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AnGes MG, Inc. (“AnGes”) and Vical Inc. (“Vical”) today announced a collaborative R&D agreement
for Vical’s Allovectin-7® for cancer immunotherapy. An announcement was also made on an equity
investment agreement signed between AnGes and Vical.
Allovectin-7® is a plasmid/lipid complex containing DNA sequences and its direct injection into
tumor lesions may augment the immune response against both local and distant metastatic tumors.
Vical conducted a Phase II trial evaluating Allovectin-7® immunotherapeutic as a single agent for
patients with metastatic melanoma; the result showed better efficacy (i.e. survival period) and safety
over the currently available therapies.
The American Cancer Society estimated that approximately 62,000 new diagnoses and
approximately 7,900 deaths from melanoma will occur in 2006 in the United States. There are
significant unmet medical needs for melanoma, but currently there are no consistently effective
therapies for advanced cases of malignant melanoma where the cancer has spread to other parts
of the body.
Under the agreement, AnGes will fund the Phase III pivotal trial of Allovectin-7® to be conducted by
Vical in the United States in accordance with a Special Protocol Assessment (SPA) completed with
the U.S. Food and Drug Administration (FDA). In return, AnGes will co-own the data generated in
the Phase III clinical trial and receive an exclusive license within the territory of Asia, including the
right to sublicense, for the development, sales and marketing and distribution for all the indications
of Allovectin-7® using the licensed technologies. Vical will pay AnGes royalties based on defined
sales levels in the United States, and fixed royalties on rest-of-the-world sales, including the
European region. AnGes expects royalty payment from Vical to become one of the major revenue
generating sources in the future.
Along with an R&D agreement for Allovectin-7®, an equity investment agreement has been signed
as well, which positions AnGes as a strategic partner for Vical.
In May 2005, AnGes entered into a global license agreement with Vical on its patented Non-viral
DNA delivery technologies, to be used for HGF gene therapy for indications of Peripheral Arterial
Disease (PAD) and Ischemic Heart Disease (IHD). Through this equity investment, the good>
ongoing relationship between AnGes and Vical will be further strengthened to direct the way for
building the strategic relationship between AnGes and Vical, in particular in the field of gene therapy.
Vical, a leading biopharmaceutical company in the area of gene therapy, has accumulated a vast
amount of experience and expertise in the development of gene-based therapy, including
manufacturing and CMC.
Through a scheduled series of cash payments and equity investments totaling $22.6 million, AnGes
will fund the Phase III pivotal trial to be conducted by Vical. In addition, AnGes will pay Vical
royalties on product sales in specific Asian countries plus future sales-based milestones if
Allovectin-7® is successfully commercialized. |
