Introgen Therapeutics, Inc. (NASDAQ:INGN), today announced that it has
strategically reorganized the company’s operations to focus on the
expansion of near-term revenues from its manufacturing and service
business, Introgen Technical Services, Inc., (ITS). In conjunction with
the reorganization, David G. Nance resigned his position as president
and chief executive officer. J. David Enloe, Jr., formerly Introgen’s
senior vice president of operations, has been named president and chief
executive officer of the company, succeeding Mr. Nance, who will
continue in his role as chairman of the board. As part of the
restructuring, Introgen will reduce its staff from approximately 45 to
15 employees, significantly lowering corporate expenses. Further,
Introgen intends to redirect internal efforts toward its priority
objectives of conserving financial resources, expanding revenues and
continuing to pursue strategic transactions.
Earlier this year, Introgen announced the formation of ITS, a wholly
owned subsidiary focused on contract production, process development and
manufacturing services at the company’s Houston, Texas facilities. As a
result of the restructuring, Introgen’s non-manufacturing operations
will be significantly reduced and will principally support the ADVEXIN
regulatory programs in the U.S. and Europe.
ADVEXIN is the subject of a Marketing Authorization Application (MAA)
which has been accepted for review in Europe by the European Medicines
Evaluation Agency (EMEA). A Biologics License Application (BLA) filed in
the U.S. was not accepted for review by the United States Food and Drug
Administration (FDA) and the company is currently appealing the decision.
Introgen also recently announced the engagement of Torreya Partners as
its advisor for the purpose of exploring a range of strategic
opportunities for both the company and its programs. Strategic
alternatives the company may pursue could include, but are not limited
to, the sale of assets, partnering or other collaboration agreements, a
merger, or other strategic transactions. Introgen owns or has rights to
more than 100 patents and five clinical stage product candidates, in
addition to its manufacturing infrastructure and facilities.
In addition to David Nance, Max Talbott Ph.D., senior vice president,
clinical affairs, Robert Sobol, M.D., senior vice president, medical and
scientific affairs, and David Parker, Ph.D., JD, senior vice president,
intellectual property have resigned their positions as officers of
Introgen as a further step to preserve financial resources. However, to
best support program continuity, these former officers, as well as other
senior regulatory and medical staff, will continue to be available to
the company through consulting or other arrangements.
"We believe these actions provide the best opportunity to achieve our
goal of increasing value for our shareholders. Given the currently
unfavorable market conditions, we believe it is important to reduce
costs, conserve resources and focus on near-term revenues as we continue
the ADVEXIN regulatory process and extend the horizon for other ongoing
strategic activities,” said Mr. Nance.
"This is an exciting time for ITS’s contract manufacturing business. We
have already had the opportunity to provide process development and Good
Manufacturing Practices, or GMP, production services for several clients
and have new contract opportunities we are working to finalize at this
time. The combination of our state-of-the-art facilities, experienced
staff and broad intellectual property portfolio makes ITS a uniquely
qualified resource for many institutions and biotechnology companies,”
said Mr. Enloe.
Mr. Enloe joined Introgen in 1995 and served as chief operating officer
prior to the company’s restructuring. During his tenure with Introgen,
he has also held the positions of senior vice president, operations;
vice president, administration; and, general business manager. Prior to
joining Introgen, Mr. Enloe held various positions at Centrilift, a
division of Baker Hughes, Inc., an energy services company, including
region general manager, Southeast Asia. A certified public accountant,
he has also worked at Arthur Andersen LLP.
ABOUT INTROGEN AND INTROGEN TECHNICAL
SERVICES (ITS)
Introgen Therapeutics, Inc. is a biopharmaceutical company focused on
the use of naturally occurring tumor suppressors to fight cancer.
Introgen Technical Services (ITS) is a wholly owned subsidiary of
Introgen, which provides its customers with flexible, scalable Good
Manufacturing Practices (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. 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 has access to intellectual properties, including patents,
proprietary quality and validation systems, and broad GMP knowledge
systems. ITS operates Introgen's current facilities, which house its
process, scale-up, production and fill/finish capabilities.
For more information about Introgen, please visit www.introgen.com.
For more information about ITS, please visit www.its-gmp.com.
About ADVEXIN
ADVEXIN p53 therapy is a targeted molecular therapy with broad
applicability in a wide range of tumor types and clinical settings
because it targets one of the most fundamental and common molecular
defects, abnormal p53 tumor suppressor function, associated with cancer
initiation, progression and treatment resistance. ADVEXIN has
demonstrated increased survival and tumor growth control in recurrent
head and neck cancer patients. ADVEXIN has demonstrated clinical
activity in a number of solid tumor types in multiple Phase 1, 2 and 3
clinical trials conducted worldwide. ADVEXIN is considered an 'Orphan
Drug' in the U.S. for the treatment of recurrent, refractory head and
neck cancer, which, if approved, entitles the drug to extended market
exclusivity for the approved indication. ADVEXIN is a registered
trademark describing p53 therapy, developed by Introgen under exclusive
worldwide licenses from The University of Texas M.D. Anderson Cancer
Center. In June 2008, Introgen submitted a BLA to the FDA requesting
marketing approval for ADVEXIN p53 therapy to treat recurrent,
refractory head and neck cancer. Simultaneously, Gendux Molecular
Limited, an Introgen subsidiary, submitted a MAA to the EMEA for the
same indication. The EMEA accepted Introgen's MAA for review. The FDA
has declined to file Introgen's BLA at this time. Introgen is in the
process of appealing the FDA’s refusal to file decision.
FORWARD-LOOKING STATEMENTS
Statements in this release that are not strictly historical may be
"forward-looking" statements, including those relating to Introgen's
ability to obtain regulatory approval of ADVEXIN, Introgen’s plans with
respect to, or ability to successfully pursue, its manufacturing
business, or to complete any strategic transaction. The actual results
may differ from those described in this release due to the risks and
uncertainties that exist in Introgen's operations and business
environment, including Introgen's stage of product development and the
limited experience in the development of gene-based drugs in general,
dependence upon proprietary technology and the current competitive
environment, history of operating losses and accumulated deficits,
reliance on collaborative relationships, uncertainties related to
Introgen’s access to capital and uncertainties related to clinical
trials, the safety and efficacy of Introgen's product candidates, the
ability to obtain the appropriate regulatory approvals, Introgen's
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.