Introgen Reduces Development Staff to Focus on Commercial Activities after ADVEXIN Regulatory Filings in U.S. and Europe
Introgen Therapeutics, Inc. (NASDAQ:INGN) today announced a
re-allocation of employees to focus on regulatory review and commercial
activities. After years of product development, Introgen is directing
corporate spending toward regulatory review programs, commercialization
and the future marketing of ADVEXIN therapy. Recently the Company
achieved the major corporate milestone of filing for regulatory approval
of ADVEXIN cancer therapy in the U.S. and Europe. From its current total
of approximately 70 employees, Introgen will eliminate approximately 20
positions primarily associated with ADVEXIN development and regulatory
submission programs that have now been completed. Some of the
approximately 50 remaining Introgen employees and some new employees are
expected to join Introgen’s manufacturing
subsidiary, Introgen Technical Services, Inc. The Company anticipated
reductions in ADVEXIN program expenses contained in previous financial
guidance.
"These steps will allow Introgen to conserve
and re-direct resources toward its current mission, the approval and
marketing of ADVEXIN p53 therapy,” said David
G. Nance, Chairman and CEO. "Over the past
twelve years we have managed more than 30 clinical trials involving more
than 700 patients. We successfully developed production methods and
manufacturing infrastructure for a new class of therapy. We linked our
molecular therapy and clinical findings with biomarkers using
pre-treatment diagnostics to guide clinical care and reduce toxicities
for cancer patients. We have completed the considerable accomplishments
of regulatory filings on two continents. We acknowledge the great
contributions of our employees, past and present, toward the realization
of truly personalized medicine.” About Introgen Technical Services (ITS)
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. 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 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 plans to enter into agreements with ITS to provide for
royalty payments from ITS under the terms of the non-exclusive licenses
to ITS. ITS is wholly owned by Introgen. Although Introgen will fund ITS’s
operations during the near-term, future financing plans for ITS may
include equity or other financing, government source funding, project or
program based transactions. 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.
Recently, The Texas A&M University
System ("A&M System”),
ITS and Introgen announced they
formed an 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.
About Introgen Therapeutics, Inc.
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. In June 2008 Introgen
submitted a Biologics License Application (BLA) to the U.S. Food and
Drug Administration (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 Marketing Authorization Application (MAA) to the European
Medicines Evaluation Agency (EMEA) for the same indication. ADVEXIN
represents the first of a new class of tumor suppressor cancer therapy
and is the first of its kind to be submitted for regulatory approval in
the United States and Europe.
Statements in this release that are not strictly historical may be "forward-looking”
statements, including those relating to Introgen’s
efforts to gain efficiencies with workforce reductions and move certain
workforce to Introgen Technical Services. The actual results may differ
from those described in this release due to 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, 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.
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.
