Gpc Biotech AG ADS (MM) (GPCB) News

GPC Biotech Reports Financial Results for Second Quarter and First Six Months of 2008
Wednesday August 13, 1:35 am ET
-- Cash, cash equivalents, marketable securities and short-term investments of EUR 44.6 million (approx. $67 million) as of June 30, 2008
-- Company confirms that existing cash position expected to support currently planned business operations until approximately the end of 2010

MARTINSRIED, Germany & MUNICH, Germany & PRINCETON, N.J.--(BUSINESS WIRE)--GPC Biotech AG (Frankfurt Stock Exchange: GPC; NASDAQ: GPCB) today reported financial results for the second quarter and first six months ended June 30, 2008.

First six months of 2008 compared to first six months of 2007

Revenues decreased 57% to € 3.1 million for the six months ended June 30, 2008, compared to € 7.2 million for the same period in 2007. The decrease in revenues is due to decreased payments from Celgene Corporation relating to the co-development and license agreement for satraplatin. Research and development (R&D) expenses decreased 62% to € 10.3 million for the first six months of 2008 compared to € 27.2 million for the same period in 2007. The decrease in R&D expenses is primarily due to staff reductions as a result of the restructuring plans implemented in 2007 and the first quarter of 2008, as well as a decrease in clinical trial costs due to reduced clinical trial volumes. In the first half of 2008, general and administrative (G&A) expenses decreased 64% to € 7.6 million compared to € 21.2 million for the same period in 2007. The decrease in G&A expenses is primarily due to staff reductions and other associated activities as a result of the restructuring plans implemented in 2007 and the first quarter of 2008. In addition, in the first half of 2007, the Company incurred costs in connection with the building of a commercial infrastructure and legal fees due to the arbitration proceedings. The Company did not incur such costs in the first half of 2008. Net loss for the first six months of 2008 improved 66% to € (13.4) million compared to € (39.3) million for the first six months of 2007. Basic and diluted loss per share was € (0.36) for the first six months of 2008 compared to € (1.10) for the same period in 2007.

Cash position

As of June 30, 2008, cash, cash equivalents, marketable securities and short-term investments totaled € 44.6 million (December 31, 2007: 65.2 million), including € 1.4 million in restricted cash. Net cash burn for the first six months of 2008 was € 18.7 million with net cash burn of € 10.6 million in the first quarter and € 8.1 million in the second quarter of 2008. Net cash burn, a non-GAAP measure, is derived by adding net cash used in operating activities and purchases of property, equipment and licenses. Net cash burn provides insight regarding the actual cash a company spent in a given period. The figures used to calculate net cash burn are contained in the Company’s unaudited consolidated statements of cash flows for the first six months ended June 30, 2008.

Second quarter of 2008 compared to second quarter of 2007

Revenues for the three months ended June 30, 2008 decreased 56% to € 1.5 million compared to € 3.4 million for the same period in 2007. R&D expenses decreased 70% to € 4.5 million for the second quarter of 2008 compared to € 15.0 million for the same period in 2007. G&A expenses for the second quarter of 2008 decreased 65% to € 4.0 million compared to € 11.4 million for the second quarter of 2007. The Company’s net loss was € (6.4) million in the second quarter of 2008 compared to € (22.1) million for the same period in 2007. Basic and diluted loss per share was € (0.17) for the second quarter of 2008 compared to € (0.61) for the same period in 2007.

Quarter over quarter results: second quarter 2008 compared to first quarter 2008

Revenues for the second quarter of 2008 were € 1.5 million compared to € 1.6 million for the previous quarter. R&D expenses decreased 21% to € 4.5 million for the second quarter of 2008, compared to € 5.7 million in the first quarter of 2008. G&A expenses for the second quarter of 2008 increased 11% to € 4.0 million compared to € 3.6 million for the previous quarter. The Company’s net loss decreased 9% to € (6.4) million in the second quarter of 2008, compared to € (7.0) million for the previous quarter. Basic and diluted loss per share was € (0.17) for the second quarter of 2008 compared to € (0.19) for the previous quarter.

“We are highly focused on rebuilding the Company and are working with great intensity on moving forward promising M&A opportunities,” said Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer. “It is critical that we broaden our oncology pipeline through such transactional activities while we continue to advance our existing drug development programs, including our two novel kinase inhibitors.”

2008 financial guidance

The Company confirmed its guidance provided in May 2008 as follows:

Revenues: Revenues for 2008 are expected to be between € 5 million and € 7 million.

Once the termination of the co-development and license agreement between GPC Biotech and Celgene Corporation for satraplatin for Europe and certain other territories is effective, GPC Biotech expects to recognize all or the majority of remaining deferred revenue related to the agreement. This deferred revenue is related to cash already received by GPC Biotech under this agreement. The Company will update revenue guidance as appropriate.

Expenses: Total expenses for 2008 are expected to be below € 35 million.

Cash Burn: Current cash reserves are expected to be sufficient to fund currently planned business operations until approximately the end of 2010. The cash burn for 2008 will include several one-time costs, including severance and other payments related to the corporate restructurings in 2007 and early 2008. The majority of these one–time costs were incurred in the first half of 2008.

This guidance does not include any potential M&A or other major transactions, and, should such an event or events occur this year, the Company’s financial expectations would likely change significantly.

Conference call scheduled

The Company has scheduled a conference call to which participants may listen via live webcast, accessible through the GPC Biotech Web site at www.gpc-biotech.com or via telephone. A replay will be available on the Web site following the live event. The call, which will be conducted in English, will be held on August 13th at 14:00 CET/8:00 AM ET. The dial-in numbers for the call are as follows:

Participants from Europe:

0049 (0)89 9982 99911


0044 (0)20 7806 1955
Participants from the U.S.:

1-718-354-1388

Please dial in 10 minutes before the beginning of the meeting.

GPC Biotech Reports that Celgene to Terminate Co-Development and License Agreement for Satraplatin
Wednesday August 6, 6:01 pm ET


MARTINSRIED/MUNICH, Germany & PRINCETON, N.J.--(BUSINESS WIRE)--GPC Biotech AG (Frankfurt Stock Exchange: GPC, NASDAQ: GPCB) today reported that the Company has received notice from Celgene Corporation of its decision to terminate its co-development and license agreement with GPC Biotech for satraplatin in Europe, Turkey, the Middle East, Australia and New Zealand. All rights to these territories will be returned to GPC Biotech.

Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer of GPC Biotech said: “We are disappointed, but we understand Celgene’s decision given their recent withdrawal of the Marketing Authorization Application for satraplatin in Europe. We plan to decide in the near future the next steps regarding the development of satraplatin, and we will continue to focus our other efforts on advancing our RGB-286638 kinase inhibitor into the clinic and exploring various merger and acquisition opportunities.”

GPC Biotech Announces Initiation of NCI-Sponsored Phase 2 Trial of Satraplatin in Patients with Metastatic Hormone-Refractory Prostate Cancer Previously Treated with Docetaxel
Tuesday June 24, 2:09 am ET
Study seeks to determine if presence of certain gene impacts patient outcome

MARTINSRIED/MUNICH, Germany & PRINCETON, N.J.--(BUSINESS WIRE)--GPC Biotech AG (Frankfurt Stock Exchange: GPC, NASDAQ: GPCB) today announced the initiation of a Phase 2 study evaluating satraplatin in combination with the steroid, prednisone, in patients with metastatic hormone-refractory prostate cancer (HRPC) who previously have been treated with docetaxel (Taxotere®). The study is being sponsored by the U.S. National Cancer Institute (NCI), and the principal investigator is William L. Dahut, MD, Chief, Genitourinary Research Section, Medical Oncology Branch, Center for Cancer Research, NCI.

The trial is a single-arm study with a planned enrollment of 66 patients with metastatic HRPC who have been previously treated with docetaxel therapy and with no more than one other previous cytotoxic chemotherapy regimen. The primary objective of the trial is to determine if the presence of certain variants of the gene, ERCC1, affects progression-free survival in this patient population. ERCC1 is involved in DNA damage repair. Satraplatin, like other platinum agents, has been shown to work via targeting the DNA in tumor cells.

“The results of this trial may provide important information in determining which hormone-refractory prostate cancer patients are more likely to benefit from treatment with satraplatin,” said Martine George, MD, Senior Vice President, Drug Development and Chief Medical Officer at GPC Biotech. “We are pleased to be working with the NCI to conduct this potentially ground-breaking study.”

About Satraplatin

Satraplatin, an investigational drug, is a member of the platinum family of compounds. Platinum-based drugs are a critical part of modern chemotherapy treatments and are used to treat a wide variety of cancers. All platinum drugs currently on the market require intravenous administration. Satraplatin is an oral compound that clinical trial patients are able to take at home. A Marketing Authorization Application for satraplatin in combination with prednisone is currently under review in Europe for the treatment of hormone-refractory prostate cancer patients whose prior chemotherapy has failed. A decision on the filing by the European regulators is expected in the second half of 2008.

GPC Biotech Announces Granting of European Patent Related to Satraplatin for Treating Tumors Resistant or Refractory to Taxanes
Thursday June 12, 4:05 am ET

MARTINSRIED/MUNICH, Germany & PRINCETON, N.J.--(BUSINESS WIRE)--GPC Biotech AG (Frankfurt Stock Exchange: GPC; NASDAQ: GPCB) today announced the granting of a European Patent (EP 1 720 540 B1) related to satraplatin, a novel, oral platinum compound. The patent is entitled, “Satraplatin for treating resistant or refractory tumors” and covers certain uses of satraplatin related to the treatment of a cancer or tumor resistant or refractory to a taxane, including docetaxel (Taxotere®) and paclitaxel (Taxol®). The term of the patent extends up to 2025.

“Docetaxel is the standard of care for the first-line treatment of patients with hormone-refractory prostate cancer, or HRPC, and approximately half of the patients in the satraplatin Phase 3 SPARC trial in second-line HRPC were previously treated with docetaxel,” said Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer. “With an active filing for satraplatin under review in Europe, we believe this patent will be of particular commercial importance, should satraplatin be approved for HRPC patients whose prior chemotherapy has failed.”

The Company conducted the SPARC Phase 3 trial evaluating satraplatin in combination with prednisone in the second-line treatment of patients with HRPC. Approximately 50% of patients recruited into the study had progressive disease following prior treatment with docetaxel. The SPARC trial results showed a statistically significant improvement in progression-free survival in the overall intent-to-treat (ITT) population, as well as in the group of patients who had progressed after receiving docetaxel. While the overall survival results in the overall ITT population did not show a difference between the two treatment arms, there was a positive trend toward improved survival observed in those patients whose disease had progressed after receiving docetaxel, when adjusting for the three significant prognostic factors in the SPARC trial*.

About Satraplatin

Satraplatin, an investigational drug, is a member of the platinum family of compounds. Platinum-based drugs are a critical part of modern chemotherapy treatments and are used to treat a wide variety of cancers. All platinum drugs currently on the market require intravenous administration. Satraplatin is an oral compound that clinical trial patients are able to take at home. A Marketing Authorization Application for satraplatin in combination with prednisone is currently under review in Europe for the treatment of hormone-refractory prostate cancer patients whose prior chemotherapy has failed. A decision on the filing by the European regulators is expected in the second half of 2008. Celgene Corporation is responsible for the regulatory filings for satraplatin and its development and commercialization for Europe and certain other territories. GPC Biotech also has a license agreement with Yakult Honsha Co. Ltd. under which Yakult has exclusive commercialization rights to satraplatin for Japan and is taking the lead in developing the drug in that territory. GPC Biotech in-licensed satraplatin from Spectrum Pharmaceuticals, Inc. in 2002.

New Data from Several Satraplatin Clinical Trials in Solid Tumors Presented at 44th ASCO Annual Meeting
Monday June 2, 4:05 am ET

MARTINSRIED/MUNICH, Germany & PRINCETON, N.J.--(BUSINESS WIRE)--GPC Biotech AG (Frankfurt Stock Exchange: GPC, NASDAQ: GPCB) today announced the presentation of data from several satraplatin clinical trials at the 44th Annual Meeting of the American Society for Clinical Oncology (ASCO) in Chicago.

“We are pleased that data from several satraplatin clinical trials evaluating satraplatin in combination with a variety of widely used cancer treatments were selected for presentation at this year’s ASCO Annual Meeting,” said Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer of GPC Biotech. “The information gained from these studies is helpful to GPC Biotech and others as we plan new trials with this active oral platinum-based compound.”

The following are summaries of the highlighted presentations.

Phase I study of satraplatin and docetaxel in solid malignancies - Ticiana B Leal, MD, (Abstract #2570)

The primary objective of this study was to determine the maximum tolerated dose (MTD) of satraplatin and docetaxel (Taxotere®) in patients with advanced solid tumors when docetaxel was administered every three weeks. Twenty-three patients were enrolled in the study. The patient population was heavily pre-treated, with a median of two prior cytotoxic chemotherapy regimens. The recommended Phase II dose was satraplatin at 40mg/m2/day given on days 1-5 and docetaxel at 60mg/m2 given on day 1 of a three-week cycle, without G-CSF, and satraplatin at 50mg/m2/day given on days 1-5 and docetaxel at 70mg/m2 given on day 1 of a three-week cycle with G-CSF. G-CSF is used to promote the recovery of white blood cells. The most commonly reported adverse event was neutropenia (decrease in white blood cells) in 22% of patients, followed by anemia, diarrhea and fatigue. Preliminary data show encouraging activity in men with high-grade androgen independent prostate cancer. As a result, this combination is currently being further explored in men with chemo-naïve, androgen independent prostate cancer.

Phase I study of the oral platinum agent satraplatin in sequential combination with capecitabine in patients with advanced solid tumours - Cristiana Sessa, MD (Abstract #2560)

The primary objective of this study was to determine the MTD and Phase 2 recommended dose for satraplatin administered sequentially with capecitabine (Xeloda®). Thirty-seven patients with a variety of solid tumors were treated in the study. The MTD and recommended dose for Phase 2 was satraplatin at 70 mg/m2 and capecitabine at 1000 mg/m2/BID (twice daily). Hematological toxicity was the main dose-limiting toxicity. In the 34 patients who were evaluated, there were three confirmed partial responses – two in platinum-sensitive ovarian cancer and one in prostate cancer patients, as well as six stable disease in prostate cancer patients. These preliminary results suggest that the sequential administration of satraplatin and capecitabine may represent a well tolerated and convenient oral treatment for patients with advanced solid tumors.

Phase I study of oral platinum with concurrent radiation therapy in non small cell lung cancer – Hak Choy, MD (Abstract #7560)

The objectives of this study were to determine the dose-limiting toxicities, MTD and recommended Phase 2 dose of satraplatin in combination with radiation therapy for patients with non-small cell lung cancer (NSCLC). Fifteen patients were enrolled in the study. The recommended Phase 2 dose for this patient population is 30 mg/d each day of radiation treatment. Dose limiting toxicities were Grade 3 pneumonia and Grade 3 elevated liver function. Of the eleven evaluable patients, eight had partial responses and three had stable disease. These results suggest therapeutic synergy of satraplatin in combination with radiation for the treatment of NSCLC and provide a rationale for future studies with this combination.

Satraplatin in patients with advanced hormone-refractory prostate cancer: Overall survival results from the phase III satraplatin and prednisone against refractory cancer (SPARC) trial, A. Oliver Sartor, MD (Abstract #5003)

Data from this oral presentation are discussed in a separate press release issued by GPC Biotech on June 2, 2008.

Additional data on satraplatin and on RGB-286638 broad-spectrum kinase inhibitor published in ASCO Annual Meeting Proceedings

The Company also reported that data from two other satraplatin clinical trials, as well as in vitro data in multiple myeloma with the RGB-286638 kinase inhibitor, were published in the ASCO Annual Meeting Proceedings.

Cirstea, Diana et al, “Pleiotropic Activity of the Novel Cyclin-Dependent Kinase Inhibitor RGB 286638 Predicts Therapeutic Potential in Multiple Myeloma.” Researchers assessed the effect of RGB-286638, a novel broad-spectrum kinase inhibitor, on inhibiting tumor growth in conventional drug-sensitive and drug-resistant multiple myeloma cell lines and primary tumor cells from multiple myeloma patients. The results demonstrated that RGB-286638 induces multiple myeloma cell death via the inhibition of cyclin-dependent kinase/cyclin complexes and cell cycle progression. In vivo studies are ongoing to assist in the design of clinical testing for RGB-286638 in multiple myeloma.

Spigel, D R et al, “Phase II Trial of Satraplatin (S) and Paclitaxel (P) in First-Line Advanced Non-Small Cell Lung Cancer (NSCLC) Treatment: Final Results.” This abstract reviewed the final results from the Phase 2 trial evaluating satraplatin plus paclitaxel (Taxol®) in patients with NSCLC. Thirty-eight patients with newly-diagnosed NSCLC were enrolled in the study, and 28 patients were evaluable. One complete response and six partial responses were observed (25.9% overall response rate). The regimen was well tolerated and associated with limited Grade 3/4 toxicity when satraplatin was administered at 70 mg/m2 on days 1-5 every 28 days. The results indicate that satraplatin appears to have activity that is similar to other platinum agents when combined with paclitaxel in first-line NSCLC treatment.

Wisinski, K B et al, “A phase I study of the oral platinum agent satraplatin (S) with capecitabine (C) in patients (pts) with advanced solid malignancies.” This abstract discussed results from a Phase 1 study evaluating the combination of satraplatin and capecitabine administered concurrently. Twenty-two patients were enrolled in the study. The dose-limiting toxicities were predominantly Grade 3/4 thrombocytopenia. The MTD for satraplatin was 100 mg/m2 on days 1-5. No responses were observed, and there was significant toxicity when these two compounds were administered together. [Abstract on data from trial evaluating sequential administration of satraplatin with capecitabine discussed earlier in this release.]

GPC Biotech Reports Financial Results for First Quarter 2008
Thursday May 15, 2:36 am ET
-- Cash, cash equivalents, marketable securities and short-term investments of EUR 53.5 million ($84.5 million) as of March 31, 2008
-- Company confirms financial guidance for fiscal year 2008: Cash position expected to support currently planned business operations until approximately end of 2010

MARTINSRIED/MUNICH, Germany & PRINCETON, N.J.--(BUSINESS WIRE)--GPC Biotech AG (Frankfurt Stock Exchange: GPC; NASDAQ: GPCB) today reported financial results for the first quarter and three months ended March 31, 2008.

First quarter 2008 compared to first quarter 2007 as adjusted*

Revenues decreased 58% to € 1.6 million for the first quarter of 2008, compared to € 3.8 million for the first quarter of 2007. The decrease in revenues is primarily due to a decline in payments received under the co-development and license agreement for satraplatin with Celgene Corporation (formerly Pharmion Corporation), as the SPARC Phase 3 trial has been mostly completed. R&D expenses decreased 53% to € 5.7 million for the first three months of 2008 compared to € 12.2 million for the same period in 2007. In the first quarter of 2008, general and administrative (G&A) expenses decreased 63% to € 3.6 million compared to € 9.8 million for the first quarter of 2007. The decrease in R&D and G&A expenses is primarily due to staff reductions and other associated activities as a result of the restructuring plans announced in the second half of 2007 and in the first quarter of 2008 to sharpen the Company’s focus on oncology clinical development efforts and to further reduce costs. Net loss for the first quarter of 2008 improved 60% to € (6.9) million compared to € (17.1) million for the first quarter of 2007. Basic and diluted loss per share was € (0.19) for the first quarter of 2008 compared to € (0.48) for the same quarter in 2007.

As of March 31, 2008, cash, cash equivalents, marketable securities and short-term investments totaled € 53.5 million (December 31, 2007: 65.2 million), including € 1.4 million in restricted cash. Net cash burn for the first quarter of 2008 was € 10.6 million. Net cash burn is derived by adding net cash used in operating activities and purchases of property, equipment and licenses. The figures used to calculate net cash burn are contained in the Company’s unaudited consolidated statements of cash flows for the first quarter ended March 31, 2008.

Quarter over quarter results: first quarter 2008 compared to fourth quarter 2007

Revenues for the first quarter of 2008 decreased 27% to € 1.6 million compared to € 2.2 million for the previous quarter. R&D expenses decreased 41% to € 5.7 million for the first quarter of 2008 compared to € 9.7 million for the fourth quarter of 2007. G&A expenses for the first quarter of 2008 decreased 36% to € 3.6 million compared to € 5.6 million for the previous quarter. The Company’s net loss was € (6.9) million in the first quarter of 2008 compared to € (11.9) million for the previous quarter. Basic and diluted loss per share was € (0.19) for the first quarter of 2008 compared to € (0.32) for the previous quarter.

“We are focused on re-energizing our employees and rebuilding GPC Biotech,” said Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer. “Our two key areas of activities are advancing our current drug development programs – satraplatin and two pre-clinical kinase inhibitors, RGB-286638 and RGB-344064 - and exploring various merger and acquisition opportunities.”

Torsten Hombeck, Ph.D., Chief Financial Officer, said: “We are confirming our previous financial guidance for 2008. We believe that we have sufficient cash reserves to fund our currently planned business operations until approximately the end of 2010. We believe that our solid cash position gives us important flexibility as we seek to expand our pipeline.”

2008 financial guidance confirmed

The Company confirmed its previous financial guidance for 2008 as follows:

Revenues: Expected to be between € 5 million and € 7 million.

Expenses: Total expenses for 2008 expected to be below € 35 million.

Cash Burn: Current cash reserves expected to be sufficient to fund currently planned business operations until approximately the end of 2010. The cash burn for 2008 will include several one-time costs, including severance and other payments related to the corporate restructurings in 2007 and early 2008.

This guidance does not include any potential M&A or other major transactions, and, should such an event or events occur this year, the Company’s financial expectations could change significantly.

GPC Biotech AG Earnings Conference Call (Q1 2008) Today's

Call Details
GPC Biotech AG Earnings Conference Call (Q1 2008)
Scheduled to start Thu, May 15, 2008, 8:00 am Eastern

Check back at the scheduled start time for
the audio link to appear in this spot.

Add this event to your Yahoo! Calendar Add This Event To Your Yahoo! Calendar

About GPC Biotech AG (NasdaqGM:GPCB)
GPC Biotech AG, a biopharmaceutical company, engages in the discovery, development, and commercialization of anticancer drugs in Germany. The company also develops genomics and proteomics technologies that comprises gene expression analysis, protein-protein interaction analysis, and bioinformatic tools, as well as provides related services. It focuses on oncology, immunology, and microbiology. The company’s lead product candidate includes satraplatin, a platinum-based compound for chemotherapy treatment in hormone-refractory prostate cancer. It also develops 1D09C3, a monoclonal antibody, which is in Phase I clinical trial for the treatment of lymphoid cancers, as well as has ongoing drug development and discovery programs that focuses on kinase inhibitors. The company has an agreement with ALTANA Pharma to license its proprietary drug-protein interaction technology, LeadCode. GPC Biotech AG was founded in 1997 and is headquartered in Munich, Germany.

http://biz.yahoo.com/cc/8/93068.html

GPC Recaps a Tough Year:

http://www.fool.com/investing/high-growth/2008/03/31/gpc-recaps-a-tough-year.aspx

GPC Biotech Announces Corporate Restructuring and Provides Pipeline Update
Monday February 25, 8:12 am ET
-- Internal oncology development efforts focused on satraplatin and cell cycle inhibitors
-- Restructuring to reduce costs and extend cash reserves
-- Management Board reduced to reflect smaller company size
-- Year-end 2007 cash position of approximately EUR 65 million (~$ 95 million), higher than previous guidance

MARTINSRIED/MUNICH, Germany & PRINCETON, N.J.--(BUSINESS WIRE)--GPC Biotech AG (Frankfurt Stock Exchange: GPC; NASDAQ: GPCB) today announced a corporate restructuring to sharpen the Company’s focus on oncology clinical development efforts and to further reduce costs to extend its cash reserves to cover approximately three years of operating expenses. The restructuring is mainly focused on the Company’s early-stage research activities in Munich and will result in a reduction in the total workforce of approximately 38% (or 38 employees). The remaining work force will be 14 in Munich and 49 in Princeton.
http://biz.yahoo.com/bw/080225/20080225005767.html?.v=1

GPC Biotech to Provide Update on Research and Development Programs at JPMorgan 26th Annual Healthcare Conference in San Francisco
Monday January 7, 10:52 am ET

MARTINSRIED/MUNICH, Germany & PRINCETON, N.J.--(BUSINESS WIRE)--GPC Biotech AG (Frankfurt Stock Exchange: GPC; NASDAQ: GPCB) today announced that the Company will give a company update at the JPMorgan 26th Annual Healthcare Conference in San Francisco, CA. The Company will provide an update on its research and development pipeline. Additional information on satraplatin, including the SPARC trial and development plan for the compound, as well as updates on other programs, will be presented.

The presentation will be today, Monday, January 7, 2008, at 3:30 PM PST at the Westin St. Francis, San Francisco, CA. The presentation will be webcast live and will be accessible through the GPC Biotech Web site at www.gpc-biotech.com. A replay will also be available via the Web site.

So wadiyah think about current pps of onyx? TIA

GPC Biotech Announces Corporate Restructuring
Thursday November 15, 4:52 am ET

MARTINSRIED/MUNICH, Germany & PRINCETON, N.J.--(BUSINESS WIRE)--GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX index; NASDAQ: GPCB) today announced a restructuring that involves staff reductions of approximately 44 percent of the Company’s current active workforce. The staff reductions are taking place in both Germany and the U.S. The Company is retaining key personnel needed to achieve the Company’s medium- and longer-term goals.

Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer, said: “Our goal of having approximately two years of operating cash on hand at the end of 2007 has sadly necessitated very significant staff reductions on both sides of the Atlantic. I would like to express my sincere appreciation to our affected employees for their contributions to GPC Biotech.”

Dr. Seizinger continued: “This is a very challenging time for GPC Biotech. However, we have retained a smaller, excellent team, who we are confident can effectively address these challenges and move our Company forward. We are implementing a revised strategic plan, which includes focusing our internal efforts on a limited number of development-stage oncology projects, significantly increasing our licensing efforts and actively exploring M&A opportunities on both sides of the Atlantic.”

The Company’s restructuring plan involves a staff reduction of 103 employees. The reduction in force affects 60 employees in Munich and 43 in Princeton. The remaining work force will be 56 in Munich and 58 in Princeton after the completion of the shutdown of the Company’s Waltham, Massachusetts facility in a few weeks. Thus, going forward the Company will have 114 active employees. Affected employees will be eligible for severance packages that include severance pay, continuation of benefits and outplacement services. The Company has retained a core drug development team that is headquartered in the U.S., with a small group of development people retained in Germany to support ongoing and future work in Europe. The Company has also retained a core drug discovery group in Munich that will support drug development in addition to continuing late stage drug discovery efforts focused on kinase inhibitors. General and administrative staff also has been reduced. A small group of key commercialization team members has been retained in the U.S. to support drug development and business development activities.

GPC Biotech confirmed its previous guidance that the Company expects its year-end 2007 cash, cash equivalents and available-for-sale securities position to be approximately € 60 million.

Strong Volume Gainers (GPCB)

Oversold with an Improving RSI (GPCB)

Sold some GPCB today, still looks good but profits are to be taken in this market.

GOOD FOR YOU..
GL

GPCB turned out to be a good trade, up everyday since the big drop!

GPC Biotech Announces Favorable Ruling in Arbitration with Spectrum Pharmaceuticals

* Arbitration panel unanimously rejects all of Spectrum’s claims and finds no violations of contract by GPC Biotech

GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX index; NASDAQ: GPCB) today announced that a three-arbitrator panel of the American Arbitration Association, which was appointed to resolve a dispute over claims raised by Spectrum Pharmaceuticals, Inc. against GPC Biotech regarding their co-development and license agreement for satraplatin, has issued its decision in favor of GPC Biotech. The panel unanimously rejected all of Spectrum’s claims and found no violations of the agreement by GPC Biotech. The decision of the panel included the following key rulings:

* Spectrum Pharmaceuticals is not entitled to any portion of the up-front payments that GPC Biotech received from Pharmion Corporation or from Yakult Honsha Co. Ltd.;
* Spectrum does not have a contractual right to co-promote satraplatin in the United States and GPC Biotech did not violate any obligation to negotiate in good faith a co-promotion agreement; and
* GPC Biotech did not violate its obligation to use commercially reasonable efforts to commercialize satraplatin in Japan.

Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer, said: “GPC Biotech takes its contractual obligations to its partners very seriously. We are pleased that the panel unanimously agreed that all of Spectrum’s allegations were without merit and that we committed no violations of the agreement.”

Although the panel ruled for GPC Biotech on the merits, it did not award GPC Biotech re-imbursement of attorneys’ fees and costs.

Background on Arbitration

In December 2006, GPC Biotech was notified by Spectrum Pharmaceuticals that Spectrum had initiated an arbitration proceeding with the American Arbitration Association in the United States to resolve a dispute between the companies under the co-development and license agreement for satraplatin. In the course of the arbitration proceedings, Spectrum made several claims of breach of contract, including (1) an assertion that it is entitled to a payment from GPC Biotech of approximately € 9.0 million relating to payments received by GPC Biotech under the co-development and license agreement between GPC Biotech and Pharmion GmbH entered on December 19, 2005, later expanded to also include a claim to a portion of the payments GPC Biotech was entitled to from Yakult Honsha Co. Ltd. under their license agreement for Japan; (2) a claim that GPC Biotech had not used commercially reasonable efforts to obtain regulatory approval and to promote the distribution of satraplatin in Japan; and (3) a claim that GPC Biotech had not negotiated with Spectrum in good faith regarding the co-promotion of satraplatin in the United States. Spectrum was also seeking a declaration that GPC Biotech’s alleged breaches of contract provided a basis for termination of the co-development and license agreement. The hearing was completed on July 13, 2007 and closing arguments were heard on August 21, 2007.

About GPC Biotech

GPC Biotech AG is a publicly traded biopharmaceutical company focused on discovering, developing and commercializing new anticancer drugs. GPC Biotech's lead product candidate is satraplatin, an oral platinum compound. The Company has various anti-cancer programs in research and development that leverage its expertise in kinase inhibitors. GPC Biotech AG is headquartered in Martinsried/Munich (Germany) and has a wholly owned U.S. subsidiary headquartered in Princeton, New Jersey. For additional information, please visit GPC Biotech's Web site at www.gpc-biotech.com.

This press release contains forward-looking statements, which express the current beliefs and expectations of the management of GPC Biotech AG. Such statements are based on current expectations and are subject to risks and uncertainties, many of which are beyond our control, that could cause future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Actual results could differ materially depending on a number of factors, and we caution investors not to place undue reliance on the forward-looking statements contained in this press release We direct you to GPC Biotech’s Annual Report on Form 20-F for the fiscal year ended December 31, 2006 and other reports filed with the U.S. Securities and Exchange Commission for additional details on the important factors that may affect the future results, performance and achievements of GPC Biotech. Forward-looking statements speak only as of the date on which they are made and GPC Biotech undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future.

GPC Biotech AG
Martin Braendle, +49 (0)89 8565-2693
Director, Investor Relations & Corporate Communications
ir@gpc-biotech.com
or
In the U.S.:
Laurie Doyle, +1 609-524-5884
Director, Investor Relations & Corporate Communications
usinvestors@gpc-biotech.com

SPPI has a much better looking chart pattern, had a Bullish Engulfing Pattern form with todays trading. I'm in GPCB just for bounce and then see what happens to it, GPCB is so thinly traded once it a bounces it should be a good bounce. I saw that the Anal-list still like SPPI and your right it has a bigger pipeline than GPCB. You have to give cash levels to GPCB nearly $3.50 in cash, but SPPI has a nice chest of cash at about $2/share.

FOOLMOTLEY's BRIAN WROTE ABOUT DNDN WHICH SURF BROUGHT TO OUR ATTENTION..
BRIAN SAID : "Those looking for an oncology-focused drugmaker with more impressive compounds in development should take a look at GPC Biotech (Nasdaq: GPCB) or Rule Breakers pick Exelixis (Nasdaq: EXEL) instead (OF DNDN --- MY ADDITION). It's time to go to CAPS and rate Dendreon underperform -- at least until the interim IMPACT data comes out."
very DRAMTIC dropp IN PPS over TIME .. IT LOOKS LIKE BOTTOM.. WHAT IS BOOK VALUE? ANY CASH? DEBT?
TIA

GOOD FIND SURF..
GL..

Surf,

You're pretty good at these blow-ups . . . but I like SPPI a lot better. Much better pipe than GPCB, and a better valuation and balance sheet, IMO. Would be curious to see what you think. As well as near term potential to pry a few million out of GPCB in arbitration related to upfront fees in GPCB/PHRM deal on satraplatin. That situation is still in play. Chances PHRM/GPCB can win EU approval of satraplatin on PFS data when OS data have come in negative are really slim, IMO.

Disclosure: I bought a bit of SPPI at $3.55 this morning.

Regards, RockRat

http://www.thestreet.com/_yahoo/newsanalysis/biotech/10387544.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA

GPC Biotech (GPCB - Cramer's Take - Stockpickr - Rating) tanked and Spectrum Pharmaceuticals (SPPI - Cramer's Take - Stockpickr - Rating) took a hit after saying Wednesday that the phase III SPARC trial on prostate cancer drug Orplanta (satraplatin) failed to show a survival benefit.

GPC licenses the drug for hormone-refractory prostate cancer from Spectrum. In July, the Oncology Drugs Advisory Committee (ODAC) recommended that the Food and Drug Administration wait to approve Orplanta until overall survival data from the SPARC trial were available, questioning the methodology of research that was submitted. Subsequently, GPC withdrew its new-drug application for accelerated approval.

Orplanta was the lead product candidate for GPC, which has an antibody in early-stage development for the treatment of lymphoid cancers, but no other mid- or late-stage prospects. GPC's shares fell $6.64, or 58%, to $4.80 -- $5.45 below its 52-week low. Spectrum, meanwhile, fell 51 cents, or 12.3%, to $3.65.

After removing Orplanta-related revenue and milestones from his model for Spectrum Pharmaceuticals, Rodman & Renshaw analyst Reni Benjamin arrived at a 12-month price target of $6. However, he seemed optimistic about Spectrum's bigger picture, noting a report: "While we are disappointed with the SPARC trial outcome, we believe Spectrum has a strong, advanced stage product portfolio that will generate shareholder value in the long-term."

Specifically, Benjamin is looking at the advancement of EOquin in two late-stage trials for low-risk superficial bladder cancer and a potential international partner for that program, and potential IIb data from the ongoing ozarelix trial in benign prostatic hyperplasia (BPH) in the second quarter of 2008 with the potential to initiate late-stage trials in 2008.

GPC Biotech Drug Fails Trial
Page 2


Shares of Pharmion (PHRM - Cramer's Take - Stockpickr - Rating), which has the right to market the drug in Europe, were seemingly unaffected. The stock rose $1.22, or 2.7%, to $48.59. Pharmion is set to release third-quarter earnings today after the close.

Already checked pipeline:

1D09C3 – Monoclonal Antibody Against Lymphoid Cancers


In 2005, it was estimated that more than 56,000 people in the U.S. and about 70,000 people in the European Union (EU) were diagnosed with non-Hodgkin’s lymphoma (NHL), the most common form of lymphoma. In recent years, good progress has been made in treating lymphoid cancers with antibodies such as Rituxan® (rituximab). However, a number of patients do not respond to existing treatments, and of those who do initially respond, the majority eventually relapses. Thus, there remains a major unmet medical need for additional therapies to treat patients who have relapsed or become resistant to currently available treatments.


Antibodies are normally produced by the body in response to the presence of foreign substances (antigens) in the body and are extremely specific. Monoclonal antibodies are manufactured proteins that share characteristics with naturally occurring antibodies. Each antibody usually binds to one particular type of antigen presented on a cell and can interfere with that cell’s activity or cause cell death. GPC Biotech’s 1D09C3 monoclonal antibody binds specifically to the MHC (major histocompatibility complex) class II molecule, which is found mainly on the surface of blood cells and certain tumor cells. In in vitro studies, 1D09C3 has been shown to kill these tumor cells by inducing programmed cell death.


Based on pre-clinical studies, the mechanism-of-action of 1D09C3 is believed to be novel and is different from those of Rituxan and other monoclonal antibodies currently approved for the treatment of NHL in the U.S. Unlike other antibodies in this indication, including Rituxan, 1D09C3 does not require a functioning immune system for its cell-killing effect. Patients who have been treated with currently approved therapies frequently have a weakened immune system. With its differentiating characteristics, 1D09C3 may hold the potential to become an important new therapy for NHL.

more

Focus on Kinase Inhibitors

GPC Biotech has ongoing drug development and discovery programs that leverage its expertise in kinase inhibitors. Protein kinases represent a large family of proteins that play an important role in signaling between and within cells. The inhibition of distinct kinases can therefore modulate various biological processes, some of which are critically important in the development of cancer. Many of the more than 500 protein kinases encoded by the human genome have been implicated in tumor growth.



One reason that a cell can become cancerous is an uncontrolled growth signal. This signal is sent to the nucleus on a pathway of kinases. As a result, the cell starts to grow and divide in an uncontrolled manner, which can eventually lead to the growth of a tumor if the signal is activated inappropriately. Inhibiting a specific kinase involved in such a pathway, and thereby interrupting the internal tumor cell communication, can be an effective way to develop a new anticancer treatment. Indeed, in recent years several new anticancer drugs that act through the inhibition of kinases have been approved for marketing.

at these prices this might be a good 'vulture' buy, but its only good if this company has other things going for them...

AP
Pharmion, GPC Cancer Drug Fails Study
Wednesday October 31, 8:01 am ET
Pharmion and GPC Biotech Cancer Drug Satraplatin Fails in Late Stage Study

NEW YORK (AP) -- Drug developers Pharmion Corp. and GPC Biotech AG said Wednesday the prostate cancer drug candidate satraplatin failed in a late-stage clinical trial.

The study involved 950 patients with a type of prostate cancer called hormone-refractory prostate cancer. Satraplatin combined with the corticosteroid prednisone did not meet the study's goal for overall survival rate when compared with placebo treatment.

The drug is being codeveloped by Spectrum Pharmaceuticals Inc. and GPC Biotech AG. In turn, GPC Biotech has a co-development and licensing agreement with Pharmion GmbH, a unit of Pharmion Corp., which has European rights to the drug candidate.

GPC Biotech said it is re-evaluating its development plans for satraplatin.

GPC Biotech Today Announced Results of Survival Analysis from the SPARC Trial
Overall Survival Results Do Not Achieve Statistical Significance

IRVINE, Calif., Oct. 30 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc.'s (Nasdaq: SPPI) licensee, GPC Biotech, today announced that the Phase 3 SPARC trial evaluating satraplatin for the treatment of hormone-refractory prostate cancer did not meet its primary efficacy endpoint.

'We are indeed disappointed that the overall survival data for satraplatin did not achieve statistical significance. Drug development is inherently risky and clinical studies do sometimes fail for various reasons, which is why we built Spectrum on a business model based on a diversified portfolio of several late- and early-stage drug candidates. We are not dependent on the success or failure of any one drug,' said Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. 'We will continue to aggressively develop our four late-stage drugs, ISO-Vorin(TM), which has a January 11th FDA action date; sumatriptan injection, which we will launch with PAR Pharmaceutical Companies in the second-half of 2008; EOquin(R), which is currently enrolling patients in two Phase 3 trials; and ozarelix, where we are currently working on the protocol for the pivotal registrational trial. Furthermore, we are currently planning and/or conducting studies for elsamitrucin, lucanthone, ortataxel, RenaZorb(TM), SPI-1620 and SPI-205.'

About Satraplatin

In 2002, Spectrum licensed the global rights to GPC Biotech (Frankfurt Stock Exchange: GPC; TecDAX index; Nasdaq: GPCB). GPC Biotech is responsible for all costs associated with the development and regulatory filings of Satraplatin. GPC Biotech has license agreements with Pharmion GmbH, a wholly owned subsidiary of Pharmion Corporation, and Yakult Honsha Co., Ltd.

Spectrum licensed worldwide rights to Satraplatin from Johnson Matthey PLC.

About Spectrum Pharmaceuticals

Spectrum Pharmaceuticals acquires, develops and commercializes a diversified portfolio of oncology drug candidates that meet critical health challenges for which there are few other treatment options. The company's pipeline includes promising early and late-stage drug candidates with unique formulations and mechanisms of action that address the needs of seriously ill patients, such as at-home chemotherapy and new treatment regimens for refractory disease. For more information, please visit our website at http://www.spectrumpharm.com.

Forward-looking statement -- This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to our business and its future, Spectrum's ability to identify, acquire, develop and commercialize its portfolio of drug candidates, the Company's promising pipeline, the Company's business model, that we are not dependent on the success or failure of any one drug, that we will continue to aggressively develop our four late-stage drugs, ISO-Vorin(TM), which has a January 11th FDA action date; sumatriptan injection, which we will launch with PAR Pharmaceutical Companies in the second-half of 2008; EOquin(R), which is currently enrolling patients in two Phase 3 trials; and ozarelix, where we are currently working on the protocol for the pivotal registrational trial, that we are currently planning and/or conducting studies for elsamitrucin, lucanthone, ortataxel, RenaZorb(TM), SPI-1620 and SPI-205 and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates, may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in- license and develop additional drug candidates may fail, our lack of revenues, our limited marketing experience, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.

COMPANY CONTACTS MEDIA CONTACT
Russell Skibsted Susan Neath
SVP & Chief Business Officer Porter Novelli Life Sciences
619-849-6007
Paul Arndt
Manager, Investor Relations
949-788-6700

SOURCE Spectrum Pharmaceuticals, Inc.

Source: PR Newswire (October 30, 2007 - 11:35 PM EDT)

News by QuoteMedia
www.quotem