Introgen Therapeutics, Inc. a biopharmaceutical company focused on the use of naturally occurring tumour suppressors to fight cancer, has restructured its operations to focus on the expansion of near-term revenues from its manufacturing and service business, Introgen Technical Services, Inc., (ITS).
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, the company's non-manufacturing operations will be significantly reduced and will principally support the Advexin regulatory programmes in US and Europe.
Advexin is the subject of a marketing authorisation application (MAA) which has been accepted for review in Europe by the European Medicines Evaluation Agency (EMEA). A biologics license application (BLA) filed in US was not accepted for review by the US Food and Drug Administration (FDA) and the company is currently appealing the decision.
As part of the restructuring activities, the company has appointed J. David Enloe as its new president and chief executive officer pursuant to David G. Nance's resignation from the post. However, David G. Nance will continue in his role as chairman of the board.
In addition to David Nance, Max Talbott, senior vice president, clinical affairs, Robert Sobol, senior vice president, medical and scientific affairs and David Parker, senior vice president, intellectual property have resigned their positions as officers of Introgen.
As part of the restructuring, the company will also 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.
"We believe these actions provide the best opportunity to achieve our goal of increasing value for our shareholders. Given the currently unfavourable 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 the outgoing president and chief executive officer 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 (GMP) production services for several clients and have new contract opportunities we are working to finalise 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 the newly appointed president and chief executive officer Enloe.
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 programmes. 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.