Somerset, NJ, July 8, 2005 – Cardinal Health, the leading provider of products and services supporting the health care industry, today announced it has completed its first manufacturing project of an antibody suitable for human clinical trials, using a cell line that was made with its patented GPExTM (Gene Product Expression) technology. The antibody will be used to support a clinical trial by the Ludwig Institute for Cancer Research (LICR) aimed at treating epithelial tumors.
“We are very pleased to have completed this significant milestone in the evolution of our business, and LICR has been a great partner in this process,” said Paul Weiss, PhD, president of Cardinal Health’s biopharmaceutical development services center in Middleton, Wisconsin. “We have made great progress in developing the GPEx technology, especially for antibodies, and to have completed our first cGMP batch from a GPEx cell line was the next step in the execution of our integrated offering that allows us to assist companies in getting their biopharmaceutical products into clinical development more rapidly.”
Cardinal Health’s GPEx technology enables rapid genetic engineering of stable, high- expressing, mammalian cell lines. These cell lines are used to produce recombinant proteins, such as monoclonal antibodies, which belong to the rapidly growing class of medicines known as biopharmaceuticals. In addition to enabling rapid cell line development, the GPEx technology is well suited for both pilot/clinical and commercial-scale production of antibodies and other therapeutic recombinant proteins.
Through insertion of multiple copies of the target genes, GPEx can generate, in as little as half the time required using traditional methods, stable cell lines with significantly higher levels of expression than those cell lines generated by other methods.
“Working with Cardinal Health for both the GPEx cell line engineering and the cGMP manufacturing offered us a number of distinct advantages,” stated Eric W. Hoffman, director of the LICR Office of Clinical Trials Management. “We are pleased that we could have the cell line expressing this antibody engineered with the GPEx technology at the same site that could then move it directly into process development followed by cGMP manufacturing of the antibody. We are also having this particular antibody aseptically filled into vials by Cardinal Health”
“We look forward to additional collaborations combining both GPEx cell line engineering and clinical-scale manufacturing since we strongly believe this a better overall value proposition for our clients. We have several such projects scheduled over the next few months - in fact, both of our cGMP suites are presently occupied with manufacturing projects involving GPEx cell lines,” commented Weiss.
Financial terms of the agreement between LICR and Cardinal Health were not disclosed, and LICR does have the option of expanding the collaboration for additional antibodies.
About Cardinal Health
Cardinal Health, Inc. (www.cardinalhealth.com) is the leading provider of products and services supporting the health care industry. Cardinal Health develops, manufactures, packages and markets products for patient care; develops drug-delivery technologies; distributes pharmaceuticals, medical-surgical and laboratory supplies; and offers consulting and other services that improve quality and efficiency in health care. Headquartered in Dublin, Ohio, Cardinal Health employs more than 55,000 people on six continents and produces annual revenues of more than $65 billion.
Except for historical information, all other information in this news release consists of forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied. The most significant of these uncertainties are described in Cardinal Health's Form 10-K, Form 8-K and Form 10-Q reports (including all amendments to those reports) and exhibits to those reports, and include (but are not limited to) the following: the costs, difficulties, and uncertainties related to the integration of acquired businesses; the loss of one or more key customer or supplier relationships or changes to the terms of those relationships; changes in the distribution patterns or reimbursement rates for health-care products and/or services; the results, consequences, effects or timing of any inquiry or investigation by any regulatory authority or any legal and administrative proceedings; the impact of previously announced restatements; difficulties or delays in implementing its global restructuring program; difficulties in opening new facilities or fully utilizing existing capacity; difficulties and uncertainties associated with business model transitions, including the conversion of margin generated from branded pharmaceutical manufacturers to non-contingent consideration; and general economic and market conditions. Cardinal Health undertakes no obligation to update or revise any forward-looking statement.