice President &CFO of Celgene Corporation, +1-732-271-4102
http://www.celgene.com
Copyright (C) 2003 PR Newswire. All rights reserved.
JS200
Last Trade: 46.520 Change: 1.650 (+3.677%)
Previous Close: 44.870 Volume: 2,736,600
Bid: 46.520 Ask: 46.990
Today`s Open: 44.640 # of Trades: 7,171
RAiDAR alerts Learn More About RAiDAR-LT
09/08/2003 (15:11 ET) VOLUME(+): CELG Volume 62% > 20-adsv, Stock +1.20% - Knobias
09/08/2003 (14:51 ET) 52W HIGH: New 52-Wk High for CELG @ $46.650 up3.97% - Knobias
09/08/2003 (14:40 ET) CELG Spikes Up;Conf Today;Thalomid Combo Study Results - Knobias
09/08/2003 (14:37 ET) BTC: Biotechs Keep Momentum in Late-day Trading - Knobias
09/08/2003 (13:32 ET) CONF: CELG To Present At Bear Stearns Tech Conference @ 16:30 ET - Knobias
09/08/2003 (08:30 ET) New Treatment Options Featured in NCCN Multiple Myeloma Clinical Practice Guidelines - Business Wire
09/08/2003 (07:30 ET) Major Peer-Reviewed Journal Publication of a Clinical Study of THALOMID(R) Plus Temozolomide as Oral Regimen for Treating Patients with Advanced-Stage Metastatic Melanoma - PR Newswire
09/05/2003 (11:16 ET) VOLUME(+): CELG Volume 11% > 20-adsv, Stock +4.76% - Knobias
09/05/2003 (10:42 ET) RATING(=): Leerink Swann Reiterates CELG Rating @ Outperform - Knobias
09/05/2003 (09:57 ET) 52W HIGH: New 52-Wk High for CELG @ $42.400 up0.95% - Knobias
09/05/2003 (09:20 ET) MORNING UPDATE: Man Securities Issues Alerts for ORCL, MWD, ASML, IDTI, And CELG - PR Newswire
09/05/2003 (08:02 ET) CONF: CELG To Present At Thomas Weisel Health Conference @ 08:35 ET - Knobias
09/04/2003 (16:22 ET) CLOSER(+): Last 90 Min, CELG Jumps +2.02%; Vol +105% - Knobias
09/04/2003 (14:16 ET) 52W HIGH: New 52-Wk High for CELG @ $41.150 up2.72% - Knobias
09/04/2003 (11:51 ET) BTC: JMP Provides Fall Preview of Biotech Industry - Knobias
09/04/2003 (10:59 ET) New 4 just released for CELG - Edgar
09/04/2003 (09:41 ET) CONF: CELG To Present At Biotech Newsmakers Conference @ 09:30 ET - Knobias
09/03/2003 (12:15 ET) JP Morgan Sees CELG as Attractive Investment - Knobias
09/03/2003 (09:59 ET) 52W HIGH: New 52-Wk High for CELG @ $40.010 up1.63% - Knobias
09/03/2003 (07:16 ET) RATING(1): JP Morgan Initiates CELG Rating @ Overweight - Knobias
09/02/2003 (17:20 ET) Celgene Corporation Will Present at Healthcare Conferences - PR Newswire
09/02/2003 (16:23 ET) CLOSER(+): Last 90 Min, CELG Jumps +2.10%; Vol +57% - Knobias
08/29/2003 (09:12 ET) HCR: Jyske Banks Starts Healthcare Sector at Neutral - Knobias
08/26/2003 (16:16 ET) CELG: Short Interest UP 20.2% to 6.9M in Aug 2003 - Knobias
08/26/2003 (07:43 ET) New Patent Broadens Celgene JNK Intellectual Property Estate - PR Newswire
JS200
Previous Close: 44.870 Volume: 2,736,600
Bid: 46.520 Ask: 46.990
Today`s Open: 44.640 # of Trades: 7,171
RAiDAR alerts Learn More About RAiDAR-LT
09/08/2003 (15:11 ET) VOLUME(+): CELG Volume 62% > 20-adsv, Stock +1.20% - Knobias
09/08/2003 (14:51 ET) 52W HIGH: New 52-Wk High for CELG @ $46.650 up3.97% - Knobias
09/08/2003 (14:40 ET) CELG Spikes Up;Conf Today;Thalomid Combo Study Results - Knobias
09/08/2003 (14:37 ET) BTC: Biotechs Keep Momentum in Late-day Trading - Knobias
09/08/2003 (13:32 ET) CONF: CELG To Present At Bear Stearns Tech Conference @ 16:30 ET - Knobias
09/08/2003 (08:30 ET) New Treatment Options Featured in NCCN Multiple Myeloma Clinical Practice Guidelines - Business Wire
09/08/2003 (07:30 ET) Major Peer-Reviewed Journal Publication of a Clinical Study of THALOMID(R) Plus Temozolomide as Oral Regimen for Treating Patients with Advanced-Stage Metastatic Melanoma - PR Newswire
09/05/2003 (11:16 ET) VOLUME(+): CELG Volume 11% > 20-adsv, Stock +4.76% - Knobias
09/05/2003 (10:42 ET) RATING(=): Leerink Swann Reiterates CELG Rating @ Outperform - Knobias
09/05/2003 (09:57 ET) 52W HIGH: New 52-Wk High for CELG @ $42.400 up0.95% - Knobias
09/05/2003 (09:20 ET) MORNING UPDATE: Man Securities Issues Alerts for ORCL, MWD, ASML, IDTI, And CELG - PR Newswire
09/05/2003 (08:02 ET) CONF: CELG To Present At Thomas Weisel Health Conference @ 08:35 ET - Knobias
09/04/2003 (16:22 ET) CLOSER(+): Last 90 Min, CELG Jumps +2.02%; Vol +105% - Knobias
09/04/2003 (14:16 ET) 52W HIGH: New 52-Wk High for CELG @ $41.150 up2.72% - Knobias
09/04/2003 (11:51 ET) BTC: JMP Provides Fall Preview of Biotech Industry - Knobias
09/04/2003 (10:59 ET) New 4 just released for CELG - Edgar
09/04/2003 (09:41 ET) CONF: CELG To Present At Biotech Newsmakers Conference @ 09:30 ET - Knobias
09/03/2003 (12:15 ET) JP Morgan Sees CELG as Attractive Investment - Knobias
09/03/2003 (09:59 ET) 52W HIGH: New 52-Wk High for CELG @ $40.010 up1.63% - Knobias
09/03/2003 (07:16 ET) RATING(1): JP Morgan Initiates CELG Rating @ Overweight - Knobias
09/02/2003 (17:20 ET) Celgene Corporation Will Present at Healthcare Conferences - PR Newswire
09/02/2003 (16:23 ET) CLOSER(+): Last 90 Min, CELG Jumps +2.10%; Vol +57% - Knobias
08/29/2003 (09:12 ET) HCR: Jyske Banks Starts Healthcare Sector at Neutral - Knobias
08/26/2003 (16:16 ET) CELG: Short Interest UP 20.2% to 6.9M in Aug 2003 - Knobias
08/26/2003 (07:43 ET) New Patent Broadens Celgene JNK Intellectual Property Estate - PR Newswire
JS200
Last Trade: 47.440 Change: 0.920 (+1.978%)
Previous Close: 46.520 Volume: 3,557,700
Bid: 47.400 Ask: 48.310
Today`s Open: 46.500 # of Trades: 7,660
09/09/2003 (10:56 ET) VOLUME(+): CELG Volume 18% > 20-adsv, Stock +1.05% - Knobias
09/09/2003 (09:47 ET) 52W HIGH: New 52-Wk High for CELG @ $47.160 up1.38% - Knobias
09/08/2003 (15:11 ET) VOLUME(+): CELG Volume 62% > 20-adsv, Stock +1.20% - Knobias
09/08/2003 (14:51 ET) 52W HIGH: New 52-Wk High for CELG @ $46.650 up3.97% - Knobias
09/08/2003 (14:40 ET) CELG Spikes Up;Conf Today;Thalomid Combo Study Results - Knobias
Mein Stoploss steht 46,50
Jetzt kann kommen was will
JS200
Previous Close: 46.520 Volume: 3,557,700
Bid: 47.400 Ask: 48.310
Today`s Open: 46.500 # of Trades: 7,660
09/09/2003 (10:56 ET) VOLUME(+): CELG Volume 18% > 20-adsv, Stock +1.05% - Knobias
09/09/2003 (09:47 ET) 52W HIGH: New 52-Wk High for CELG @ $47.160 up1.38% - Knobias
09/08/2003 (15:11 ET) VOLUME(+): CELG Volume 62% > 20-adsv, Stock +1.20% - Knobias
09/08/2003 (14:51 ET) 52W HIGH: New 52-Wk High for CELG @ $46.650 up3.97% - Knobias
09/08/2003 (14:40 ET) CELG Spikes Up;Conf Today;Thalomid Combo Study Results - Knobias
Mein Stoploss steht 46,50
Jetzt kann kommen was will
JS200
100% seit thread-eröffnung?
das mit der prozentrechnung müssen wir aber noch mal üben...
das mit der prozentrechnung müssen wir aber noch mal üben...
Schon wieder eine neue Meldung wegen eines Patents!
@ARRO
Ich habe zu 22.24 gekauft Ende März 2003
Habe ich glaube 2 Wochen später den Tread eröffnet, kann mich nicht mehr errinnern, wie der Kurs bei Eröffnung stand und konnte dieses nicht einsehen
80% sind besser als NIX, gell
JS200
Ich habe zu 22.24 gekauft Ende März 2003
Habe ich glaube 2 Wochen später den Tread eröffnet, kann mich nicht mehr errinnern, wie der Kurs bei Eröffnung stand und konnte dieses nicht einsehen
80% sind besser als NIX, gell
JS200
09/10/2003 (07:30 ET) New Patent Broadens Celgene JNK Intellectual Property Estate - PR Newswire
09/09/2003 (10:56 ET) VOLUME(+): CELG Volume 18% > 20-adsv, Stock +1.05% - Knobias
09/09/2003 (09:47 ET) 52W HIGH: New 52-Wk High for CELG @ $47.160 up1.38% - Knobias
09/08/2003 (15:11 ET) VOLUME(+): CELG Volume 62% > 20-adsv, Stock +1.20% - Knobias
09/08/2003 (14:51 ET) 52W HIGH: New 52-Wk High for CELG @ $46.650 up3.97% - Knobias
JS200
09/09/2003 (10:56 ET) VOLUME(+): CELG Volume 18% > 20-adsv, Stock +1.05% - Knobias
09/09/2003 (09:47 ET) 52W HIGH: New 52-Wk High for CELG @ $47.160 up1.38% - Knobias
09/08/2003 (15:11 ET) VOLUME(+): CELG Volume 62% > 20-adsv, Stock +1.20% - Knobias
09/08/2003 (14:51 ET) 52W HIGH: New 52-Wk High for CELG @ $46.650 up3.97% - Knobias
JS200
Meine wurden verkauft 
JS200
ja, in der phantasie geht alles...
ende märz, 22.24... welche währung? welche aktie?
also nochmal, js, wann und wo hast du gekauft?
nein wirklich, js, auf die gefahr hin, dass ich nerve, hehe...
aber da liegt wohl ein kleiner irrtum deinerseits vor.
ende märz bewegte sich CELG tagelang in einer spanne zwischen $26 und $28.
zum zeitpunkt deiner 100%-meldung war CELG grade auf $42 geklettert.
damit dürftest du bei günstigem einkauf und währungsbereinigt auf gut 61% gekommen sein.
berücksichtigt man leichte währungsverluste, errechnen wir weniger als 60%...
glücklicherweise stieg CELG bis heute weiter, so dass sich deine performance zwischenzeitlich auf etwa 85% verbesserte und mittlerweile immer noch bei knapp 80% liegt.
dies ist gut, herzlichen glückwunsch!
da bleiben beim verkauf etwa 40% nach steuern übrig, und das in einem knappen halben jahr.
ausgezeichnete performance!
will mich ja nicht selbst loben, aber eine performance nach knapp 14 monaten unter berücksichtung von währungsverlusten von über 230% kann sich doch auch sehen lassen, hehe... währungsbereinigt sind es etwa 280%.
aber gut bist du auch!
mr.A
ende märz, 22.24... welche währung? welche aktie?
also nochmal, js, wann und wo hast du gekauft?
nein wirklich, js, auf die gefahr hin, dass ich nerve, hehe...
aber da liegt wohl ein kleiner irrtum deinerseits vor.
ende märz bewegte sich CELG tagelang in einer spanne zwischen $26 und $28.
zum zeitpunkt deiner 100%-meldung war CELG grade auf $42 geklettert.
damit dürftest du bei günstigem einkauf und währungsbereinigt auf gut 61% gekommen sein.
berücksichtigt man leichte währungsverluste, errechnen wir weniger als 60%...
glücklicherweise stieg CELG bis heute weiter, so dass sich deine performance zwischenzeitlich auf etwa 85% verbesserte und mittlerweile immer noch bei knapp 80% liegt.
dies ist gut, herzlichen glückwunsch!
da bleiben beim verkauf etwa 40% nach steuern übrig, und das in einem knappen halben jahr.
ausgezeichnete performance!
will mich ja nicht selbst loben, aber eine performance nach knapp 14 monaten unter berücksichtung von währungsverlusten von über 230% kann sich doch auch sehen lassen, hehe... währungsbereinigt sind es etwa 280%.
aber gut bist du auch!
mr.A
Dan Sullivan Recommends the Following Stocks: BEA Systems, Computer Associates, Celgene Corp., Foundry Networks, and Network Appliance
via COMTEX
September 17, 2003
CHICAGO, Sep 17, 2003 (BUSINESS WIRE) --
Mental stops must be strictly followed in this volatile environment, according to Dan Sullivan. Sharpen your skills with five recent top recommendations. Learn about BEA Systems Inc. (NASDAQ:BEAS), Computer Associates (NYSE:CA), Celgene Corp (NASDAQ:CELG), Foundry Networks (NASDAQ:FDRY), Network Appliance Corp. (NASDAQ:NTAP). Click here for the full story exclusively on Zacks.com: http://featuredexpert2bw.zacks.com/
Here are the highlights from the Featured Expert column:
As the cycle matures, Dan Sullivan will make the mental stocks increasingly tighter. It`s always been his contention that once you establish a position in a winning stock, you should give it every opportunity to live up to your original expectations.
Most Recent Recommendations
BEA Systems Inc. (NASDAQ:BEAS) is a leading infrastructure software company with more than 15,000 customers. For the second quarter net income was $25.9 million, or 6 cents a share, up from $20.2 million, or 5 cents a share, a year earlier. Total revenue was $245 million, up 8 percent from $225.9 million.
Computer Associates (NYSE:CA) is a leading provider of solutions and services for the management of IT infrastructure, business information and application development. Another top performer in a strong industry group, it appears poised to move into the top tier of relative strength ratings. For the three months ended June 30, 2003, revenues rose 6% to $813 million. Net income totaled $10 million versus a loss of $65 million.
Celgene Corp (NASDAQ:CELG) is a pharmaceutical company with a major focus on the discovery, development and commercialization of small molecules for cancer and immunological diseases. For the six months ended June 30, 2003, revenue rose 81% to $116.4 million. Net income totaled $3.8 million compared to a loss of $2.5 million.
Foundry Networks (NASDAQ:FDRY) is a leading provider of next-generation networking products covering an end-to-end suite of high performance Ethernet Layer 2 and Layer 3 switches, metro routers and Internet traffic management products. For the six months ended June 30, 2003, revenue rose 36% to $186.9 million. Net income totaled $30.2 million, up from $5.1 million.
Network Appliance Corp. (NASDAQ:NTAP) is a world leader in unified storage solutions for today`s data-intensive enterprise. For the first quarter ended July 31, 2003, net income rose 67% to $27.1 million compared with $16.2 million a year ago. Revenue increased 26% to $260.5 million from $201.8 million. Excluding certain items, it earned 8 cents a share to top analyst`s estimates by a penny.
Get more information on the above-mentioned companies, including their all-important mental stops, and make sure to get five other recommendations from Dan Sullivan by clicking: http://featuredexpert3bw.zacks.com/
About Zacks Featured Experts
To be a successful investor you need professional advice. Experts who know what they`re talking about and can help you achieve your financial goals in good markets...and especially in bad ones will help you improve your portfolio. That is why Zacks Investment Research has assembled the best investment experts in the business to offer their powerful advisory newsletters to you on all the major investment topics: Stocks, Mutual Funds, Bonds, Options, Futures etc.
Recommendations from Featured Experts Highlighted in FREE Investment Newsletter
The best way to tap into the powerful advice from these experts is through our free weekly e-mail newsletter, `Profit from the Pros`. Each week we highlight several Featured Experts in this free e-mail newsletter. Get your free subscription to `Profit from the Pros`at: http://www.freeprofit1bw.zacks.com
About Zacks
Zacks.com is a property of Zacks Investment Research, Inc., which was formed in 1981 to compile, analyze, and distribute investment research to both institutional and individual investors. The guiding principle behind our work is the belief that investment experts, such as brokerage analysts and investment newsletter writers, have superior knowledge about how to invest successfully. Our goal is to unlock their profitable insights for our customers. And there is no better way to enjoy this investment success, than with a FREE subscription to `Profit from the Pros`weekly e-mail newsletter. For your free newsletter, visit http://www.freeprofitbw.zacks.com
Zacks Investment Research is under common control with affiliated entities (including a broker-dealer and an investment adviser), which may engage in transactions involving the foregoing securities for the clients of such affiliates.
Disclaimer: Past performance does not guarantee future results. Investors should always research companies and securities before making any investments. Nothing herein should be construed as an offer or solicitation to buy or sell any security.
SOURCE: Zacks.com
Zacks.com Terry Batey, 312-630-9880 x 307 myzacks@zacks.com www.Zacks.com
http://www.businesswire.com
Today`s News On The Net - Business Wire`s full file on the Internet with Hyperlinks to your home page.
Copyright (C) 2003 Business Wire. All rights reserved.
JS200
via COMTEX
September 17, 2003
CHICAGO, Sep 17, 2003 (BUSINESS WIRE) --
Mental stops must be strictly followed in this volatile environment, according to Dan Sullivan. Sharpen your skills with five recent top recommendations. Learn about BEA Systems Inc. (NASDAQ:BEAS), Computer Associates (NYSE:CA), Celgene Corp (NASDAQ:CELG), Foundry Networks (NASDAQ:FDRY), Network Appliance Corp. (NASDAQ:NTAP). Click here for the full story exclusively on Zacks.com: http://featuredexpert2bw.zacks.com/
Here are the highlights from the Featured Expert column:
As the cycle matures, Dan Sullivan will make the mental stocks increasingly tighter. It`s always been his contention that once you establish a position in a winning stock, you should give it every opportunity to live up to your original expectations.
Most Recent Recommendations
BEA Systems Inc. (NASDAQ:BEAS) is a leading infrastructure software company with more than 15,000 customers. For the second quarter net income was $25.9 million, or 6 cents a share, up from $20.2 million, or 5 cents a share, a year earlier. Total revenue was $245 million, up 8 percent from $225.9 million.
Computer Associates (NYSE:CA) is a leading provider of solutions and services for the management of IT infrastructure, business information and application development. Another top performer in a strong industry group, it appears poised to move into the top tier of relative strength ratings. For the three months ended June 30, 2003, revenues rose 6% to $813 million. Net income totaled $10 million versus a loss of $65 million.
Celgene Corp (NASDAQ:CELG) is a pharmaceutical company with a major focus on the discovery, development and commercialization of small molecules for cancer and immunological diseases. For the six months ended June 30, 2003, revenue rose 81% to $116.4 million. Net income totaled $3.8 million compared to a loss of $2.5 million.
Foundry Networks (NASDAQ:FDRY) is a leading provider of next-generation networking products covering an end-to-end suite of high performance Ethernet Layer 2 and Layer 3 switches, metro routers and Internet traffic management products. For the six months ended June 30, 2003, revenue rose 36% to $186.9 million. Net income totaled $30.2 million, up from $5.1 million.
Network Appliance Corp. (NASDAQ:NTAP) is a world leader in unified storage solutions for today`s data-intensive enterprise. For the first quarter ended July 31, 2003, net income rose 67% to $27.1 million compared with $16.2 million a year ago. Revenue increased 26% to $260.5 million from $201.8 million. Excluding certain items, it earned 8 cents a share to top analyst`s estimates by a penny.
Get more information on the above-mentioned companies, including their all-important mental stops, and make sure to get five other recommendations from Dan Sullivan by clicking: http://featuredexpert3bw.zacks.com/
About Zacks Featured Experts
To be a successful investor you need professional advice. Experts who know what they`re talking about and can help you achieve your financial goals in good markets...and especially in bad ones will help you improve your portfolio. That is why Zacks Investment Research has assembled the best investment experts in the business to offer their powerful advisory newsletters to you on all the major investment topics: Stocks, Mutual Funds, Bonds, Options, Futures etc.
Recommendations from Featured Experts Highlighted in FREE Investment Newsletter
The best way to tap into the powerful advice from these experts is through our free weekly e-mail newsletter, `Profit from the Pros`. Each week we highlight several Featured Experts in this free e-mail newsletter. Get your free subscription to `Profit from the Pros`at: http://www.freeprofit1bw.zacks.com
About Zacks
Zacks.com is a property of Zacks Investment Research, Inc., which was formed in 1981 to compile, analyze, and distribute investment research to both institutional and individual investors. The guiding principle behind our work is the belief that investment experts, such as brokerage analysts and investment newsletter writers, have superior knowledge about how to invest successfully. Our goal is to unlock their profitable insights for our customers. And there is no better way to enjoy this investment success, than with a FREE subscription to `Profit from the Pros`weekly e-mail newsletter. For your free newsletter, visit http://www.freeprofitbw.zacks.com
Zacks Investment Research is under common control with affiliated entities (including a broker-dealer and an investment adviser), which may engage in transactions involving the foregoing securities for the clients of such affiliates.
Disclaimer: Past performance does not guarantee future results. Investors should always research companies and securities before making any investments. Nothing herein should be construed as an offer or solicitation to buy or sell any security.
SOURCE: Zacks.com
Zacks.com Terry Batey, 312-630-9880 x 307 myzacks@zacks.com www.Zacks.com
http://www.businesswire.com
Today`s News On The Net - Business Wire`s full file on the Internet with Hyperlinks to your home page.
Copyright (C) 2003 Business Wire. All rights reserved.
JS200
09/16/2003 (08:29 ET) RATING(1): Friedman Starts CELG Rating @ Outperform; Sets Tgt @ $59; Analyst Notes - Knobias
09/12/2003 (16:22 ET) CLOSER(+): Last 90 Min, CELG Jumps +1.77%; Vol +67% - Knobias
09/10/2003 (07:30 ET) New Patent Broadens Celgene JNK Intellectual Property Estate - PR Newswire
09/09/2003 (10:56 ET) VOLUME(+): CELG Volume 18% > 20-adsv, Stock +1.05% - Knobias
09/09/2003 (09:47 ET) 52W HIGH: New 52-Wk High for CELG @ $47.160 up1.38% - Knobias
JS200
09/12/2003 (16:22 ET) CLOSER(+): Last 90 Min, CELG Jumps +1.77%; Vol +67% - Knobias
09/10/2003 (07:30 ET) New Patent Broadens Celgene JNK Intellectual Property Estate - PR Newswire
09/09/2003 (10:56 ET) VOLUME(+): CELG Volume 18% > 20-adsv, Stock +1.05% - Knobias
09/09/2003 (09:47 ET) 52W HIGH: New 52-Wk High for CELG @ $47.160 up1.38% - Knobias
JS200
tja, lügen einzugestehen fällt den meisten schwer...
das hab ich von dir, lieber joseph, auch nicht erwartet...
das hab ich von dir, lieber joseph, auch nicht erwartet...
09/25/2003 (04:02 ET) CELG CEO to Appear on Bloomberg TV Today @ 7:24 AM ET - Knobias
09/24/2003 (16:16 ET) CELG: Short Interest DN 3.9% to 6.7M in Sep 2003 - Knobias
09/24/2003 (14:23 ET) Comment: Big Movers From Weak Biotech Industry - Knobias
09/23/2003 (16:26 ET) RATING(=): Friedman Keeps CELG Rating @ Outperform - Knobias
09/22/2003 (07:30 ET) Celgene Will Present at Morgan Stanley Convertible Conference - PR Newswire
JS200
09/24/2003 (16:16 ET) CELG: Short Interest DN 3.9% to 6.7M in Sep 2003 - Knobias
09/24/2003 (14:23 ET) Comment: Big Movers From Weak Biotech Industry - Knobias
09/23/2003 (16:26 ET) RATING(=): Friedman Keeps CELG Rating @ Outperform - Knobias
09/22/2003 (07:30 ET) Celgene Will Present at Morgan Stanley Convertible Conference - PR Newswire
JS200
Thalomid(R) Phase I/II Clinical Data Presented as Combination Therapy For Treating Prostate Cancer
via COMTEX
September 25, 2003
COPENHAGEN, Denmark, Sep 25, 2003 /PRNewswire-FirstCall via COMTEX/ --
Celgene Corporation (Nasdaq: CELG) announced today the results of data presented at the European Cancer Conference (ECCO) in Copenhagen, Denmark which used THALOMID(R) in combination with chemotherapy androgen-independent prostate carcinoma (AIPCa). The Phase I/II study results demonstrated that 18 of 33 (55%) patients who were evaluable for response achieved a 50-79% decline in PSA and 7 (21%) patients had a > 80% PSA decline.
`This Phase I/II study increases our clinical knowledge base of THALOMID and its potential in the clinical use as a combination therapy,`explained Sol J. Barer, Ph.D., President and Chief Operating Officer of Celgene Corporation `These preliminary results show that a statistical significant number of patients responded to the treatment regimen which justifies further clinical investigation to substantiate this combination therapy in this severe and life-threatening form of cancer.`
Dr. Paul Matthews from M.D. Anderson Cancer Center initiated the Phase I/II trial to assess incremental anti-tumor response with THALOMID and chemotherapy in AIPCa patients. Primary objectives of the study were to determine the following, namely; 1) evaluate toxicity and maximum tolerated dose of THALOMID plus Paclitaxel and Estramustine (PE) in patients with chemotherapy-refractory AIPCa. 2) Assess the response of THALOMID plus (PE) in this patient population. 3) Assess the outcome of THALOMID plus (PE) on time to progression and overall survival in this patient population (The Kaplan- Meier probability of survival at 15 months is more than 50%).
To date, 36 patients (median age 66 (range, 49-80); median Zubrod performance status 1 (range, 0-2)) were entered (10 in the phase I and 25 in the phase II study) and received a median number of 3 (range, 1-8) cycles. Patients had 1 (n=18) or 2 (n=8) prior chemotherapy regimens (11 patients with prior Taxane/Estramustine-based chemotherapy; 11 patients with prior Ketoconazole /Adriamycin / Vinblastine/Estramustine). Thirty-five patients were evaluable for toxicity (1 patient developed DVT prior to chemotherapy initiation and did not receive any therapy); 33 are evaluable for response (2 patients were taken off study before 2 Cycles (1 refused chemotherapy after 1 week, 1 developed pneumonia after Cycle 1) and 4 patients are too early). During Cycle 1 of the phase I study: at 200 mg/day THALOMID, 0 of 3 patients showed grade 3/4 toxicity; at 400 mg/day THALOMID, 9 of 14 patients experienced grade 3 neutropenia (< 7 days duration) and 1 of 4 patients had grade 3 edema (relieved promptly by diuretics); at 600 mg/day THALOMID, 0 of 3 patients had grade 3/4 toxicity. Of the 28 total patients assigned to the 600 mg/day dose level of THALOMID (in both phases of the study), 14 patients tolerated the 600 mg/day continuously, 17 patients tolerated 400 mg/day, 3 patient 200 mg/day, and 2 patients are too early. All dose reductions of THALOMID were due to somnolence/fatigue (grade 1-2). Peripheral neuropathy was limited to grade 1. Two of 33 patients developed grade 3/4 DVT, 2 additional patients discontinued chemotherapy due to intercurrent infection, and 1 patient died from sepsis.
About Prostate Cancer:
Prostate cancer is the most diagnosed cancer in American men and the second leading cause of cancer death. Prostate cancer is twice as common and has more than twice the mortality rate in African-American men than in Caucasian men. The 5-year survival rate for patients whose cancer is caught while still confined to the prostate is 99% while the 5-year survival rate for those diagnosed with distant (metastatic) disease is 30.9%. In the U.S. alone, nearly 200,000 men will be diagnosed with prostate cancer this year equaling one man diagnosed every three minutes. It is estimated that more than 32,500 men in the U.S. will die of prostate cancer. Prostate cancer affects one in eight American men.
Safety Notice:
If thalidomide is taken during pregnancy, it can cause severe birth defects or death to an unborn baby. Thalidomide should never be used by women who are pregnant or who could become pregnant while taking the drug. Even a single dose, one capsule (50 mg, 100 mg and 200 mg), taken by a pregnant woman can cause severe birth defects. Because thalidomide is present in the semen of male patients, males receiving thalidomide must always use a latex condom during sexual contact with women of childbearing potential even if he has undergone a successful vasectomy. Thalidomide can only be marketed under a special restricted distribution program. This program is called the `System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.(R)). Under this program, only registered prescribers and pharmacists may dispense the drug. In addition, patients must be advised of, agree to and comply with the requirements of S.T.E.P.S.
Thalidomide is known to cause nerve damage that may be permanent. Peripheral neuropathy is a common, potentially severe, side effect of treatment with thalidomide that may be irreversible. Decreased white blood cell counts, including neutropenia, have been reported in the clinical use of thalidomide. In placebo controlled clinical trials of HIV-seropositive patient populations, there have been reports of increased plasma HIV RNA levels associated with thalidomide therapy. The most common adverse events observed in clinical use in ENL and HIV-seropositive patient populations are rash, maculo-papular rash, drowsiness/somnolence, peripheral neuropathy, dizziness/orthostatic hypotension, neutropenia, and increased HIV-viral load. Patients should be advised about these associated adverse events and routinely monitored by a physician during treatment with thalidomide.
THALOMID(R) (thalidomide), manufactured by Celgene Corporation, received U.S. Food and Drug Administration (FDA) clearance on July 16, 1998 for the acute treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence. THALOMID(R) is not indicated as monotherapy for ENL treatment in the presence of moderate to severe neuritis.
Celgene Corporation, headquartered in Warren, New Jersey, is an integrated biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company`s website at www.celgene.com.
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company`s control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company`s filings with the Securities and Exchange Commission such as 10K, 10Q and 8K reports.
SOURCE Celgene Corporation
Robert J. Hugin Senior VP and CFO of Celgene Corporation, +1-732-271-4102
http://www.celgene.com
Copyright (C) 2003 PR Newswire. All rights reserved.
JS200
via COMTEX
September 25, 2003
COPENHAGEN, Denmark, Sep 25, 2003 /PRNewswire-FirstCall via COMTEX/ --
Celgene Corporation (Nasdaq: CELG) announced today the results of data presented at the European Cancer Conference (ECCO) in Copenhagen, Denmark which used THALOMID(R) in combination with chemotherapy androgen-independent prostate carcinoma (AIPCa). The Phase I/II study results demonstrated that 18 of 33 (55%) patients who were evaluable for response achieved a 50-79% decline in PSA and 7 (21%) patients had a > 80% PSA decline.
`This Phase I/II study increases our clinical knowledge base of THALOMID and its potential in the clinical use as a combination therapy,`explained Sol J. Barer, Ph.D., President and Chief Operating Officer of Celgene Corporation `These preliminary results show that a statistical significant number of patients responded to the treatment regimen which justifies further clinical investigation to substantiate this combination therapy in this severe and life-threatening form of cancer.`
Dr. Paul Matthews from M.D. Anderson Cancer Center initiated the Phase I/II trial to assess incremental anti-tumor response with THALOMID and chemotherapy in AIPCa patients. Primary objectives of the study were to determine the following, namely; 1) evaluate toxicity and maximum tolerated dose of THALOMID plus Paclitaxel and Estramustine (PE) in patients with chemotherapy-refractory AIPCa. 2) Assess the response of THALOMID plus (PE) in this patient population. 3) Assess the outcome of THALOMID plus (PE) on time to progression and overall survival in this patient population (The Kaplan- Meier probability of survival at 15 months is more than 50%).
To date, 36 patients (median age 66 (range, 49-80); median Zubrod performance status 1 (range, 0-2)) were entered (10 in the phase I and 25 in the phase II study) and received a median number of 3 (range, 1-8) cycles. Patients had 1 (n=18) or 2 (n=8) prior chemotherapy regimens (11 patients with prior Taxane/Estramustine-based chemotherapy; 11 patients with prior Ketoconazole /Adriamycin / Vinblastine/Estramustine). Thirty-five patients were evaluable for toxicity (1 patient developed DVT prior to chemotherapy initiation and did not receive any therapy); 33 are evaluable for response (2 patients were taken off study before 2 Cycles (1 refused chemotherapy after 1 week, 1 developed pneumonia after Cycle 1) and 4 patients are too early). During Cycle 1 of the phase I study: at 200 mg/day THALOMID, 0 of 3 patients showed grade 3/4 toxicity; at 400 mg/day THALOMID, 9 of 14 patients experienced grade 3 neutropenia (< 7 days duration) and 1 of 4 patients had grade 3 edema (relieved promptly by diuretics); at 600 mg/day THALOMID, 0 of 3 patients had grade 3/4 toxicity. Of the 28 total patients assigned to the 600 mg/day dose level of THALOMID (in both phases of the study), 14 patients tolerated the 600 mg/day continuously, 17 patients tolerated 400 mg/day, 3 patient 200 mg/day, and 2 patients are too early. All dose reductions of THALOMID were due to somnolence/fatigue (grade 1-2). Peripheral neuropathy was limited to grade 1. Two of 33 patients developed grade 3/4 DVT, 2 additional patients discontinued chemotherapy due to intercurrent infection, and 1 patient died from sepsis.
About Prostate Cancer:
Prostate cancer is the most diagnosed cancer in American men and the second leading cause of cancer death. Prostate cancer is twice as common and has more than twice the mortality rate in African-American men than in Caucasian men. The 5-year survival rate for patients whose cancer is caught while still confined to the prostate is 99% while the 5-year survival rate for those diagnosed with distant (metastatic) disease is 30.9%. In the U.S. alone, nearly 200,000 men will be diagnosed with prostate cancer this year equaling one man diagnosed every three minutes. It is estimated that more than 32,500 men in the U.S. will die of prostate cancer. Prostate cancer affects one in eight American men.
Safety Notice:
If thalidomide is taken during pregnancy, it can cause severe birth defects or death to an unborn baby. Thalidomide should never be used by women who are pregnant or who could become pregnant while taking the drug. Even a single dose, one capsule (50 mg, 100 mg and 200 mg), taken by a pregnant woman can cause severe birth defects. Because thalidomide is present in the semen of male patients, males receiving thalidomide must always use a latex condom during sexual contact with women of childbearing potential even if he has undergone a successful vasectomy. Thalidomide can only be marketed under a special restricted distribution program. This program is called the `System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.(R)). Under this program, only registered prescribers and pharmacists may dispense the drug. In addition, patients must be advised of, agree to and comply with the requirements of S.T.E.P.S.
Thalidomide is known to cause nerve damage that may be permanent. Peripheral neuropathy is a common, potentially severe, side effect of treatment with thalidomide that may be irreversible. Decreased white blood cell counts, including neutropenia, have been reported in the clinical use of thalidomide. In placebo controlled clinical trials of HIV-seropositive patient populations, there have been reports of increased plasma HIV RNA levels associated with thalidomide therapy. The most common adverse events observed in clinical use in ENL and HIV-seropositive patient populations are rash, maculo-papular rash, drowsiness/somnolence, peripheral neuropathy, dizziness/orthostatic hypotension, neutropenia, and increased HIV-viral load. Patients should be advised about these associated adverse events and routinely monitored by a physician during treatment with thalidomide.
THALOMID(R) (thalidomide), manufactured by Celgene Corporation, received U.S. Food and Drug Administration (FDA) clearance on July 16, 1998 for the acute treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence. THALOMID(R) is not indicated as monotherapy for ENL treatment in the presence of moderate to severe neuritis.
Celgene Corporation, headquartered in Warren, New Jersey, is an integrated biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company`s website at www.celgene.com.
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company`s control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company`s filings with the Securities and Exchange Commission such as 10K, 10Q and 8K reports.
SOURCE Celgene Corporation
Robert J. Hugin Senior VP and CFO of Celgene Corporation, +1-732-271-4102
http://www.celgene.com
Copyright (C) 2003 PR Newswire. All rights reserved.
JS200
09/26/2003 (13:00 ET) Celgene presents statistically significant data for prostate cancer drug - Datamonitor
09/25/2003 (13:12 ET) BTC: Smith Barney Sees Cont Profit-Taking in Biotechs - Knobias
09/25/2003 (13:10 ET) RATING(=): JMP Sec Keeps CELG Rating @ Mkt Outperform; Keeps Tgt @ $42 - Knobias
09/25/2003 (10:02 ET) CELG CFO to Present at Morgan Stanley Conf Today - Knobias
09/25/2003 (07:32 ET) CONF: CELG To Present At UBS Life Sciences Conference @ 09:30 ET - Knobias
JS200
09/25/2003 (13:12 ET) BTC: Smith Barney Sees Cont Profit-Taking in Biotechs - Knobias
09/25/2003 (13:10 ET) RATING(=): JMP Sec Keeps CELG Rating @ Mkt Outperform; Keeps Tgt @ $42 - Knobias
09/25/2003 (10:02 ET) CELG CFO to Present at Morgan Stanley Conf Today - Knobias
09/25/2003 (07:32 ET) CONF: CELG To Present At UBS Life Sciences Conference @ 09:30 ET - Knobias
JS200
10/07/2003 (07:50 ET) HCR: Smith Barney Highlights the Healthcare Sector - Knobias
10/06/2003 (16:57 ET) Mkt Wrap: MOT & RMBS Up Big; SOX Flat; Biotechs Down - Knobias
10/06/2003 (15:16 ET) Profit Taking Hits Equities in Late Trading - Knobias
10/03/2003 (11:55 ET) Wall Street Journal: Thalidomide is boon to Celgene - World Media Abstract (US)
10/03/2003 (10:18 ET) Techs/Cyclicals Leave Interest Sensitive Issues Behind - Knobias
JS200
10/06/2003 (16:57 ET) Mkt Wrap: MOT & RMBS Up Big; SOX Flat; Biotechs Down - Knobias
10/06/2003 (15:16 ET) Profit Taking Hits Equities in Late Trading - Knobias
10/03/2003 (11:55 ET) Wall Street Journal: Thalidomide is boon to Celgene - World Media Abstract (US)
10/03/2003 (10:18 ET) Techs/Cyclicals Leave Interest Sensitive Issues Behind - Knobias
JS200
In dieser Woche kommen wieder einmal die Zahlen. Das wird einen erneuten Impuls geben!
Celgene Corporation Reports Record Operating Performance in Third Quarter As Total Revenue Increases 117% and Profits Rise
- Third Quarter Product Sales Increase 112%, versus the year ago quarter, driven by strong THALOMID(R) performance - Quarterly Diluted Earnings Per Share of $0.05 Exceeds Earnings Consensus - Progress in Key REVIMID(TM) Regulatory Trials On-Track; Enrollment of First Cohort Completed in Phase II MDS/5Q minus Trials Recent Highlights: - THALOMID Phase I/II Clinical Data Presented on Combination Therapy For Treating Prostate Cancer - Major Peer-Reviewed Journal Publication of a Clinical Study of THALOMID Plus Temozolomide as Oral Regimen for Treating Patients with Advanced- Stage Metastatic Melanoma - THALOMID in Combination with Dexamethasone Included as New Treatment Options in NCCN Multiple Myeloma Clinical Practice Guidelines - Newly Issued Patents Broaden Strong Celgene JNK Intellectual Property Estate - Thalidomide Received Australian Approval For the Treatment of Relapsed and Refractory Multiple Myeloma
WARREN, N.J., Oct 23, 2003 /PRNewswire-FirstCall via COMTEX/ -- Celgene Corporation (Nasdaq: CELG) today announced diluted earnings per share of $0.05 driven by record THALOMID(R) (thalidomide) product sales. Total revenue for the third quarter increased 117.0% to $74.3 million from $34.3 million for the prior-year quarter. THALOMID sales in the third quarter of 2003 increased 88.7% to $57.6 million from $30.5 million in the third quarter of 2002. Celgene posted third quarter net income of $4.3 million, or $0.05 per diluted share compared to a net loss of $1.0 million or ($0.01) per share in the third quarter of last year.
Sequentially, total revenue increased 10.5% to $74.3 million from $67.3 million in the second quarter of 2003, with THALOMID sales rising 4.9% quarter-over-quarter to $57.6 million from $54.8 million. Total revenue for the first nine months of 2003 was a record $190.7 million, an increase of 93.5% over the same period in 2002. THALOMID(R) sales for the nine-month period ended September 30, 2003 were $158.1 million, compared to $85.1 million in 2002, up 85.8% year-over-year. Revenue from the Ritalin(R) family of drugs totaled approximately $5.2 million for the third quarter and approximately $9.9 million for the first nine months of 2003. Celgene posted net income for the first nine months of 2003 of $8.1 million or $0.10 per diluted share, compared to a net loss of $3.6 million or ($0.05) per share in the comparable 2002 period.
As planned, Celgene increased R&D expenditures to accelerate the regulatory programs for REVIMID(TM) in myelodysplastic syndromes, multiple myeloma and for the ongoing pivotal Phase III Special Protocol Assessment (SPA) trials for multiple myeloma and metastatic melanoma. Celgene incurred expenses of $33.3 million in the third quarter of 2003, representing an increase of 61.9% compared to the year ago quarter. These R&D expenditures supported rapid clinical progress in multiple development core programs in THALOMID, REVIMID, and ACTIMID(TM), as well as for high potential SelCID(TM) and kinase programs. Increased expenditures also enabled accelerated progress in a number of additional meaningful preclinical and early clinical programs, including benzopyran, ligase and tubulin inhibitor programs.
Celgene reported $673 million in cash, marketable securities and investments -- including the $12 million Pharmion convertible notes investment -- representing an increase of $10.8 million over the previous quarter.
"This quarter was filled with significant commercial, regulatory and clinical achievements, including: record THALOMID sales and the initiation of three Phase II accelerated approval programs for REVIMID in myelodysplastic syndromes, 5Q minus syndrome and multiple myeloma. Additionally, THALOMID`s potential in cancers and blood disorders was underscored by peer-reviewed publications and presentations, as well as the approval of thalidomide for multiple myeloma in Australia through our partner Pharmion," said John W. Jackson, Chairman and Chief Executive Officer of Celgene Corporation. "We look forward to an eventful fourth quarter with meaningful milestones such as major presentations and publications around THALOMID, REVIMID and ACTIMID at upcoming medical meetings, as well as further advancement of our extensive product pipeline."
2003 Guidance:
Based on strong performance during the first nine months of 2003, we are again increasing THALOMID revenue guidance to a range of $215-220 million from our prior guidance of $200-210 million. We are maintaining 2003 target revenue for the Ritalin(R) family of drugs in a range of $15 million, $40 million and $60 million, in 2003, 2004 and 2005, respectively. Celgene plans 2003 research and development expenses in a range of $125 - 130 million, an increase of approximately 50%, year-over-year, as we aggressively accelerate spending to support multiple pivotal programs and multiple accelerated regulatory approval programs for REVIMID. Our earnings goal for a record full- year profitability for 2003 is at or slightly above the high end of the previous range of $0.10 to $0.15 per diluted share.
COMPANY HIGHLIGHTS:
Clinical, Regulatory and Drug Discovery Achievements:
-- Celgene announced the results of data presented at the European Cancer
Conference (ECCO) in Copenhagen, Denmark which used THALOMID(R) in
combination with chemotherapy for the treatment of androgen-
independent prostate carcinoma (AIPCa). The Phase I/II study results
demonstrated that 18 of 33 (55%) patients who were evaluable for
response achieved a 50-79% decline in PSA and 7 (21%) patients had a
> 80% PSA decline.
-- To further expand the potential of our lead development compound,
REVIMID(TM), Celgene initiated three Phase II accelerated regulatory
approval clinical programs in the third quarter: a multi-center Phase
II trial in multiple myeloma designed as a single-agent, open label
trial to determine safety and efficacy in relapsed and refractory
multiple myeloma patients, and two multi-center Phase II trials in
myelodysplastic syndromes - with or without an associated 5Q minus
cytogenetic abnormality - designed as single-agent, open-label trials
in MDS patients dependent on red blood cell transfusions. Both MDS
trials will evaluate efficacy, based on objectively determined reduced
transfusion needs, hemostatic response and safety. The accelerated
Phase II trials augment the ongoing pivotal Phase III SPA trials in
multiple myeloma and metastatic melanoma. Patient enrollment in these
trials is on or ahead of timelines.
-- Celgene announced the results of a clinical study using THALOMID in
combination with temozolomide as an oral regimen for treatment of
metastatic melanoma, published in the September 1, 2003 issue of the
Journal of Clinical Oncology (JCO). This clinical study, initiated by
Dr. Wen-Jen Hwu of Memorial Sloan Kettering Cancer Center,
investigated the combination of a low-dose daily schedule of
temozolomide with THALOMID (200 mg - 400 mg) in patients with
advanced-stage metastatic melanoma. This study achieved an overall
objective response rate of 32% and a median survival, in this
advanced-stage patient population, of 9.5 months.
Toxicities associated with the above mentioned studies, included:
grade 1-2, somnolence and fatigue, grade 1 peripheral neuropathy,
grade 3/4 DVT, sepsis, grade 3 lymphopenia, grade 4 leukopenia and
neutropenia and grade 4 thrombocytopenia.
-- Celgene signed a cooperative research and development agreement
(CRADA) with The National Cancer Institute (NCI) to collaborate on
clinical and preclinical development of CC-8490 and other benzopyran
agents that target the destruction of brain cancer cells. The
four-year agreement facilitates clinical and preclinical evaluation of
CC-8490 in biochemical and cell based assays as well as assays
directed at measuring anti-tumor effects. The goals of this research
collaboration are to further examine CC-8490 and other agents
(Celgene`s benzopyran class of molecules), both in vitro and in vivo
studies to advance the most promising agents for use in clinical
trials and to assess the efficacy of CC-8490 in the treatment of
glioblastoma in humans. Patient enrollment for the clinical study with
CC-8490 has begun.
-- Celgene announced that the Australian Drug Evaluation Committee
approved thalidomide for the treatment of both patients with relapsed
and refractory multiple myeloma and for the treatment of cutaneous
manifestations of erythema nodosum leprosum (ENL), a severe
and debilitating condition associated with leprosy. The Australian
regulatory authority and our partner, Pharmion, worked together to
finalize the details for registration, labeling and distribution using
our proprietary S.T.E.P.S.(R) program, known as the Pharmion Risk-
Management Program (PRMP) in Australia.
-- A new FOCALIN LA(TM) Phase III pivotal study was initiated by Novartis
to evaluate the safety and efficacy of FOCALIN LA at 5-30 mg/day
administered once daily as compared with placebo in pediatric patients
6-17 years of age who meet DSM-IV criteria for Attention-
Deficit/Hyperactivity Disorder (ADHD). Additionally, Novartis
initiated a new Phase III clinical study - known as G.R.A.C.E. (Girls,
Ritalin LA, and ADHD: A Controlled Evaluation) - to evaluate the
efficacy and safety of Ritalin(R) LA (methylphenidate HCL) extended
release capsules in girls aged 12-17. The study is the first clinical
trial to examine the effects of medication specifically in females
with ADHD. A Phase III pivotal trial in FOCALIN LA for adults is
ongoing.
Corporate and Commercial Achievements:
-- Our intellectual property estate for JNK inhibitors was broadened with
the issuance of two fundamental U.S. patents. The newly issued
patents, U.S. Patents 6,610,505 and 6,610,523, contain broad claims to
methods utilized for screening and developing novel small molecule
therapies to modulate the JNK signaling pathway and covers
polypeptides of mitogen-activated protein kinase kinases (MKKs) that
are involved in the c-Jun N-terminal kinase (JNK) pathways,
respectively. Importantly, the JNK gene regulation pathway has been
shown to play a pivotal role in the onset and progression of several
significant human diseases.
-- During the quarter our drug discovery operations were strengthened by
the addition of David Webb, Ph.D., who joined Celgene San Diego as
Vice President of Research. Dr. Webb`s distinguished career is
underscored by the breadth and depth of his experience in product
development and senior management positions in several biotechnology
and pharmaceutical companies where he developed and led drug discovery
programs focused on inflammation, asthma, cancer and diabetes.
Moreover, Dr. Webb has held several distinguished academic positions,
including: Consulting Professor of Cancer Biology at Stanford
University, member of the Department of Cell Biology at the Roche
Institute, and Adjunct Professor of Human Genetics at Columbia
University College of Physicians and Surgeons.
-- We are very pleased to announce that Eve E. Slater, M.D., former US
Assistant Secretary for Health and Senior Vice President of Merck
Research Laboratories, has been retained by Celgene Cellular
Therapeutics, as a Senior Advisor. Dr. Slater will advise Celgene
Cellular Therapeutics on key governmental, academic and clinical
development initiatives.
Celgene senior management will host a conference call to discuss the results and achievements of its third quarter operating and financial performance on October 23, 2003 at 9:00 a.m. EDT. The conference call will be available by webcast at www.celgene.com. An audio replay of the call will be available from noon EDT October 23, 2003 until midnight EDT October 30, 2003. To access the replay, dial 1-800-642-1687 and enter Reservation Number 3232927.
Celgene Corporation, headquartered in Warren, New Jersey, is an integrated biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company`s website at www.celgene.com.
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company`s control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company`s filings with the Securities and Exchange Commission such as 10K, 10Q and 8K reports.
Celgene Corporation
Consolidated Financial Results
(Unaudited)
(In thousands, except per share data)
Consolidated Statement of Operations Data
Three Month Period Nine Month Period
Ended September 30, Ended September 30,
2003 2002 2003 2002
Product sales $ 65,587 $ 30,896 $173,888 $ 88,893
Collaborative agreement
and other revenue 6,066 1,556 9,453 6,442
Royalty revenue 2,679 1,806 7,366 3,238
Total revenue 74,332 34,258 190,707 98,573
Cost of goods sold 13,639 4,429 29,909 12,203
Research and development 33,270 20,549 89,095 57,584
Selling, general
and administrative 26,517 15,738 75,229 50,154
Total costs and expenses 73,426 40,716 194,233 119,941
Operating profit (loss) 906 (6,458) (3,526) (21,368)
Interest and other
income, net 3,765 5,421 12,388 17,794
Income (loss) before tax 4,671 (1,037) 8,862 (3,574)
Income tax 378 - 723 -
Net income (loss) $ 4,293 $ (1,037) $ 8,139 $(3,574)
Per common share-basic
and diluted
Net income(loss)-basic $ 0.05 $ (0.01) $ 0.10 $ (0.05)
Net income(loss)-diluted $ 0.05 $ (0.01) $ 0.10 $ (0.05)
Weighted average shares
outstanding-basic 81,047 78,583 80,760 76,872
Weighted average shares
outstanding-diluted 86,329 78,583 85,214 76,872
Consolidated Balance Sheet Data
September 30, December 31,
2003 2002
Cash, cash equivalents & marketable
securities $ 660,875 $ 261,182
Total assets 772,931 327,287
Convertible notes 400,000 -
Stockholders` equity 300,327 276,698
SOURCE Celgene Corporation
Robert J. Hugin, Senior VP and CFO, Celgene Corporation,
+1-732-271-4102
http://www.celgene.com
Copyright (C) 2003 PR Newswire. All rights reserved.
- Third Quarter Product Sales Increase 112%, versus the year ago quarter, driven by strong THALOMID(R) performance - Quarterly Diluted Earnings Per Share of $0.05 Exceeds Earnings Consensus - Progress in Key REVIMID(TM) Regulatory Trials On-Track; Enrollment of First Cohort Completed in Phase II MDS/5Q minus Trials Recent Highlights: - THALOMID Phase I/II Clinical Data Presented on Combination Therapy For Treating Prostate Cancer - Major Peer-Reviewed Journal Publication of a Clinical Study of THALOMID Plus Temozolomide as Oral Regimen for Treating Patients with Advanced- Stage Metastatic Melanoma - THALOMID in Combination with Dexamethasone Included as New Treatment Options in NCCN Multiple Myeloma Clinical Practice Guidelines - Newly Issued Patents Broaden Strong Celgene JNK Intellectual Property Estate - Thalidomide Received Australian Approval For the Treatment of Relapsed and Refractory Multiple Myeloma
WARREN, N.J., Oct 23, 2003 /PRNewswire-FirstCall via COMTEX/ -- Celgene Corporation (Nasdaq: CELG) today announced diluted earnings per share of $0.05 driven by record THALOMID(R) (thalidomide) product sales. Total revenue for the third quarter increased 117.0% to $74.3 million from $34.3 million for the prior-year quarter. THALOMID sales in the third quarter of 2003 increased 88.7% to $57.6 million from $30.5 million in the third quarter of 2002. Celgene posted third quarter net income of $4.3 million, or $0.05 per diluted share compared to a net loss of $1.0 million or ($0.01) per share in the third quarter of last year.
Sequentially, total revenue increased 10.5% to $74.3 million from $67.3 million in the second quarter of 2003, with THALOMID sales rising 4.9% quarter-over-quarter to $57.6 million from $54.8 million. Total revenue for the first nine months of 2003 was a record $190.7 million, an increase of 93.5% over the same period in 2002. THALOMID(R) sales for the nine-month period ended September 30, 2003 were $158.1 million, compared to $85.1 million in 2002, up 85.8% year-over-year. Revenue from the Ritalin(R) family of drugs totaled approximately $5.2 million for the third quarter and approximately $9.9 million for the first nine months of 2003. Celgene posted net income for the first nine months of 2003 of $8.1 million or $0.10 per diluted share, compared to a net loss of $3.6 million or ($0.05) per share in the comparable 2002 period.
As planned, Celgene increased R&D expenditures to accelerate the regulatory programs for REVIMID(TM) in myelodysplastic syndromes, multiple myeloma and for the ongoing pivotal Phase III Special Protocol Assessment (SPA) trials for multiple myeloma and metastatic melanoma. Celgene incurred expenses of $33.3 million in the third quarter of 2003, representing an increase of 61.9% compared to the year ago quarter. These R&D expenditures supported rapid clinical progress in multiple development core programs in THALOMID, REVIMID, and ACTIMID(TM), as well as for high potential SelCID(TM) and kinase programs. Increased expenditures also enabled accelerated progress in a number of additional meaningful preclinical and early clinical programs, including benzopyran, ligase and tubulin inhibitor programs.
Celgene reported $673 million in cash, marketable securities and investments -- including the $12 million Pharmion convertible notes investment -- representing an increase of $10.8 million over the previous quarter.
"This quarter was filled with significant commercial, regulatory and clinical achievements, including: record THALOMID sales and the initiation of three Phase II accelerated approval programs for REVIMID in myelodysplastic syndromes, 5Q minus syndrome and multiple myeloma. Additionally, THALOMID`s potential in cancers and blood disorders was underscored by peer-reviewed publications and presentations, as well as the approval of thalidomide for multiple myeloma in Australia through our partner Pharmion," said John W. Jackson, Chairman and Chief Executive Officer of Celgene Corporation. "We look forward to an eventful fourth quarter with meaningful milestones such as major presentations and publications around THALOMID, REVIMID and ACTIMID at upcoming medical meetings, as well as further advancement of our extensive product pipeline."
2003 Guidance:
Based on strong performance during the first nine months of 2003, we are again increasing THALOMID revenue guidance to a range of $215-220 million from our prior guidance of $200-210 million. We are maintaining 2003 target revenue for the Ritalin(R) family of drugs in a range of $15 million, $40 million and $60 million, in 2003, 2004 and 2005, respectively. Celgene plans 2003 research and development expenses in a range of $125 - 130 million, an increase of approximately 50%, year-over-year, as we aggressively accelerate spending to support multiple pivotal programs and multiple accelerated regulatory approval programs for REVIMID. Our earnings goal for a record full- year profitability for 2003 is at or slightly above the high end of the previous range of $0.10 to $0.15 per diluted share.
COMPANY HIGHLIGHTS:
Clinical, Regulatory and Drug Discovery Achievements:
-- Celgene announced the results of data presented at the European Cancer
Conference (ECCO) in Copenhagen, Denmark which used THALOMID(R) in
combination with chemotherapy for the treatment of androgen-
independent prostate carcinoma (AIPCa). The Phase I/II study results
demonstrated that 18 of 33 (55%) patients who were evaluable for
response achieved a 50-79% decline in PSA and 7 (21%) patients had a
> 80% PSA decline.
-- To further expand the potential of our lead development compound,
REVIMID(TM), Celgene initiated three Phase II accelerated regulatory
approval clinical programs in the third quarter: a multi-center Phase
II trial in multiple myeloma designed as a single-agent, open label
trial to determine safety and efficacy in relapsed and refractory
multiple myeloma patients, and two multi-center Phase II trials in
myelodysplastic syndromes - with or without an associated 5Q minus
cytogenetic abnormality - designed as single-agent, open-label trials
in MDS patients dependent on red blood cell transfusions. Both MDS
trials will evaluate efficacy, based on objectively determined reduced
transfusion needs, hemostatic response and safety. The accelerated
Phase II trials augment the ongoing pivotal Phase III SPA trials in
multiple myeloma and metastatic melanoma. Patient enrollment in these
trials is on or ahead of timelines.
-- Celgene announced the results of a clinical study using THALOMID in
combination with temozolomide as an oral regimen for treatment of
metastatic melanoma, published in the September 1, 2003 issue of the
Journal of Clinical Oncology (JCO). This clinical study, initiated by
Dr. Wen-Jen Hwu of Memorial Sloan Kettering Cancer Center,
investigated the combination of a low-dose daily schedule of
temozolomide with THALOMID (200 mg - 400 mg) in patients with
advanced-stage metastatic melanoma. This study achieved an overall
objective response rate of 32% and a median survival, in this
advanced-stage patient population, of 9.5 months.
Toxicities associated with the above mentioned studies, included:
grade 1-2, somnolence and fatigue, grade 1 peripheral neuropathy,
grade 3/4 DVT, sepsis, grade 3 lymphopenia, grade 4 leukopenia and
neutropenia and grade 4 thrombocytopenia.
-- Celgene signed a cooperative research and development agreement
(CRADA) with The National Cancer Institute (NCI) to collaborate on
clinical and preclinical development of CC-8490 and other benzopyran
agents that target the destruction of brain cancer cells. The
four-year agreement facilitates clinical and preclinical evaluation of
CC-8490 in biochemical and cell based assays as well as assays
directed at measuring anti-tumor effects. The goals of this research
collaboration are to further examine CC-8490 and other agents
(Celgene`s benzopyran class of molecules), both in vitro and in vivo
studies to advance the most promising agents for use in clinical
trials and to assess the efficacy of CC-8490 in the treatment of
glioblastoma in humans. Patient enrollment for the clinical study with
CC-8490 has begun.
-- Celgene announced that the Australian Drug Evaluation Committee
approved thalidomide for the treatment of both patients with relapsed
and refractory multiple myeloma and for the treatment of cutaneous
manifestations of erythema nodosum leprosum (ENL), a severe
and debilitating condition associated with leprosy. The Australian
regulatory authority and our partner, Pharmion, worked together to
finalize the details for registration, labeling and distribution using
our proprietary S.T.E.P.S.(R) program, known as the Pharmion Risk-
Management Program (PRMP) in Australia.
-- A new FOCALIN LA(TM) Phase III pivotal study was initiated by Novartis
to evaluate the safety and efficacy of FOCALIN LA at 5-30 mg/day
administered once daily as compared with placebo in pediatric patients
6-17 years of age who meet DSM-IV criteria for Attention-
Deficit/Hyperactivity Disorder (ADHD). Additionally, Novartis
initiated a new Phase III clinical study - known as G.R.A.C.E. (Girls,
Ritalin LA, and ADHD: A Controlled Evaluation) - to evaluate the
efficacy and safety of Ritalin(R) LA (methylphenidate HCL) extended
release capsules in girls aged 12-17. The study is the first clinical
trial to examine the effects of medication specifically in females
with ADHD. A Phase III pivotal trial in FOCALIN LA for adults is
ongoing.
Corporate and Commercial Achievements:
-- Our intellectual property estate for JNK inhibitors was broadened with
the issuance of two fundamental U.S. patents. The newly issued
patents, U.S. Patents 6,610,505 and 6,610,523, contain broad claims to
methods utilized for screening and developing novel small molecule
therapies to modulate the JNK signaling pathway and covers
polypeptides of mitogen-activated protein kinase kinases (MKKs) that
are involved in the c-Jun N-terminal kinase (JNK) pathways,
respectively. Importantly, the JNK gene regulation pathway has been
shown to play a pivotal role in the onset and progression of several
significant human diseases.
-- During the quarter our drug discovery operations were strengthened by
the addition of David Webb, Ph.D., who joined Celgene San Diego as
Vice President of Research. Dr. Webb`s distinguished career is
underscored by the breadth and depth of his experience in product
development and senior management positions in several biotechnology
and pharmaceutical companies where he developed and led drug discovery
programs focused on inflammation, asthma, cancer and diabetes.
Moreover, Dr. Webb has held several distinguished academic positions,
including: Consulting Professor of Cancer Biology at Stanford
University, member of the Department of Cell Biology at the Roche
Institute, and Adjunct Professor of Human Genetics at Columbia
University College of Physicians and Surgeons.
-- We are very pleased to announce that Eve E. Slater, M.D., former US
Assistant Secretary for Health and Senior Vice President of Merck
Research Laboratories, has been retained by Celgene Cellular
Therapeutics, as a Senior Advisor. Dr. Slater will advise Celgene
Cellular Therapeutics on key governmental, academic and clinical
development initiatives.
Celgene senior management will host a conference call to discuss the results and achievements of its third quarter operating and financial performance on October 23, 2003 at 9:00 a.m. EDT. The conference call will be available by webcast at www.celgene.com. An audio replay of the call will be available from noon EDT October 23, 2003 until midnight EDT October 30, 2003. To access the replay, dial 1-800-642-1687 and enter Reservation Number 3232927.
Celgene Corporation, headquartered in Warren, New Jersey, is an integrated biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company`s website at www.celgene.com.
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company`s control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company`s filings with the Securities and Exchange Commission such as 10K, 10Q and 8K reports.
Celgene Corporation
Consolidated Financial Results
(Unaudited)
(In thousands, except per share data)
Consolidated Statement of Operations Data
Three Month Period Nine Month Period
Ended September 30, Ended September 30,
2003 2002 2003 2002
Product sales $ 65,587 $ 30,896 $173,888 $ 88,893
Collaborative agreement
and other revenue 6,066 1,556 9,453 6,442
Royalty revenue 2,679 1,806 7,366 3,238
Total revenue 74,332 34,258 190,707 98,573
Cost of goods sold 13,639 4,429 29,909 12,203
Research and development 33,270 20,549 89,095 57,584
Selling, general
and administrative 26,517 15,738 75,229 50,154
Total costs and expenses 73,426 40,716 194,233 119,941
Operating profit (loss) 906 (6,458) (3,526) (21,368)
Interest and other
income, net 3,765 5,421 12,388 17,794
Income (loss) before tax 4,671 (1,037) 8,862 (3,574)
Income tax 378 - 723 -
Net income (loss) $ 4,293 $ (1,037) $ 8,139 $(3,574)
Per common share-basic
and diluted
Net income(loss)-basic $ 0.05 $ (0.01) $ 0.10 $ (0.05)
Net income(loss)-diluted $ 0.05 $ (0.01) $ 0.10 $ (0.05)
Weighted average shares
outstanding-basic 81,047 78,583 80,760 76,872
Weighted average shares
outstanding-diluted 86,329 78,583 85,214 76,872
Consolidated Balance Sheet Data
September 30, December 31,
2003 2002
Cash, cash equivalents & marketable
securities $ 660,875 $ 261,182
Total assets 772,931 327,287
Convertible notes 400,000 -
Stockholders` equity 300,327 276,698
SOURCE Celgene Corporation
Robert J. Hugin, Senior VP and CFO, Celgene Corporation,
+1-732-271-4102
http://www.celgene.com
Copyright (C) 2003 PR Newswire. All rights reserved.
Celgene Corporation and The National Cancer Institute Initiate Clinical Trial In Brain Cancer With New Anti-Cancer Compounds
WARREN, N.J., Oct 31, 2003 /PRNewswire-FirstCall via COMTEX/ -- Celgene Corporation (Nasdaq: CELG) and the National Cancer Institute (NCI) announced today the initiation of a clinical trial with CC-8490, a new anti-cancer compound from Celgene`s proprietary class of benzopyrans, being evaluated as a potential therapy for brain cancer. Recently, Celgene signed a cooperative research and development agreement (CRADA) with The National Cancer Institute (NCI), a component of the National Institutes of Health (NIH) to collaborate on clinical and preclinical development of CC-8490 and other agents that specifically target the destruction of brain cancer cells.
This is part of a four-year cooperative research agreement encompassing clinical and preclinical evaluation of CC-8490 in biochemical and cell based assays as well as assays directed at measuring anti-tumor effects. The goals of this research collaboration are to further examine CC-8490 and its analogs, both in vitro and in vivo studies to advance the most promising agents for use in clinical trials. Pending successful outcomes of the initial research, the National Cancer Institute will conduct additional Phase I and Phase II clinical trials of CC-8490 and other benzopyrans under this CRADA.
Previously, Celgene worked with The National Cancer Institute to study the potential anti-glioma activity of CC-8490 using multiple cell lines. The mechanism for this anti-tumor effect of CC-8490 may be novel and is being further explored. The NCI Chief Investigator, who will lead the pre-clinical and clinical activities under the CRADA, has extensive experience in both in vitro and in vivo evaluations of novel cytotoxic and cytostatic agents for treating primary brain tumors. The investigator will lead the pre-clinical and clinical activities under the CRADA.
About Brain Tumors
Primary tumors are tumors that begin in brain tissue. Primary brain tumors are named according to the type of cells or the part of the brain in which they originated. The most common primary brain tumors are gliomas. Glioma is a cancer of the brain that begins in glial cells (surround and support nerve cells). There is no exact cause of brain tumors, doctors cannot specify why one person develops a brain tumor and another person does not. Research illustrates that people with certain risk factors are more likely than others to develop a brain tumor. The following risk factors are associated with an increased chance of developing a primary brain tumor: male gender, race, age and family history. The symptoms of brain tumors depend on size, type and location. The following are the most common symptoms: headaches (worse in the morning), nausea or vomiting, changes in speech, vision or hearing, problems balancing or walking, mood, personality changes, ability to concentrate, memory problems, muscle jerking or twitching and joint numbness or tingling. Once a person has been diagnosed with a brain tumor, people have several available treatment options. Depending on tumor size and type, patients can be treated with surgery, radiation therapy or chemotherapy. Some patients receive a combination of treatments including oral medication.
About The National Cancer Institute
The National Cancer Institute (NCI) is a part of the National Institutes of Health (NIH), which is one of eight agencies of the Public Health Service (PHS) in the Department of Health and Human Services (DHHS). NCI was established in 1937 under the National Cancer Act; the federal government`s principal agency for cancer research and training. The National Cancer Act of 1971 expanded the responsibilities of the NCI and created the National Cancer Program. The National Cancer Program conducts and supports research, training, health information dissemination and other programs with respect to the cause, diagnosis, prevention and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients.
Celgene Corporation, headquartered in Warren, New Jersey, is an integrated biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company`s website at www.celgene.com.
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company`s control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company`s filings with the Securities and Exchange Commission such as 10K, 10Q and 8K reports.
SOURCE Celgene Corporation
Robert J. Hugin, Senior Vice President & CFO of Celgene
Corporation, +1-732-271-4102
http://www.celgene.com
Copyright (C) 2003 PR Newswire. All rights reserved.
WARREN, N.J., Oct 31, 2003 /PRNewswire-FirstCall via COMTEX/ -- Celgene Corporation (Nasdaq: CELG) and the National Cancer Institute (NCI) announced today the initiation of a clinical trial with CC-8490, a new anti-cancer compound from Celgene`s proprietary class of benzopyrans, being evaluated as a potential therapy for brain cancer. Recently, Celgene signed a cooperative research and development agreement (CRADA) with The National Cancer Institute (NCI), a component of the National Institutes of Health (NIH) to collaborate on clinical and preclinical development of CC-8490 and other agents that specifically target the destruction of brain cancer cells.
This is part of a four-year cooperative research agreement encompassing clinical and preclinical evaluation of CC-8490 in biochemical and cell based assays as well as assays directed at measuring anti-tumor effects. The goals of this research collaboration are to further examine CC-8490 and its analogs, both in vitro and in vivo studies to advance the most promising agents for use in clinical trials. Pending successful outcomes of the initial research, the National Cancer Institute will conduct additional Phase I and Phase II clinical trials of CC-8490 and other benzopyrans under this CRADA.
Previously, Celgene worked with The National Cancer Institute to study the potential anti-glioma activity of CC-8490 using multiple cell lines. The mechanism for this anti-tumor effect of CC-8490 may be novel and is being further explored. The NCI Chief Investigator, who will lead the pre-clinical and clinical activities under the CRADA, has extensive experience in both in vitro and in vivo evaluations of novel cytotoxic and cytostatic agents for treating primary brain tumors. The investigator will lead the pre-clinical and clinical activities under the CRADA.
About Brain Tumors
Primary tumors are tumors that begin in brain tissue. Primary brain tumors are named according to the type of cells or the part of the brain in which they originated. The most common primary brain tumors are gliomas. Glioma is a cancer of the brain that begins in glial cells (surround and support nerve cells). There is no exact cause of brain tumors, doctors cannot specify why one person develops a brain tumor and another person does not. Research illustrates that people with certain risk factors are more likely than others to develop a brain tumor. The following risk factors are associated with an increased chance of developing a primary brain tumor: male gender, race, age and family history. The symptoms of brain tumors depend on size, type and location. The following are the most common symptoms: headaches (worse in the morning), nausea or vomiting, changes in speech, vision or hearing, problems balancing or walking, mood, personality changes, ability to concentrate, memory problems, muscle jerking or twitching and joint numbness or tingling. Once a person has been diagnosed with a brain tumor, people have several available treatment options. Depending on tumor size and type, patients can be treated with surgery, radiation therapy or chemotherapy. Some patients receive a combination of treatments including oral medication.
About The National Cancer Institute
The National Cancer Institute (NCI) is a part of the National Institutes of Health (NIH), which is one of eight agencies of the Public Health Service (PHS) in the Department of Health and Human Services (DHHS). NCI was established in 1937 under the National Cancer Act; the federal government`s principal agency for cancer research and training. The National Cancer Act of 1971 expanded the responsibilities of the NCI and created the National Cancer Program. The National Cancer Program conducts and supports research, training, health information dissemination and other programs with respect to the cause, diagnosis, prevention and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients.
Celgene Corporation, headquartered in Warren, New Jersey, is an integrated biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company`s website at www.celgene.com.
This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company`s control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company`s filings with the Securities and Exchange Commission such as 10K, 10Q and 8K reports.
SOURCE Celgene Corporation
Robert J. Hugin, Senior Vice President & CFO of Celgene
Corporation, +1-732-271-4102
http://www.celgene.com
Copyright (C) 2003 PR Newswire. All rights reserved.
Hallo - es gab lange keinen Beitrag mehr über Celgene - obwohl sie sich doch recht wacker geschlagen hat.
Heute sieht es jedoch nicht so nett aus - rund 9 % im Minus. Weiß jemand was genaues?
Noch einen netten Abend Gruß StLeske
Heute sieht es jedoch nicht so nett aus - rund 9 % im Minus. Weiß jemand was genaues?
Noch einen netten Abend Gruß StLeske
hallo st leske schau mal unter www.consors.de nach gruß fsv
.
09/14/2005 (10:46 ET) Wall Street pharma - Biopharma indexes inch up, Celgene halted - AFX News - UK
09/14/2005 (10:46 ET) Wall Street pharma - Biopharma indexes inch up, Celgene halted - AFX News - Europe
09/14/2005 (10:32 ET) Wall Street pharma - Biopharma indexes inch up, Celgene halted - Xinhua News Agency - Financial Network
09/14/2005 (09:51 ET) MORNING UPDATE: Seven Summits Research issues alerts for BBY, PWAV, AMR, CELG, and LEH - PR Newswire
09/14/2005 (08:19 ET) Zacks.com Announces That Jim Collins Highlights the Following Stocks: NutriSystem, Arris Group, Celgene Corp., American Eagle Outfitters, and LCA-Vision - Business Wire
09/14/2005 (10:46 ET) Wall Street pharma - Biopharma indexes inch up, Celgene halted - AFX News - Europe
09/14/2005 (10:32 ET) Wall Street pharma - Biopharma indexes inch up, Celgene halted - Xinhua News Agency - Financial Network
09/14/2005 (09:51 ET) MORNING UPDATE: Seven Summits Research issues alerts for BBY, PWAV, AMR, CELG, and LEH - PR Newswire
09/14/2005 (08:19 ET) Zacks.com Announces That Jim Collins Highlights the Following Stocks: NutriSystem, Arris Group, Celgene Corp., American Eagle Outfitters, and LCA-Vision - Business Wire
Wall Street pharma - Biopharma indexes inch up, Celgene halted
Wednesday, September 14, 2005 10:46 ET
BOSTON (AFX)-The pharmaceutical index moved slightly higher early Wednesday, while shares of Celgene were halted pending the outcome of a regulatory panel vote on the approvability of its drug Revlimid.
The Amex Biotechnology Index was virtually flat at 645.16 and the Amex Pharmaceutical Index inched up 0.5% to 328.96.
Celgene shares were halted in early trade at $52.91. An advisory panel of the Food and Drug Administration is scheduled to hold a vote later today on whether to recommend Revlimid be approved to treat a type of anemia associated with myelodysplastic syndromes, a group of diseases whereby the bone marrow doesn`t produce enough healthy cells.
According to Celgene, a vote is expected by 12:30 p.m. Eastern time. While the vote is not a final decision, the FDA generally always follows the recommendations of its expert committees.
Progenics Pharmaceuticals shed 4% to trade at $24.02. The company priced a public offering of 2.5 million common shares at $23.90 a share, a transaction that is expected to garner about $57.4 million.
Genentech was up 1% at $91.56, the day after it announced positive news for its cancer drugs Herceptin and Tarceva. Analysts at Piper Jaffray early Wednesday raised their price target of the stock to $100.
This story was supplied by MarketWatch. For further information see www.marketwatch.com.
Copyright 2005. AFX News Ltd. All rights reserved. ********************************************************************** As of Saturday, 09-10-2005 23:59, the latest Comtex SmarTrend(SM) Alert, an automated pattern recognition system, indicated a DOWNTREND on 08-18-2005 for CELG @ $46.07. (C) 2005 Comtex News Network, Inc. All rights reserved.
Wednesday, September 14, 2005 10:46 ET
BOSTON (AFX)-The pharmaceutical index moved slightly higher early Wednesday, while shares of Celgene were halted pending the outcome of a regulatory panel vote on the approvability of its drug Revlimid.
The Amex Biotechnology Index was virtually flat at 645.16 and the Amex Pharmaceutical Index inched up 0.5% to 328.96.
Celgene shares were halted in early trade at $52.91. An advisory panel of the Food and Drug Administration is scheduled to hold a vote later today on whether to recommend Revlimid be approved to treat a type of anemia associated with myelodysplastic syndromes, a group of diseases whereby the bone marrow doesn`t produce enough healthy cells.
According to Celgene, a vote is expected by 12:30 p.m. Eastern time. While the vote is not a final decision, the FDA generally always follows the recommendations of its expert committees.
Progenics Pharmaceuticals shed 4% to trade at $24.02. The company priced a public offering of 2.5 million common shares at $23.90 a share, a transaction that is expected to garner about $57.4 million.
Genentech was up 1% at $91.56, the day after it announced positive news for its cancer drugs Herceptin and Tarceva. Analysts at Piper Jaffray early Wednesday raised their price target of the stock to $100.
This story was supplied by MarketWatch. For further information see www.marketwatch.com.
Copyright 2005. AFX News Ltd. All rights reserved. ********************************************************************** As of Saturday, 09-10-2005 23:59, the latest Comtex SmarTrend(SM) Alert, an automated pattern recognition system, indicated a DOWNTREND on 08-18-2005 for CELG @ $46.07. (C) 2005 Comtex News Network, Inc. All rights reserved.
RAiDAR alerts Learn More About RAiDAR-LT
09/14/2005 (10:46 ET) Wall Street pharma - Biopharma indexes inch up, Celgene halted - AFX News - UK
09/14/2005 (10:46 ET) Wall Street pharma - Biopharma indexes inch up, Celgene halted - AFX News - Europe
09/14/2005 (10:32 ET) Wall Street pharma - Biopharma indexes inch up, Celgene halted - Xinhua News Agency - Financial Network
09/14/2005 (09:51 ET) MORNING UPDATE: Seven Summits Research issues alerts for BBY, PWAV, AMR, CELG, and LEH - PR Newswire
09/14/2005 (08:19 ET) Zacks.com Announces That Jim Collins Highlights the Following Stocks: NutriSystem, Arris Group, Celgene Corp., American Eagle Outfitters, and LCA-Vision - Business Wire
09/13/2005 (16:22 ET) CELG: Drops -1.04%; Vol +60%; Last 90 Min of Trading - Knobias
09/13/2005 (16:04 ET) CELG: Filed New Form 8-K, Material Event Disclosure - Edgar
09/13/2005 (12:05 ET) CELG: Volume Spike; 21% > 20-adsv, Stock -3.39% - Knobias
09/13/2005 (09:49 ET) FDA and Celgene Revlimid(R) Briefing Documents for Advisory Committee Meeting Available Online - PR Newswire
09/13/2005 (08:28 ET) CELG: Merrill Lynch Cuts to Neutral from Buy; Analyst Notes - Knobias
09/12/2005 (13:15 ET) CELG: New 52-Wk High @ $54.380 up 7.39% - Knobias
09/12/2005 (11:25 ET) CELG: Volume Spike; 11% > 20-adsv, Stock +4.29% - Knobias
09/12/2005 (07:32 ET) CELG: To Present At Bear Stearns Conference @ 09:30 ET - Knobias
09/12/2005 (06:03 ET) CELG: mentioned in latest Barron`s Publication - Knobias
09/11/2005 (23:57 ET) FirstAlert: 9-11 A.M. Investrend / Bestcalls - Investrend
09/09/2005 (19:11 ET) CELG: New Form 4 Filed, Change in Beneficial Ownership - Edgar
09/09/2005 (09:02 ET) CELG: To Present At Thomas Weisel Conference @ 11:00 ET - Knobias
09/09/2005 (09:02 ET) CELG: To Present At BioCentury NewsMaker Conference @ 11:00 ET - Knobias
09/09/2005 (07:30 ET) Celgene Will Present at Bear Stearns Healthcare Conference - PR Newswire
09/09/2005 (00:08 ET) FirstAlert: 9 A.M. Investrend / Bestcalls - Investrend
09/08/2005 (07:30 ET) Celgene Will Present at Thomas Weisel Healthcare Tailwinds Conference - PR Newswire
09/08/2005 (07:00 ET) SmallCap Sentinel: Skin Cell Discovery Could Bridge Moral Gap in Stem Cell Research - PrimeZone Media Network
09/07/2005 (16:05 ET) Celgene Will Present at NewsMakers in the Biotech Industry Conference - PR Newswire
09/06/2005 (20:21 ET) CELG: New Form 4 Filed, Change in Beneficial Ownership - Edgar
09/06/2005 (11:55 ET) CELG: Volume Spike; 21% > 20-adsv, Stock +4.07% - Knobias
09/14/2005 (10:46 ET) Wall Street pharma - Biopharma indexes inch up, Celgene halted - AFX News - UK
09/14/2005 (10:46 ET) Wall Street pharma - Biopharma indexes inch up, Celgene halted - AFX News - Europe
09/14/2005 (10:32 ET) Wall Street pharma - Biopharma indexes inch up, Celgene halted - Xinhua News Agency - Financial Network
09/14/2005 (09:51 ET) MORNING UPDATE: Seven Summits Research issues alerts for BBY, PWAV, AMR, CELG, and LEH - PR Newswire
09/14/2005 (08:19 ET) Zacks.com Announces That Jim Collins Highlights the Following Stocks: NutriSystem, Arris Group, Celgene Corp., American Eagle Outfitters, and LCA-Vision - Business Wire
09/13/2005 (16:22 ET) CELG: Drops -1.04%; Vol +60%; Last 90 Min of Trading - Knobias
09/13/2005 (16:04 ET) CELG: Filed New Form 8-K, Material Event Disclosure - Edgar
09/13/2005 (12:05 ET) CELG: Volume Spike; 21% > 20-adsv, Stock -3.39% - Knobias
09/13/2005 (09:49 ET) FDA and Celgene Revlimid(R) Briefing Documents for Advisory Committee Meeting Available Online - PR Newswire
09/13/2005 (08:28 ET) CELG: Merrill Lynch Cuts to Neutral from Buy; Analyst Notes - Knobias
09/12/2005 (13:15 ET) CELG: New 52-Wk High @ $54.380 up 7.39% - Knobias
09/12/2005 (11:25 ET) CELG: Volume Spike; 11% > 20-adsv, Stock +4.29% - Knobias
09/12/2005 (07:32 ET) CELG: To Present At Bear Stearns Conference @ 09:30 ET - Knobias
09/12/2005 (06:03 ET) CELG: mentioned in latest Barron`s Publication - Knobias
09/11/2005 (23:57 ET) FirstAlert: 9-11 A.M. Investrend / Bestcalls - Investrend
09/09/2005 (19:11 ET) CELG: New Form 4 Filed, Change in Beneficial Ownership - Edgar
09/09/2005 (09:02 ET) CELG: To Present At Thomas Weisel Conference @ 11:00 ET - Knobias
09/09/2005 (09:02 ET) CELG: To Present At BioCentury NewsMaker Conference @ 11:00 ET - Knobias
09/09/2005 (07:30 ET) Celgene Will Present at Bear Stearns Healthcare Conference - PR Newswire
09/09/2005 (00:08 ET) FirstAlert: 9 A.M. Investrend / Bestcalls - Investrend
09/08/2005 (07:30 ET) Celgene Will Present at Thomas Weisel Healthcare Tailwinds Conference - PR Newswire
09/08/2005 (07:00 ET) SmallCap Sentinel: Skin Cell Discovery Could Bridge Moral Gap in Stem Cell Research - PrimeZone Media Network
09/07/2005 (16:05 ET) Celgene Will Present at NewsMakers in the Biotech Industry Conference - PR Newswire
09/06/2005 (20:21 ET) CELG: New Form 4 Filed, Change in Beneficial Ownership - Edgar
09/06/2005 (11:55 ET) CELG: Volume Spike; 21% > 20-adsv, Stock +4.07% - Knobias
FDA and Celgene Revlimid(R) Briefing Documents for Advisory Committee Meeting Available Online
Tuesday , September 13, 2005 09:49 ET
WASHINGTON, Sept 13, 2005 /PRNewswire-FirstCall via COMTEX/ --Celgene Corporation (Nasdaq: CELG) announced that the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) has posted on its website briefing documents for the ODAC meeting scheduled to review the REVLIMID(R) (lenalidomide) New Drug Application (NDA) seeking approval for REVLIMID for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. In order to obtain access to the FDA and Celgene REVLIMID briefing documents, go to http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4174B2_… Revlimid.pdf. The ODAC meeting is scheduled from 8:00 a.m. EDT to 12:30 p.m. EDT on Wednesday, September 14, 2005. The NDA for REVLIMID is under FDA priority review with a PDUFA date of October 7, 2005.
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company`s website at www.celgene.com.
This release contains forward-looking statements which are subject to known and unknown risks, delays, uncertainties and other factors not under the Company`s control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations expressed or implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and other factors described in the Company`s filings with the Securities and Exchange Commission such as our 10K, 10Q and 8K reports.
SOURCE Celgene Corporation
Robert J. Hugin, Senior VP and CFO, or Brian P. Gill, Director PR
http://www.prnewswire.com
Copyright (C) 2005 PR Newswire. All rights reserved. ********************************************************************** As of Friday, 09-09-2005 23:59, the latest Comtex SmarTrend(SM) Alert, an automated pattern recognition system, indicated a DOWNTREND on 08-18-2005 for CELG @ $46.07. (C) 2005 Comtex News Network, Inc. All rights reserved.
Tuesday , September 13, 2005 09:49 ET
WASHINGTON, Sept 13, 2005 /PRNewswire-FirstCall via COMTEX/ --Celgene Corporation (Nasdaq: CELG) announced that the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) has posted on its website briefing documents for the ODAC meeting scheduled to review the REVLIMID(R) (lenalidomide) New Drug Application (NDA) seeking approval for REVLIMID for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. In order to obtain access to the FDA and Celgene REVLIMID briefing documents, go to http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4174B2_… Revlimid.pdf. The ODAC meeting is scheduled from 8:00 a.m. EDT to 12:30 p.m. EDT on Wednesday, September 14, 2005. The NDA for REVLIMID is under FDA priority review with a PDUFA date of October 7, 2005.
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company`s website at www.celgene.com.
This release contains forward-looking statements which are subject to known and unknown risks, delays, uncertainties and other factors not under the Company`s control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations expressed or implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and other factors described in the Company`s filings with the Securities and Exchange Commission such as our 10K, 10Q and 8K reports.
SOURCE Celgene Corporation
Robert J. Hugin, Senior VP and CFO, or Brian P. Gill, Director PR
http://www.prnewswire.com
Copyright (C) 2005 PR Newswire. All rights reserved. ********************************************************************** As of Friday, 09-09-2005 23:59, the latest Comtex SmarTrend(SM) Alert, an automated pattern recognition system, indicated a DOWNTREND on 08-18-2005 for CELG @ $46.07. (C) 2005 Comtex News Network, Inc. All rights reserved.
Celgene gets good news on blood disorder drug
Thursday , September 15, 2005 23:07 ET
By Kathleen Lynn
Sep 15, 2005 (The Record - Knight Ridder/Tribune Business News via COMTEX) --A Food and Drug Administration committee recommended Wednesday that Celgene Corp.`s experimental drug Revlimid be approved for treating life-threatening blood disorders.
Although the FDA is not bound by the decisions of its advisory committees, it usually follows their recommendations. It is scheduled to act on Revlimid on Oct. 7.
Celgene`s stock, which has been on a steady upward slope for years, rose $1.86 on Wednesday to close at $54.77.
"We are excited," Celgene CEO John W. Jackson said in a statement after the 10-5 vote.
Merrill Lynch analyst Thomas McGahren predicted in a report Wednesday that if Revlimid is approved, it will have sales of about $206 million in 2006, adding about 10 cents to the company`s earnings per share, now estimated at $1 a share.
Revlimid is a form of thalidomide, which caused serious birth defects when taken by pregnant women several decades ago. Summit-based Celgene already sells another form of thalidomide, Thalomid, which is used to treat leprosy and multiple myeloma under careful supervision so that pregnant patients are not given the drug.
In recent trials, Revlimid was found to be much more powerful than expected in treating myelodysplastic syndromes.
With this disorder, the bone marrow fails to make enough healthy blood cells, causing anemia and fatigue. About 300,000 people worldwide have the disease. Most need regular blood transfusions to survive, and life expectancy for patients ranges from about six months to 6 years after diagnosis.
But in a clinical trial sponsored by Celgene, about two-thirds of patients who took Revlimid for six months no longer needed transfusions, researchers found. And signs of the genetic mutation that causes the disease disappeared in many patients, the study found.
The FDA advisory committee debated whether approval should be held up until the completion of studies on proper dosing of Revlimid, McGahren wrote.
"But in the end, the sentiment seemed to be that physicians want the drug available and that hematologists are very capable of modulating dosing," McGahren wrote.
To see more of The Record, or to subscribe to the newspaper, go to
http://www.NorthJersey.com.
Copyright (c) 2005, The Record, Hackensack, N.J. ********************************************************************** As of Sunday, 09-11-2005 23:59, the latest Comtex SmarTrend(SM) Alert, an automated pattern recognition system, indicated a DOWNTREND on 08-18-2005 for CELG @ $46.07. (C) 2005 Comtex News Network, Inc. All rights reserved.
Thursday , September 15, 2005 23:07 ET
By Kathleen Lynn
Sep 15, 2005 (The Record - Knight Ridder/Tribune Business News via COMTEX) --A Food and Drug Administration committee recommended Wednesday that Celgene Corp.`s experimental drug Revlimid be approved for treating life-threatening blood disorders.
Although the FDA is not bound by the decisions of its advisory committees, it usually follows their recommendations. It is scheduled to act on Revlimid on Oct. 7.
Celgene`s stock, which has been on a steady upward slope for years, rose $1.86 on Wednesday to close at $54.77.
"We are excited," Celgene CEO John W. Jackson said in a statement after the 10-5 vote.
Merrill Lynch analyst Thomas McGahren predicted in a report Wednesday that if Revlimid is approved, it will have sales of about $206 million in 2006, adding about 10 cents to the company`s earnings per share, now estimated at $1 a share.
Revlimid is a form of thalidomide, which caused serious birth defects when taken by pregnant women several decades ago. Summit-based Celgene already sells another form of thalidomide, Thalomid, which is used to treat leprosy and multiple myeloma under careful supervision so that pregnant patients are not given the drug.
In recent trials, Revlimid was found to be much more powerful than expected in treating myelodysplastic syndromes.
With this disorder, the bone marrow fails to make enough healthy blood cells, causing anemia and fatigue. About 300,000 people worldwide have the disease. Most need regular blood transfusions to survive, and life expectancy for patients ranges from about six months to 6 years after diagnosis.
But in a clinical trial sponsored by Celgene, about two-thirds of patients who took Revlimid for six months no longer needed transfusions, researchers found. And signs of the genetic mutation that causes the disease disappeared in many patients, the study found.
The FDA advisory committee debated whether approval should be held up until the completion of studies on proper dosing of Revlimid, McGahren wrote.
"But in the end, the sentiment seemed to be that physicians want the drug available and that hematologists are very capable of modulating dosing," McGahren wrote.
To see more of The Record, or to subscribe to the newspaper, go to
http://www.NorthJersey.com.
Copyright (c) 2005, The Record, Hackensack, N.J. ********************************************************************** As of Sunday, 09-11-2005 23:59, the latest Comtex SmarTrend(SM) Alert, an automated pattern recognition system, indicated a DOWNTREND on 08-18-2005 for CELG @ $46.07. (C) 2005 Comtex News Network, Inc. All rights reserved.
09/22/2005 (09:20 ET) Zacks.com announces that Nadine Wong Highlights: Celgene and Dendreon - Business Wire
09/20/2005 (16:22 ET) CELG: Drops -1.11%; Vol +77%; Last 90 Min of Trading - Knobias
09/16/2005 (18:25 ET) CELG: New Form 4 Filed, Change in Beneficial Ownership - Edgar
09/16/2005 (17:49 ET) CELG: New Form 4 Filed, Change in Beneficial Ownership - Edgar
09/16/2005 (17:48 ET) CELG: New Form 4 Filed, Change in Beneficial Ownership - Edgar
09/20/2005 (16:22 ET) CELG: Drops -1.11%; Vol +77%; Last 90 Min of Trading - Knobias
09/16/2005 (18:25 ET) CELG: New Form 4 Filed, Change in Beneficial Ownership - Edgar
09/16/2005 (17:49 ET) CELG: New Form 4 Filed, Change in Beneficial Ownership - Edgar
09/16/2005 (17:48 ET) CELG: New Form 4 Filed, Change in Beneficial Ownership - Edgar
REVLIMID(R) PDUFA Date Extended Three Months By FDA
- Extension to Allow for Completion of Review of REVLIMID Risk-Management
Program
- Celgene Prepared for REVLIMID Launch As First Oral Targeted Therapy For
Low To Intermediate-1-Risk MDS Patients With Deletion 5q Chromosomal
Abnormality
- Celgene Expects November Filing of REVLIMID application for Multiple
Myeloma
SUMMIT, N.J., Oct. 3 /PRNewswire-FirstCall/ -- Celgene Corporation (Nasdaq: CELG) announced today that they received notification late Friday from the United States Food and Drug Administration (FDA) that the action date for FDA`s priority review of the New Drug Application (NDA) for REVLIMID (lenalidomide), for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities, has been extended to January 7, 2006. The original action date under the Prescription Drug User Fee Act (PDUFA) for the REVLIMID NDA was October 7, 2005.
The extension is a result of the FDA requiring more time to review additional information on Celgene`s RevAssist(R) risk-management program. This additional material has been considered by the FDA to be a major amendment to the REVLIMID NDA allowing the extension of the action date under PDUFA regulations.
"We are working closely with the FDA to enable completion of their review as quickly as possible for REVLIMID approval" said Sol Barer, Ph.D., President and Chief Operating Officer of Celgene Corporation. "We will be ready for immediate commercial launch upon FDA action, and expect a November submission of our REVLIMID application for treatment of previously-treated patients with relapsed or refractory multiple myeloma."
About REVLIMID(R)
REVLIMID is a member of a new class of novel IMiDs(R), immunomodulatory drugs. Celgene continues to evaluate treatments with REVLIMID for a broad range of hematology and oncology conditions, including multiple myeloma, the malignant blood cell disorders known as myelodysplastic syndromes (MDS), chronic lymphocytic leukemia, and solid tumor cancers. REVLIMID affects multiple intracellular biological pathways. The IMiD pipeline, including REVLIMID, is covered by a comprehensive intellectual property estate of U.S. and foreign issued and pending patent applications including composition-of- matter and use patents.
About Myelodysplastic Syndromes
Myelodysplastic syndromes (MDS) are a group of hematologic malignancies that affect approximately 300,000 people worldwide. Myelodysplastic syndromes occur when blood cells remain in an immature or "blast" stage within the bone marrow and never develop into mature cells capable of performing their necessary functions. Eventually, the bone marrow may be filled with blast cells suppressing normal cell development. According to the American Cancer Society, 10,000 to 20,000 new cases of MDS are diagnosed each year in the United States, with mean survival rates ranging from approximately six months to six years for the different classifications of MDS. MDS patients must often rely on blood transfusions to manage symptoms of anemia and fatigue until they develop life-threatening iron overload and/or toxicity, thus underscoring the critical need for new therapies targeting the cause of the condition as well as therapies that manage symptoms.
About Deletion 5q Chromosomal Abnormality
Chromosomal (cytogenetic) abnormalities are detected in more than half of patients with myelodysplastic syndrome (MDS), and involve a deletion in all or part of one or more specific chromosomes. The most common cytogenetic abnormalities in MDS are deletions in the long arm of chromosomes 5, 7, and 20. Another common abnormality is an extra copy of chromosome 8. A deletion involving the 5q chromosome may be involved in up to 20 to 30% of all MDS patients. The World Health Organization has also recently identified a unique subset of MDS patients with a "5q- Syndrome" where the only chromosomal abnormality is a specific portion of the 5q chromosome.
Celgene`s management team will host a conference call at 8:30 a.m. EDT today, October 3, 2005. The conference call will be available by web cast at http://www.celgene.com. An audio replay of the call will be available for one week starting from 12 p.m. EDT October 3, 2005. To access the replay, please dial 1-800-642-1687 and enter Reservation Number 1153913.
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company`s website at http://www.celgene.com .
This release contains forward-looking statements which are subject to known and unknown risks, delays, uncertainties and other factors not under the Company`s control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations expressed or implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and other factors described in the Company`s filings with the Securities and Exchange Commission such as our 10K, 10Q and 8K reports.
SOURCE Celgene Corporation
-0- 10/03/2005
/CONTACT: Robert J. Hugin, Senior VP and CFO, +1-908-673-9102, or Brian
P. Gill, Director PR/IR, +1-908-673-9530, both of Celgene Corporation /
/Web site: http://www.celgene.com /
(CELG)
CO: Celgene Corporation; United States Food and Drug Administration
ST: New Jersey
IN: MTC HEA BIO
SU: FDA CCA
EA
-- NYM113A --
5513 10/03/2005 07:18 EDT http://www.prnewswire.com
- Extension to Allow for Completion of Review of REVLIMID Risk-Management
Program
- Celgene Prepared for REVLIMID Launch As First Oral Targeted Therapy For
Low To Intermediate-1-Risk MDS Patients With Deletion 5q Chromosomal
Abnormality
- Celgene Expects November Filing of REVLIMID application for Multiple
Myeloma
SUMMIT, N.J., Oct. 3 /PRNewswire-FirstCall/ -- Celgene Corporation (Nasdaq: CELG) announced today that they received notification late Friday from the United States Food and Drug Administration (FDA) that the action date for FDA`s priority review of the New Drug Application (NDA) for REVLIMID (lenalidomide), for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities, has been extended to January 7, 2006. The original action date under the Prescription Drug User Fee Act (PDUFA) for the REVLIMID NDA was October 7, 2005.
The extension is a result of the FDA requiring more time to review additional information on Celgene`s RevAssist(R) risk-management program. This additional material has been considered by the FDA to be a major amendment to the REVLIMID NDA allowing the extension of the action date under PDUFA regulations.
"We are working closely with the FDA to enable completion of their review as quickly as possible for REVLIMID approval" said Sol Barer, Ph.D., President and Chief Operating Officer of Celgene Corporation. "We will be ready for immediate commercial launch upon FDA action, and expect a November submission of our REVLIMID application for treatment of previously-treated patients with relapsed or refractory multiple myeloma."
About REVLIMID(R)
REVLIMID is a member of a new class of novel IMiDs(R), immunomodulatory drugs. Celgene continues to evaluate treatments with REVLIMID for a broad range of hematology and oncology conditions, including multiple myeloma, the malignant blood cell disorders known as myelodysplastic syndromes (MDS), chronic lymphocytic leukemia, and solid tumor cancers. REVLIMID affects multiple intracellular biological pathways. The IMiD pipeline, including REVLIMID, is covered by a comprehensive intellectual property estate of U.S. and foreign issued and pending patent applications including composition-of- matter and use patents.
About Myelodysplastic Syndromes
Myelodysplastic syndromes (MDS) are a group of hematologic malignancies that affect approximately 300,000 people worldwide. Myelodysplastic syndromes occur when blood cells remain in an immature or "blast" stage within the bone marrow and never develop into mature cells capable of performing their necessary functions. Eventually, the bone marrow may be filled with blast cells suppressing normal cell development. According to the American Cancer Society, 10,000 to 20,000 new cases of MDS are diagnosed each year in the United States, with mean survival rates ranging from approximately six months to six years for the different classifications of MDS. MDS patients must often rely on blood transfusions to manage symptoms of anemia and fatigue until they develop life-threatening iron overload and/or toxicity, thus underscoring the critical need for new therapies targeting the cause of the condition as well as therapies that manage symptoms.
About Deletion 5q Chromosomal Abnormality
Chromosomal (cytogenetic) abnormalities are detected in more than half of patients with myelodysplastic syndrome (MDS), and involve a deletion in all or part of one or more specific chromosomes. The most common cytogenetic abnormalities in MDS are deletions in the long arm of chromosomes 5, 7, and 20. Another common abnormality is an extra copy of chromosome 8. A deletion involving the 5q chromosome may be involved in up to 20 to 30% of all MDS patients. The World Health Organization has also recently identified a unique subset of MDS patients with a "5q- Syndrome" where the only chromosomal abnormality is a specific portion of the 5q chromosome.
Celgene`s management team will host a conference call at 8:30 a.m. EDT today, October 3, 2005. The conference call will be available by web cast at http://www.celgene.com. An audio replay of the call will be available for one week starting from 12 p.m. EDT October 3, 2005. To access the replay, please dial 1-800-642-1687 and enter Reservation Number 1153913.
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company`s website at http://www.celgene.com .
This release contains forward-looking statements which are subject to known and unknown risks, delays, uncertainties and other factors not under the Company`s control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations expressed or implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and other factors described in the Company`s filings with the Securities and Exchange Commission such as our 10K, 10Q and 8K reports.
SOURCE Celgene Corporation
-0- 10/03/2005
/CONTACT: Robert J. Hugin, Senior VP and CFO, +1-908-673-9102, or Brian
P. Gill, Director PR/IR, +1-908-673-9530, both of Celgene Corporation /
/Web site: http://www.celgene.com /
(CELG)
CO: Celgene Corporation; United States Food and Drug Administration
ST: New Jersey
IN: MTC HEA BIO
SU: FDA CCA
EA
-- NYM113A --
5513 10/03/2005 07:18 EDT http://www.prnewswire.com
10/04/2005 (10:40 ET) CELG: JMP Sec Keeps @ Mkt Outperform; Ups Tgt to $59 vs $57; Analyst Notes - Knobias
10/04/2005 (03:10 ET) FDA delays decision on Celgene blood drug - Knight Ridder/Tribune Business News
10/03/2005 (11:16 ET) Galapagos to webcast Analyst Day on Friday, October 7, 2005 - HUGIN AS
10/03/2005 (10:28 ET) Semis and Retail Stocks Higher; JDSU Material Weaknesses - Knobias
10/03/2005 (10:17 ET) Celgene Corp. Conference Call - Abstract - M2 Communications
10/04/2005 (03:10 ET) FDA delays decision on Celgene blood drug - Knight Ridder/Tribune Business News
10/03/2005 (11:16 ET) Galapagos to webcast Analyst Day on Friday, October 7, 2005 - HUGIN AS
10/03/2005 (10:28 ET) Semis and Retail Stocks Higher; JDSU Material Weaknesses - Knobias
10/03/2005 (10:17 ET) Celgene Corp. Conference Call - Abstract - M2 Communications
10/06/2005 (17:44 ET) CELG: New Form 4 Filed, Change in Beneficial Ownership - Edgar
10/06/2005 (17:37 ET) CELG: New Form 4 Filed, Change in Beneficial Ownership - Edgar
10/06/2005 (17:32 ET) CELG: New Form 4 Filed, Change in Beneficial Ownership - Edgar
10/05/2005 (16:22 ET) CELG: Drops -0.89%; Vol +54%; Last 90 Min of Trading - Knobias
10/04/2005 (10:40 ET) CELG: JMP Sec Keeps @ Mkt Outperform; Ups Tgt to $59 vs $57; Analyst Notes - Knobias
10/06/2005 (17:37 ET) CELG: New Form 4 Filed, Change in Beneficial Ownership - Edgar
10/06/2005 (17:32 ET) CELG: New Form 4 Filed, Change in Beneficial Ownership - Edgar
10/05/2005 (16:22 ET) CELG: Drops -0.89%; Vol +54%; Last 90 Min of Trading - Knobias
10/04/2005 (10:40 ET) CELG: JMP Sec Keeps @ Mkt Outperform; Ups Tgt to $59 vs $57; Analyst Notes - Knobias
10/18/2005 (07:23 ET) CELG: Banc of Amer Starts @ Buy; Sets Tgt @ $64; Analyst Notes - Knobias
10/18/2005 (06:40 ET) TABLE: Unconfirmed Earnings Expected Thursday, Oct 20 - Knobias
10/14/2005 (18:26 ET) CELG: New Form 4 Filed, Change in Beneficial Ownership - Edgar
10/14/2005 (17:41 ET) Wall Street pharma - Upgrades help Bradley, Celgene - UPDATE 1 - AFX News - UK
10/14/2005 (17:41 ET) Wall Street pharma - Upgrades help Bradley, Celgene - UPDATE 1 - AFX News - Europe
10/18/2005 (06:40 ET) TABLE: Unconfirmed Earnings Expected Thursday, Oct 20 - Knobias
10/14/2005 (18:26 ET) CELG: New Form 4 Filed, Change in Beneficial Ownership - Edgar
10/14/2005 (17:41 ET) Wall Street pharma - Upgrades help Bradley, Celgene - UPDATE 1 - AFX News - UK
10/14/2005 (17:41 ET) Wall Street pharma - Upgrades help Bradley, Celgene - UPDATE 1 - AFX News - Europe
10/20/2005 (16:22 ET) CELG: Drops -1.11%; Vol +68%; Last 90 Min of Trading - Knobias
10/19/2005 (13:07 ET) Schaeffer`s Street Chatter Highlights the Following Stocks: Celgene, Toll Brothers, Research in Motion Limited - Business Wire
10/19/2005 (03:30 ET) SmallCap Sentinel: Despite Breakthroughs, Stem Cell Companies Volatile - PrimeZone Media Network
10/18/2005 (16:22 ET) CELG: Drops -0.62%; Vol +51%; Last 90 Min of Trading - Knobias
10/18/2005 (07:23 ET) CELG: Banc of Amer Starts @ Buy; Sets Tgt @ $64; Analyst Notes - Knobias
10/19/2005 (13:07 ET) Schaeffer`s Street Chatter Highlights the Following Stocks: Celgene, Toll Brothers, Research in Motion Limited - Business Wire
10/19/2005 (03:30 ET) SmallCap Sentinel: Despite Breakthroughs, Stem Cell Companies Volatile - PrimeZone Media Network
10/18/2005 (16:22 ET) CELG: Drops -0.62%; Vol +51%; Last 90 Min of Trading - Knobias
10/18/2005 (07:23 ET) CELG: Banc of Amer Starts @ Buy; Sets Tgt @ $64; Analyst Notes - Knobias
EMEA billigt Prüfung des Antrags auf Marktzulassung für REVLIMID(R)
Wirtschaft
Summit, New Jersey (ots/PRNewswire) -
- REVLIMID wird von der EMEA als orale Therapie für die Behandlung von MDS-Patienten (Myelodysplastische Syndrome) mit Deletion von 5q als Chromosomenaberration bewertet
Die Celgene Corporation (Nasdaq: CELG) gab bekannt, dass die EMEA (Europäische Behörde für Arzneimittel) eine Prüfung des Antrags auf Marktzulassung (MAA) für das Medikament REVLIMID (Lenalidomid) des Unternehmens (Antrag auf Marktzulassung) genehmigt hat, der im August 2005 eingereicht worden war. Der Antrag basiert auf den klinischen Daten einer Open-Label Phase-II-Studie, bei der REVLIMID in dem bis dato grössten klinischen Versuch an MDS- Patienten mit Deletion von 5q als Chromosomenaberration bewertet wurde. Celgene strebt nach der Vertriebsgenehmigung für REVLIMID als Therapie für transfusionsabhängige Anämie infolge von Myelodysplastischen Syndromen (MDS) mit niedrigem oder intermediärem Risiko 1 in Zusammenhang mit einer Deletion von 5q zytogenetischer Anomalie mit oder ohne weitere zytogenetische Anomalien.
MDS ist eine maligne Störung der Blutzellenbildung, von der in ganz Europa etwa 67.000 Menschen betroffen sind. Zu den häufigsten klinischen Manifestationen in Verbindung mit MDS gehört die chronisch-refraktäre Anämie und die zahlreichen Komplikationen, die durch häufige Bluttransfusionen verursacht werden. REVLIMID wurde innerhalb der Europäischen Union (EU) als Orphan Medicinal Product’ für die Behandlung von MDS bestimmt.
REVLIMID wurde in der EU auch als Orphan Medicinal Product für die Behandlung von Multiplem Myelom (MM) bestimmt. Celgene geht davon aus, die sNDA (ergänzenden Antrag für ein neues Medikament) und die MAA für REVLIMID bei früher behandelten Patienten mit rezidiviertem und refraktärem MM bei der FDA im letzten Quartal 2005 und bei der EMEA im ersten Quartal 2006 einzureichen.
"Celgene freut sich darauf, mit der EMEA zusammenzuarbeiten, wenn die Prüfung von REVLIMID in Angriff genommen wird. Wir wissen die Bemühungen all derer zu schätzen, die diese Eingabe möglich gemacht haben, und sprechen allen Teilnehmern an den MDS-Studien unsere Anerkennung für ihr Engagement aus. Ihrer Mithilfe haben wir es zu verdanken, dass REVLIMID es bis zu diesem Abschnitt im Prozess der europäischen Zulassung geschafft hat", so Graham Burton, M.D. und Sr.VP für Behördenangelegenheiten und Arzneimittelüberwachung bei der Celgene Corporation.
Informationen zu REVLIMID(R)
REVLIMID gehört zu einer neuen Gruppe von gesetzlich geschützten Präparaten der Celgene Corporation. Zu den verschiedenen biologischen Eigenschaften dieser neuartigen Präparate oder IMiDs(R) gehören auch immunmodulatorische Eigenschaften. Celgene wird weiterhin die Behandlungsmöglichkeiten mittels REVLIMID für eine breite Palette von hämatologischen und onkologischen Erkrankungen untersuchen, u.a.: multiples Myelom, die unter dem Namen myelodysplastischen Syndrome (MDS) bekannten malignen Erkrankungen der Blutzellen, chronisch lymphozytische Leukämie sowie solide Karzinome. REVLIMID wirkt auf mehrere intrazelluläre biologische Pfade ein. Die ImiD-Produkte, einschliesslich REVLIMID, sind durch umfassende geistige Urheberrechte in Form von amerikanischen und ausländischen erteilten und schwebenden Patentanmeldungen geschützt, darunter Stoff- und Nutzungspatente.
REVLIMID ist weder von der FDA noch von anderen Zulassungsbehörden zur Behandlung einer Indikation genehmigt und wird gegenwärtig für zukünftige Anträge bei den Zulassungsbehörden in klinischen Studien auf seine Wirksamkeit und Unbedenklichkeit geprüft.
Informationen zu Myelodysplastischen Syndromen
Bei Myelodysplastischen Syndromen (MDS) handelt es sich um eine Gruppe von malignen hämatologischen Erkrankungen, von denen weltweit etwa 300.000 Menschen betroffen sind. MDS tritt auf, wenn Blutzellen innerhalb des Knochenmarks in einer unreifen oder "Blast"-Stufe verbleiben und sich nicht zu reifen Zellen entwickeln, die ihre notwendigen Funktionen wahrnehmen können. Das Knochenmark kann sich schliesslich mit unreifen Zellen füllen, die die Entwicklung normaler Zellen verhindern. Laut Angaben der Weltgesundheitsorganisation werden jedes Jahr 15.000 bis 25.000 neue Fälle von MDS in Europa diagnostiziert, wobei die mittlere Überlebensrate bei den verschiedenen Formen von MDS etwa zwischen sechs Monaten und sechs Jahren liegt. An MDS leidende Patienten sind häufig auf Bluttransfusionen angewiesen, um die Symptome von Anämie und Ermüdung in den Griff zu bekommen, bis sie einen lebensbedrohlichen Eisenüberschuss und/oder -toxizität entwickeln. Dies unterstreicht den kritischen Bedarf an neuen Therapien, die sich auf die Ursache der Erkrankung konzentrieren, anstatt lediglich die Symptome zu behandeln.
Informationen zur Deletion von 5q als Chromosomenaberration
Chromosomenaberrationen (auch zytogenetische Anomalien) werden bei über der Hälfte aller MDS-Patienten festgestellt. Sie involvieren die gesamte oder partielle Deletion von einem oder mehreren spezifischen Chromosomen. Die häufigsten zytogenetischen Anomalien bei MDS sind die Deletionen am langen Arm der Chromosome 5, 7, und 20. Zu weiteren geläufigen Anomalien zählt ein zusätzliches Chromosom 8. Eine Deletion, bei der ein 5q - Chromosom involviert ist, kann bei 20 bis 30 Prozent aller MDS-Patienten auftreten. Die Weltgesundheitsorganisation hat kürzlich auch eine einzigartige Subpopulation von MDS-Patienten mit einem "5q-Syndrom" registriert, bei dem die einzige Chromosomen-Anomalie ein spezifischer Anteil des 5q-Chromosoms ist.
Informationen zur EMEA
Die EMEA (European Medicines Agency) ist die europäische Genehmigungsgsbehörde, die für die Zulassung und Kontrolle von medizinischen Produkten für den menschlichen und tierärztlichen Gebrauch in europäischen Ländern zuständig ist, deren Zahl sich bis dato auf etwa fünfzehn beläuft. Diese Behörde hat vier Hauptaufgaben: (1) Den Schutz der Öffentlichen Gesundheit, indem die optimalen wissenschaftlichen Ressourcen innerhalb der Europäischen Union mobilisiert werden; (2) die Förderung des Gesundheitswesens durch die wirksame Regulierung neuer Arzneimittel und die bessere Unterrichtung von Verbrauchern und Medizinern; (3) beschleunigte Zulassungsverfahren und freier Umlauf von Arzneimitteln im europäischen Binnenmarkt; und schliesslich (4) die Unterstützung der pharmazeutischen Forschung und Entwicklung in Europa durch die Implementierung von effizienten, effektiven und ansprechenden Betriebsverfahren.
Unternehmensprofil Celgene
Die Celgene Corporation, die ihren Hauptsitz in Summit im US-Bundesstaat New Jersey hat, ist ein integriertes, globales Pharmazeutik-Unternehmen, das sich hauptsächlich für die Entdeckung, Entwicklung und Vermarktung von innovativen Therapien zur Behandlung von Krebs und entzündlichen Erkrankungen durch Gen- und Proteinregulierung einsetzt. Für weitere Informationen besuchen Sie bitte die Website des Unternehmens unter http://www.celgene.com.
Diese Pressemitteilung enthält forward-looking statements (Prognosen), die Gegenstand bekannter und unbekannter Risiken, Verzögerungen, Unwägbarkeiten und anderer Faktoren sind, die nicht der Kontrolle des Unternehmens unterliegen. Dies kann dazu führen, dass tatsächliche Ergebnisse, Leistungen oder Erfolge des Unternehmens erheblich von den Ergebnissen, Leistungen oder anderen Erwartungen abweichen, die in diesen Prognosen ausdrücklich oder implizit dargelegt werden. Zu diesen Faktoren zählen die Ergebnisse gegenwärtiger oder laufender Forschungs- und Entwicklungstätigkeiten, Massnahmen der FDA und anderer Genehmigungsbehörden sowie andere Faktoren, die als Eingaben des Unternehmens bei der Securities and Exchange Commission in Form von 10K, 10Q und 8K Berichten eingereicht wurden.
Website: http://www.celgene.com
Originaltext: Celgene Corporation Digitale Pressemappe: http://presseportal.de/story.htx?firmaid=57352 Pressemappe via RSS : feed://presseportal.de/rss/pm_57352.rss2
Pressekontakt: Robert J. Hugin, Senior VP und CFO, Celgene Corporation, +1-908-673-9102, oder Brian P. Gill, Director PR, IR, Celgene Corporation, +1-908-673-9530
Wirtschaft
Summit, New Jersey (ots/PRNewswire) -
- REVLIMID wird von der EMEA als orale Therapie für die Behandlung von MDS-Patienten (Myelodysplastische Syndrome) mit Deletion von 5q als Chromosomenaberration bewertet
Die Celgene Corporation (Nasdaq: CELG) gab bekannt, dass die EMEA (Europäische Behörde für Arzneimittel) eine Prüfung des Antrags auf Marktzulassung (MAA) für das Medikament REVLIMID (Lenalidomid) des Unternehmens (Antrag auf Marktzulassung) genehmigt hat, der im August 2005 eingereicht worden war. Der Antrag basiert auf den klinischen Daten einer Open-Label Phase-II-Studie, bei der REVLIMID in dem bis dato grössten klinischen Versuch an MDS- Patienten mit Deletion von 5q als Chromosomenaberration bewertet wurde. Celgene strebt nach der Vertriebsgenehmigung für REVLIMID als Therapie für transfusionsabhängige Anämie infolge von Myelodysplastischen Syndromen (MDS) mit niedrigem oder intermediärem Risiko 1 in Zusammenhang mit einer Deletion von 5q zytogenetischer Anomalie mit oder ohne weitere zytogenetische Anomalien.
MDS ist eine maligne Störung der Blutzellenbildung, von der in ganz Europa etwa 67.000 Menschen betroffen sind. Zu den häufigsten klinischen Manifestationen in Verbindung mit MDS gehört die chronisch-refraktäre Anämie und die zahlreichen Komplikationen, die durch häufige Bluttransfusionen verursacht werden. REVLIMID wurde innerhalb der Europäischen Union (EU) als Orphan Medicinal Product’ für die Behandlung von MDS bestimmt.
REVLIMID wurde in der EU auch als Orphan Medicinal Product für die Behandlung von Multiplem Myelom (MM) bestimmt. Celgene geht davon aus, die sNDA (ergänzenden Antrag für ein neues Medikament) und die MAA für REVLIMID bei früher behandelten Patienten mit rezidiviertem und refraktärem MM bei der FDA im letzten Quartal 2005 und bei der EMEA im ersten Quartal 2006 einzureichen.
"Celgene freut sich darauf, mit der EMEA zusammenzuarbeiten, wenn die Prüfung von REVLIMID in Angriff genommen wird. Wir wissen die Bemühungen all derer zu schätzen, die diese Eingabe möglich gemacht haben, und sprechen allen Teilnehmern an den MDS-Studien unsere Anerkennung für ihr Engagement aus. Ihrer Mithilfe haben wir es zu verdanken, dass REVLIMID es bis zu diesem Abschnitt im Prozess der europäischen Zulassung geschafft hat", so Graham Burton, M.D. und Sr.VP für Behördenangelegenheiten und Arzneimittelüberwachung bei der Celgene Corporation.
Informationen zu REVLIMID(R)
REVLIMID gehört zu einer neuen Gruppe von gesetzlich geschützten Präparaten der Celgene Corporation. Zu den verschiedenen biologischen Eigenschaften dieser neuartigen Präparate oder IMiDs(R) gehören auch immunmodulatorische Eigenschaften. Celgene wird weiterhin die Behandlungsmöglichkeiten mittels REVLIMID für eine breite Palette von hämatologischen und onkologischen Erkrankungen untersuchen, u.a.: multiples Myelom, die unter dem Namen myelodysplastischen Syndrome (MDS) bekannten malignen Erkrankungen der Blutzellen, chronisch lymphozytische Leukämie sowie solide Karzinome. REVLIMID wirkt auf mehrere intrazelluläre biologische Pfade ein. Die ImiD-Produkte, einschliesslich REVLIMID, sind durch umfassende geistige Urheberrechte in Form von amerikanischen und ausländischen erteilten und schwebenden Patentanmeldungen geschützt, darunter Stoff- und Nutzungspatente.
REVLIMID ist weder von der FDA noch von anderen Zulassungsbehörden zur Behandlung einer Indikation genehmigt und wird gegenwärtig für zukünftige Anträge bei den Zulassungsbehörden in klinischen Studien auf seine Wirksamkeit und Unbedenklichkeit geprüft.
Informationen zu Myelodysplastischen Syndromen
Bei Myelodysplastischen Syndromen (MDS) handelt es sich um eine Gruppe von malignen hämatologischen Erkrankungen, von denen weltweit etwa 300.000 Menschen betroffen sind. MDS tritt auf, wenn Blutzellen innerhalb des Knochenmarks in einer unreifen oder "Blast"-Stufe verbleiben und sich nicht zu reifen Zellen entwickeln, die ihre notwendigen Funktionen wahrnehmen können. Das Knochenmark kann sich schliesslich mit unreifen Zellen füllen, die die Entwicklung normaler Zellen verhindern. Laut Angaben der Weltgesundheitsorganisation werden jedes Jahr 15.000 bis 25.000 neue Fälle von MDS in Europa diagnostiziert, wobei die mittlere Überlebensrate bei den verschiedenen Formen von MDS etwa zwischen sechs Monaten und sechs Jahren liegt. An MDS leidende Patienten sind häufig auf Bluttransfusionen angewiesen, um die Symptome von Anämie und Ermüdung in den Griff zu bekommen, bis sie einen lebensbedrohlichen Eisenüberschuss und/oder -toxizität entwickeln. Dies unterstreicht den kritischen Bedarf an neuen Therapien, die sich auf die Ursache der Erkrankung konzentrieren, anstatt lediglich die Symptome zu behandeln.
Informationen zur Deletion von 5q als Chromosomenaberration
Chromosomenaberrationen (auch zytogenetische Anomalien) werden bei über der Hälfte aller MDS-Patienten festgestellt. Sie involvieren die gesamte oder partielle Deletion von einem oder mehreren spezifischen Chromosomen. Die häufigsten zytogenetischen Anomalien bei MDS sind die Deletionen am langen Arm der Chromosome 5, 7, und 20. Zu weiteren geläufigen Anomalien zählt ein zusätzliches Chromosom 8. Eine Deletion, bei der ein 5q - Chromosom involviert ist, kann bei 20 bis 30 Prozent aller MDS-Patienten auftreten. Die Weltgesundheitsorganisation hat kürzlich auch eine einzigartige Subpopulation von MDS-Patienten mit einem "5q-Syndrom" registriert, bei dem die einzige Chromosomen-Anomalie ein spezifischer Anteil des 5q-Chromosoms ist.
Informationen zur EMEA
Die EMEA (European Medicines Agency) ist die europäische Genehmigungsgsbehörde, die für die Zulassung und Kontrolle von medizinischen Produkten für den menschlichen und tierärztlichen Gebrauch in europäischen Ländern zuständig ist, deren Zahl sich bis dato auf etwa fünfzehn beläuft. Diese Behörde hat vier Hauptaufgaben: (1) Den Schutz der Öffentlichen Gesundheit, indem die optimalen wissenschaftlichen Ressourcen innerhalb der Europäischen Union mobilisiert werden; (2) die Förderung des Gesundheitswesens durch die wirksame Regulierung neuer Arzneimittel und die bessere Unterrichtung von Verbrauchern und Medizinern; (3) beschleunigte Zulassungsverfahren und freier Umlauf von Arzneimitteln im europäischen Binnenmarkt; und schliesslich (4) die Unterstützung der pharmazeutischen Forschung und Entwicklung in Europa durch die Implementierung von effizienten, effektiven und ansprechenden Betriebsverfahren.
Unternehmensprofil Celgene
Die Celgene Corporation, die ihren Hauptsitz in Summit im US-Bundesstaat New Jersey hat, ist ein integriertes, globales Pharmazeutik-Unternehmen, das sich hauptsächlich für die Entdeckung, Entwicklung und Vermarktung von innovativen Therapien zur Behandlung von Krebs und entzündlichen Erkrankungen durch Gen- und Proteinregulierung einsetzt. Für weitere Informationen besuchen Sie bitte die Website des Unternehmens unter http://www.celgene.com.
Diese Pressemitteilung enthält forward-looking statements (Prognosen), die Gegenstand bekannter und unbekannter Risiken, Verzögerungen, Unwägbarkeiten und anderer Faktoren sind, die nicht der Kontrolle des Unternehmens unterliegen. Dies kann dazu führen, dass tatsächliche Ergebnisse, Leistungen oder Erfolge des Unternehmens erheblich von den Ergebnissen, Leistungen oder anderen Erwartungen abweichen, die in diesen Prognosen ausdrücklich oder implizit dargelegt werden. Zu diesen Faktoren zählen die Ergebnisse gegenwärtiger oder laufender Forschungs- und Entwicklungstätigkeiten, Massnahmen der FDA und anderer Genehmigungsbehörden sowie andere Faktoren, die als Eingaben des Unternehmens bei der Securities and Exchange Commission in Form von 10K, 10Q und 8K Berichten eingereicht wurden.
Website: http://www.celgene.com
Originaltext: Celgene Corporation Digitale Pressemappe: http://presseportal.de/story.htx?firmaid=57352 Pressemappe via RSS : feed://presseportal.de/rss/pm_57352.rss2
Pressekontakt: Robert J. Hugin, Senior VP und CFO, Celgene Corporation, +1-908-673-9102, oder Brian P. Gill, Director PR, IR, Celgene Corporation, +1-908-673-9530
11/04/2005 (12:28 ET) CELG: JMP Sec Keeps @ Mkt Outperform; Ups Tgt to $70 vs $59; Analyst Notes - Knobias
11/04/2005 (10:41 ET) JAGfn Rumors - JAGNotes
11/04/2005 (10:10 ET) CELG: New 52-Wk High @ $61.330 up 4.21% - Knobias
11/03/2005 (11:55 ET) 2005 Celgene Q305 Earnings Announcement And Analyst And Investor Day - Abstract - M2 Communications
11/03/2005 (10:55 ET) CELG: New 52-Wk High @ $59.100 up 2.44% - Knobias
-----------------
Last Trade: 59.690 Change: 0.840 (+1.427%)
Previous Close: 58.850 Volume: 2,420,900
Bid: 0.010 Ask: 9,000.000
Today`s Open: 59.300 # of Trades: 5,060
11/04/2005 (10:41 ET) JAGfn Rumors - JAGNotes
11/04/2005 (10:10 ET) CELG: New 52-Wk High @ $61.330 up 4.21% - Knobias
11/03/2005 (11:55 ET) 2005 Celgene Q305 Earnings Announcement And Analyst And Investor Day - Abstract - M2 Communications
11/03/2005 (10:55 ET) CELG: New 52-Wk High @ $59.100 up 2.44% - Knobias
-----------------
Last Trade: 59.690 Change: 0.840 (+1.427%)
Previous Close: 58.850 Volume: 2,420,900
Bid: 0.010 Ask: 9,000.000
Today`s Open: 59.300 # of Trades: 5,060
11/09/2005 (16:16 ET) CELG: Filed New Form 10-Q, Quarterly Report - Edgar
11/08/2005 (17:17 ET) CELG: New Form 4 Filed, Change in Beneficial Ownership - Edgar
11/08/2005 (10:32 ET) CELG: To Present At Rodman & Renshaw Conference @ 12:20 ET - Knobias
11/04/2005 (12:28 ET) CELG: JMP Sec Keeps @ Mkt Outperform; Ups Tgt to $70 vs $59; Analyst Notes - Knobias
11/04/2005 (10:41 ET) JAGfn Rumors - JAGNotes
11/08/2005 (17:17 ET) CELG: New Form 4 Filed, Change in Beneficial Ownership - Edgar
11/08/2005 (10:32 ET) CELG: To Present At Rodman & Renshaw Conference @ 12:20 ET - Knobias
11/04/2005 (12:28 ET) CELG: JMP Sec Keeps @ Mkt Outperform; Ups Tgt to $70 vs $59; Analyst Notes - Knobias
11/04/2005 (10:41 ET) JAGfn Rumors - JAGNotes
FDA requests more information from Celgene
Thursday , November 17, 2005 09:30 ET
Nov 17, 2005 (Datamonitor via COMTEX) -- The FDA has requested further data from Celgene to support the company`s application to market its leprosy treatment Thalomid as a treatment of blood cancer.
Although Thalomid is already prescribed off-label by doctors wishing to treat multiple myeloma (progressive blood cancer), Celgene is intent on acquiring official recognition for the indication.
In response to the company`s application, the FDA issued an approvable letter requesting revised product labeling with the specific indication of newly diagnosed multiple myeloma and updated safety information, as well as some additional patient information to finalize its review.
Celgene`s application for Thalomid is based on results from a large phase III randomized study comparing thalidomide plus dexamethasone to dexamethasone alone in previously untreated multiple myeloma patients.
"Based on ongoing discussions with the FDA we expect to complete our responses to these requests quickly," said Dr Graham Burton, senior vice president for regulatory affairs and pharmacovigilance at Celgene.
http://www.datamonitor.com
Republication or redistribution, including by framing or similar means,
is expressly prohibited without prior written consent. Datamonitor shall
not be liable for errors or delays in the content, or for any actions
taken in reliance thereon
Copyright (C) 2005 Datamonitor. All rights reserved
**********************************************************************
As of Sunday, 11-13-2005 23:59, the latest Comtex SmarTrend(SM) Alert,
an automated pattern recognition system, indicated an UPTREND on
10-25-2005 for CELG @ $54.04.
(C) 2005 Comtex News Network, Inc. All rights reserved.
Thursday , November 17, 2005 09:30 ET
Nov 17, 2005 (Datamonitor via COMTEX) -- The FDA has requested further data from Celgene to support the company`s application to market its leprosy treatment Thalomid as a treatment of blood cancer.
Although Thalomid is already prescribed off-label by doctors wishing to treat multiple myeloma (progressive blood cancer), Celgene is intent on acquiring official recognition for the indication.
In response to the company`s application, the FDA issued an approvable letter requesting revised product labeling with the specific indication of newly diagnosed multiple myeloma and updated safety information, as well as some additional patient information to finalize its review.
Celgene`s application for Thalomid is based on results from a large phase III randomized study comparing thalidomide plus dexamethasone to dexamethasone alone in previously untreated multiple myeloma patients.
"Based on ongoing discussions with the FDA we expect to complete our responses to these requests quickly," said Dr Graham Burton, senior vice president for regulatory affairs and pharmacovigilance at Celgene.
http://www.datamonitor.com
Republication or redistribution, including by framing or similar means,
is expressly prohibited without prior written consent. Datamonitor shall
not be liable for errors or delays in the content, or for any actions
taken in reliance thereon
Copyright (C) 2005 Datamonitor. All rights reserved
**********************************************************************
As of Sunday, 11-13-2005 23:59, the latest Comtex SmarTrend(SM) Alert,
an automated pattern recognition system, indicated an UPTREND on
10-25-2005 for CELG @ $54.04.
(C) 2005 Comtex News Network, Inc. All rights reserved.
11/18/2005 (09:45 ET) CELG: New 52-Wk High @ $62.020 up 1.19% - Knobias
11/17/2005 (09:30 ET) FDA requests more information from Celgene - Datamonitor
11/16/2005 (10:01 ET) CELG: New 52-Wk High @ $61.410 up 2.40% - Knobias
11/15/2005 (10:23 ET) Chicago Fed Pres Moskow Says Rate Hikes to Continue; Retail Takes Early Hit - Knobias
11/15/2005 (08:00 ET) StreetInsider Alert for CELG - Street Insider
11/17/2005 (09:30 ET) FDA requests more information from Celgene - Datamonitor
11/16/2005 (10:01 ET) CELG: New 52-Wk High @ $61.410 up 2.40% - Knobias
11/15/2005 (10:23 ET) Chicago Fed Pres Moskow Says Rate Hikes to Continue; Retail Takes Early Hit - Knobias
11/15/2005 (08:00 ET) StreetInsider Alert for CELG - Street Insider
JAGfn Rumors
Monday , November 21, 2005 11:40 ET
Nov 21, 2005 (JAGfn.com via COMTEX) -- STOCKS ON THE MOVE (CELG)$62.20 NEW YEAR HIGH LARGE SHORT POSITION IN STOCK
Copyright 2005 JAGfn.com All Rights Reserved
**********************************************************************
As of Thursday, 11-17-2005 23:59, the latest Comtex SmarTrend(SM) Alert,
an automated pattern recognition system, indicated an UPTREND on
10-25-2005 for CELG @ $54.04.
(C) 2005 Comtex News Network, Inc. All rights reserved.
Monday , November 21, 2005 11:40 ET
Nov 21, 2005 (JAGfn.com via COMTEX) -- STOCKS ON THE MOVE (CELG)$62.20 NEW YEAR HIGH LARGE SHORT POSITION IN STOCK
Copyright 2005 JAGfn.com All Rights Reserved
**********************************************************************
As of Thursday, 11-17-2005 23:59, the latest Comtex SmarTrend(SM) Alert,
an automated pattern recognition system, indicated an UPTREND on
10-25-2005 for CELG @ $54.04.
(C) 2005 Comtex News Network, Inc. All rights reserved.
11/22/2005 (10:41 ET) JAGfn Rumors - JAGNotes
11/22/2005 (09:56 ET) CELG: New 52-Wk High @ $62.520 up 0.95% - Knobias
11/21/2005 (11:40 ET) JAGfn Rumors - JAGNotes
11/21/2005 (09:46 ET) CELG: New 52-Wk High @ $61.590 up -0.26% - Knobias
11/18/2005 (09:45 ET) CELG: New 52-Wk High @ $62.020 up 1.19% - Knobias
11/22/2005 (09:56 ET) CELG: New 52-Wk High @ $62.520 up 0.95% - Knobias
11/21/2005 (11:40 ET) JAGfn Rumors - JAGNotes
11/21/2005 (09:46 ET) CELG: New 52-Wk High @ $61.590 up -0.26% - Knobias
11/18/2005 (09:45 ET) CELG: New 52-Wk High @ $62.020 up 1.19% - Knobias
Servus allerseits 
Aus "Börse Online" - mehr aus der aktuellen Ausgabe siehe
Thread: ■■■ Empfehlungen ● Der Aktionär, Börse-Online & Euro am Sonntag ■`
CelGene
Plus 165 Prozent seit Jahresanfang, plus 30 Prozent seit Oktober – unsere Dauerkaufempfehlung unter den US-Biotechs schreibt dank Thalomid fette Gewinne.
Das ursprünglich zur Behandlung von Lepra zugelassene Medikament wird in erster Linie gegen Multiples Myelom, eine besonders aggressive Form von Blutkrebs, verschrieben. Die offizielle Zulassung durch die US-Behörde FDA wird in den kommenden Wochen erwartet. Dasselbe gilt für das Nachfolgeprodukt Revlimid. Auf einem Fachkongress Anfang Dezember will Celgene weitere klinische Ergebnisse vorlegen – was dem Aktienkurs neue Impulse geben sollte. Empfehlung: KAUFEN
Aus "Börse Online" - mehr aus der aktuellen Ausgabe siehe
Thread: ■■■ Empfehlungen ● Der Aktionär, Börse-Online & Euro am Sonntag ■` CelGene
Plus 165 Prozent seit Jahresanfang, plus 30 Prozent seit Oktober – unsere Dauerkaufempfehlung unter den US-Biotechs schreibt dank Thalomid fette Gewinne.
Das ursprünglich zur Behandlung von Lepra zugelassene Medikament wird in erster Linie gegen Multiples Myelom, eine besonders aggressive Form von Blutkrebs, verschrieben. Die offizielle Zulassung durch die US-Behörde FDA wird in den kommenden Wochen erwartet. Dasselbe gilt für das Nachfolgeprodukt Revlimid. Auf einem Fachkongress Anfang Dezember will Celgene weitere klinische Ergebnisse vorlegen – was dem Aktienkurs neue Impulse geben sollte. Empfehlung: KAUFEN
Das Biopharma-Unternehmen Celgene Corp. (ISIN US1510201049/ WKN 881244) erhielt von der U.S. Food and Drug Administration die Marktzulassung für sein Medikament REVLIMID (Lenalidomid).
Unternehmensangaben vom Dienstagabend zufolge bezieht sich die FDA-Zulassung auf die Indikation Anämie. REVLIMID zählt zu einer Klasse neuartiger proprietärer immunmodulatorischer Medikamente oder IMiDs und wirkt auf mehrere biologische intrazelluläre Mechanismen.
Da die Freigabe später als erwartet erfolgte, musste das Unternehmen zusätzliche Kosten verbuchen, weshalb Celgene nun für das Gesamtjahr 2005 nur noch einen Gewinn pro Aktie in Höhe von 36 bis 38 Cents erwartet.
Den weiteren Angaben zufolge wird John Jackson zum 1. Mai 2006 von seinem Amt als Chief Executive Officer zurücktreten, jedoch weiterhin als Chairman im Unternehmen tätig sein. Neuer CEO wird Sol Barer, dessen Nachfolge als President und Chief Operating Officer Robert Hugin antreten wird.
Unternehmensangaben vom Dienstagabend zufolge bezieht sich die FDA-Zulassung auf die Indikation Anämie. REVLIMID zählt zu einer Klasse neuartiger proprietärer immunmodulatorischer Medikamente oder IMiDs und wirkt auf mehrere biologische intrazelluläre Mechanismen.
Da die Freigabe später als erwartet erfolgte, musste das Unternehmen zusätzliche Kosten verbuchen, weshalb Celgene nun für das Gesamtjahr 2005 nur noch einen Gewinn pro Aktie in Höhe von 36 bis 38 Cents erwartet.
Den weiteren Angaben zufolge wird John Jackson zum 1. Mai 2006 von seinem Amt als Chief Executive Officer zurücktreten, jedoch weiterhin als Chairman im Unternehmen tätig sein. Neuer CEO wird Sol Barer, dessen Nachfolge als President und Chief Operating Officer Robert Hugin antreten wird.
Celgene outperform
Quelle: Thomas Weisel Partners
Datum: 30.01.06
Rating-Update:
Die Analysten von Thomas Weisel stufen die Aktie von Celgene (ISIN US1510201049/ WKN 881244) unverändert mit "outperform" ein.
Analyse-Datum: 30.01.2006
Quelle: Thomas Weisel Partners
Datum: 30.01.06
Rating-Update:
Die Analysten von Thomas Weisel stufen die Aktie von Celgene (ISIN US1510201049/ WKN 881244) unverändert mit "outperform" ein.
Analyse-Datum: 30.01.2006
Celgene Will Present at Merrill Lynch Global Pharmaceutical, Biotechnology and Medical Conference
via COMTEX
January 31, 2006
Jan 31, 2006 /PRNewswire-FirstCall via COMTEX/ --
Celgene Corporation (Nasdaq: CELG) announced today that its presentation at the 17th Annual Merrill Lynch Global Pharmaceutical, Biotechnology, and Medical Device Conference on Tuesday, February 7, 2006 at 11:00 am EST will be webcast live and will be available in the investor relations section of the Company`s website at http://www.celgene.com. Robert J. Hugin, Senior Vice President and Chief Financial Officer will provide an overview of the company.
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company`s website at http//www.celgene.com.
This release contains forward-looking statements which are subject to known and unknown risks, delays, uncertainties and other factors not under the Company`s control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations expressed or implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and other factors described in the Company`s filings with the Securities and Exchange Commission such as our 10K, 10Q and 8K reports.
SOURCE Celgene Corporation
Robert J. Hugin, Senior VP and CFO of Celgene Corporation, +1-908-673-9102, or Brian P. Gill, Director PR/IR, +1-908-673-9530, both of Celgene Corporation http://www.prnewswire.com
Copyright (C) 2006 PR Newswire. All rights reserved. ********************************************************************** As of Friday, 01-27-2006 23:59, the latest Comtex SmarTrend(SM) Alert, an automated pattern recognition system, indicated an UPTREND on 12-29-2005 for CELG @ $63.61. (C) 2006 Comtex News Network, Inc. All rights reserved.
via COMTEX
January 31, 2006
Jan 31, 2006 /PRNewswire-FirstCall via COMTEX/ --
Celgene Corporation (Nasdaq: CELG) announced today that its presentation at the 17th Annual Merrill Lynch Global Pharmaceutical, Biotechnology, and Medical Device Conference on Tuesday, February 7, 2006 at 11:00 am EST will be webcast live and will be available in the investor relations section of the Company`s website at http://www.celgene.com. Robert J. Hugin, Senior Vice President and Chief Financial Officer will provide an overview of the company.
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company`s website at http//www.celgene.com.
This release contains forward-looking statements which are subject to known and unknown risks, delays, uncertainties and other factors not under the Company`s control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations expressed or implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and other factors described in the Company`s filings with the Securities and Exchange Commission such as our 10K, 10Q and 8K reports.
SOURCE Celgene Corporation
Robert J. Hugin, Senior VP and CFO of Celgene Corporation, +1-908-673-9102, or Brian P. Gill, Director PR/IR, +1-908-673-9530, both of Celgene Corporation http://www.prnewswire.com
Copyright (C) 2006 PR Newswire. All rights reserved. ********************************************************************** As of Friday, 01-27-2006 23:59, the latest Comtex SmarTrend(SM) Alert, an automated pattern recognition system, indicated an UPTREND on 12-29-2005 for CELG @ $63.61. (C) 2006 Comtex News Network, Inc. All rights reserved.
tja und wann kommt millennium 
ich bleibe in celgene und habe nen teil von millennium verkauft.
@js200
beruhige mal die "lampen", die ärgern sich immer noch
ich bleibe in celgene und habe nen teil von millennium verkauft.
@js200
beruhige mal die "lampen", die ärgern sich immer noch
welch ein chart... celgene steigt und steigt und steigt 
bin mir grad mal am überlegen ob ich nen teil verkaufen soll... aber das hatte ich mir auch vor 2 monaten schon überlegt und währenddessen steigen sie einfach weiter
und nach solchen Meldungen wie gestern mag man auch nciht verkaufen:
FDA Grants Priority Review for REVLIMID(R) sNDA for Treatment of Relapsed or Refractory Multiple Myeloma
hier der link
http://biz.yahoo.com/prnews/060303/nyf013.html?.v=40
bin mir grad mal am überlegen ob ich nen teil verkaufen soll... aber das hatte ich mir auch vor 2 monaten schon überlegt und währenddessen steigen sie einfach weiter
und nach solchen Meldungen wie gestern mag man auch nciht verkaufen:
FDA Grants Priority Review for REVLIMID(R) sNDA for Treatment of Relapsed or Refractory Multiple Myeloma
hier der link
http://biz.yahoo.com/prnews/060303/nyf013.html?.v=40
[posting]18.948.862 von HSM am 23.11.05 11:06:29[/posting]@HSM
in welchen werten treibst du dich eigentlich gerade so rum ?
in welchen werten treibst du dich eigentlich gerade so rum ?
Guten Morgen,
da schaut man sich gestern Abend den Schlusskurs an - Aktie schloß im Plus, Nachbörslich wurde sie abgestraft, kein riesiges Volumen, aber prozentmäßig doch recht ordentlich, letzter Kurs 38,31$. Hat einer von Euch eine Ahnung warum?
Gruß Stefan
da schaut man sich gestern Abend den Schlusskurs an - Aktie schloß im Plus, Nachbörslich wurde sie abgestraft, kein riesiges Volumen, aber prozentmäßig doch recht ordentlich, letzter Kurs 38,31$. Hat einer von Euch eine Ahnung warum?
Gruß Stefan
[posting]20.590.181 von StLeske am 09.03.06 09:47:18[/posting]Study: Thalidomide Boosts Short-Term Myeloma Survival
NEW YORK (AP)--On the heels of disappointing results for thalidomide as a treatment for bone-marrow cancer, a smaller study suggests the drug may prolong survival of elderly patients, but at a price.
In people over 65 - who are most likely to be diagnosed with the cancer multiple myeloma - thalidomide increased survival when added to milder chemotherapy, the newest research showed. The milder drugs have been standard because most older patients can`t tolerate the bone marrow transplants and stronger cancer drugs considered more effective.
After three years, 80% of the older patients who got thalidomide along with standard treatment were still alive, versus 64% who got traditional treatment alone. However, twice as many patients on thalidomide suffered dangerous side effects.
The study will appear in Saturday`s edition of The Lancet, a British medical journal. A larger study that has followed patients longer appeared Thursday in the New England Journal of Medicine and it had indicated thalidomide didn`t increase survival.
Thalidomide, used a half-century ago in other countries for morning sickness and insomnia, was banned worldwide in 1962 because it caused birth defects. It has been resurrected recently as a promising cancer drug.
Experts said patients in the newest study must be followed longer to see if the drug increases long-term survival, but they think thalidomide will soon be part of standard therapy for elderly patients.
About two-thirds of people diagnosed with multiple myeloma are over 65. The disease includes a half-dozen types of incurable cancers of the bone marrow, the body`s blood-manufacturing plant.
"Even though this is a relatively mild treatment, the results are actually pretty good," similar to those for grueling regimens that include bone-marrow stem-cell transplants, said Dr. Brian Durie, chairman of the International Myeloma Foundation. "This is probably the way to go."
Durie expects the foundation this spring will change the recommended treatment for elderly patients to thalidomide plus the two standard drugs, partly because of positive findings from other research.
In the Lancet study, researchers at 54 Italian hospitals gave 126 patients standard myeloma drugs. Another 129 got those drugs plus thalidomide.
The thalidomide was provided by Pharmion Corp. (PHRM). It licensed rights to sell it in several countries from Celgene Corp. (CELG) of Summit, N.J., which sells it in the U.S. as Thalomid.
At two years, just over half those in the thalidomide group hadn`t suffered a relapse or severe side effects, versus one-fourth of the other group.
However, half the patients on thalidomide suffered infections, blood clots, heart problems and other side effects, which killed nearly one in 10 patients within nine months and forced nearly two-thirds to stop taking the drug within several months.
A 668-patient study by researchers at the University of Arkansas for Medical Sciences, which was reported Thursday, found thalidomide given on top of a grueling chemotherapy regimen with two stem-cell transplants didn`t prolong survival.
In both studies, many patients not on thalidomide who worsened then got the drug as salvage therapy; that could have improved their outcomes.
Dr. Shaji Kumar of the Mayo Clinic in Rochester, Minn., wrote in an editorial that thalidomide should now be the standard treatment along with the other cancer drugs for elderly patients, but doctors need to limit thalidomide`s side effects.
"This is a historic moment in myeloma therapy," Kumar wrote, because, after decades with little progress, several experimental drugs hold promise.
___
On the Net: http://content.nejm.org/
International Myeloma Foundation: http://www.myeloma.org
(END) Dow Jones Newswires
03-09-061845ET
Copyright (c) 2006 Dow Jones & Company, Inc.
NEW YORK (AP)--On the heels of disappointing results for thalidomide as a treatment for bone-marrow cancer, a smaller study suggests the drug may prolong survival of elderly patients, but at a price.
In people over 65 - who are most likely to be diagnosed with the cancer multiple myeloma - thalidomide increased survival when added to milder chemotherapy, the newest research showed. The milder drugs have been standard because most older patients can`t tolerate the bone marrow transplants and stronger cancer drugs considered more effective.
After three years, 80% of the older patients who got thalidomide along with standard treatment were still alive, versus 64% who got traditional treatment alone. However, twice as many patients on thalidomide suffered dangerous side effects.
The study will appear in Saturday`s edition of The Lancet, a British medical journal. A larger study that has followed patients longer appeared Thursday in the New England Journal of Medicine and it had indicated thalidomide didn`t increase survival.
Thalidomide, used a half-century ago in other countries for morning sickness and insomnia, was banned worldwide in 1962 because it caused birth defects. It has been resurrected recently as a promising cancer drug.
Experts said patients in the newest study must be followed longer to see if the drug increases long-term survival, but they think thalidomide will soon be part of standard therapy for elderly patients.
About two-thirds of people diagnosed with multiple myeloma are over 65. The disease includes a half-dozen types of incurable cancers of the bone marrow, the body`s blood-manufacturing plant.
"Even though this is a relatively mild treatment, the results are actually pretty good," similar to those for grueling regimens that include bone-marrow stem-cell transplants, said Dr. Brian Durie, chairman of the International Myeloma Foundation. "This is probably the way to go."
Durie expects the foundation this spring will change the recommended treatment for elderly patients to thalidomide plus the two standard drugs, partly because of positive findings from other research.
In the Lancet study, researchers at 54 Italian hospitals gave 126 patients standard myeloma drugs. Another 129 got those drugs plus thalidomide.
The thalidomide was provided by Pharmion Corp. (PHRM). It licensed rights to sell it in several countries from Celgene Corp. (CELG) of Summit, N.J., which sells it in the U.S. as Thalomid.
At two years, just over half those in the thalidomide group hadn`t suffered a relapse or severe side effects, versus one-fourth of the other group.
However, half the patients on thalidomide suffered infections, blood clots, heart problems and other side effects, which killed nearly one in 10 patients within nine months and forced nearly two-thirds to stop taking the drug within several months.
A 668-patient study by researchers at the University of Arkansas for Medical Sciences, which was reported Thursday, found thalidomide given on top of a grueling chemotherapy regimen with two stem-cell transplants didn`t prolong survival.
In both studies, many patients not on thalidomide who worsened then got the drug as salvage therapy; that could have improved their outcomes.
Dr. Shaji Kumar of the Mayo Clinic in Rochester, Minn., wrote in an editorial that thalidomide should now be the standard treatment along with the other cancer drugs for elderly patients, but doctors need to limit thalidomide`s side effects.
"This is a historic moment in myeloma therapy," Kumar wrote, because, after decades with little progress, several experimental drugs hold promise.
___
On the Net: http://content.nejm.org/
International Myeloma Foundation: http://www.myeloma.org
(END) Dow Jones Newswires
03-09-061845ET
Copyright (c) 2006 Dow Jones & Company, Inc.
Was soll an dieser Nachricht, so makaber auch die Darstellung der in Italien durchgeführten Versuchsreihen klingt, schlecht sein? Quintessenz ist doch: Thalomid scheint sich als Standardmedikament zur Behandlung älterer Patienten zu etablieren, wobei allerdings an der Reduzierung der Nebenwirkungen weiter gearbeitet werden muss.
Ich bin seit 2000 investiert und sehe zurzeit kein Problem.
Ich bin seit 2000 investiert und sehe zurzeit kein Problem.
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