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Topic: VaxGen

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	CIDRAP >> VaxGen to seek US licensing for attenuated smallpox vaccine
		Dec 19, 2002 (CIDRAP News) – VaxGen Inc., a California biotechnology company, announced plans this week to seek US licensing for an attenuated smallpox vaccine that is considered safer than existing vaccines but was developed too recently to be proved effective against the disease.
		VaxGen has agreed with the vaccine's Japanese manufacturer, the Chemo-Sero-Therapeutic Research Institute, or Kaketsuken, to pursue regulatory approval of the vaccine in the United States.
		VaxGen officials said their joints plans with Kaketsuken call for the Japanese company to manufacture the vaccine and export it to the United States.
	www.cidrap.umn.edu /cidrap/content/bt/smallpox/news/vaxgenatten.html (845 words)

	Sample Contracts - Employment Agreement - VaxGen Inc. and Piers Whitehead - Competitive Intelligence for Investors
		VaxGen shall pay Whitehead's reasonable business expenses, including expenses incurred for travel on VaxGen business, in accordance with the policies and procedures of VaxGen, as may be adopted or amended from time to time at VaxGen's sole discretion.
		VaxGen shall maintain, for the benefit of Whitehead, director and officer liability insurance in form at least as comprehensive as, and in an amount that is at least equal to, that maintained by VaxGen as of the Effective Date of this Agreement for its other officers and directors.
		VaxGen shall pay the entire cost of the arbitrator's services, the facility in which the arbitration is to be held, and any similar costs that Whitehead would not have otherwise incurred if the dispute were adjudicated in a court of law rather than through arbitration.
	contracts.onecle.com /vaxgen/whitehead.emp.2002.07.01.shtml (3821 words)

	Sample Contracts - Employment Agreement - VaxGen Inc. and Lance Ignon - Competitive Intelligence for Investors
		VaxGen shall pay Ignon's reasonable business expenses, including expenses incurred for travel on VaxGen business, in accordance with the policies and procedures of VaxGen, as may be adopted or amended from time to time at VaxGen's sole discretion.
		VaxGen shall maintain, for the benefit of Ignon, director and officer liability insurance in form at least as comprehensive as, and in an amount that is at least equal to, that maintained by VaxGen as of the Effective Date of this Agreement for its other officers and directors.
		VaxGen shall pay the entire cost of the arbitrator's services, the facility in which the arbitration is to be held, and any similar costs that Ignon would not have otherwise incurred if the dispute were adjudicated in a court of law rather than through arbitration.
	contracts.onecle.com /vaxgen/ignon.emp.2001.09.25.shtml (3871 words)

	Brian Deer on VaxGen's AidsVax - vaccine results
		VaxGen intends to conduct additional analyses to confirm if there was a direct correlation between the level of antibodies and the prevention of infection.
		VaxGen is nearing completion of its Phase III trial in Thailand, testing a formulation of AIDSVAX designed to protect against HIV subtypes B and E, and expects to announce results of that trial in the second half of 2003.
		VaxGen is also in an early stage of developing a vaccine against HIV subtype C, prevalent in Sub-Saharan Africa, India and China.
	briandeer.com /vaxgen/aidsvax-release.htm (1434 words)

	VaxGen Suffers Delisting
		VaxGen announced the Nasdaq verdict late Friday, repeating earlier comments that it is implementing "a more appropriate revenue recognition policy." The company said those efforts caused the delay in filing its quarterly financial reports for the three months ended March 30 and for the three months ended June 30.
		VaxGen had $18 million in cash and investment securities as of June 30, and the company said it believes it has sufficient cash resources to operate into the first quarter of 2005.
		VaxGen has noted that this issue had been revealed to investors as early as February 2003, but it wasn't until May 2004 that the company delayed filing its first-quarter financial report.
	www.thestreet.com /stocks/biotech/10177198.html (438 words)

	The Body: VaxGen AIDS Vaccine Fails to Protect Participants From HIV Infection in Thai Clinical Trial
		VaxGen said that the vaccine failed to meet its primary endpoint of preventing HIV infection; the vaccine also failed to meet the secondary endpoint of "slow[ing] the progression of disease among those who received the vaccine but later became infected with HIV," according to a VaxGen release.
		VaxGen in July announced that it is conducting another trial in Thailand using AIDSVAX along with Aventis Pasteur's ALVAC in 16,000 HIV-negative volunteers from Rayong and Chon Buri provinces in Thailand.
		VaxGen President Donald Francis said that the trial results show "how important it is for the international public health community to redouble the effort to develop an effective vaccine" (Washington Post, 11/13).
	www.thebody.com /kaiser/2003/nov13_03/vaxgen_trial.html (1134 words)

	FDA Clears VaxGen's IND For Anthrax Vaccine Candidate
		VaxGen plans to launch a phase I human clinical trial involving about 100 volunteers to evaluate the safety and efficacy of its candidate vaccine compared with the existing licensed anthrax vaccine.
		VaxGen is already required under its existing NIAID contract to submit a plan for manufacturing 25 million doses in the case of an emergency under an active investigational new drug application.
		VaxGen plans to produce the vaccine candidate at its South San Francisco, Calif., facility if it wins either or both of the contracts.
	www.ph.ucla.edu /epi/Bioter/vaxgenanthraxvac.html (372 words)

	VaxGen CFO Resigns
		"VaxGen's goal is to file all of its amended outstanding financial statements with the SEC by the end of the third quarter of 2005, although the timing could slip into the fourth quarter," the company said in a prepared statement.
		VaxGen, which is developing an anthrax vaccine under contract with the U.S. government, said it intends to seek readmission to Nasdaq once the filings have been made.
		VaxGen, based in Brisbane, Calif., said James M. Cunha, the chief financial officer, had resigned and would be replaced on an acting basis by Kevin C. Lee, VaxGen's senior director of finance.
	www.thestreet.com /stocks/robertsteyer/10226693.html (508 words)

	VAXGEN, INC. - Complaint For Violations Of The Federal Securities Laws
		VaxGen is engaged in the development and commercialization of AIDSVAX, a vaccine designed to prevent infection or disease caused by HIV (Human Immunodeficiency Virus), the virus that causes AIDS.
		VaxGen was founded in November 1995 to complete the development of, and to commercialize, an AIDS vaccine in partnership with Genentech, Inc., which reserved the rights to market any AIDS vaccine ever developed.
		At midnight on Sunday, February 23, 2003, VaxGen announced initial results from the Phase III trials of AIDSVAX to prevent HIV infection in the U.S. The results for the Thailand part of the study would not be released until the end of 2003.
	securities.stanford.edu /1027/VXGN03-01/20030325_o02c_Braun.html (4736 words)

	VaxGen reports Phase I clinical trial results of anthrax vaccine candidate
		VaxGen, Inc. is a biopharmaceutical company engaged in the development, manufacture and commercialization of biologic products for the prevention and treatment of human infectious diseases.
		VaxGen also is the largest shareholder in Celltrion, Inc., a joint venture formed to build operations for the manufacture of biopharmaceutical products, including VaxGen's product candidates.
		VaxGen undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date of this release except as required by law.
	www.eurekalert.org /pub_releases/2004-03/vi-vrp022504.php (1026 words)

	VaxGen News
		VaxGen, Inc. announced today that peer-reviewed data from the company's Phase I clinical trial of its candidate anthrax vaccine rPA102 were published in the journal Vaccine.
		VaxGen, Inc. today announced that it has postponed a presentation by its Senior Vice President of Research and Development at a pre-conference symposium scheduled for today but that the company' President and...
		VaxGen said it believed the $877 million contract for 75 million doses of its vaccine was won following an open, competitive and fair bidding process that, "to the best of our knowledge, complied with any and...
	www.topix.net /com/vxgn?scoring=r (712 words)

	VaxGen Awarded Anthrax Vaccine Contract Worth $877.5 million
		VaxGen expects to recognize revenue from the supply contract upon acceptance of the vaccine by the U.S. government and delivery to the SNS.
		Under the terms of the contract, VaxGen is required to continue developing the vaccine with the goal of receiving FDA approvals for use of the vaccine both before and after exposure to anthrax.
		VaxGen's rPA102 vaccine is composed of a purified protein called recombinant Protective Antigen (rPA) and an aluminum salt routinely used in many vaccines.
	www.medicalnewstoday.com /medicalnews.php?newsid=15998 (1141 words)

	SignOnSanDiego.com > News > Business -- VaxGen wins $80 million U.S. anthrax vaccine contract
		LOS ANGELES – Vaccine developer VaxGen Inc. Tuesday said it was awarded an $80.3 million contract from the U.S. National Institutes of Health for development of an experimental anthrax vaccine.
		VaxGen, which received funding under an earlier U.S. vaccine development contract, said the new program is intended to fund animal studies, mid-stage human trials, manufacturing needs and production of 3 million doses of finished product.
		VaxGen plans to manufacture the protein antigen used in the vaccine, known as rPA102, in its manufacturing facility in South San Francisco.
	www.signonsandiego.com /news/business/20030930-1819-health-vaxgen.html (289 words)

	SignOnSanDiego.com > News > Business > Biotechnology -- VaxGen wins anthrax vaccine contract
		Vical's DNA-based vaccine technology is different from VaxGen's – among other things, it targets two proteins from the deadly bacteria instead of one – Samant said.
		The company has to provide proof that the drug protects two species of animals exposed to anthrax; it would be unethical to expose humans to the bacteria in order to test the drug.
		VaxGen said it expects to begin delivering the vaccine in early 2006.
	signonsandiego.com /news/business/biotech/20041105-9999-1b5vaxgen.html (522 words)

	NIAID And VaxGen, Inc. Collaborate On AIDS vaccine Studies (Site not responding. Last check: 2007-11-02)
		VaxGen is using a subunit vaccine of the gp120 protein, exploring the role of antibodies in protection.
		VaxGen's AIDSVAX vaccine is currently in late-stage (Phase III) clinical trials in 5,000 volunteers in North America.
		VaxGen is pursuing its development, and NIAID is pursuing development of the combination approach.
	www.hivpositive.com /f-Topics/AIDS-Topics/AIDSvaccine.html (1220 words)

	Millipore - Millipore Homepage - VaxGen and Millipore
		VaxGen, Inc., is focused on the commercial development of biologic products for the prevention and treatment of human infectious diseases and is currently developing vaccine candidates against HIV/AIDS, anthrax and smallpox.
		VaxGen is the largest shareholder of Celltrion, Inc., a joint venture created to provide manufacturing services, principally for products produced in mammalian cell culture.
		Millipore products are used in VaxGen's research and process development laboratories, while our services and systems are used in manufacturing.
	www.millipore.com /corporate.nsf/docs/5n5txe (183 words)

	Pharmaceutical Technology - VaxGen Biopharmaceutical Manufacturing Plant, San Francisco, USA
		VaxGen is already working towards an anthrax vaccine for the National Institute of Allergy and Infectious Diseases (NIAID).
		VaxGen has not had to contribute any cash or equity to the project.
		VaxGen's new plant has 17,000ft² of floor space for the manufacture of protein therapeutics, vaccines and monoclonal antibodies, using recombinant bacterial fermentation and mammalian cell cultures.
	www.pharmaceutical-technology.com /projects/vaxgen (643 words)

	RedOrbit - Health - Published Study Demonstrates Single Dose of VaxGen's Smallpox Vaccine Candidate Provides Complete ...
		VaxGen is developing LC16m8 in the United States in partnership with the Chemo-Sero-Therapeutic Research Institute (KAKETSUKEN) of Kumamoto, Japan, the licensed manufacturer of LC16m8.
		VaxGen is the largest shareholder in Celltrion, Inc., a joint venture formed to build operations for the manufacture of biopharmaceutical products.
		VaxGen undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date of this release except as required.
	www.redorbit.com /news/display?id=228249&source=r_health (707 words)

	CIDRAP >> NIAID awards two contracts to develop new anthrax vaccine
		Contracts worth a total of $22.5 million through fiscal 2003 were awarded to VaxGen Inc. of Brisbane, Calif., and Avecia of Manchester, United Kingdom, the NIAID announced last week.
		"If results from the first phase are positive, VaxGen will be eligible for an additional $13.6 million in 2003 as a continuation of the current contract to support a Phase II clinical trial," the company statement said.
		Battelle, a VaxGen subcontractor in Columbus, Ohio, will have the main responsibility for manufacturing the vaccine and conducting preclinical safety and efficacy studies, VaxGen officials said.
	www.cidrap.umn.edu /cidrap/content/bt/anthrax/news/vaxgen.html (619 words)

	VaxGen and EndoBiologics form collaboration to pursue early stage research for meningitis B vaccine
		VaxGen intends to fund proof-of-concept studies during the next 12 months and has an exclusive option to continue product development if the studies yield promising results.
		VaxGen and EndoBiologics believe that EndoBiologics' production method could alleviate this concern by using a biological, rather than chemical, means for detoxifying the antigen, thus potentially preserving important regions thought to be involved in the induction of protective antibodies.
		VaxGen is also the single largest shareholder in Celltrion, Inc., a contract manufacturing organization established in South Korea for the production of biopharmaceutical products grown in mammalian cell culture.
	www.eurekalert.org /pub_releases/2005-05/vi-vae050305.php (928 words)

	VaxGen, Inc.
		VaxGen, Inc., incorporated 1995, is a biopharmaceutical company engaged in the development, manufacture and commercialization of biologic products for the prevention and treatment of serious human infectious disease.
		In November 2004, VaxGen was awarded an $877.5 million contract to supply 75 million doses of anthrax vaccine for civilian defense.
		The contract calls on VaxGen to deliver 25 million doses of the vaccine to the Strategic National Stockpile within two years of the award and a total of 75 million doses within three years.
	www.biospace.com /company_profile.aspx?CompanyID=3399 (512 words)

	(BW) (VAXGEN-INC) VaxGen Gains FDA Go-Ahead for First-Ever Phase III Trial of HIV Vaccine; Company to Begin Large-Scale ...
		The company also is preparing to conduct Phase III clinical trials in Thailand and anticipates receiving the go-ahead from official agencies, including the FDA and Thai Health Ministry, to begin inoculating volunteers there this fall.
		VaxGen presented its initial proposal to an FDA advisory committee in June 1997; it submitted its final protocol for the Phase III trials to the FDA and received that agency's permission last month to proceed in the United States with the large-scale trial, which will involve approximately 5,000 volunteers at multiple sites in North America.
		VaxGen, based in South San Francisco, Calif., is a biotechnology company committed to making an HIV vaccine for worldwise use.
	www.aegis.com /news/bw/1998/bw980602.html (1472 words)

	First AIDS Vaccine May Protect Minorities-Vaxgen - HardwareGeeks.com A Community For the Sophisticated Geek or Geekette
		Long-awaited results from VaxGen's trial of AIDSVAX show the vaccine only reduced the rate of HIV infection by 3.8 percent in 5,400 men and women considered at high risk, VaxGen said in a statement.
		When VaxGen's figures were analyzed closely, they showed that Asians and fls who got the vaccine had a 67 percent lower rate of infection that those who got a placebo shot.
		After praising VaxGen for "taking the first AIDS vaccine candidate through the rigors of human trials," Berkley said the company "demonstrated that a large trial of an AIDS vaccine could be completed with high retention of volunteers, and that the volunteers would not increase their risk behavior."
	www.hardwaregeeks.com /board/showthread.php?t=6995 (952 words)

	NIAID Collaborates with VaxGen on Vaccine Studies
		VaxGen is sponsoring these trials and anticipates conducting additional Phase III studies in Thailand.
		These activities are part of NIAID’s ongoing efforts to determine systematically the effects of immunization and the potential for different approaches to prevent HIV disease.
		VaxGen, Inc., based in South San Francisco, Calif., is a biotechnology company committed to making an HIV vaccine for worldwide use.
	www3.niaid.nih.gov /news/newsreleases/1998/vaxgen.htm (378 words)

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