Current Report — Form 8-K
Filing Table of Contents
Document/Exhibit Description Pages Size
1: 8-K Current Report 4 12K
2: EX-99.1 Press Release Issued July 2, 2002 2 10K
3: EX-99.2 Amended and Restated License and Supply Agreement 31 120K
4: EX-99.3 Press Release Issued July 8, 2002 2 11K
EX-99.1 — Press Release Issued July 2, 2002
EX-99.1 | 1st Page of 2 | TOC | ↑Top | Previous | Next | ↓Bottom | Just 1st |
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Exhibit 99.1
VaxGen and Genentech Amend Agreement to Facilitate Commercial
Introduction of AIDS Vaccine Candidate
BRISBANE, Calif., July 2 - VaxGen Inc. announced today that its May 1, 1996
License and Supply Agreement with Genentech, Inc. has been revised to give
VaxGen greater flexibility in commercializing the company's AIDS vaccine
candidate. While Genentech maintains its option to market and sell the vaccine
candidate in North America, the company has relinquished its option to
commercialize it in the rest of the world.
The new agreement also reduces VaxGen's royalty obligations to Genentech for
sales to the World Health Organization or United Nations for underdeveloped
countries by up to 50% so that the vaccine can be made more widely available
there. "This reflects the commitments of VaxGen and Genentech to ensure that
AIDSVAX reaches not only the affluent markets but also countries where the AIDS
epidemic is at its worst," said Donald P. Francis, M.D., D.Sc., VaxGen's
president.
Additionally, the agreement formalized Genentech's previous decision to waive
its option to manufacture the vaccine candidate. "VaxGen and Genentech agreed
that, given VaxGen's role in advancing the project, VaxGen should have control
over the manufacturing of the AIDSVAX vaccine," said Lance K. Gordon, Ph.D.,
VaxGen's chief executive officer.
The revisions also facilitate VaxGen's ability to pursue international marketing
partnerships. "If AIDSVAX proves effective and is licensed, VaxGen intends to
sell directly to selected bulk purchasers and to partner with companies with
established sales and marketing forces to reach individual customers, including
hospitals and physicians," Gordon said.
Lastly, Genentech extended the milestone date associated with VaxGen submitting
a license application to the FDA.
Genentech's formal decision not to manufacture AIDSVAX follows VaxGen's
announcement earlier this year that it is creating a cGMP manufacturing facility
in the South San Francisco area with the capacity to produce at least 10 million
doses of AIDSVAX per year. VaxGen's strategy is to initiate commercial
manufacture in the South San Francisco facility and then amend its license to
include manufacture in a facility being built in Incheon, South Korea, by
VaxGen's Celltrion Inc. joint venture. This larger facility is scaled to
initially produce in excess of 200 million doses of AIDSVAX per year.
As well as retaining an economic interest in the sales of AIDSVAX, Genentech
owns approximately 11% of VaxGen's common shares.
About VaxGen
VaxGen is focused on the commercial development of biologic products for the
prevention and treatment of human infectious diseases and is the only company
with AIDS vaccine candidates in Phase III clinical trials. The two trials,
involving nearly 8,000 volunteers in North America, Europe and Thailand, are
designed to determine if VaxGen's AIDSVAX investigational vaccine can prevent
humans from becoming infected with HIV, the virus that causes AIDS. VaxGen
expects to announce primary results from the first trial in the first quarter of
2003, with results from the second trial expected about nine months later.
VaxGen is also the largest shareholder of Celltrion, Inc., a company created to
provide manufacturing services, principally for products produced in mammalian
cell culture. VaxGen is located in Brisbane, Calif. For more information, please
visit the company's web site at: www.vaxgen.com. AIDSVAX(R)is a registered
trademark of VaxGen.
NOTE: This press release contains "forward-looking statements" within the
meaning of the federal securities laws. These forward-looking statements include
without limitation statements regarding the progress, costs and results of our
Phase III clinical trials; domestic and foreign regulatory approvals of AIDSVAX;
the ability to manufacture AIDSVAX; our ability to commercialize AIDSVAX and
strike marketing partnerships; our ability to manage our foreign manufacturing
joint venture; the timing, and announcement of results of either of our Phase
III clinical trials; our beliefs regarding the future success of AIDSVAX and
other products currently under development or proposed to be developed. These
statements are subject to risks and uncertainties that could cause actual
results and events to differ materially from those anticipated. Reference should
be made to VaxGen's Annual Report on Form 10-K, filed with the Securities and
Exchange Commission on April 1, 2002, under the headings "Risk Factors" and
"Business" for a more detailed description of such factors. Readers are
cautioned not to place undue reliance on these forward-looking statements that
speak only as of the date of this release. VaxGen undertakes no obligation to
update publicly any forward-looking statements to reflect new information,
events, or circumstances after the date of this release or to reflect the
occurrence of anticipated events.
Dates Referenced Herein and Documents Incorporated by Reference
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This ‘8-K’ Filing | | Date | | First | | Last | | | Other Filings |
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Filed on: | | 7/15/02 |
For Period End: | | 7/2/02 |
| | 4/1/02 | | 2 | | | | | 10-K |
| | 5/1/96 | | 1 |
| List all Filings |
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