VaxGen Wins 2 Separate AIDS Vaccine Patent Disputes
Patents Give Exclusive Use of HIV Proteins for Prevention and Treatment of AIDS
Brisbane, Calif. - May 25, 2000 - VaxGen Inc. (Nasdaq: VXGN) announced today that it has prevailed in two separate European patent disputes, confirming its exclusive rights to vaccines containing key proteins for preventing AIDS.
Following oral arguments in Munich, Germany, on May 9 and May 18, the Opposition Division of the European Patent Office upheld two patents originally filed by Genentech Inc. and now licensed exclusively to VaxGen for its use in making preventive HIV/AIDS vaccines. The patents, which had
been challenged by Chiron Corp., cover specific forms of the envelope proteins known as gp120 and gp160, methods for manufacturing the proteins, and their use for the prevention and treatment of HIV/AIDS. Located on the envelope of the HIV virus, gp120 and gp160 are the only known viral targets
that effectively induce antibodies that prevent HIV infection.
"These patents encompass envelope proteins from any HIV strain and provide powerful protection for our intellectual property rights, " said Dr. Robert C. Nowinski, VaxGen's chairman and chief executive. "Since most vaccines under development include HIV envelope proteins, these patents not
only provide protection for our own vaccine but should enable VaxGen to participate financially in most other HIV/AIDS vaccines."
VaxGen will actively enforce its rights for all HIV/AIDS vaccines that contain envelope proteins, providing exclusivity for its AIDSVAX© vaccine formulation. VaxGen also anticipates licensing certain rights to these
proteins to vaccine developers pursuing HIV/AIDS vaccines that use HIV envelope proteins in combination with DNA or live virus.
Vaccine Development
Early research with gp120 and gp160 envelope proteins yielded many vaccine candidates, but all of them failed to prevent HIV infection. A breakthrough occurred when a team of Genentech scientists that included Dr. Phillip Berman, now with VaxGen, identified the specific molecular forms of
gp120 and gp160 that were required for a protective vaccine. Berman went on to lead the team that developed the first vaccine capable of protecting chimpanzees against HIV infection and later developed AIDSVAX©, which is
currently undergoing phase III clinical trials to determine how well it prevents HIV infection.
The importance of Dr. Berman's discovery of the specific forms of gp120 and gp160 was acknowledged by the Opposition Division as well as by affidavits from HIV/AIDS vaccine experts. In a declaration to the Opposition Division, Dr. Jorg Eichberg described the results of 17 separate
studies in which researchers tried to protect chimpanzees against HIV infections. Eichberg, a leading expert on the testing of HIV/AIDS vaccines, noted that 13 of the formulations induced antibody responses, with 11 of
them also inducing cellular immune responses. "However," Eichberg concluded, "only one, the vaccine described in the Patent, protected against viral (HIV) challenge." The vaccine he referred to was the precursor to AIDSVAX©.
Description of Patents
Patent EP0527760 was issued to Genentech in 1995 and is in force in 14 European countries. The patent covers vaccines containing the effective forms of gp120 and gp160 and their medical use for prophylaxis and treatment of AIDS. As described in the patent, the effective forms contain
characteristics that are important for generating protective antibodies and are the only forms of these proteins that have been shown to prevent HIV infection. The patent also covers the methods used for purifying the effective forms of gp120 and gp160. The issued patent was challenged by Chiron and Immuno AG, the latter of which dropped its opposition in 1997. Genentech/VaxGen successfully defended the patent during oral arguments in Munich on May 18. A U.S.
counterpart to this European patent has been divided into three applications, two of which have already been issued and to which there are no challenges to date. The remaining application is pending in the U.S. Patent and Trademark Office.
Patent EP0187041 was issued to Genentech in 1996 and is in force in 11 European countries. The patent covers fusion proteins for producing the large quantities of gp120 and gp160 required to manufacture HIV/AIDS vaccines.
The patent was challenged by Chiron in 1997.Genentech/VaxGen successfully defended the patent during oral arguments in Munich on May 9. Genentech/VaxGen also hold a comparable U.S. patent for the same discovery.
As a result of having an adjudicated patent in Europe and an unchallenged patent in the U.S., VaxGen believes it has a dominating position with regard to manufacturing gp120 and gp160.
Company Description
VaxGen is the worldwide leader in developing vaccines for the prevention of HIV/AIDS and is the only company with a vaccine in phase III clinical trials, the final stage before regulatory approval. Two formulations of the vaccine, AIDSVAX©, are being tested in separate trials involving nearly 8,000 volunteers. The first trial is taking place principally in North America and the second in Bangkok, Thailand. An interim analysis of the North American trial is scheduled for late 2001. If the analysis yields
sufficient evidence to show that AIDSVAX© is at least 30 percent effective in reducing HIV infections, VaxGen intends to submit an application for regulatory approval. If the trial does not show sufficient statistical evidence to definitively determine efficacy, VaxGen intends to proceed as planned to complete the trials at the end of 2002, at which time the statistical power of the trials will have increased. VaxGen is located in Brisbane, Calif. For more information, please visit the company's web site
at www.vaxgen.com.
AIDSVAX© is a registered trademark of VaxGen.
Contact:
Lance Ignon, Senior Director, Corporate and Financial Communications
(650) 624-1016
Note: This news release contains "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995. Such
forward-looking statements are subject to known and unknown risks,
uncertainties or other factors that may cause VaxGen's actual results to be
materially different from historical results, expressed or implied by such
forward-looking statements. Factors that might cause such a difference
include, but are not limited to, uncertainties related to the progress and
costs of the company's phase III clinical trials, the progress of other
internal research and development projects, the establishment of
collaborative arrangements with governmental agencies, the receipt of
research grants and the timing of certain expenses. Reference should be
made to VaxGen's Annual Report on Form 10-K, filed with the Securities and
Exchange Commission, for a more detailed description of such factors
discussed in the "Factors Affecting Future Results" and "Business" sections.
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. |
