
PARTNERS
To effectively execute our business plan and develop novel products, we strongly believe in
the mutual benefits that result from external collaborations with partners. Accordingly, AVANT
has established a number of corporate, government and academic partnerships that have proven to
be successful relationships.
Our strategy is to demonstrate proof of concept for our products before leveraging their value
through partnerships. Our current collaborations encompass the development of an oral human
rotavirus vaccine, vaccines to combat threats of biological warfare, and vaccines addressed to
human food safety and animal health.
In 1997,
we licensed our oral rotavirus vaccine to GlaxoSmithKline. In 1999, after our Phase 2 study demonstrated
89% protection in a study involving 215 infants, Glaxo paid us an additional license fee and assumed full
responsibility for funding and performing all remaining clinical development. Glaxo completed Phase 2
and Phase 3 studies in over 70,000 subjects in Europe, Latin America and Asia using its two-dose oral rotavirus
vaccine, called Rotarix®. Rotarix® gained its first marketing approval in Mexico in July 2004,and is now approved in 100 countries worldwide, including the EU.
In April 2008, Rotarix® received marketing approval in the United States, triggering a milestone payment to AVANT.
In
May 2005, AVANT entered into an agreement with Paul Royalty Fund II, L.P. ("PRF") whereby PRF
purchased, for up to $60 million, an interest in the net royalties AVANT will receive on worldwide
sales of Rotarix®. AVANT has received $50 million of this funding; the terms of the agreement
with PRF include an additional milestone payment from PRF of up to
$10 million due and payable upon U. S. launch. At the same time, AVANT retains a portion of future
gross milestones payable by Glaxo, as well as upside participation in the worldwide net royalty stream
from Rotarix®. Thus, the value of this transaction to AVANT is considerably in excess of the $60
million in PRF-related payments.
Review Frequently Asked Questions
In July
2005, the International Vaccine Institute (IVI), in collaboration with the
International Centre for Diarrhoel Disease Research, Bangladesh, completed a Phase 2 clinical
trial of AVANT's cholera vaccine, CholeraGarde®, in approximately 70 adult and 280 pediatric
subjects in Bangladesh. Through its Diseases of the Most Impoverished (DOMI) Program, IVI seeks
to accelerate the development and introduction of vaccines against cholera, typhoid fever and
shigellosis in the developing world.
In 2006, IVI received $21 million in funding from the Gates foundation for a Cholera Vaccine
Initiative (CHOVI), which includes conducting Phase 2 and 3 clinical trials of
CholeraGarde® in India and Bangladesh.
The
National Institute of Allergy and Infectious Disease (NIAID) of the National Institutes
of Health (NIH) has completed a Phase 1 in-patient dose-ranging
clinical trial aimed at demonstrating the safety and immunogenicity of the Ty800 typhoid fever
vaccine. The trial was run at a NIAID-funded clinical site using NIAID-funded clinical
material. The NIAID trial confirmed the safety and immunogenicity of the Ty800 oral
vaccine observed in an earlier physician-sponsored Ty800 vaccine study, with over 90% of vaccinated subjects generating immune responses.
NIAID and AVANT have entered into an agreement whereby NIAID will sponsor a Phase 1 study of AVANT's
investigational single-dose, oral vaccine designed to offer combined protection against both enterotoxigenic
Escherichia coli (ETEC) and cholera. The Phase 1 study is expected to initiate in the first half of 2008.
In
December 2000, AVANT partnered with Pfizer Inc, which is applying AVANT's vaccine technologies
to animal health and human food safety markets. The Pfizer research programs have progress and in late 2002 we achieved a milestone, which resulted in
a modest payment to AVANT. Under the agreement, we may receive additional milestone payments
based upon attainment of specified milestones. We received research and development
funding from Pfizer through November 2002 and again in 2006 and may receive royalty payments on eventual product
sales.
In
September 2002, we appointed Lohmann Animal Health International (LAHI) as the exclusive
distributor of our Megan Health poultry vaccines in North America. LAHI, an established animal
health company, is taking over marketing and distribution of Megan's currently marketed poultry
products and assuming control of the late-stage food safety and animal health vaccines under
development for the commercial poultry market. Our marketed products, Megan®Vac 1 and Megan®Egg, are double
gene-deleted modified vaccines for use in broiler chickens and laying hens for protection against multiple species and/or
strains of Salmonella bacteria. Under the distribution agreement, AVANT receives a percentage of
Megan® Vac 1 and Megan®Egg product sales in the form of royalty payments.
Please see our Business Development page or contact Ron Newbold, Senior Vice President, Business Development at (908) 454-7120 x312
for more information. |