Cell Genesys

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

GVAX questions depress Dendreon shares

John Carroll — Thu, 28 Aug 2008 11:43:55 -0400

After halting one GVAX study so it could further investigate a disturbing number of deaths, Cell Genesys' hopes for the vaccine are now focused on a separate Phase III trial that has not raised the same safety concerns. And analysts note that a success in that trial--which provides GVAX alone--could still warrant an approval. In the meantime, shares of Dendreon also traded lower as investors considered the possible implications for all the developers advancing cancer vaccines. Report

Deaths force halt to Cell Genesys cancer vaccine trial

John Carroll — Wed, 27 Aug 2008 10:07:55 -0400

A closely watched trial for Cell Genesys' prostate cancer vaccine GVAX was brought to a sudden halt after an independent monitoring committee noted a significantly higher death rate in the group taking a combination of the vaccine and Taxotere compared to the control arm of the study. In a statement, Cell Genesys said that 67 patients taking the combo therapy had died compared to 47 who were taking Taxotere alone. The company said it doesn't know why the vaccine group would experience a higher rate of death.

Investors weren't waiting for details. The news quickly wiped out 70 percent of the company's share price, leaving it at 85 cents this morning and pointed downward. The committee will now examine the death rate in a separate trial of GVAX called VITAL-1. In January, the committee gave researchers a green light to continue with that trial.

- check out the Cell Genesys release
- read the AP report

Takeda makes $8.8B bid for Millennium

John Carroll — Thu, 10 Apr 2008 08:51:20 -0400

Looking to expand out of a budget-bound Japanese market, Takeda is taking a big chunk of its $10 billion war chest and offering $8.8 billion in cash for U.S.-based Millennium Pharmaceuticals. The $25 per share offer is a 65 percent premium over Wednesday's close. Millennium is best known for the cancer drug Velcade, which Takeda is looking to turn into a global blockbuster. That would go a long way toward overcoming the looming patent expirations for Actos and Prevacid.

Recently Takeda and Abbott split up their long-time drug development partnership. That move boosted Takeda to the 14th largest drug company in the world, but investors have been fretting over the absence of a big takeover. Millennium has more than a half billion dollars in revenue last year and also has a number of inflammation and cancer therapies in the pipeline, which would also address Takeda's interest in oncology.

"Millennium greatly strengthens Takeda's global oncology portfolio, led by the flagship product Velcade, and further enhances its pipeline with clinically differentiated, high-quality product candidates," said Yasuchika Hasegawa, President of Takeda Pharmaceutical Company Limited.

- here's the release
- see this article from Forbes

Millinneum News:
Millennium chief scientist takes offbeat approach
Millennium spent $1.3M on lobbying
Positive Velcade data fuels stock rise
Analysts tag Velcade as blockbuster

Takeda News:
Amgen, Takeda ink massive development deals
Takeda expands R&D budget, may look for buyout.
Safety, efficacy problems sink Takeda drug
Cell Genesys scores $320M blockbuster deal with Takeda

Takeda makes $8.8B bid for Millennium

Thu, 10 Apr 2008 06:59:58 -0400

Recently Takeda and Abbott split up their long-time drug development partnership. That move boosted Takeda to the fourteenth largest drug company in the world, but investors have been fretting over the absence of a big takeover. Millennium has more than a half billion dollars in revenue last year and also has a number of inflammation and cancer therapies in the pipeline, which would also address Takeda's interest in oncology. "Millennium greatly strengthens Takeda's global oncology portfolio, led by the flagship product Velcade, and further enhances its pipeline with clinically differentiated, high-quality product candidates," said Yasuchika Hasegawa, President of Takeda.

- here's the release
- check out the report from Forbes

Related Articles:
Millennium chief scientist takes offbeat approach
Positive Velcade data fuels stock rise
Analysts tag Velcade as blockbuster
Amgen, Takeda ink massive development deals
Takeda expands R&D budget, may look for buyout.
Cell Genesys scores $320M blockbuster deal with Takeda

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

C&L: Stonehouse tapped to run Biocryst

Tue, 09 Jan 2007 19:01:32 -0500

BioCryst Pharmaceuticals announced that Jon P. Stonehouse, has been appointed CEO and a member of the company's board of directors. Stonehouse succeeds Charles E. Bugg, Ph.D., founder and former CEO who previously announced his intention to retire in 2007. In his new role, Dr. Bugg will become non-executive chairman of BioCryst.

Vincent F. Simmon, Ph.D., has joined Xytis as president, CEO and member of the board of directors. Dr. Simmon had been COO of Merrimack Pharmaceuticals previously served as the president and CEO of Cortex Pharmaceuticals.

Nektar Therapeutics has named Howard W. Robin as the company's new president and CEO. Robin will replace acting president and CEO Robert Chess who will remain chairman.

Panacos Pharmaceuticals announced that Alan W. Dunton, M.D. has joined the company as CEO.

Capnia has appointed Joseph J. Vallner, Ph.D., as president and CEO. Dr. Vallner joins Capnia from Cell Genesys where he served as president and COO.

Access Pharmaceuticals announced that Stephen R. Seiler has joined the company to serve as president and CEO and has been named a member of the board. Rosemary Mazanet, MD, PhD, former acting CEO of Access, has been appointed vice-chairman of the board and David P. Luci, C.P.A., has agreed to serve as audit committee chairman.

Aerovance has named Mark L. Perry, currently the company's executive chairman, as president and CEO.

Covance has promoted Luis Gutierrez to the new role of president of Covance Commercialization Services.

Dr. Michael Morrissey, formerly executive vice president of discovery at Exelixis, has been promoted to president of research and development. Lupe Rivera has been promoted to senior vice president of human resources and communication. Dr. Jeffrey Latts, formerly executive vice president of development, has decided to retire.

The Biotechnology Industry Organization has hired Sandra J. P. Dennis as BIO's new deputy general counsel for healthcare regulatory affairs.

Thomas Ichim has joined Medistem Laboratories as its chief of scientific development.

Cerimon Pharmaceuticals has named Daniel Levitt, M.D., Ph.D., executive vice president of research and development.

Ambit Biosciences has named Wendell Wierenga, Ph.D., as executive vice president of research and development.

NovaCardia, has named John E. Crawford as CFO.

Aptuit has appointed Peter J. Adamski as CFO.

ForteBio has named William A. Albright, Jr. as the company's CFO.

PharmAthene has named Christopher C. Camut as vice president and CFO.

ChemoCentryx has named Juan Jaen, Ph.D., to the position of senior vice president, drug discovery.

Idenix Pharmaceuticals has named Douglas Mayers, M.D. to the position of executive vice president and chief medical officer.

China Aoxing Pharmaceutical Company has named Hui (David) Shao, Ph.D., MBA, as senior vice president of finance.

INC Research has named Hans J. Moebius, M.D., Ph.D., as senior vice president of its central nervous system business for Europe.

Pozen named Gilda M. Thomas as senior vice president and general counsel.

Auriga Laboratories has appointed Jae Yu as its vice president of finance.

Takeda Pharmaceuticals North America has named Laurene Bentel vice president of human resources and administration.

Panacea Pharmaceuticals has named Pamela Harris, MD, as vice president medical and clinical affairs.

Hana Biosciences has promoted Gavin S. Choy, Pharm.D. and Alex Tkachenko, Ph.D. In their new roles, Dr. Choy will be responsible for all clinical operations as vice president, clinical operations, while Dr. Tkachenko gains added responsibility overseeing Hana's business development as vice president, corporate development and strategic planning.

Agile Therapeutics has made several appointments: Dr. Gary Shangold, M.D., has been engaged by the company as a senior scientific advisor; Greg Arnold, I.E., has joined the company as vice president of manufacturing and scale up; Bob Conway, M.E., has joined the team as vice president of operations.

Tikvah Therapeutics has named Lou Barbato, M.D., as vice president of clinical research and development and chief medical officer.

Progenics Pharmaceuticals has named Walter M. Capone to the newly created position of vice president, commercial development and operations. Additionally, Nicole S. Williams has been appointed to the company's board of directors.

Urigen has appointed Dennis H. Giesing, PhD to serve as the company's director of product development.

Avalon Pharmaceuticals has formed a clinical advisory board with Brian J. Druker, M.D.; Beverly Mitchell, M.D.; Carmen Allegra, M.D.; Kenneth C. Anderson, M.D.; Otis Brawley, M.D.; Edward A. Sausville, M.D. and Chris H. Takimoto, M.D.

CytoDyn has appointed Shan Lu, MD, PhD, to its scientific advisory board.

Acorda Therapeutics has elected Barry Greene, COO of Alnylam Pharmaceuticals, to its board of directors.

Bradley Pharmaceuticals has elected Leonard S. Jacob, M.D., Ph.D., as its non-executive chairman of the board.

Celgene announced that James J. Loughlin has been elected to the board of directors.

William D. Anderson, former president of Bell Canada Enterprises Ventures, will be joining MDS's board of directors.

David P. Meeker, M.D., president of the LSD Therapeutics business unit of Genzyme Corporation, has been named to the board of Penwest Pharmaceuticals.

David Mann of Spring Mill Venture Partners has joined BioStorage Technologies' board of directors.

C&L: Cell Genesys COO Vallner resigns

Tue, 31 Oct 2006 19:01:32 -0500

Cell Genesys announced that Joseph J. Vallner, Ph.D., the company's president and COO, has resigned to become the CFO of an early-stage, private biotechnology company.

Le@p Technology has named Dr. Donald J. Ciappenelli as CEO and chairman.

Access Genetics has named industry veteran George M. Hoedeman as its CEO.

Ilypsa has named William D. Waddill CFO.

ARCA Discovery has appointed Thomas A. Keuer as executive vice president of pharmaceutical operations.

Taro Pharmaceutical Industries said its CFO, Kevin Connelly, resigned after a critical auditor's report.

DeCODE Genetics has appointed Jakob Sigurdsson as senior vice president, corporate development.

Koronis Pharmaceuticals has appointed Stephen Becker, M.D., chief medical officer.

Kosan has appointed Robert De Jager as chief medical officer.

Gene Express has appointed John C. Anders, Ph.D. as vice president of operations.

Michael Ostrach has joined Dynavax as vice president, chief business officer and general counsel.

Dr. Yuan-Chi Su has accepted a position with Industrial Biotechnology to assist and oversee the process development and scale up of targeted compounds prior to large scale production and manufacturing.

Schering-Plough Corporation has appointed Eduardo Cortes as general manager, Schering-Plough Argentina.

Clarus Ventures announced Dr. Jeff Leiden, former president and COO of Abbott's Pharmaceuticals business, has joined the firm's Cambridge office as Partner.

Jody M. LoMenzo has joined Insmed as director, investor relations and corporate communications.

NeoStem has named Julio C. Guerra, MD, ABP, as the company's director of sales and marketing.

Cleveland BioLabs has named John Gordon, Ph.D. director of clinical operations.

GammaCan International has named Lynn Schuchter M.D. to the company's Scientific Advisory Board.

Pharmaceutical industry experts Dr Richard Jones and Dr Roy Bullingham have joined Xceleron's Scientific Advisory Board.

Avalon Pharmaceuticals has named Todd R. Golub, M.D., to the newly created position of chairman, Scientific Advisory Board.

OMRIX Biopharmaceuticals has named Joseph Akers as a new member of the board of directors.

Heiner Dreismann, Ph.D. has been named Nanogen's board of directors.

The board of directors of Zila elected Dr. David Sidransky to join its ranks.

Inspire Pharmaceuticals has appointed Nancy J. Hutson, Ph.D. to the company's board of directors.

Panacos Pharmaceuticals has named Laurent Fischer, M.D. to its board.

Sciele Pharma has named Jerry C. Griffin, M.D., to its board.

Blair touts biotech biz in San Francisco sit-down

Mon, 31 Jul 2006 20:01:38 -0400

Singling out Genentech for high praise, British Prime Minister Tony Blair sat down with a group of biotech execs in San Francisco yesterday to highlight his own commitment to boosting Britain's drug development industry. In a marked break with the Bush administration, Blair also emphasized the need for more research work in embryonic stem cells. A number of British biotech officials feel their country's research groups have stolen a march on the U.S., pushing ahead while stem cell work in the U.S. founders under a federal policy that severely restricts funding in the field. Executives from Gilead Sciences, Entelos, PDL BioPharma, StemCells, Cell Genesys and Amylin Pharmaceuticals met with the prime minister.

- check out the report from the San Jose Mercury News for more information

ALSO NOTED: Cadence files $86.3M IPO; Chutes & Ladders: Merck exec steps down; and much more...

Mon, 17 Jul 2006 20:00:50 -0400

> Yesterday, Cadence Pharmaceuticals filed an $86.3 million IPO with the SEC. The company currently has two Phase III products in development. Release

> Cangene today has filed an NDA for its recombinant human growth hormone product (rhGH) Accretropin with the FDA. Accretropin combats short stature in children with growth hormone deficiency and girls with Turner Syndrome. Release

> Chutes & Ladders: Merck's president of intercontinental human health, Per Wold-Olsen, has announced that he will retire. Wold-Olsen was the head of the company's prescription drug business in Europe, the Middle East, Africa, Latin American and Canada, as well as worldwide drug marketing. Report

> A federal court has upheld King Pharmaceuticals' patent for Altace, a treatment for high blood pressure. India's Lupin had been planning a generic version of the drug that would have infringed on one of King's patents. Report

> Cell Genesys has begun enrollment in a Phase I trial of CG0070 for the treatment of recurrent bladder cancer. Release

And Finally... Researchers from the University of Montana have potential treatments for cancer and migraines in the most unlikely place: a polluted lake. Article

ALSO NOTED: Nektar gains fast track for lung infection drug; Vertex reports positive hep C data; and much more...

Sun, 21 May 2006 20:00:50 -0400

> Nektar Therapeutics was given a fast-track designation for its lung infection prevention drug. Report

> Vertex announced that all 12 patients in a mid-stage trial of its VX-950 hepatitis C therapy showed no detectable signs of the virus after 28 days of therapy. Report

> ViroPharma announced that HCV-796, in development with Wyeth, cut levels of the hepatitis C virus by 97 percent in a small Phase I trial. Report

> CombinatoRx has released positive data for its mid-stage trial of Crx-102 for patients with periodontitis. Report

> Cell Genesys reports that an early-stage trial demonstrated that its experimental therapy, CG-0070, was safe and may have anti-tumor activity. Report

> A new study presented at the scientific meeting of the American Psychiatric Association has identified five predictors of bipolar disease. Researchers concluded that significant risk factors of bipolar disorder among patients already diagnosed with major depression were anxiety, feelings of people being unfriendly, family history of bipolar disorder, a recent diagnosis of depression and legal problems. Release

> Repros Therapeutics provided an update for its ongoing clinical studies. Release

> Consumer groups are asking the FDA to do a better job at policing nanotechnology. Report

> Alexza Pharmaceuticals has launched a Phase I trial of an experimental pain therapy. Release

And Finally… The search for an HIV vaccine has moved overseas amid a storm of controversy. Article

SPOTLIGHT: Cancer vaccines make headway

Tue, 28 Mar 2006 19:01:33 -0500

US News & World Report reports on the development of new cancer vaccines, with a special focus on Cell Genesys. Cell Genesys recently arranged $75 million in new capital. Article

ALSO NOTED: Cell Genesys arranges financing; GenVec expands TNFerade trial; Wisconsin to build flu research center;and much mor

Tue, 14 Mar 2006 19:00:50 -0500

> Cell Genesys of South San Francisco has arranged $75 million in financing from Kingsbridge Capital over the next three years. Report

> The FDA has given GenVec approval to expand a mid-stage trial of TNFerade for pancreatic cancer into a Phase II/III study. GenVec also announced that Kingsbridge Capital will provide $30 million in financing over three years. Report

> Wisconsin is devoting $9 million to a new research facility for pandemic flu viruses like bird flu. The 20,000 square-foot facility will be built in University Research Park in Madison. Report

> Pharmacopeia is expanding its collaboration deal with Neurocrine Biosciences. Report

> DuPont will cut 1,500 jobs and close facilities in Europe as part of its restructuring of its performance coatings division. Report

> Avant Immunotherapeutics has amended an agreement to accelerate a $40 million milestone payment. Release

> Nastech has entered into a multi-compound agreement with Novo Nordisk. Release

And Finally… As Sweden and Denmark were added to the list of countries confirming bird flu, HHS Secretary Michael Leavitt repeated warnings that the virus was likely to wind up on American shores in a matter of months. Article

ALSO NOTED: Varian buys IonSpec; China's Phynova debuts;and much more...

Sun, 26 Feb 2006 19:00:50 -0500

> Varian acquired IonSpec for $16 million. Varian gains the Fourier Transform mass spectrometry technology for its information-rich detection portfolio. Report

> China's Phynova surged on its public debut today. The drug developer has six drug candidates in the pipeline. Report

> Cell Genesys says that it expects to see the median survival time of patients rise in its second mid-stage trial of the cancer vaccine GVAX. Report

> Schering has exercised its option to purchase or lease the assets Chiron uses to manufacture Schering's MS drug Betaseron interferon beta-1b products. Report

> A category of popular drugs that includes Fosamax and Actonel can lead to bone death of the jaw. Report

> Norway's Algeta announced that its Phase II study of Alpharadin highlights its potential as a treatment for bone metastases in prostate cancer patients. Release

> Avalon Pharmaceuticals raised $7.25 million in a private placement. Release

> Peregrine Pharmaceuticals said that its therapy Tarvacin performed well in a Phase I trial. Release

> The FDA has approved Wockhardt's Ranitidine 75mg tablets as an over-the-counter therapy. Release

> Denmark's Genmab has reached its first milestone in its development deal with Serono. Release

And Finally... More than 60 bills have been filed by state lawmakers who either want to expand or restrict access to Plan B. Article

SPOTLIGHT: Cell Genesys reports vaccine data

Sun, 11 Dec 2005 19:01:33 -0500

Cell Genesys reports vaccine data
Cell Genesys today reported encouraging clinical data from a Phase II trial of GVAX vaccine for chronic myelogenous leukemia. Release

ALSO NOTED: German court rules against Pfizer; Diamyd buys Nurel; Genzyme acquires San Diego plant; and much more...

Mon, 21 Nov 2005 19:00:50 -0500

> A German court has ruled that regulators' price caps on Pfizer's Lipitor are legal. Pfizer's sales in Germany have plunged by one-fifth in the first half of this year. Report

> Sweden's Diamyd Medical has agreed to acquire all of the outstanding shares in Nurel, a Pittsburgh-based biotech valued at $1.5 million. Release

> Genzyme of Cambridge, MA, has acquired Cell Genesys' San Diego manufacturing operation for $3.2 million. Release

> Myriad Genetics has extended its research alliance with Abbott studying how genetics affect people's response to medicine. Report

> AMDL has inked a letter of intent to buy two Chinese pharmaceutical companies for more than 13 million shares of company stock. Release

> Bentley Pharmaceuticals has been given approval to market omeprazole for heartburn in Ireland. Report

> Cubist Pharmaceuticals of Lexington, MA, has expanded its US hospital sales organization. Release

> Oragenics has completed a deal to gain up to $1.2 million in equity based financing. Release

And Finally… A new procedure--preimplantation genetic diagnosis--is being used to help women successfully give birth after multiple miscarriages. Article

ALSO NOTED: UK officials give limited OK to Sativex; Lipitor fails to beat Zocor in head-to-head trial; Celsion to focus on dru

Mon, 14 Nov 2005 19:00:50 -0500

> Shares of the UK's GW Pharmaceuticals surged after UK officials indicated that its cannabis-based painkiller could be imported from Canada for certain uses. Earlier this year British regulators said they needed more data from GW before they could make a final decision on Sativex. Report

> A head-to-head trial of Pfizer's Lipitor versus Zocor failed to demonstrate that Lipitor was any better than Zocor in preventing heart attacks and deaths from heart disease. Report

> Maryland's Celsion is shifting out of the medical device field in order to focus on drug development work. A pending deal with Boston Scientific would fund the company through 2008, leaving the biotech enough resources to push a new drug down the pipeline. Article

> Researchers have identified gene variants that limit the effectiveness of statins in lowering bad cholesterol. Article

> Duke University Medical Center stands to gain $8 million to $10 million per year in royalties from an FDA approval of Genzyme's Myozyme for Pompe disease, which could come by year's end. Report

> South San Francisco-based Cell Genesys has announced positive Phase II data for its pancreatic cancer vaccine. Release

> Roche has rejected a possible link between Tamiflu and the recent suicides of two Japanese youths, saying there is no established link between the drug and abnormal behavior. Report

> Botox-maker Allergan has bid $3.2 billion for Inamed, which makes breast implants. Report

> The FDA wants a US court to reject a lawsuit from Novartis claiming undue regulatory delays in approving its generic human growth hormone. Report

And Finally… Seven Israeli biotech companies are journeying to investment capital-rich California this month to woo stem cell investors. Article

Cell Genesys cuts jobs, focuses on lead drugs

Mon, 06 Jun 2005 20:01:39 -0400

Citing a strategic realignment, Cell Genesys has decided to slash 95 jobs -- one quarter of its work force -- as it scales back some of its operations and concentrates on its leading drug candidates. The biotech touted positive data last month on GVAX for prostate cancer, pancreatic cancer and leukemia. It also wants to push CG0070 for recurrent bladder cancer. Cell Genesys is putting its San Diego manufacturing site up for sale and will reduce its operations in Memphis. The biotech had $145 million in cash at the end of the first quarter.

"As with similar decisions in the past, we are implementing this restructuring from a position of financial strength and at a time when encouraging progress in our clinical trials gives us the opportunity to optimize portfolio management," said Stephen A. Sherwin, Cell Genesys chairman and CEO, in a statement.

- read this story from the AP for more