GPC Biotech

Celgene drops development deal with GPC

Maureen Martino — Wed, 06 Aug 2008 21:48:32 -0400

In another blow to GPC, Celgene has decided to drop out of its co-development and licensing pact for the cancer drug satraplatin. Celgene is returning rights to the drug in Europe, Turkey, the Middle East, Australia and New Zealand. GCP has been on the ropes since satraplatin failed to help prostate cancer patients live longer in a critical late-stage trial. Since then the drug developer has cut staff and is on the hunt for an M&A partner.

GPC CEO Bernd R. Seizinger 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."

- here's the GPC release

Report: Wilex, GPC nearing merger pact

Wed, 07 May 2008 06:59:58 -0400

Two German biotech companies which share a very big investor are preparing to merge, according to a prominent German newspaper. Wilex and GPC Biotech, both involved in developing new cancer therapies, are each backed by SAP founder Dietmar Hopp. Analysts say that a merger would suit both biotechs. GPC is well funded but doesn't have the late-stage therapeutics that investors love, while Wilex has a compelling late-stage project for kidney cancer. GPC's satraplatin recently failed in a clinical trial, adding to its motivation to merge.

The companies, though, aren't talking about any of it. Complicating the rumors: A third Hopp-based biotech--Heidelberg Pharma--has also been touted as a potential partner for GPC and Wilex. Hopp owns 15 percent of GPC, 28.52 percent of Wilex and 75 percent of Heidelberg. Wilex was a 2005 Fierce 15 company.

Just days ago GPC announced a new round of layoffs, with some of its top execs headed out the door.

- read the AFX report

GPC jettisons 38 workers in new round of layoffs

Mon, 25 Feb 2008 06:59:55 -0500

GPC Biotech's failure to get an FDA approval on satraplatin for cancer will cost the jobs of another 38 of its employees. GPC announced its first round of cuts last November. The new layoffs will preserve enough working capital for three years worth of work, says the developer. In addition to the latest cuts, COO Elmar Maier and the senior vice president of business development, Sebastian Meier-Ewert, are resigning from the management board but will remain as advisers. GPC's remaining work force will consist of 14 workers in Munich and 49 in Princeton.

"We have implemented a comprehensive strategic plan which includes a sharper focus on what we believe are our most promising oncology development programs and a further reduction of the company's cost structure,'' CEO Bernd Seizinger said.

- check out the release

Related Articles:
Struggling GPC looking for merger or acquisition. Report
More takeover targets for Big Pharma. Report
Troubled GPC cuts staff, looks for M&A deals. Report
GPC Biotech reports Q3 results, layoffs. Report
GPC shares crater on Phase III cancer failure. Report
FDA delay forces cutbacks at GPC Biotech. Report
GPC yanks FDA application for satraplatin. Report

ALSO NOTED: GPC Biotech's CFO resigns; Abbott Labs cuts 1,200 jobs; and much more...

Wed, 05 Dec 2007 06:59:50 -0500

> GPC Biotech's CFO Mirko Scherer has resigned; he will be replaced by Torsten Hombeck, Ph.D. Release

> A new entrant into the layoff club is Abbott Laboratories, which says it's cutting 1,200 jobs in Ireland and California. Report

> Immtech Pharmaceuticals will allow BioAlliance Pharma to commercialize Immtech's oral drug, pafuramidine maleate, in Europe for the treatment of pneumocystis pneumonia in AIDS patients and for the treatment of Human African trypanosomiasis, also known as African sleeping sickness. Release

> Lexicon Pharmaceuticals has begun dosing in a Phase IIa trial of LX6171, an oral drug candidate for the treatment of cognitive impairment associated with disorders such as Alzheimer's disease, schizophrenia, and vascular dementia. Report

> Adventrx Pharmaceuticals has completed patient enrollment in its Phase II trial of ANX-510, or CoFactor, for the treatment of advanced breast cancer. Report

> Preempt away. That's what the Bush Administration told the Supreme Court yesterday, supporting Medtronic's contention that its FDA-approved products shouldn't be subject to liability claims in state court. Report

> Scientists at Johns Hopkins were able to repair damaged skulls by transplanting human embryonic stem cells directly to the site of massive injuries. Report

> A team of scientists in the UK have designed a genetic tool that can disable genes equipped with antibiotic resistance, an approach that could scuttle superbugs like MRSA. Report

> Stimulating an "exercise" gene has a profound therapeutic effect on mice, raising the likelihood that a new drug that can trigger the same effect in humans, could work as a blockbuster antidepressant. Report

> The FDA warned doctors that desmopressin, a drug used to control bed-wetting, can cause some children to have potentially fatal seizures. Report

> Are drug makers responsible for a hospital's medical error? That's what actor Dennis Quaid and his wife are alleging in a lawsuit over the blood thinner given to their newborn twins last month. Report

And Finally... Honey may be an effective and safe alternative than over the counter children's cough medicines, according to a Penn State College of Medicine study. Release

Struggling GPC looking for merger or acquisition

Wed, 28 Nov 2007 06:59:58 -0500

Wanted: Private drug developer interested in partnering with struggling biotech specializing in cancer therapies. GPC Biotech essentially posted that message when its CEO announced that he is looking to partner up with a private biopharma player that would see extra value in the drug developer's listings in the U.S. and German markets. CEO Bernd Seizinger tells Financial Time Deutschland that he plans to stay on with the company as it tries to survive the late-stage failure of satraplatin. In recent days GPC has laid off almost half of its staff. Any alliance the company makes would focus exclusively on cancer therapies, he says. And Seizinger denies that he ignored warnings from the FDA when he pushed ahead with satraplatin. GPC has about $90 million in cash reserves.

- read the report from Thomson Financial

Related Articles:
More takeover targets for Big Pharma. Report
Troubled GPC cuts staff, looks for M&A deals. Report
GPC Biotech reports Q3 results, layoffs. Report
GPC shares crater on Phase III cancer failure. Report
FDA delay forces cutbacks at GPC Biotech. Report
GPC yanks FDA application for satraplatin. Report

Troubled GPC cuts staff, looks for M&A deals

Thu, 15 Nov 2007 06:59:58 -0500

The failure of GPC Biotech's cancer drug satraplatin in a Phase III trial is being paid for with the jobs of 44 percent of its workforce. PC announced late last week that it needed to significantly cut back to account for the setback. Now the company says it will concentrate "internal efforts on a limited number of development-stage oncology projects, significantly increasing our licensing efforts and actively exploring M&A opportunities." Sixty workers in Germany and 43 more in Princeton are getting pink slips. The remaining staff of 114 will be about evenly split between Germany and Princeton after GPC's Waltham, MA facility is closed.

"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," says CEO Bernd R. Seizinger.

- see this release
- read the AFX report for more

Related Articles:
GPC Biotech reports Q3 results, layoffs. Report
GPC shares crater on Phase III cancer failure. Report
FDA delay forces cutbacks at GPC Biotech. Report
GPC yanks FDA application for satraplatin. Report
FDA questions satraplatin. Report
Top 5 layoffs of 2007. Report

GPC Biotech reports Q3 results, layoffs

Fri, 09 Nov 2007 06:59:58 -0500

GPC Biotech is regrouping after last week's announcement that a Phase III trial of its prostate cancer drug candidate, satraplatin, failed to help patients live longer in a critical trial. With the possibility of near-term revenue from satraplatin gone, GPC said it will reorganized in order to make its $87 million in cash last through 2009. "Numerous cost-cutting measures to be implemented shortly, including a significant workforce reduction," the company stated in a release. No word yet on just how significant the cuts will be.

GPC will continue Phase II testing of satraplatin. In addition, the company has a Phase I monocolonal antibody in development, and plans to advance a small-molecule drug candidate into Phase I testing in the near future.

- see GPC's Q3 results
- read this Motley Fool item

Related Articles:
GPC shares crater on Phase III cancer failure. Report
FDA delay forces cutbacks at GPC Biotech. Report
GPC yanks FDA application for satraplatin. Report
FDA questions satraplatin. Report
Top 5 layoffs of 2007. Report

GPC shares crater on Phase III cancer failure

Wed, 31 Oct 2007 07:59:58 -0400

Germany's GPC Biotech saw its already battered stock price crater this morning after announcing that its experimental prostate cancer drug, satraplatin, failed to help patients live longer in a critical late-stage trial. GPC announced it was cutting its workforce by 15 percent to account for the trial disaster, which sliced 65 percent off of its remaining stock value.

The vultures had already been gathering around satraplatin after GPC and its partner, Pharmion, announced that they were withdrawing their FDA application until survival data was in. The data is also expected to have an impact on their European regulatory filing. In the trial, patients taking the therapy in combination with prednisone lived an average of 61.3 weeks compared to 61.4 weeks for the control group. That kind of survival response would not pass muster with regulators. Researchers say they will evaluate how they plan to proceed with the cancer program.

"We are extremely disappointed with the findings,'' said GPC Chief Executive Officer Bernd Seizinger in an understatement of the week. One analyst noted that the company's business model is somewhat "unclear" after the results were announced.

- see this release from GPC
- here's the report from MarketWatch

Related Articles:
FDA delay forces cutbacks at GPC Biotech. Report
GPC yanks FDA application for satraplatin. Report
FDA questions satraplatin. Report
Shares surge as satraplatin succeeds in Phase III. Report
Pharmion signs $270M licensing deal for GPC's satraplatin. Report

FDA delay forces cutbacks at GPC Biotech

Thu, 23 Aug 2007 06:59:58 -0400

Struggling to overcome FDA hurdles for its cancer drug satraplatin, Germany's GPC Biotech says it will slash its staff by 15 percent and ratchet down research and development costs. An FDA advisory committee opted to delay approval until the company can deliver final data on patient survival, which GPC has estimated would take six months. To survive the delay, the biotech is handing out 46 pink slips among its 316 employees. GPC licensed satraplatin five years ago, agreeing to take on development and regulatory costs. As part of the restructuring, GPC says it will slow down--for a while anyway--its work on its 1D09C3 monoclonal antibody and cell cycle inhibitors.

As part of a planned succession, Dr. Martine George is succeeding Dr. Marcel Rozencweig as senior vice president of drug development and chief medical officer. Dr. Rozencweig will remain with the company in the new role of senior vice president, clinical science and drug evaluation.

- check out the release

Related Articles:
GPC yanks FDA application for satraplatin. Report
FDA questions satraplatin. Report
Shares surge as satraplatin succeeds in Phase III. Report
Pharmion signs $270M licensing deal for GPC's satraplatin. Report

SPOTLIGHT: GPC hit by high R&D costs

Wed, 08 Aug 2007 06:59:53 -0400

Germany's GPC Biotech announced wider losses as a result of the expense of developing its prostate cancer therapy Satraplatin. A recent delay in gaining FDA approval of the drug sent GPC shares tumbling. Release

Industry exec says FDA approval process too strict

Wed, 01 Aug 2007 06:59:55 -0400

Citing the recent decision by GPC Biotech to withdraw its application for satraplatin, Pharmacyclics CEO Richard Miller says that the FDA is making it too tough to gain approvals for new cancer therapies and other drugs that fight life-threatening illnesses. Writing in The Wall Street Journal, Miller maintains that satraplatin is just the latest in a series of cases where the FDA has been making life too difficult for developers. Only one therapy achieved accelerated approval last year and none have made it through that process so far this year. He calls on the agency to revise its approach to drugs that can save the lives of patients who have exhausted other possible treatments.

- read the commentary from the Wall Street Journal (sub. req.)

Related Article:
Pharmacyclics shares plunge after Xcytrin flunks Phase III. Report

GPC yanks FDA application for satraplatin

Mon, 30 Jul 2007 06:59:54 -0400

Stymied by FDA regulators, GPC Biotech has pulled its application for satraplatin, an experimental therapy for prostate cancer. Regulators demanded to see more data on the drug before they could make a final decision, and GPC now plans to wait until a late-stage trial is complete before resubmitting. Data from the Phase III trial is expected in six months.

- read the report from Hemscott

Related Articles:
GPC cancer drug voted down by FDA committee. Report
FDA questions satraplatin. Report
Phase III data backs Satraplatin for prostate cancer. Report
GPC posts positive satraplatin data. Report
Pharmion signs $270M licensing deal for GPC's satraplatin. Report

GPC cancer drug voted down by FDA committee

Wed, 25 Jul 2007 06:59:58 -0400

An FDA expert committee has dealt a blow to GPC Biotech, concluding unanimously that regulators should wait for survival data before approving its prostate cancer drug Orplatna (satraplatin). The news triggered a rout among investors as GPC's stock slid 42 percent, wiping out $310 million of valuation. Shares of Spectrum Pharmaceuticals as well as Pharmion, GPC's partners on the drug, both slipped.

The committee wants to see if volunteers taking the pill in a trial lived longer than the placebo arm. Interim data from last summer demonstrated no improvement in survival rates and the company says that it could be another year before the new batch of data would be available. GPC based its application on the potential benefit for patients who had not responded to other treatments. Progression-free survival for the group on the drug was 11.1 weeks compared to 9.7 weeks for patients taking a placebo.

- see the release
- here's the AP report on the committee vote

Related Articles:
FDA questions satraplatin. Report
Phase III data backs Satraplatin for prostate cancer. Report
GPC posts positive satraplatin data. Report
Pharmion signs $270M licensing deal for GPC's satraplatin. Report

SPOTLIGHT: FDA questions satraplatin

Mon, 23 Jul 2007 06:59:53 -0400

Shares of GPC Biotech and Spectrum Pharmaceuticals took a big hit on Friday after the FDA raised questions regarding their cancer drug satraplatin. Analysts were alarmed that the agency was highlighting a disagreement between two radiologists over the progression of prostate cancer in patients who have failed to respond to chemotherapy. Reviewers may ask for a delay on any decision until final survival data is in. An expert FDA panel is scheduled to review the drug this week. Report

ALSO NOTED: Natco wins FDA OK; Clinquest gets stake in Enceladus; Pharmion submits MMA; and much more...

Tue, 26 Jun 2007 00:01:30 -0400

> The FDA has approved Natco's anti-cancer drug Ondansetron Hydrochloride tablets in multiple strengths. Report

> The Dutch company Clinquest has acquired a stake in Enceladus and has led a syndicate of investors to provide additional funding. Financial details were not disclosed. Release

> GPC Biotech announced that its partner, Pharmion, has submitted an MMA to the European Medicines Agency for satraplatin in combination with prednisone for the treatment of patients with metastatic hormone refractory prostate cancer who have failed prior chemotherapy. Release

> UCB and Biogen Idec announced the initiation of a Phase II study of CDP323--an oral VLA-4 antagonist--under development for relapsing-remitting multiple sclerosis. Release

> The FDA is allowing Allergan to change the label for Juvederm to indicate that the wrinkle filler lasts longer than had previously been thought. Release

> The UK's Intercytex has unveiled new early-stage data that supports its contention that an experimental artificial skin can reduce scarring. Report

And Finally... Disgraced scientist Hwang Woo-suk is back at work on cloned embryos. Report

ALSO NOTED: GPC inks deal for satraplatin; Acusphere's CFO takes his leave; and much more...

Mon, 25 Jun 2007 00:01:30 -0400

> GPC Biotech has signed a licensing agreement with Yakult Honsha for satraplatin in Japan. Release

> Sangamo BioSciences has presents encouraging data from a Phase I trial of its ZFP Therapeutic program. The drug is currently in two Phase II trials for the treatment of diabetic neuropathy. Release

> AstraZeneca today announced that Symbicort pressurized Metered Dose Inhaler is now available in the United States for the long-term maintenance treatment of asthma in patients 12 years of age and older. Release

> Chutes & Ladders: Acusphere CFO John Thero announced that he is leaving the company in order to "pursue other interests." Finance VP Frederick Ahlholm will fill the position until a replacement is named. Report (WSJ sub. req.)

> The FDA has approved new labeling for Genzyme's cartilage repair drug Carticel based on the completion of a post-approval commitment study. Release

And Finally... A new report predicts that China's Pharmaceutical market will become the fifth largest by 2010 and the world's largest by 2050. However, there are a number of hurdles the country must overcome before it can take its place as a leader in the pharmaceutical industry. Release

ALSO NOTED: Rosetta cuts share price; FDA committee to focus on Pentacel; and much more...

Tue, 23 Jan 2007 19:01:30 -0500

> Rosetta Genomics has cut the price range for its IPO to $7.50 to $8.50 a share. Report

> An FDA advisory committee will examine safety and efficacy issues surrounding the vaccine Pentacel from Sanofi-Aventis. Report

> Molecular Insight Pharmaceuticals has inked a licensing deal to develop and sell Onalta, a radiotherapeutic candidate, from Novartis. No financial details were released. Release

> GPC Biotech has raised € 33.6 million in a private placement. Release

> Chutes & Ladders: John Dyer is moving from CMS to the FDA, where he will be the deputy commissioner for operations and the new COO. Report

And Finally... A new study says that learning can slow the development of brain lesions in Alzheimer's. Report

Shares surge as satraplatin succeeds in Phase III

Sun, 24 Sep 2006 20:01:37 -0400

Shares of Pharmion and GPC Biotech surged after the drug developers announced that volunteers in a Phase III trial of satraplatin for prostate cancer demonstrated a 40 percent reduction in the risk of disease progression. The reduced risks were compared to disease progression among volunteers taking a placebo along with prednisone. Researchers say they will continue to treat volunteers whose cancer has not progressed and track their outcomes. Germany's GPC says it plans to push ahead with an application for marketing approval in the U.S. later this year while Boulder, CO-based Pharmion is planning a European application in the first half of next year. Spectrum Pharmaceuticals stands to earn $20 million in milestones based on the regulatory approval of Satraplatin, which is why their shares shot up 48 percent on the news.

- here's the AP report on the trial data

ALSO NOTED: Forest files suit against Caraco; Cephalon R&D chief sees potential; and much more...

Tue, 11 Jul 2006 20:00:50 -0400

> Forest Laboratories is suing Caraco Pharmaceutical Laboratories claiming patent infringements on the antidepressant Lexapro. Report

> Cephalon's R&D chief says Wall Street is underestimating the market potential of its experimental cancer therapies. Report

> Germany's GPC Biotech has filed another part of its marketing application for the cancer therapy satraplatin. Report

> Kos Pharmaceuticals has filed a drug application with the FDA for a new form of its Niaspan cholesterol therapy. Report

> Array BioPharma has pocketed $18 million of the $32 million it will receive from a sale-leaseback deal. Report

And Finally… A new study says that people taking a potion made from a hallucinogenic mushroom reported mystical experiences that led to behavioral changes that lasted for weeks. Researchers urged people not to try to replicate this study at home. Article

ALSO NOTED: Zolinza gets priority review; Origen touts transgenics advance; and much more...

Wed, 07 Jun 2006 20:00:50 -0400

> The FDA has granted a priority review of Merck's cancer drug Zolinza. The therapy is designed to treat advanced cutaneous T-cell lympyhoma, a cancer of white blood cells. Merck says it expects a decision on Zolinza by October. Report

> Origen Therapeutics says it has designed new techniques for producing genetically altered chickens which can produce drugs. The field of transgenics has attracted growing interest since GTC Biotherapeutics' recent ability to gain the EMEA approve of a new therapy from goat's milk. Report

> Chutes & Ladders: Digene Chairman and CEO Evan Jones has announced plans to retire. Report

> MediGene announced that it had won a patent fight in Europe over cancer-killing HSV. Report

> Haemonetics has acquired the outstanding shares of Arryx it doesn't already own for $26 million. The two companies have been collaborating on a new method for blood separation and processing. Release

> GlobeImmune has launched a Phase II clinical trial of GI-4000, a therapeutic vaccine for the treatment of patients with early-stage pancreas cancer. Release

> GPC Biotech says it will continue with a late-stage trial of Satraplatin following clearance from an independent monitoring board. Report

> Denmark's Genmab announced today that HuMax-CD38 was shown to inhibit the enzymatic activity of the CD38 molecule in preclinical studies. Release

> Merck KGaA confirmed that it holds more than five percent of Schering shares. Release

> Laureate Pharma has announced plans to invest $9 million in its Princeton, NJ plant. Release

> Repligen has begun a trial for a new imaging agent. Report

> In a new study, researchers say the market for protein therapeutics has more than doubled in four years. Report

> Canada's Cannasat Therapeutics has gained $5 million in financing. Release

And Finally... Connecticut's stem cell program has attracted proposals from 77 scientists. Article