cege (biotech) (1 Viewer)
- Creatore Discussione osinod
- Data di Inizio
learcario
Forumer storico
0,64$
be' non 0,66$
ma comunque credo che sia partita
Complimenti a te.....
Ora, la prima fermata la farà a 0,9 o supera e rimane sopra a 1 per un pò?
Domandina: i dati che ho cercato di fornire sono di qualche utilità?
Grazie per l'attenzione
osinod
Banned
Complimenti a te.....
Ora, la prima fermata la farà a 0,9 o supera e rimane sopra a 1 per un pò?
Domandina: i dati che ho cercato di fornire sono di qualche utilità?
Grazie per l'attenzione
capzo e se' sono utili , sono utilissimi
ad esempio adesso grazie ai tuoi numeri cosa vediamo in un secondo:
1) lo short è abbastanza alto 10% ma accettabile anzi puo' tornare utile per il rally perche' dovranno ricoprirsi
2)che dai minimi(annuali) siamo cresciuti del 84% e che non è un c.azzo e che quindi puo' tranquillamente continuare a salire
3) dai massimi (annuali) siamo a -525% cioe' moltissimo segno che il titolo puo' ancora salire moltissimo
4) la 50 ma è a 0,54 l' abbiamo quindi brekkata, di solito quando si brekka la 50 ma si ha un bel rally
5) stessa cosa per la 200 ma
6) il 19 % sono istituzionali ed il titolo scambia per volumi sopra la media
learcario
Forumer storico
capzo e se' sono utili , sono utilissimi
ad esempio adesso grazie ai tuoi numeri cosa vediamo in un secondo:
1) lo short è abbastanza alto 10% ma accettabile anzi puo' tornare utile per il rally perche' dovranno ricoprirsi
2)che dai minimi(annuali) siamo cresciuti del 84% e che non è un c.azzo e che quindi puo' tranquillamente continuare a salire
3) dai massimi (annuali) siamo a -525% cioe' moltissimo segno che il titolo puo' ancora salire moltissimo
4) la 50 ma è a 0,54 l' abbiamo quindi brekkata, di solito quando si brekka la 50 ma si ha un bel rally
5) stessa cosa per la 200 ma
6) il 19 % sono istituzionali ed il titolo scambia per volumi sopra la media
Ottimo
farò tesoro delle tue considerazioni. Ogni quanto devo rinfrescarti questi dati? Ogni giorno, ogni settimana....... ?learcario
Forumer storico
Di seguito, e nei prossimi post, riporto una carrellata di notizie significative che hanno riguardato Cege nel corso del 2009. Per correttezza riporto fonte e testo integrale, chi volesse può leggersele interamente; alternativamente e compatibilmente con le mie conoscenze della lingua inglese cercherò di farne un sunto.
http://www.euroinvestor.co.uk/News 9 marzo 2009
Cell Genesys Announces Fourth Quarter and Year-End 2008 Financial Results 09/03/2009 - 20:00
Cell Genesys, Inc. (NASDAQ:CEGE) today reported financial results for the fourth quarter and full year ended December 31, 2008. The company reported a net loss of $13.3 million ($0.15 per fully diluted share), for the fourth quarter of 2008, compared to a net loss of $33.4 million ($0.43 per fully diluted share) for the corresponding period in 2007. The net loss for the year ended December 31, 2008 was $47.0 million ($0.56 per fully diluted share), compared to a net loss of $99.3 million ($1.39 per fully diluted share) for the year ended December 31, 2007.
During the fourth quarter of 2008, the Company ended further development of GVAX immunotherapy for prostate cancer and implemented a substantial restructuring plan that resulted in the reduction of the Company’s 290 person staff by approximately 80 percent as of December 31, 2008, and by approximately 90 percent total as of the date of this announcement. Twenty-one employees remain. The Company anticipates further reductions in the first half of 2009 as additional activities are phased out. In connection with this restructuring, the Company terminated its lease for its facility in South San Francisco, California, and temporarily relocated its corporate headquarters to Hayward, California. The Company paid the South San Francisco facility landlord a lease termination fee of $14.7 million in December 2008. The Company would have been obligated to make lease payments of approximately $86 million through the lease expiration in 2018 if it had not terminated this lease. As a result, the Company recorded a restructuring charge of $13.8 million in the fourth quarter of 2008 for expenses related to the restructuring, including $14.3 million for workforce reduction costs, $0.1 million of non-cash stock-based compensation expense, and $14.1 million for lease termination costs, expenses which were offset by a $14.7 million gain from the termination of a capital lease.
Due to the termination of the Company’s collaborative agreement with Takeda Pharmaceutical Company Limited for GVAX immunotherapy for prostate cancer in December 2008, all deliverables under this agreement were cancelled. As a result, during the fourth quarter of 2008, the Company recognized as revenue the remaining balance of deferred revenue of $40.9 million of the $50 million upfront non-refundable payment received from Takeda in April 2008. For the full year 2008, the Company recognized as revenue the full $50 million of this upfront payment. Additionally, the Company recognized $6.5 million and $30.4 million, during the fourth quarter and full year ended December 31, 2008, respectively, in revenue from Takeda related to the external development costs associated with the now terminated Phase 3 clinical development of GVAX immunotherapy for prostate cancer.
In October and December 2008, the Company repurchased an aggregate of approximately $74.1 million principal amount of its 3.125% Convertible Senior Notes due in 2011, or notes, at an overall discount of approximately 60 percent from face value for aggregate consideration of approximately $29.6 million in cash, plus accrued but unpaid interest. This early retirement of debt resulted in a net gain of approximately $42.7 million after deducting transaction costs of approximately $0.8 million and $1.1 million of unamortized debt issuance costs related to the repurchased notes. In January 2009, the Company repurchased an additional aggregate of $2.6 million face value of its notes, at an overall discount of approximately 60 percent from face value in a series of privately negotiated transactions with institutional holders of the notes, for aggregate consideration of $1.0 million in cash, plus accrued but unpaid interest. As of the date of this press release, $68.3 million aggregate principal amount remained outstanding.
In May 2008, the Company issued warrants as part of a registered direct offering, which was classified as a derivative liability pursuant to Statement of Financial Accounting Standards No. 133 and No. 150 requiring the Company to record the fair value of the warrants as a derivative liability and adjusted to fair value at each financial reporting date thereafter. The fair value of the warrant liability at December 31, 2008 was $0.6 million which was $11.5 million lower than its fair value at the date of issuance. This difference resulted in a non-cash gain of $0.8 million and $11.5 million for the fourth quarter and full year ended December 31, 2008, respectively.
During the fourth quarter of 2008, as a result of ending further development of GVAX immunotherapy for prostate cancer, the Company recorded a $69.5 million impairment charge related to leasehold improvements, equipment and other assets in its South San Francisco, Hayward and Memphis facilities, and a $2.1 million impairment charge related to certain intangible assets and construction in process that were deemed not recoverable as the Company abandoned these projects. For the full year 2008, the Company recorded $71.8 million of impairment charges. In late February 2009, the Company vacated its Hayward facility and relocated its corporate headquarters to 400 Oyster Point Boulevard, Suite 525, South San Francisco, CA.
As of December 31, 2008, the Company had $86.1 million in cash, cash equivalents and short-term investments. The Company currently expects to have approximately $73 million and $69 million in cash, cash equivalents and short-term investments at March 31, 2009 and June 30, 2009, respectively.
The Company continues to explore strategic alternatives, including merger with or acquisition by another company, further restructuring, allocation of its resources toward other biopharmaceutical product areas, and sale of the Company’s assets and liquidation of the Company. The Company has engaged Lazard in connection with the evaluation of strategic alternatives. The Company cannot predict whether it will be able to identify strategic transactions on a timely basis or at all and anticipates that any such transaction would be time-consuming.
Recent Highlights
Cell Genesys is a biotechnology company that was focused on the development and commercialization of novel biological therapies for patients with cancer. Following the termination of both the VITAL-1 and VITAL-2 Phase 3 clinical trials of GVAX immunotherapy for prostate cancer, the Company’s lead product program, the Company implemented a substantial restructuring plan in October 2008 and is currently evaluating strategic alternatives for the business. Cell Genesys is headquartered in South San Francisco, California. For additional information, please visit the company’s website at www.cellgenesys.com.
Forward-Looking Statement
Statements made herein about the company, other than statements of historical fact, including statements about cash, cash equivalents and short-term investments and related cash forecasts, restructuring plans and estimated restructuring charges, strategic alternatives, repurchases of outstanding indebtedness, lease terminations, current corporate partnerships, anticipated operating results and cash expenditures, and the progress, results, findings and timing of the Company’s clinical trials and preclinical trials are forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the statements made, including risks and uncertainties associated with the timing of the termination of VITAL-1 and VITAL-2, the timing of the further analyses of VITAL-1 and VITAL-2, the success of clinical trials and research and development programs generally, the regulatory approval process for clinical trials, competitive technologies and products, patents, the occurrence of additional expenses if the Company enters into a strategic transaction, the ability to raise capital, operating expense levels and other risks. For information about these and other risks which may affect Cell Genesys, please see the company's reports on Form 10-K, 10-Q, and 8-K and other reports filed from time to time with the Securities and Exchange Commission. The company assumes no obligation to update the forward-looking information in this press release.
http://www.euroinvestor.co.uk/News 9 marzo 2009
Cell Genesys Announces Fourth Quarter and Year-End 2008 Financial Results 09/03/2009 - 20:00
Cell Genesys, Inc. (NASDAQ:CEGE) today reported financial results for the fourth quarter and full year ended December 31, 2008. The company reported a net loss of $13.3 million ($0.15 per fully diluted share), for the fourth quarter of 2008, compared to a net loss of $33.4 million ($0.43 per fully diluted share) for the corresponding period in 2007. The net loss for the year ended December 31, 2008 was $47.0 million ($0.56 per fully diluted share), compared to a net loss of $99.3 million ($1.39 per fully diluted share) for the year ended December 31, 2007.
During the fourth quarter of 2008, the Company ended further development of GVAX immunotherapy for prostate cancer and implemented a substantial restructuring plan that resulted in the reduction of the Company’s 290 person staff by approximately 80 percent as of December 31, 2008, and by approximately 90 percent total as of the date of this announcement. Twenty-one employees remain. The Company anticipates further reductions in the first half of 2009 as additional activities are phased out. In connection with this restructuring, the Company terminated its lease for its facility in South San Francisco, California, and temporarily relocated its corporate headquarters to Hayward, California. The Company paid the South San Francisco facility landlord a lease termination fee of $14.7 million in December 2008. The Company would have been obligated to make lease payments of approximately $86 million through the lease expiration in 2018 if it had not terminated this lease. As a result, the Company recorded a restructuring charge of $13.8 million in the fourth quarter of 2008 for expenses related to the restructuring, including $14.3 million for workforce reduction costs, $0.1 million of non-cash stock-based compensation expense, and $14.1 million for lease termination costs, expenses which were offset by a $14.7 million gain from the termination of a capital lease.
Due to the termination of the Company’s collaborative agreement with Takeda Pharmaceutical Company Limited for GVAX immunotherapy for prostate cancer in December 2008, all deliverables under this agreement were cancelled. As a result, during the fourth quarter of 2008, the Company recognized as revenue the remaining balance of deferred revenue of $40.9 million of the $50 million upfront non-refundable payment received from Takeda in April 2008. For the full year 2008, the Company recognized as revenue the full $50 million of this upfront payment. Additionally, the Company recognized $6.5 million and $30.4 million, during the fourth quarter and full year ended December 31, 2008, respectively, in revenue from Takeda related to the external development costs associated with the now terminated Phase 3 clinical development of GVAX immunotherapy for prostate cancer.
In October and December 2008, the Company repurchased an aggregate of approximately $74.1 million principal amount of its 3.125% Convertible Senior Notes due in 2011, or notes, at an overall discount of approximately 60 percent from face value for aggregate consideration of approximately $29.6 million in cash, plus accrued but unpaid interest. This early retirement of debt resulted in a net gain of approximately $42.7 million after deducting transaction costs of approximately $0.8 million and $1.1 million of unamortized debt issuance costs related to the repurchased notes. In January 2009, the Company repurchased an additional aggregate of $2.6 million face value of its notes, at an overall discount of approximately 60 percent from face value in a series of privately negotiated transactions with institutional holders of the notes, for aggregate consideration of $1.0 million in cash, plus accrued but unpaid interest. As of the date of this press release, $68.3 million aggregate principal amount remained outstanding.
In May 2008, the Company issued warrants as part of a registered direct offering, which was classified as a derivative liability pursuant to Statement of Financial Accounting Standards No. 133 and No. 150 requiring the Company to record the fair value of the warrants as a derivative liability and adjusted to fair value at each financial reporting date thereafter. The fair value of the warrant liability at December 31, 2008 was $0.6 million which was $11.5 million lower than its fair value at the date of issuance. This difference resulted in a non-cash gain of $0.8 million and $11.5 million for the fourth quarter and full year ended December 31, 2008, respectively.
During the fourth quarter of 2008, as a result of ending further development of GVAX immunotherapy for prostate cancer, the Company recorded a $69.5 million impairment charge related to leasehold improvements, equipment and other assets in its South San Francisco, Hayward and Memphis facilities, and a $2.1 million impairment charge related to certain intangible assets and construction in process that were deemed not recoverable as the Company abandoned these projects. For the full year 2008, the Company recorded $71.8 million of impairment charges. In late February 2009, the Company vacated its Hayward facility and relocated its corporate headquarters to 400 Oyster Point Boulevard, Suite 525, South San Francisco, CA.
As of December 31, 2008, the Company had $86.1 million in cash, cash equivalents and short-term investments. The Company currently expects to have approximately $73 million and $69 million in cash, cash equivalents and short-term investments at March 31, 2009 and June 30, 2009, respectively.
The Company continues to explore strategic alternatives, including merger with or acquisition by another company, further restructuring, allocation of its resources toward other biopharmaceutical product areas, and sale of the Company’s assets and liquidation of the Company. The Company has engaged Lazard in connection with the evaluation of strategic alternatives. The Company cannot predict whether it will be able to identify strategic transactions on a timely basis or at all and anticipates that any such transaction would be time-consuming.
Recent Highlights
- Announced in February 2009 final results from VITAL-1, the Company’s recently terminated Phase 3 clinical trial which compared GVAX immunotherapy for prostate cancer to Taxotere® (docetaxel) chemotherapy plus prednisone and enrolled 626 advanced prostate cancer patients with asymptomatic castrate-resistant metastatic disease. VITAL-1 was terminated in October 2008 based on the results of a futility analysis conducted at the Company’s request by the study's Independent Data Monitoring Committee (IDMC) which indicated that the trial had less than a 30 percent chance of meeting its predefined primary endpoint of an improvement in overall survival. However, the final Kaplan-Meier survival curves for the two treatment arms suggest a late favorable effect of GVAX immunotherapy on patient survival compared to chemotherapy, with the curve for GVAX patients crossing above the chemotherapy curve at approximately the same time median survival was reached in both treatment arms (21 months). Additionally, the data suggest that patients with Halabi predicted survival (HPS) greater than or equal to 18 months may have a more favorable response to the immunotherapy. Treatment with GVAX immunotherapy was generally well-tolerated and had a very favorable side-effect profile compared to Taxotere chemotherapy particularly with respect to a lower frequency of grade 3 or higher toxicity of nine percent versus 43 percent. These results were presented at the American Society of Clinical Oncology's Genitourinary Cancer Symposium on February 27, 2009.
- Announced in February 2009 final results from VITAL-2, the Company’s second Phase 3 clinical trial of GVAX immunotherapy for prostate cancer used in combination with Taxotere. VITAL-2, which compared GVAX immunotherapy for prostate cancer in combination with Taxotere to Taxotere plus prednisone and enrolled 408 patients with symptomatic castrate-resistant metastatic prostate cancer, was prematurely terminated in August 2008 following the recommendation of the trial’s IDMC, which in a routine safety meeting, observed an imbalance in deaths between the two treatment arms of the study. Updated analyses show no significant toxicities in the GVAX plus Taxotere arm that could explain the imbalance in deaths. Eighty-five percent of deaths were reported as due to prostate cancer in both arms, and there was no trend in the causes of death in the remaining patients. These observations are consistent with the hypothesis that the decision to omit concomitant prednisone in the GVAX immunotherapy treatment arm to avoid the immunosuppressive effects of prednisone may have contributed to an unfavorable outcome compared to the combination of chemotherapy and prednisone. Additionally, further analyses of VITAL-2 have indicated that the imbalance in deaths between the two treatment arms has decreased from 20 deaths as reported at the time of the IDMC’s initial analysis (August 2008) to 9 deaths at the time of the final analysis (December 2008). These results were presented at the ASCO Genitourinary Cancer Symposium on February 26, 2009.
- On March 6, 2009, the Company entered into agreements to terminate its Hayward manufacturing facility leases. The termination agreements are subject to certain conditions. Subject to fulfillment or waiver of these conditions, the leases will terminate by March 31, 2009. In consideration of the early termination of the leases, the Company will pay the landlords an aggregate amount of $3.6 million and issue one million shares of the Company’s common stock. The Company would be obligated to make lease payments of approximately $27 million through the expiration of the leases in 2017 if the leases are not terminated.
Cell Genesys is a biotechnology company that was focused on the development and commercialization of novel biological therapies for patients with cancer. Following the termination of both the VITAL-1 and VITAL-2 Phase 3 clinical trials of GVAX immunotherapy for prostate cancer, the Company’s lead product program, the Company implemented a substantial restructuring plan in October 2008 and is currently evaluating strategic alternatives for the business. Cell Genesys is headquartered in South San Francisco, California. For additional information, please visit the company’s website at www.cellgenesys.com.
Forward-Looking Statement
Statements made herein about the company, other than statements of historical fact, including statements about cash, cash equivalents and short-term investments and related cash forecasts, restructuring plans and estimated restructuring charges, strategic alternatives, repurchases of outstanding indebtedness, lease terminations, current corporate partnerships, anticipated operating results and cash expenditures, and the progress, results, findings and timing of the Company’s clinical trials and preclinical trials are forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the statements made, including risks and uncertainties associated with the timing of the termination of VITAL-1 and VITAL-2, the timing of the further analyses of VITAL-1 and VITAL-2, the success of clinical trials and research and development programs generally, the regulatory approval process for clinical trials, competitive technologies and products, patents, the occurrence of additional expenses if the Company enters into a strategic transaction, the ability to raise capital, operating expense levels and other risks. For information about these and other risks which may affect Cell Genesys, please see the company's reports on Form 10-K, 10-Q, and 8-K and other reports filed from time to time with the Securities and Exchange Commission. The company assumes no obligation to update the forward-looking information in this press release.
Ultima modifica:
learcario
Forumer storico
http://www.euroinvestor.co.uk/News notizia del 30 aprile 2009
Cell Genesys Announces First Quarter 2009 Financial Results 30/04/2009 - 13:30
Cell Genesys, Inc. (NASDAQ:CEGE) today reported financial results for the first quarter 2009. The company reported a net loss of $8.7 million ($0.10 per fully diluted share), for the first quarter of 2009, compared to a net loss of $22.6 million ($0.29 per fully diluted share) for the corresponding period in 2008. The reduction in net loss was primarily the result of the Company’s reduced level of operations following the implementation of its previously announced restructuring plan.
During the first quarter of 2009, the Company continued to explore strategic alternatives, including merger with or acquisition by another company, additional restructuring, repurchase of additional amounts of convertible notes, allocation of its remaining resources toward other biopharmaceutical product areas, which may include the acquisition or licensing of other product candidates and liquidation of the Company. The Company engaged Lazard Freres & Co, LLC in connection with the evaluation of strategic alternatives.
In order to pursue the above strategic alternatives, the Company has implemented its previously described restructuring plan and taken the following steps:
As of March 31, 2009, the Company had $77.6 million in cash, cash equivalents and short-term investments. In connection with the Hayward facility lease termination becoming effective, we paid the landlord a lease termination fee of $3.6 million in April 2009, which in addition to ongoing operating expenses will reduce the Company’s cash, cash equivalents and short-term investments from the March 31, 2009 balance.
About Cell Genesys, Inc.
Cell Genesys is headquartered in South San Francisco, California. For additional information, please visit the company’s website at www.cellgenesys.com.
Forward-Looking Statements made herein about the Company, other than statements of historical fact, including statements about future restructuring plans and the Company’s exploration of strategic alternatives including merger with or acquisition by another company, liquidation of the Company, additional restructuring, repurchase of additional amounts of convertible notes and allocation of its remaining resources toward other biopharmaceutical product areas are forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the statements made, including risks and uncertainties associated with the ability to successfully complete a strategic transaction, the occurrence of additional costs, expenses or other liabilities if the Company enters into a strategic transaction or pursues other strategic alternatives, including without limitation as a result of any litigation or claim asserted in connection with a potential transaction, the possibility that in the event of liquidation the stockholders may receive little or no distribution from the Company, the ability to raise capital, operating expense levels, and other risks. For information about these and other risks which may affect Cell Genesys, please see the Company's reports on Form 10-K, 10-Q, and 8-K and other reports filed from time to time with the Securities and Exchange Commission. The Company assumes no obligation to update the forward-looking information in this press release.
Cell Genesys Announces First Quarter 2009 Financial Results 30/04/2009 - 13:30
Cell Genesys, Inc. (NASDAQ:CEGE) today reported financial results for the first quarter 2009. The company reported a net loss of $8.7 million ($0.10 per fully diluted share), for the first quarter of 2009, compared to a net loss of $22.6 million ($0.29 per fully diluted share) for the corresponding period in 2008. The reduction in net loss was primarily the result of the Company’s reduced level of operations following the implementation of its previously announced restructuring plan.
During the first quarter of 2009, the Company continued to explore strategic alternatives, including merger with or acquisition by another company, additional restructuring, repurchase of additional amounts of convertible notes, allocation of its remaining resources toward other biopharmaceutical product areas, which may include the acquisition or licensing of other product candidates and liquidation of the Company. The Company engaged Lazard Freres & Co, LLC in connection with the evaluation of strategic alternatives.
In order to pursue the above strategic alternatives, the Company has implemented its previously described restructuring plan and taken the following steps:
- Ended the development of GVAX immunotherapy for prostate cancer and oncolytic virus therapy products, closed or transferred all IND filings with the FDA and closed out all clinical trial sites and contracts related to those activities. The Company has transferred the GVAX immunotherapy for prostate cancer IND and remaining clinical product to investigators at Johns Hopkins University while maintaining its commercial rights to this and other GVAX therapy products.
- Reduced the Company’s staff by approximately 95% from 290 persons to 16 as of the date of this announcement, as a result of eliminating all of the Company’s research and development, manufacturing, clinical and regulatory activities and personnel. The Company expects to reduce headcount further during the next few months as additional activities are phased out or outsourced.
- Completed the termination of all major facility leases including for the Company’s head office and research facility in South San Francisco, California and for its manufacturing facility in Hayward, California following a payment of $14.7 million to the South San Francisco landlord in December 2008 and a payment of $3.6 million and the issuance of one million shares of common stock to the Hayward landlord in April 2009. The Company would have been obligated to make rental payments of approximately $86 million through the lease expiration in 2018 for South San Francisco, and approximately $24 million through the lease expiration in 2017 for Hayward if it had not terminated these leases. Corporate headquarters have been relocated to short-term office space in South San Francisco.
- Effective first quarter of 2009, completed termination of the Company’s collaborative agreement with Takeda Pharmaceutical Company Limited for GVAX immunotherapy for prostate cancer. The Company recognized $0.6 million in reimbursement revenue from Takeda related to wind-down costs associated with the now terminated Phase 3 clinical development of this product in the first quarter of 2009.
- Substantially reduced the number of patents and terminated a number of license agreements in order to reduce costs. Included among the terminated agreements were those relating to the development and commercialization of oncolytic therapies with Novartis Pharma, AG and certain affiliates as well as a gene activation technology license agreement with sanofi-Aventis which resulted in recognition of $0.1 million of revenue.
- Terminated a Committed Equity Financing Facility with Kingsbridge Capital, Ltd. signed in 2007 due to a substantial fall in our stock price below the minimum purchase price of $1.75 per share. We had previously raised $23.0 million from the sale of 7.1 million shares of our common stock to Kingsbridge under this facility.
- Repurchased in January 2009 $2.6 million in face value of the Company’s 3.125% convertible notes due in November, 2011 at 60% discount to face value for an average cost of approximately $1 million. As of the date of this announcement, the outstanding note balance is $68.3 million in face value. The Company intends to continue to explore the repurchase of additional amounts of convertible notes to the extent it can do so on favorable terms.
As of March 31, 2009, the Company had $77.6 million in cash, cash equivalents and short-term investments. In connection with the Hayward facility lease termination becoming effective, we paid the landlord a lease termination fee of $3.6 million in April 2009, which in addition to ongoing operating expenses will reduce the Company’s cash, cash equivalents and short-term investments from the March 31, 2009 balance.
About Cell Genesys, Inc.
Cell Genesys is headquartered in South San Francisco, California. For additional information, please visit the company’s website at www.cellgenesys.com.
Forward-Looking Statements made herein about the Company, other than statements of historical fact, including statements about future restructuring plans and the Company’s exploration of strategic alternatives including merger with or acquisition by another company, liquidation of the Company, additional restructuring, repurchase of additional amounts of convertible notes and allocation of its remaining resources toward other biopharmaceutical product areas are forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the statements made, including risks and uncertainties associated with the ability to successfully complete a strategic transaction, the occurrence of additional costs, expenses or other liabilities if the Company enters into a strategic transaction or pursues other strategic alternatives, including without limitation as a result of any litigation or claim asserted in connection with a potential transaction, the possibility that in the event of liquidation the stockholders may receive little or no distribution from the Company, the ability to raise capital, operating expense levels, and other risks. For information about these and other risks which may affect Cell Genesys, please see the Company's reports on Form 10-K, 10-Q, and 8-K and other reports filed from time to time with the Securities and Exchange Commission. The Company assumes no obligation to update the forward-looking information in this press release.
learcario
Forumer storico
http://www.euroinvestor.co.uk/News notizia del 11 maggio 2009
Cell Genesys Announces Plans to Commence Exchange Offer for Its Outstanding 3.125% Convertible Notes 11/05/2009 - 13:00
Cell Genesys, Inc. (NASDAQ:CEGE) today announced that the Company expects to commence an exchange offer to exchange all of the $68.3 million aggregate principal amount of its outstanding 3.125% Convertible Senior Notes due in 2011 (“Existing Notes”) at a purchase price for each $1,000 principal amount of (i) $500 in cash, plus accrued interest, (ii) $140 worth of common stock equal to approximately 206 shares of common stock, and (iii) $310 of new 3.125% convertible senior notes due in May 2013 (“New Notes”).
On May 5, 2009, Tang Capital Partners, LP filed a creditor derivative lawsuit in The Court of Chancery of the State of Delaware against Cell Genesys and its directors and executive officers. The lawsuit seeks, among other things, a declaration that the Company is insolvent and an injunction prohibiting previously disclosed executive retention payments. On May 10, 2009, the Company and Tang Capital Partners, LP entered into a settlement and exchange offer agreement pursuant to which the Company agreed to commence and offer to exchange all of the $68.3 million aggregate principal amount of Existing Notes at a purchase price for each $1,000 principal amount of (i) $500 in cash, plus accrued interest, (ii) $140 worth of common stock equal to approximately 206 shares of common stock, and (iii) $310 of New Notes. The New Notes will have a conversion price of $0.68 per share. If all holders of the Existing Notes tender into the exchange offer, the exchange is estimated to result in a cash expenditure of approximately $34.2 million plus approximately $0.2 million in accrued interest, the issuance of approximately 14.1 million new shares of common stock and approximately $21.2 of New Notes. Tang Capital Partners, LP has agreed to tender into the exchange offer and withdraw the lawsuit if the exchange offer is consummated. The exchange offer has a minimum exchange requirement of 87.5% of the outstanding aggregate principal amount of the Existing Notes. The settlement and exchange offer agreement is subject to a number of terms and conditions.
This release is for informational purposes only and is not an offer to buy or the solicitation of an offer to sell any security. An exchange offer will only be made pursuant to exchange offer documents that are to be made available to the holders of the Existing Notes and filed with the Securities and Exchange Commission (“SEC”). Holders of Existing Notes are advised to read the exchange offer documents when they become available, as these documents will contain important information about the exchange offer. Copies of the exchange offer documents and other filed documents will be available for free at the SEC’s website.
About Cell Genesys, Inc.
Cell Genesys is headquartered in South San Francisco, California. For additional information, please visit the Company’s website at www.cellgenesys.com.
Forward-Looking Statements made herein about the Company, other than statements of historical fact, including statements about settlement of litigation, commencing an exchange offer, the results of an exchange offer, and cash expenditures and other costs to repurchase additional amounts of convertible notes are forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the statements made, including risks and uncertainties associated with the ability to successfully complete the exchange offer, the ability to successfully complete a strategic transaction, the occurrence of additional costs, expenses or other liabilities if the Company enters into a strategic transaction or pursues other strategic alternatives, including without limitation as a result of any litigation or claim asserted in connection with a potential transaction, the possibility that in the event of liquidation the stockholders may receive little or no distribution from the Company, the ability to raise capital, operating expense levels, and other risks. For information about these and other risks which may affect Cell Genesys, please see the Company's reports on Form 10-K, 10-Q, and 8-K and other reports filed from time to time with the Securities and Exchange Commission. The Company assumes no obligation to update the forward-looking information in this press release.
Cell Genesys Announces Plans to Commence Exchange Offer for Its Outstanding 3.125% Convertible Notes 11/05/2009 - 13:00
Cell Genesys, Inc. (NASDAQ:CEGE) today announced that the Company expects to commence an exchange offer to exchange all of the $68.3 million aggregate principal amount of its outstanding 3.125% Convertible Senior Notes due in 2011 (“Existing Notes”) at a purchase price for each $1,000 principal amount of (i) $500 in cash, plus accrued interest, (ii) $140 worth of common stock equal to approximately 206 shares of common stock, and (iii) $310 of new 3.125% convertible senior notes due in May 2013 (“New Notes”).
On May 5, 2009, Tang Capital Partners, LP filed a creditor derivative lawsuit in The Court of Chancery of the State of Delaware against Cell Genesys and its directors and executive officers. The lawsuit seeks, among other things, a declaration that the Company is insolvent and an injunction prohibiting previously disclosed executive retention payments. On May 10, 2009, the Company and Tang Capital Partners, LP entered into a settlement and exchange offer agreement pursuant to which the Company agreed to commence and offer to exchange all of the $68.3 million aggregate principal amount of Existing Notes at a purchase price for each $1,000 principal amount of (i) $500 in cash, plus accrued interest, (ii) $140 worth of common stock equal to approximately 206 shares of common stock, and (iii) $310 of New Notes. The New Notes will have a conversion price of $0.68 per share. If all holders of the Existing Notes tender into the exchange offer, the exchange is estimated to result in a cash expenditure of approximately $34.2 million plus approximately $0.2 million in accrued interest, the issuance of approximately 14.1 million new shares of common stock and approximately $21.2 of New Notes. Tang Capital Partners, LP has agreed to tender into the exchange offer and withdraw the lawsuit if the exchange offer is consummated. The exchange offer has a minimum exchange requirement of 87.5% of the outstanding aggregate principal amount of the Existing Notes. The settlement and exchange offer agreement is subject to a number of terms and conditions.
This release is for informational purposes only and is not an offer to buy or the solicitation of an offer to sell any security. An exchange offer will only be made pursuant to exchange offer documents that are to be made available to the holders of the Existing Notes and filed with the Securities and Exchange Commission (“SEC”). Holders of Existing Notes are advised to read the exchange offer documents when they become available, as these documents will contain important information about the exchange offer. Copies of the exchange offer documents and other filed documents will be available for free at the SEC’s website.
About Cell Genesys, Inc.
Cell Genesys is headquartered in South San Francisco, California. For additional information, please visit the Company’s website at www.cellgenesys.com.
Forward-Looking Statements made herein about the Company, other than statements of historical fact, including statements about settlement of litigation, commencing an exchange offer, the results of an exchange offer, and cash expenditures and other costs to repurchase additional amounts of convertible notes are forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the statements made, including risks and uncertainties associated with the ability to successfully complete the exchange offer, the ability to successfully complete a strategic transaction, the occurrence of additional costs, expenses or other liabilities if the Company enters into a strategic transaction or pursues other strategic alternatives, including without limitation as a result of any litigation or claim asserted in connection with a potential transaction, the possibility that in the event of liquidation the stockholders may receive little or no distribution from the Company, the ability to raise capital, operating expense levels, and other risks. For information about these and other risks which may affect Cell Genesys, please see the Company's reports on Form 10-K, 10-Q, and 8-K and other reports filed from time to time with the Securities and Exchange Commission. The Company assumes no obligation to update the forward-looking information in this press release.
learcario
Forumer storico
http://www.euroinvestor.co.uk/News/ notizia del 23 maggio 2009
Cell Genesys Commences Exchange Offer for $68.3 million Convertible Notes 23/05/2009 - 23:37
Cell Genesys, Inc. (NASDAQ:CEGE) today announced that it has commenced an exchange offer (the “Exchange Offer”) to exchange all of the approximately $68.3 million aggregate principal amount of its outstanding 3.125% Convertible Senior Notes due November 1, 2011 (the “Existing Notes”). For each $1,000 principal amount of Existing Notes validly tendered, the holder thereof will receive (i) $500 in cash, plus accrued and unpaid interest on such $1,000 principal amount of Existing Notes, (ii) 205.8824 shares of Cell Genesys’ common stock, and (iii) $310 principal amount of Cell Genesys’ new 3.125% Convertible Senior Notes due May 1, 2013 (“New Notes”). If all holders of the Existing Notes tender into the Exchange Offer, the exchange is estimated to result in a cash expenditure of approximately $34.2 million plus approximately $0.2 million in accrued and unpaid interest, and the issuance of approximately 14.1 million new shares of common stock and approximately $21.2 million principal amount of New Notes. As of May 21, 2009, the Company had 91,809,651 shares of common stock outstanding.
A holder of approximately 67.6% of the outstanding principal amount of Existing Notes has committed to tender its Existing Notes in the Exchange Offer, subject to certain terms and conditions.
The Exchange Offer will expire at 5:00 p.m. New York City time, on Thursday, June 22, 2009, unless extended. Tenders of the Existing Notes must be made before the Exchange Offer expires and may be withdrawn at any time before the Exchange Offer expires. The Exchange Offer is conditioned upon at least 87.5% of the aggregate principal amount of the outstanding Existing Notes being validly tendered and not withdrawn. The Exchange Offer is also subject to several other conditions.
Further details about the terms, conditions, risk factors, tax considerations and other factors that should be considered in evaluating the Exchange Offer are set forth in an Offer to Exchange and a related Letter of Transmittal, which are expected to be distributed to holders of the Existing Notes beginning today.
Written materials explaining the full terms and conditions of the Exchange Offer were filed with the Securities and Exchange Commission (the “SEC”) today. The materials are available free of charge at the SEC’s website — www.sec.gov. In addition, the company will provide copies of these documents free of charge to holders of its outstanding Existing Notes upon request to the company at 650-266-3000 or from the exchange agent for the Exchange Offer, U.S. Bank National Association, at (800) 934-6802.
This news release is for informational purposes only, and is not an offer to buy or the solicitation of an offer to sell any security. The Exchange Offer is being made only pursuant to the Exchange Offer documents that are being distributed to the holders of the Existing Notes and filed with the SEC.
About Cell Genesys, Inc.
Cell Genesys is headquartered in South San Francisco, California. For additional information, please visit the company’s website at www.cellgenesys.com.
Forward-Looking Statements made herein about the Company, other than statements of historical fact, including statements about commencing an exchange offer, the results of an exchange offer, and cash expenditures and other costs to repurchase additional amounts of convertible notes are forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the statements made, including risks and uncertainties associated with the ability to successfully complete the exchange offer, the ability to successfully complete a strategic transaction, the occurrence of additional costs, expenses or other liabilities if the Company enters into a strategic transaction or pursues other strategic alternatives, including without limitation as a result of any litigation or claim asserted in connection with a potential transaction, the possibility that in the event of liquidation the stockholders may receive little or no distribution from the Company, the ability to raise capital, operating expense levels, and other risks. For information about these and other risks which may affect Cell Genesys, please see the Company’s reports on Form 10-K, 10-Q, and 8-K and other reports filed from time to time with the Securities and Exchange Commission. The Company assumes no obligation to update the forward-looking information in this press release.
Cell Genesys Commences Exchange Offer for $68.3 million Convertible Notes 23/05/2009 - 23:37
Cell Genesys, Inc. (NASDAQ:CEGE) today announced that it has commenced an exchange offer (the “Exchange Offer”) to exchange all of the approximately $68.3 million aggregate principal amount of its outstanding 3.125% Convertible Senior Notes due November 1, 2011 (the “Existing Notes”). For each $1,000 principal amount of Existing Notes validly tendered, the holder thereof will receive (i) $500 in cash, plus accrued and unpaid interest on such $1,000 principal amount of Existing Notes, (ii) 205.8824 shares of Cell Genesys’ common stock, and (iii) $310 principal amount of Cell Genesys’ new 3.125% Convertible Senior Notes due May 1, 2013 (“New Notes”). If all holders of the Existing Notes tender into the Exchange Offer, the exchange is estimated to result in a cash expenditure of approximately $34.2 million plus approximately $0.2 million in accrued and unpaid interest, and the issuance of approximately 14.1 million new shares of common stock and approximately $21.2 million principal amount of New Notes. As of May 21, 2009, the Company had 91,809,651 shares of common stock outstanding.
A holder of approximately 67.6% of the outstanding principal amount of Existing Notes has committed to tender its Existing Notes in the Exchange Offer, subject to certain terms and conditions.
The Exchange Offer will expire at 5:00 p.m. New York City time, on Thursday, June 22, 2009, unless extended. Tenders of the Existing Notes must be made before the Exchange Offer expires and may be withdrawn at any time before the Exchange Offer expires. The Exchange Offer is conditioned upon at least 87.5% of the aggregate principal amount of the outstanding Existing Notes being validly tendered and not withdrawn. The Exchange Offer is also subject to several other conditions.
Further details about the terms, conditions, risk factors, tax considerations and other factors that should be considered in evaluating the Exchange Offer are set forth in an Offer to Exchange and a related Letter of Transmittal, which are expected to be distributed to holders of the Existing Notes beginning today.
Written materials explaining the full terms and conditions of the Exchange Offer were filed with the Securities and Exchange Commission (the “SEC”) today. The materials are available free of charge at the SEC’s website — www.sec.gov. In addition, the company will provide copies of these documents free of charge to holders of its outstanding Existing Notes upon request to the company at 650-266-3000 or from the exchange agent for the Exchange Offer, U.S. Bank National Association, at (800) 934-6802.
This news release is for informational purposes only, and is not an offer to buy or the solicitation of an offer to sell any security. The Exchange Offer is being made only pursuant to the Exchange Offer documents that are being distributed to the holders of the Existing Notes and filed with the SEC.
About Cell Genesys, Inc.
Cell Genesys is headquartered in South San Francisco, California. For additional information, please visit the company’s website at www.cellgenesys.com.
Forward-Looking Statements made herein about the Company, other than statements of historical fact, including statements about commencing an exchange offer, the results of an exchange offer, and cash expenditures and other costs to repurchase additional amounts of convertible notes are forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the statements made, including risks and uncertainties associated with the ability to successfully complete the exchange offer, the ability to successfully complete a strategic transaction, the occurrence of additional costs, expenses or other liabilities if the Company enters into a strategic transaction or pursues other strategic alternatives, including without limitation as a result of any litigation or claim asserted in connection with a potential transaction, the possibility that in the event of liquidation the stockholders may receive little or no distribution from the Company, the ability to raise capital, operating expense levels, and other risks. For information about these and other risks which may affect Cell Genesys, please see the Company’s reports on Form 10-K, 10-Q, and 8-K and other reports filed from time to time with the Securities and Exchange Commission. The Company assumes no obligation to update the forward-looking information in this press release.
learcario
Forumer storico
http://www.euroinvestor.it/News notizia del 27 maggio 2009
Ceregene Presents Additional Clinical Data from Phase 2 Trial of CERE-120 for Parkinson's Disease 27/05/2009 - 11.00
SAN DIEGO, May 27 /PRNewswire/ -- Ceregene, Inc. today reported additional clinical data from a double-blind, controlled Phase 2 trial of CERE-120 in 58 patients with advanced Parkinson's disease. CERE-120 uses AAV-based gene therapy to deliver the neurotrophic factor, neurturin, to Parkinson's disease patients in order to restore the function and protect degenerating nigrostriatal neurons. The company previously announced that the Phase 2 trial did not meet its primary endpoint of improvement in the Unified Parkinson's Disease Rating Scale (UPDRS) motor off score at 12 months of follow-up, although several secondary endpoints suggested a modest clinical benefit.
The additional, protocol-prescribed analyses reported today focused on further analyses of the data from the 30 subjects who continued to be evaluated under double-blind conditions for up to 18 months which indicate increasing effects of CERE-120 over time. A clinically modest but statistically significant treatment effect in the primary efficacy measure (UPDRS motor off; p=0.025), as well as similar effects on several more secondary motor measures (p<0.05), were seen at the 18 month endpoint. Not a single measure similarly favored sham surgery at either the 12 month or 18 month time points. Additionally, CERE-120 appears safe when administered to advanced Parkinson's disease patients, with no significant concerns related to the neurosurgical procedure, the gene therapy vector, or the expression of neurturin in the Parkinson's disease brain.
The company also reported the results of analyses of neurturin gene expression in the brains from two CERE-120 treated subjects who died of causes unrelated to treatment. These analyses revealed that CERE-120 produced clear evidence of neurturin expression in the targeted putamen but no evidence for transport of this protein to the cell bodies of the degenerating neurons, located in the substantia nigra. In addition to the known cell loss in Parkinson's disease, these findings suggest that deficient axonal transport in degenerating nigrostriatal neurons in advanced Parkinson's disease impaired transport of CERE-120 and/or neurturin from putaminal terminals to nigral cell bodies, reducing the bioactivity of CERE-120. The data were presented today at the American Society of Gene Therapy Meeting in San Diego, CA by Raymond T. Bartus, Ph.D., Ceregene's executive vice president and chief scientific officer.
"While we were disappointed that our initial analysis of the data from this trial did not demonstrate a benefit of CERE-120 in the primary endpoint at 12 months, we are greatly encouraged by both the results of these protocol-prescribed analyses in patients who remained blinded for up to 18 months, as well as by the insight we gained," stated Dr. Bartus. "Collectively, these data suggest that CERE-120 is indeed exerting a unique and potentially important biological effect on the degenerating dopamine neurons in moderately advanced Parkinson's disease patients but that the inability of these neurons to efficiently transport neurturin back to their cell bodies compromises and delays the neurotrophic effects of neurturin in a manner that had not been anticipated. Importantly, we believe that we can overcome the transport problems of these degenerating neurons by modifying the dosing paradigm to also directly target their cell bodies in the substantia nigra with CERE-120."
"We remain optimistic that CERE-120 has the potential to significantly improve the treatment of advanced Parkinson's disease patients," stated Jeffrey M. Ostrove, Ph.D., president and chief executive officer of Ceregene. "The information gained from this initial controlled Phase 2 trial in advanced Parkinson's disease patients has been invaluable, and we can now incorporate these insights in a follow-on clinical trial that we are planning to initiate later this year. Our goal remains to significantly improve the symptoms of Parkinson's patients and also to provide the opportunity to delay further disease progression."
About Phase 2 Trial of CERE-120
Ceregene's Phase 2 trial was a double-blind, controlled clinical trial that completed enrollment of 58 patients with advanced Parkinson's disease in October 2007. This study was launched after successful execution of an extensive nonclinical program and preliminary evidence of safety and efficacy in advanced Parkinson's patients via an open-label Phase 1 trial in 12 patients. Patients in the Phase 2 trial were enrolled across nine leading academic medical centers in the United States, with two thirds of patients receiving CERE-120 and one third enrolled into a control group. Patients received a single administration of CERE-120 via stereotactic neurosurgery to deliver the drug into the putamen region of the brain and were followed for a minimum of 12 months for safety and efficacy, with over half the subjects followed for 15 to 18 months under blinded conditions, allowing longer-term analyses of the therapeutic effects of CERE-120. Ceregene gratefully acknowledges the financial support received from the Michael J. Fox Foundation for Parkinson's Research to help defray some of the costs of the CERE-120 Phase 1 and Phase 2 clinical trials.
About CERE-120 and its Application to Treating Parkinson's Disease
CERE-120 is composed of an adeno-associated virus (AAV) vector carrying the gene for neurturin, a naturally occurring protein known to repair damaged and dying dopamine-secreting neurons, keeping them alive and restoring normal function. Neurturin is a member of the same protein family as glial cell-derived neurotrophic factor (GDNF). The two molecules have similar pharmacological properties, and both have been shown to benefit the midbrain dopamine neurons that degenerate in Parkinson's disease. Degeneration of these neurons is responsible for the major motor impairments of Parkinson's disease. CERE-120 has been delivered by stereotactic injection to the terminal fields (i.e., the ends of the degenerating neurons), located in an area of the brain called the putamen. The cell bodies for these same neurons are located in a different area of the brain, called the substantia nigra. Once CERE-120 is delivered to the brain, it provides stable, long-lasting expression of neurturin in a highly targeted fashion. Genzyme Corporation has licensed the ex-North American rights for the development and commercialization of CERE-120 from Ceregene, an agreement that was announced in June 2007.
About Parkinson's Disease
Parkinson's disease is a progressive movement disorder that affects a million people in the United States. Its main symptoms, stiffness, tremors and slowed movements and gait, are caused by a loss of dopamine-containing nerve cells in the substantia nigra, which project their axons to the putamen. Dopamine is a neurotransmitter involved in controlling movement and coordination, so Parkinson's patients exhibit a progressive inability to initiate and control physical movements. There is currently no treatment that can reverse the degeneration of these neurons, let alone cure Parkinson's disease.
About Ceregene
Ceregene, Inc. is a San Diego-based biotechnology company focused on the delivery of nervous system growth (neurotrophic) factors for the treatment of neurodegenerative and retinal disorders using gene delivery. Ceregene's clinical programs include CERE-110, an AAV2 based vector expressing nerve growth factor that is currently in a multi-center, controlled Phase 2 study for the treatment of Alzheimer's disease, and CERE-120 (AAV2-Neurturin) for Parkinson's disease. CERE-135 and CERE-140 are in preclinical development for ALS (Lou Gehrig's disease) and ocular disorders, respectively. Ceregene was launched in January 2001. The company's investors include Alta Partners, MPM Capital, Investor Growth Capital and Cell Genesys, Inc. as well as Hamilton BioVentures and California Technology Partners.
Contacts: Jeffrey M. Ostrove, Ph.D.
President and CEO
Ceregene, Inc.
(858) 458-8808
Ceregene Presents Additional Clinical Data from Phase 2 Trial of CERE-120 for Parkinson's Disease 27/05/2009 - 11.00
SAN DIEGO, May 27 /PRNewswire/ -- Ceregene, Inc. today reported additional clinical data from a double-blind, controlled Phase 2 trial of CERE-120 in 58 patients with advanced Parkinson's disease. CERE-120 uses AAV-based gene therapy to deliver the neurotrophic factor, neurturin, to Parkinson's disease patients in order to restore the function and protect degenerating nigrostriatal neurons. The company previously announced that the Phase 2 trial did not meet its primary endpoint of improvement in the Unified Parkinson's Disease Rating Scale (UPDRS) motor off score at 12 months of follow-up, although several secondary endpoints suggested a modest clinical benefit.
The additional, protocol-prescribed analyses reported today focused on further analyses of the data from the 30 subjects who continued to be evaluated under double-blind conditions for up to 18 months which indicate increasing effects of CERE-120 over time. A clinically modest but statistically significant treatment effect in the primary efficacy measure (UPDRS motor off; p=0.025), as well as similar effects on several more secondary motor measures (p<0.05), were seen at the 18 month endpoint. Not a single measure similarly favored sham surgery at either the 12 month or 18 month time points. Additionally, CERE-120 appears safe when administered to advanced Parkinson's disease patients, with no significant concerns related to the neurosurgical procedure, the gene therapy vector, or the expression of neurturin in the Parkinson's disease brain.
The company also reported the results of analyses of neurturin gene expression in the brains from two CERE-120 treated subjects who died of causes unrelated to treatment. These analyses revealed that CERE-120 produced clear evidence of neurturin expression in the targeted putamen but no evidence for transport of this protein to the cell bodies of the degenerating neurons, located in the substantia nigra. In addition to the known cell loss in Parkinson's disease, these findings suggest that deficient axonal transport in degenerating nigrostriatal neurons in advanced Parkinson's disease impaired transport of CERE-120 and/or neurturin from putaminal terminals to nigral cell bodies, reducing the bioactivity of CERE-120. The data were presented today at the American Society of Gene Therapy Meeting in San Diego, CA by Raymond T. Bartus, Ph.D., Ceregene's executive vice president and chief scientific officer.
"While we were disappointed that our initial analysis of the data from this trial did not demonstrate a benefit of CERE-120 in the primary endpoint at 12 months, we are greatly encouraged by both the results of these protocol-prescribed analyses in patients who remained blinded for up to 18 months, as well as by the insight we gained," stated Dr. Bartus. "Collectively, these data suggest that CERE-120 is indeed exerting a unique and potentially important biological effect on the degenerating dopamine neurons in moderately advanced Parkinson's disease patients but that the inability of these neurons to efficiently transport neurturin back to their cell bodies compromises and delays the neurotrophic effects of neurturin in a manner that had not been anticipated. Importantly, we believe that we can overcome the transport problems of these degenerating neurons by modifying the dosing paradigm to also directly target their cell bodies in the substantia nigra with CERE-120."
"We remain optimistic that CERE-120 has the potential to significantly improve the treatment of advanced Parkinson's disease patients," stated Jeffrey M. Ostrove, Ph.D., president and chief executive officer of Ceregene. "The information gained from this initial controlled Phase 2 trial in advanced Parkinson's disease patients has been invaluable, and we can now incorporate these insights in a follow-on clinical trial that we are planning to initiate later this year. Our goal remains to significantly improve the symptoms of Parkinson's patients and also to provide the opportunity to delay further disease progression."
About Phase 2 Trial of CERE-120
Ceregene's Phase 2 trial was a double-blind, controlled clinical trial that completed enrollment of 58 patients with advanced Parkinson's disease in October 2007. This study was launched after successful execution of an extensive nonclinical program and preliminary evidence of safety and efficacy in advanced Parkinson's patients via an open-label Phase 1 trial in 12 patients. Patients in the Phase 2 trial were enrolled across nine leading academic medical centers in the United States, with two thirds of patients receiving CERE-120 and one third enrolled into a control group. Patients received a single administration of CERE-120 via stereotactic neurosurgery to deliver the drug into the putamen region of the brain and were followed for a minimum of 12 months for safety and efficacy, with over half the subjects followed for 15 to 18 months under blinded conditions, allowing longer-term analyses of the therapeutic effects of CERE-120. Ceregene gratefully acknowledges the financial support received from the Michael J. Fox Foundation for Parkinson's Research to help defray some of the costs of the CERE-120 Phase 1 and Phase 2 clinical trials.
About CERE-120 and its Application to Treating Parkinson's Disease
CERE-120 is composed of an adeno-associated virus (AAV) vector carrying the gene for neurturin, a naturally occurring protein known to repair damaged and dying dopamine-secreting neurons, keeping them alive and restoring normal function. Neurturin is a member of the same protein family as glial cell-derived neurotrophic factor (GDNF). The two molecules have similar pharmacological properties, and both have been shown to benefit the midbrain dopamine neurons that degenerate in Parkinson's disease. Degeneration of these neurons is responsible for the major motor impairments of Parkinson's disease. CERE-120 has been delivered by stereotactic injection to the terminal fields (i.e., the ends of the degenerating neurons), located in an area of the brain called the putamen. The cell bodies for these same neurons are located in a different area of the brain, called the substantia nigra. Once CERE-120 is delivered to the brain, it provides stable, long-lasting expression of neurturin in a highly targeted fashion. Genzyme Corporation has licensed the ex-North American rights for the development and commercialization of CERE-120 from Ceregene, an agreement that was announced in June 2007.
About Parkinson's Disease
Parkinson's disease is a progressive movement disorder that affects a million people in the United States. Its main symptoms, stiffness, tremors and slowed movements and gait, are caused by a loss of dopamine-containing nerve cells in the substantia nigra, which project their axons to the putamen. Dopamine is a neurotransmitter involved in controlling movement and coordination, so Parkinson's patients exhibit a progressive inability to initiate and control physical movements. There is currently no treatment that can reverse the degeneration of these neurons, let alone cure Parkinson's disease.
About Ceregene
Ceregene, Inc. is a San Diego-based biotechnology company focused on the delivery of nervous system growth (neurotrophic) factors for the treatment of neurodegenerative and retinal disorders using gene delivery. Ceregene's clinical programs include CERE-110, an AAV2 based vector expressing nerve growth factor that is currently in a multi-center, controlled Phase 2 study for the treatment of Alzheimer's disease, and CERE-120 (AAV2-Neurturin) for Parkinson's disease. CERE-135 and CERE-140 are in preclinical development for ALS (Lou Gehrig's disease) and ocular disorders, respectively. Ceregene was launched in January 2001. The company's investors include Alta Partners, MPM Capital, Investor Growth Capital and Cell Genesys, Inc. as well as Hamilton BioVentures and California Technology Partners.
Contacts: Jeffrey M. Ostrove, Ph.D.
President and CEO
Ceregene, Inc.
(858) 458-8808