Introgen Creates Technical Services Company and Announces Strategic Alliance with Texas A&M University System to Expand GMP Manufacturing Programs
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Today, Introgen Therapeutics, Inc. (NASDAQ:INGN) announced the formation
of Introgen Technical Services, Inc. ("ITS”)
to pursue contract production, process development and manufacturing
services. It is anticipated that ITS will supply Introgen’s
future product inventory needs for development stage and future
commercial products. Advances in both scale and flexibility of biologics
production have allowed Introgen to build its product inventories and to
manufacture under contract for select projects. Aimed at increasing
value for shareholders, the creation of ITS will allow for expansion of
contract manufacturing and services to utilize Introgen’s
production capacities and assets in its multiple facilities.
The Texas A&M University System
("A&M System”)
and Introgen also announced today
that they have formed an alliance (the "Alliance”)
to address opportunities for process development and production of
therapeutics, vaccines, delivery systems and devices for human and
veterinary applications for biopharmaceutical industry, academic
research and government clients, including the bio-defense and public
health sectors. The Introgen-Texas A&M System Alliance will seek to
enhance GMP capabilities at multiple sites in Texas. The Alliance will
initially include the use of Introgen’s two
GMP facilities in Houston, TX, with future GMP plant expansions planned
for other Texas locations.
"I hope the Texas A&M System - Introgen Alliance becomes a model for
future collaboration in Texas," said Phil Wilson, Secretary of State of
the State of Texas. "With our State's continued investment in biotech,
our strong military network and our future investment in oncology, this
is the type of collaboration between companies and universities that
will strengthen our overall manufacturing capabilities in healthcare and
bio-defense."
"This is a very logical next step for
leveraging Introgen’s knowledge and assets in
GMP production and compliance areas,” said J.
David Enloe, Jr. Introgen’s senior vice
president of Operations, who will assume the additional title of Chief
Executive Officer of ITS. "Our process
development and manufacturing capabilities are assets which can be
deployed to address broader markets. Together, we expect to leverage the
diverse and considerable assets of the Texas A&M System along with
Introgen’s expertise and infrastructure to
address wider opportunities in the commercial, academic, government and
defense sectors and to create additional value for our shareholders,”
said Mr. Enloe.
Brett P. Giroir, M.D., incoming vice chancellor of Research of The Texas
A&M University System stated, "This
Alliance supplies a critical research and development capability that
will enable the rapid translation of science discoveries into new
life-saving therapies. It will also open up new opportunities for the
Alliance to address national needs for the development and assured
manufacture of vaccines and therapeutics for public health and
biodefense.” Dr. Giroir begins his tenure at
the A&M System on June 23, 2008. He currently serves as the director of
the Defense Sciences Office of the Defense Advanced Research Projects
Agency (DARPA) and serves as a member of the Federal Threat Reduction
Advisory Committee associated with the Defense Threat Reduction Agency.
About Introgen Technical Services (ITS)
Sourcing commercial grade clinical materials produced to Good
Manufacturing Practices ("GMP”)
specifications has historically been one of the most difficult
challenges faced by drug developers and researchers. In developing its
own product pipeline, Introgen has created flexible, scalable GMP
production capabilities, including the skills needed to convert early
stage, lab-grade production into robust and scalable therapeutic product
classes, suitable for clinical studies and commercial use. It is
anticipated that ITS will have responsibility for supplying Introgen
with stocks of ADVEXIN and other of the Company’s
five clinical-stage products. ITS plans to expand contract GMP
manufacturing and process development services to meet demands and
opportunities from commercial, academic and government clients. Under
licenses from Introgen, ITS will obtain access to intellectual
properties, including patents, proprietary quality and validation
systems, and broad GMP knowledge systems. ITS will control and operate
Introgen’s current facilities which house its
process, scale-up, production and fill/finish capabilities. ITS plans to
develop revenues by supplying contract technical and production services
to clients. Introgen will receive royalty payments from ITS under the
terms of the non-exclusive licenses to ITS. ITS is wholly owned by
Introgen. Future financing plans for ITS may include equity or other
financing, government source funding, project or program based
transactions. Certain Introgen employees may transition to full or
part-time employment by ITS. ITS may acquire, lease or sublease
facilities and equipment from Introgen. The goal of ITS is to leverage
Introgen’s broad commercial manufacturing and
related capabilities and to profitably and proactively make those
capabilities available to commercial, academic, and government entities
worldwide. For many years, Introgen has been approached by entities from
around the world to provide these services. The formation of ITS will
enable this market to be served and to optimize Introgen’s
shareholder investment in its GMP capabilities
Max Talbott, Ph.D., senior vice president of Worldwide Commercial
Development will assume the additional title of Chief Regulatory Officer
at ITS. Dr. Talbott was previously the world wide head of regulatory
affairs at several global pharmaceutical companies, where he led the
approval of more than 30 new pharmaceutical products. Dr. Talbott is
also a former acting division head at the U.S. Food and Drug
Administration (FDA).
Directors of ITS include Bob Pearson, formerly head of Global Corporate
Communications and Global Pharma Communications at Novartis and
currently vice president of Communities and Conversations (digital
media) for Dell Inc. (NASDAQ:DELL) and David Nance, Chairman and Chief
Executive Officer of Introgen. Advisory Committee members of ITS are
William Cunningham, Ph.D., former Chancellor of The University of Texas
System, Malcolm Gillis, Ph.D., former president of Rice University and
Peter Barton Hutt, former chief counsel to the FDA. Messrs Pearson,
Nance, Cunningham, Gillis and Hutt also serve as members of Introgen’s
Board of Directors.
About the Introgen-Texas A&M System
Alliance
The Introgen-Texas A&M System Alliance (the Alliance) was designed to
address a collaborative vision of developing synergies in the fields of
biological, medical, chemical, engineering and industrial sciences. The
Alliance was created to provide GMP production, process development,
scale-up and other services to meet the needs of industry, government
and academic users. The Alliance will focus on production of
therapeutics, vaccines and delivery systems for human and veterinary
application. The Alliance will seek to develop new methods, standards
and intellectual properties to advance healthcare research regulation of
new healthcare technologies. The Alliance plans to work collaboratively
with non-profit and government institutions to enhance research,
educational, technical training and economic development goals. The
Alliance will seek to expand the academic collaborations with an
expanding number of universities in Texas and worldwide. In addition the
Alliance plans to work cooperatively to develop new research and
manufacturing opportunities with prospective partners and clients in
government, academic and commercial sectors. The Alliance may create new
commercial enterprises or develop new business combinations to pursue
its objectives.
About Introgen’s
Manufacturing
Introgen has previously engaged in contract manufacturing for select
clients from commercial sectors, including the global pharmaceutical,
large biotechnology and emerging biotechnology industries. The Company
has also provided clinical and research materials for academic
institutions, academic researchers and government agencies. Introgen has
designed and constructed four biologics production facilities, and
currently operates two GMP facilities in Houston, TX, including a
commercial scale production facility. One of Introgen’s
facilities has been designated as the producer worldwide reference
material for adenovirus. Adenovirus is used in numerous research,
therapeutics and vaccines programs. Introgen’s
nanoparticle systems are used to deliver genes and proteins. This
nanoparticle platform can also be used to deliver peptides and multiple
DNA and RNAi constructs. Introgen has developed a number of process,
purification, manufacturing and regulatory standards for new therapeutic
product classes. Introgen has exported products to countries in Western
and Eastern Europe, Asia and North America.
About the Texas A&M University System
The Texas A&M University System is one of the largest systems of higher
education in the nation, with a budget of $2.9 billion. Through a
statewide network of nine universities, seven state agencies and a
comprehensive health science center, the Texas A&M University System
educates more than 106,000 students and makes more than 15 million
additional educational contacts through service and outreach programs
each year. Externally funded research brings in almost $627 million
every year and helps drive the State’s
economy. The A&M System recently created the Texas A&M Institute for
Preclinical Studies which is uniquely positioned to perform pre-clinical
development and testing of drugs and devices leading to human clinical
trials. Texas A&M System also created the Texas Institute for Genomic
Medicine, which houses the world’s largest
collection of mouse embryonic stem cells, as a key drug discovery asset.
The alliance with Introgen will add ready access to GMP manufacturing
capabilities to the therapeutics discovery, development, and
commercialization pipeline for the A&M System.
About Introgen
Introgen Therapeutics, Inc. is a biopharmaceutical company focused on
the discovery, development and commercialization of targeted molecular
therapies for the treatment of cancer and other diseases. Introgen is
developing molecular therapeutics, immunotherapies, vaccines and
nano-particle tumor suppressor therapies to treat a wide range of
cancers using tumor suppressors, cytokines and genes. Introgen maintains
integrated research, development, manufacturing, clinical and regulatory
departments and operates multiple manufacturing facilities including a
commercial scale cGMP manufacturing facility.
Forward Looking Statements
Statements in this release that are not strictly historical may be "forward-looking”
statements, including those relating to the future activities, methods
of operation, and success of the Alliance, entry into contracts and
transactions with Texas A & M University System, future activities,
methods of operation and success of Introgen Technical Services, Inc.,
and the future success of Introgen, the Alliance, and Introgen Technical
Services, Inc., with their development programs for biologics and other
products. The actual results may differ from those described in this
release due to the early stage of formation and operation of the
Alliance, risks and uncertainties that exist in the operations and
business environment of the Alliance, Introgen and Introgen Technical
Services, Inc., including the limited experience in the development and
manufacturing of gene-based drugs, adenoviral products, and other
biologics in general, dependence upon proprietary technology and the
current competitive environment, history of operating losses and
accumulated deficits, reliance on collaborative relationships, and
uncertainties related to the safety and efficacy of Introgen’s
product candidates and other products to be developed or manufactured by
Introgen, Introgen Technical Services, Inc. or the Alliance, the ability
to obtain the appropriate regulatory approvals, the ability to obtain
adequate funding, available patent protection and market acceptance, as
well as other risks detailed from time to time in Introgen’s
filings with the Securities and Exchange Commission including its
filings on Form 10-K and Form 10-Q. Introgen undertakes no obligation to
publicly release the results of any revisions to any forward-looking
statements that reflect events or circumstances arising after the date
hereof.
Editor's Note: For more information on Introgen Therapeutics, or for a
menu of archived press releases, please visit Introgen’s
Website at: www.introgen.com.