Nanotechnology Now - Press Release: Introgen Creates Technical Services Company and Announces Strategic Alliance with Texas A&M University System to Expand GMP Manufacturing Programs

Home > Press > Introgen Creates Technical Services Company and Announces Strategic Alliance with Texas A&M University System to Expand GMP Manufacturing Programs

Abstract:
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.

Introgen Creates Technical Services Company and Announces Strategic Alliance with Texas A&M University System to Expand GMP Manufacturing Programs

Austin, TX | Posted on June 11th, 2008

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 Therapeutics, Inc.
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.