Prostate Cancer

Cell Genesys halts GVAX program, cuts jobs

Maureen Martino — Thu, 16 Oct 2008 09:29:51 -0400

Cell Genesys has terminated a late-stage trial of GVAX immunotherapy in patients with prostate cancer. The company had 626 patients enrolled in the trial. The decision to halt the trial was made after an independent monitoring committee found that the trial had less than a 30 percent chance of meeting its predefined primary endpoint of an improvement in survival. Back in August a committee also noted a significantly higher death rate in the group taking a combination of GVAX and Taxotere compared to the control arm of the study.

You'll recall that Cell Genesys signed a $320 million deal with Takeda Pharmaceutical for global marketing rights to GVAX immunotherapy. Cell Genesys got $50 million up front and stood to earn $270 million more for hitting clinical and regulatory milestones. Now the company said that it will hold off on further development of the drug until Takeda reviews the program and decides what steps to take next. All this, of course, is very bad news for Cell Genesys employees. The company said it will reduce its staff of 290 by approximately 75 percent by year-end with further reductions anticipated in the first half of 2009 as additional activities are phased out.

"We are, needless to say, extremely disappointed with the outcome of the futility analysis for the VITAL-1 Phase 3 clinical trial, but remain committed to learning as much as we can about the potential role for immunotherapy in the treatment of cancer," stated Stephen A. Sherwin, M.D., chairman and chief executive officer of Cell Genesys.

- see Cell Genesys' release

ALSO NOTED: Acorda shares soar; Lexicon wins fast track; NIH grants $533N in research funds; and much more...

Tue, 03 Jun 2008 06:59:50 -0400

> News yesterday that Acorda Therapeutics' experimental MS drug helped patients walk better sent its shares up 27 percent. Report

> The FDA has provided fast-track status to Lexicon Pharmaceuticals' therapy for carcinoid syndrome. Story

> Cougar Biotech says it presented positive Phase I and Phase II data for CB7630, an experimental therapy for castration resistant prostate cancer. Release

> Arana Therapeutics and Greenovation Biotech have forged a pact to develop up to five anti-cancer antibodies. Report

> China's Genesis Pharmaceuticals Enterprises has raised $30 million in a private placement. Release

> Novartis "stole the show" at ASCO, Forbes says. Between the big Zometa news--that the bone drug may actually prevent breast cancer recurrence--and dramatic data on an experimental med, the Swiss pharma came out of ASCO looking pretty sweet. ASCO report

> Guess who's the new up-and-comer in pharma? Brazil. Report

> It's not a new question, but it's one whose urgency is growing: How long can Pfizer pay its big dividend? Report

> Eugene Melnyk (photo) said he'd do it, and now he has. The founder of Canada's Biovail launched a proxy battle for the company, looking to sweep out its board and senior management. Report

And Finally… The Scripps Transitional Research Institute was one of 14 research groups that will gain $533 million from the NIH over five years. The funds are earmarked to speed the development of new technologies. Report

Sonus, OncoGenex to merge

Wed, 28 May 2008 06:59:58 -0400

Bothell, WA-based Sonus Pharmaceuticals is merging with Canada's OncoGenex Technologies and will operate under the name OncoGenex Pharmaceuticals. OncoGenex's CEO Scott Cormack will head up the new company.

Sonus has been struggling since September when it pulled the plug on its lead therapy for breast cancer. Since then the company said it has been looking for ways to rebuild shareholder value. A merger with OncoGenex was the best way to do that, CEO Michael Martino said in a release.

The combined company has a strong oncology pipeline with three candidates in various stages of clinical development. Its lead candidate, OGX-011 for prostate cancer, is being evaluated in five Phase II clinical trials.

- see the merger release

Merck's osteoporosis drug performs in Phase II

Wed, 28 May 2008 06:59:56 -0400

Merck's experimental osteoporosis drug odanacatib turned in positive results in a Phase II trial. The drug reduced measures of bone turnover (breakdown and rebuilding of bone) in women with breast cancer that has spread to the bones. Odanacatib beat out Novartis's med Zometam in the trial.

Odanacatib inhibits cathepsin K enzyme, which plays a key role in breaking down the protein in bone. By inhibiting cathepsin K activity, odanacatib could offer a different approach for treating metastatic bone disease.

"Based on these findings, larger Phase III studies using the 5 mg daily dose of odanacatib are being planned for patients with breast and prostate cancer," said Antonio Lombardi, M.D., senior director, Merck Research Laboratories.

- check out Merck's release for more
- read the BusinessWeek article

Pfizer rumored to be eyeing MediGene buyout

Wed, 14 May 2008 06:59:57 -0400

Rumors are swirling that Pfizer is looking to take over the German biotech MediGene. Shares of the smaller company leapt more than 12 percent today as reports of a possible deal hit the newswires. Neither company would comment on whether they've held talks, as reports suggest.

MediGene specializes in cancer, autoimmune disease and skin disease; its two marketed products are the prostate cancer treatment Eligard and a genital warts med Veregen. European approval for a skin drug, Oracea, is pending. In the pipeline: a pancreatic cancer drug, Endotag.

- see the story in Forbes
- check out the brief at Thomson Merger News

Novacea cuts staff after partner dumps collaboration

Tue, 13 May 2008 06:59:54 -0400

A month after Schering-Plough pulled the plug on its collaboration with Novacea for a new prostate cancer therapy--Asentar--the little biotech company announced that it will cut its work force by more than half. Over the next two months Novacea's head count will dwindle from 37 to 15.

"While we believe the company is in a good financial position, the work force reduction was a very difficult decision for the management team, and we extend our sincere gratitude and appreciation to all of the affected employees," said Chairman and Chief Executive John P. Walker.

- see Novacea's release for more on the cuts
- read the AP report

Optimistic Dendreon revs up second program

Wed, 16 Apr 2008 06:59:57 -0400

Dendreon is making bullish noises about its development efforts. The CMO of the Seattle biotech says that Provenge will deliver positive new data to the FDA on the delayed cancer therapy Provenge later this year. And that advance is allowing Dendreon to free up some money so researchers can get back to its number two program: Neuvenge for breast cancer, which has already gone through two early-stage trials.

Dendreon presented new data on Neuvenge at AACR. The Post-Intelligencer reports that two of 11 patients with breast cancer whose disease had spread had their tumors stabilize after being on the Dendreon treatment for 49 weeks and 72 weeks, respectively. Researchers at the University of California-San Francisco and Mayo Clinic in Rochester, MN., didn't see any cases of tumor shrinkage.

Neuvenge is an offshoot of the prostate cancer drug Provenge, which reengineers patients' white blood cells to kill cancer cells. Earlier this month Dendreon announced that it had raised $47 million from an unnamed institutional investor. The unnamed investor, the Post-Intelligencer reports, is Susquehanna International Group.

- read the article in the Seattle Post-Intelligencer
- here's the earlier P-I story on the financing deal

Related Articles:
FDA accelerates Provenge timeline. Provenge report
FDA's stand on Provenge riles cancer patients. Provenge Report
Provenge delay triggers furor among cancer victims. Dendreon report
Dendreon gets approvable letter for Provenge. Dendreon report

ALSO NOTED: Targeted Genetics buys Sirna's share of program; Indevus in $21M licensing deal;Atrium Innovations sells division;

Mon, 07 Apr 2008 06:59:50 -0400

> Targeted Genetics has bought out Sirna's share of a Huntington's disease program three years after the partnership began. The deal follows Merck's buyout of Sirna at the end of last year. Targeted Genetics gains exclusive rights in return for a share of royalties from any future sales. Release

> Orion has licensed the European rights to Indevus Pharmaceuticals' prostate cancer therapy Vantas in a deal that's worth up to $21 million in upfront licensing fees and sales milestones. Indevus gets $7 million upfront with $14 million for certain sales goals. And Orion has agreed to buy a minimum amount of the therapy from Indevus. Already approved in the U.S. and U.K., a number of European countries are considering regulatory approval of Vantas as well. The therapy is implanted in prostate cancer patients, releasing a therapy over the course of 12 months. Report

> Atrium Innovations has inked a deal to sell its active ingredients and specialty chemicals division to AXA Private Equity for about $165 million. Report

> U.K. regulators are indicating that some major obstacles still stand in the way of approving Biopure's artificial blood product. They say that pharmacological and clinical issues remain unresolved about five months after the company filed for approval. Story

> Urigen Pharmaceuticals announced that it has terminated the development and license agreement for intranasal testosterone. Report

> In a bid to diversify its business away from traditional pharma, Novartis has bought a 25 percent stake in Alcon and is eyeing the purchase of another 52 percent in 2010. Report

> Drug companies appear to be close to gaining a long-coveted prize: A shield against patient lawsuits. Report

> You can bet the execs at AstraZeneca are biting their nails this week. Next Monday, April 14, marks the end of a 30-month stay on Ranbaxy Laboratories' copycat form of the mega-blockbuster Nexium. Report

> Wonder what it was like to be Fred Hassan (photo) last week, when his top products were getting hammered first at the American College of Cardiology meeting and then in the press? The Star-Ledger has a behind-the-scenes play-by-play of the Schering-Plough CEO's week. Report

And Finally... A (small) dose of anxiety may be good for your health. Release

Cell Genesys scores $320M blockbuster deal

Tue, 01 Apr 2008 07:59:58 -0400

Japan's Takeda Pharmaceutical will pay Cell Genesys $50 million upfront and up to $270 million more for hitting clinical and regulatory milestones in a marketing pact for its lead, late-stage prostate cancer therapy. Takeda gains global marketing rights while Cell Genesys retains co-promotion rights in the U.S. for GVAX immunotherapy. Cell Genesys will also maintain responsibility for the worldwide manufacture and supply of the product.

Stephen Sherwin, Cell Genesys' CEO, told analysts in a conference call that the deal was one of the most important in the company's history. Takeda has agreed to pay a tiered, double-digit royalty in the U.S. for the potential blockbuster and a flat double-digit royalty in other countries. Cell Genesys' GVAX technology is intended to stimulate the human immune system to recognize the cancer and attack it.

- check out the press release
- read the story from Wall Street 24/7

Related Articles:
Cell Genesys gains $75M in R&D funds. Report
Cell Genesys cuts jobs, focuses on lead drugs. Report
Cell Genesys reports vaccine data. Report
Takeda expands R&D budget, may look for buyout. Report

Oxford BioMedica benefits from TroVax results

Wed, 26 Mar 2008 07:59:55 -0400

Oxford BioMedica shares were boosted by the news that its first mid-stage trial of TroVax produced encouraging results for prostate cancer. Disease stabilization in patients currently ranges from two to 10 months. And anti-tumor immune response correlated with the clinical benefit, researchers say. TroVax is Oxford BioMedica's lead cancer immunotherapy product, which is being developed in collaboration with Sanofi-Aventis. The Phase II data were presented by the clinical investigators from the Methodist Hospital in Houston, Texas.

- and check out the press release
- read the report from Hemscott

Related Articles:
Is Sanofi preparing a bid for Oxford BioMedica? Report
Sanofi inks $690M pact for cancer vaccine. Report
Oxford BioMedica says licensing talks heating up. Report
Oxford BioMedica touts mid-stage TroVax trial data. Report

QLT stock rockets as acne drug is cleared for takeoff

Tue, 18 Mar 2008 07:59:57 -0400

Shares of QLT rocketed up 55 percent in a tense market yesterday after the biotech finished a lengthy task in persuading the FDA that a blood test should not be required before doctors prescribe its new acne medication. QLT's Aczone was approved three years ago but never commercialized as the company set out to prove in clinical trials that a blood test should not be required. The regulatory approval also clears the way for QLT to complete its planned sale of its U.S. division, which holds the rights to aczone and eligard, a prostate cancer drug. QLT says the acne medication has the potential to earn around $100 million a year. Analysts say that even if a buyer can't be found QLT can go ahead and launch the new drug.

QLT has been restructuring, laying off more than 100 workers near the start of year. QLT was disappointed by the sales of Visudyne, a therapy for age-related macular degeneration, but hopes that tests of a combination therapy using Visudyne will demonstrate it can be a cheaper, quicker alternative to current therapies. A new acne drug is also in the pipeline.

- see QLT's release for more
- check out the report in the Globe and Mail

Related Articles:
QLT posts 'for sale' sign. Report
QLT gains drug delivery tech in $42M buyout. Report
QLT says therapy fails Phase II trial. Report
QLT slashes spending as competition looms. Report

SPOTLIGHT: FDA accelerates Provenge timeline

Wed, 12 Mar 2008 07:59:53 -0400

More news in the ongoing Dendreon/Provenge saga. The FDA has agreed to amend Dendreon's Special Protocol Assessment (SPA) for a Phase III trial of Provenge, the company's prostate cancer treatment candidate. The amended SPA accelerates the expected timing of the trial results by about one year. Release

ALSO NOTED: Avastin approval may lower FDA bar; GTX shares skyrocket on cancer data; Novartis wins approval; and much more...

Mon, 25 Feb 2008 06:59:50 -0500

> Medicure shares plunged 80 percent this morning after the developer announced that its lead therapy, MC-1 for cardiovascular disease, failed to meet its primary endpoint in a late-stage trial. Company executive say they're disappointed but still hold hopes for the therapy's future. Report

> Some see the FDA's approval of Avastin for breast cancer as a sea change. In this view, the FDA has now lowered the bar for other cancer-drug approvals. That's because Avastin proved effective at stopping tumor growth but not at extending survival time, which has long been the gold standard for cancer treatments. If Avastin got an OK based on disease progression, so might many other cancer hopefuls waiting in the wings. Or so the theory goes. As we say, fortunetelling can be a dicey business. Report

> Shares of GTX shot up this morning after the company announced that late-stage data for toremifene citrate demonstrated its ability to reduce symptoms of prostate cancer. Based on the data, GTX says it will file an NDA by summer. Release

> Novartis has won approval from European regulators of its new combinatorial drug Eucreas for diabetes. Release

> In the latest round of cutbacks at Seattle companies, Rosetta Inpharmatics announced plans to lay off 12 workers. Report

> Actelion has formally withdrawn its application to the EMEA to extend approval of Zavesca. Release

> The NIH has kicked off a big trial pitting Avastin against Genentech sister med Lucentis. Eye docs have commonly used Avastin off-label, saying it's almost as effective as Lucentis, and costs significantly less. Report

> The Bush administration wants to hand the FDA more authority over food and drugs made overseas for U.S. use. But as several reports and audits have concluded recently, the FDA is already overladen with mandates and under-endowed with funding. Report

> Could Big Pharma be held to account for gray market sales of its drugs? Report

And finally… Researchers have identified a gene that plays a key role in baldness. That discovery is likely to generate new therapies for hair growth. Article

OncoGenex, Isis report Phase II success

Fri, 15 Feb 2008 06:59:57 -0500

OncoGenex and collaborator Isis Pharmaceuticals say that in a Phase II trial, OGX-011, in combination with either docetaxel or mitoxantrone, was well-tolerated as a second-line treatment for patients with prostate cancer. In addition, the trials demonstrated ongoing survival rates better than results published with chemotherapy alone.

"These data show that the combination of OGX-011 with docetaxel or mitoxantrone may improve treatment outcomes in second-line prostate cancer," said Dr. Fred Saad, the primary investigator in the study. "The data also suggests that re-treatment with docetaxel when combined with OGX-011 may reverse chemotherapy resistance in second-line docetaxel re-treatment." The results were presented at the 2008 Genitourinary Cancers Symposium. Planning is underway for a Phase III study utilizing chemotherapy plus OGX-011 as second-line therapy in patients progressing after a first-line docetaxel regimen.

- see OncoGenex's release for more

Related Articles:
OncoGenex outlines plans for $48 million IPO. Report

SPOTLIGHT: S&P likes GTx's Acapodene

Tue, 12 Feb 2008 06:59:53 -0500

Standard & Poor's Equity Research says that GTx is in an enviable position. Late-stage data is due this quarter for Acapodene, an experimental therapy for prostate cancer. "We believe both target markets represent population opportunities of more than 1 million patients." Report

Eisai faces delay for cancer drug

Fri, 01 Feb 2008 06:59:55 -0500

The FDA has delayed Eisai's NDA submission for E7389 (eribulin mesylate) for third-line treatment of advanced breast cancer. The company was hoping to gain accelerated approval for the drug, but can't because Bristol-Myers Squibb won approval for another drug for the same indication last October. The drug is also in Phase II trials for prostate cancer.

- see this release for more

Related Articles:
Eisai expands U.S. ops with $3.9B MGI buyout. Report
Eisai acquires Morphotek in $325M deal. Report
Eisai plans $105M expansion in NC. Report

More Congressmen call for FDA decision probe

Fri, 01 Feb 2008 06:59:54 -0500

Three more congressmen have joined the fray over Denderon's Provenge, a prostate cancer vaccine. Vern Buchanan (R-FL), Chris Van Hollen (D-MD), and Pat Murphy (D-PA), each wrote letters to John Dingell, who chairs the Energy and Commerce Committee. "As a member of Congress, I believe we must provide the necessary oversight to ensure that the federal approval process of life-saving therapies such as Provenge is prompt and efficient," Buchanan wrote. Two months ago, three other Congressmen also petitioned Dingell to investigate the FDA's controversial decision.

In May 2007, the FDA outraged cancer patients when it delayed the approval of Provenge. Previously, an FDA panel approved Provenge in a 13-4 vote, and though the FDA isn't required to follow the panel's recommendation, it almost always does. Critics say that two people who voted against the drug's approval may have a conflict of interest that interfered with their ability to make an unbiased decision.

- read this report from Pharmalot

Related Articles:
Congressmen want closer look at Provenge delay. Report
FDA's stand on Provenge riles cancer patients. Report
Congressmen want closer look at Provenge delay. Report
Provenge delay triggers furor among cancer victims. Report
Denderon gets approvable letter for Provenge. Report

SPOTLIGHT: GPC finds positive satraplatin data

Tue, 08 Jan 2008 06:59:53 -0500

Researchers at GPC Biotech say that they've discovered that a group of patients previously treated with Taxotere demonstrated a positive trend toward survival when treated with the experimental prostate cancer drug satraplatin. That data has persuaded the company to continue research on the therapy, which failed a pivotal late-stage trial. Report

FDA's stand on Provenge riles cancer patients

Thu, 03 Jan 2008 06:59:57 -0500

The FDA's decision to demand more data on Dendreon's cancer drug Provenge--after an advisory committee had recommended approval--has energized a host of prostate cancer patients. Advocacy groups have been raising their voices to protest--and in some cases make death threats--over what they see as a last hope for late-stage prostate cancer. Doctors have joined their voices to the chorus and some lawmakers have called for a probe of the decision. Regulators say there's no proof that it works. Patients say it's their only hope to add a couple of months to their lives.

- read the article from the Los Angeles Times

Related Articles:
Congressmen want closer look at Provenge delay. Report
Think tank asks FDA to purge conflicts. Report
Provenge delay triggers furor among cancer victims. Report
Dendreon gets approvable letter for Provenge. Report

Novacea slows down development program for AQ4N

Thu, 03 Jan 2008 06:59:55 -0500

Novacea, which is burning through $17 million to $19 million this year, says it will scale back on the development of AQ4N, shelving a clinical trial in acute lymphoblastic leukemia and delaying a clinical trial in B-cell lymphoma. The news was included in a strategic review of its plans for 2008. An ongoing Phase Ib/IIa clinical trial of AQ4N in patients with glioblastoma multiforme will continue.

"Since we terminated the ASCENT-2 trial in advanced prostate cancer, managing our capital resources, which totaled approximately $110 million in cash and receivables at the end of the third quarter of 2007, is a top priority as we seek to maximize the strategic options available to the company," says Novacea CEO John Walker.

- see Novacea's release
- read the report from Trading Markets

Related Articles:
Novacea ends Asentar trial, shares plunge. Report
Novacea cheered on decision to expand cancer trial. Report
Novacea stock rockets up on $440M deal. Report
Novacea files $75M IPO. Report