PLANEGG, GERMANY and MUNICH, GERMANY and PRINCETON, NJ and HOUSTON, TX--(Marketwire - March 13, 2012) - DSM Pharmaceutical Products, the custom manufacturing business of Royal DSM N.V. (NYSE, Euronext: DSM KON), and Agennix AG (FRANKFURT: AGX) (XETRA: AGX), a biopharmaceutical company focused on developing novel therapies that have the potential to substantially improve the length and quality of life of critically ill patients in areas of major unmet medical need, announced that they have signed a new contract under which DSM will manufacture the oral Dendritic Cell Mediated Immunotherapy (DCMI) talactoferrin for Agennix at commercial levels in anticipation of positive Phase III clinical data and product approval. DSM is currently manufacturing talactoferrin for use in ongoing clinical trials, including the FORTIS-M trial in non-small cell lung cancer (NSCLC), and will continue to supply talactoferrin for clinical trials as well as to support a potential commercial launch.
Villaume Kal, Vice President of DSM BioSolutions, a business unit of DSM Pharmaceutical Products serving the biopharmaceutical market, stated, "This agreement recognizes intensive collaboration between DSM and Agennix. DSM's process design for application in large scale manufacturing largely contributed to this success, and we are delighted to continue our support of Agennix."
Rajesh Malik, M.D., Chief Medical Officer and Management Board member of Agennix, said: "We are pleased to continue our productive relationship with DSM. Their long-term experience with talactoferrin will be invaluable as we work with them in preparation for a potential product approval and subsequent commercialization of talactoferrin. It is important for Agennix to put in place now the key elements of the talactoferrin supply chain, and expanding our contract with DSM is an important part of this process."
The contract includes the manufacture of commercial supply of talactoferrin, process development to continue to optimize the manufacturing process, and the opportunity to significantly expand production capacity as needed.
Talactoferrin is a first-in-class oral Dendritic Cell Mediated Immunotherapy (DCMI) currently being studied for the treatment of NSCLC. In randomized, double-blind, placebo-controlled Phase II studies in NSCLC, talactoferrin appeared to improve survival across a broad range of patients, including the difficult-to-treat refractory population, without many of the common toxicities seen with other cancer therapies. Two Phase III trials with talactoferrin in NSCLC are ongoing. The FORTIS-M trial, which completed enrollment in March 2011, is evaluating talactoferrin in NSCLC patients whose disease has progressed following two or more prior treatment regimens. A second Phase III trial -- FORTIS-C -- is evaluating talactoferrin in combination with the standard chemotherapy regimen, carboplatin/paclitaxel, in first-line NSCLC patients. NSCLC is one of the most common types of cancer worldwide and the most frequent cause of cancer death.
Agennix AG is a publicly listed biopharmaceutical company that is focused on the development of novel therapies that have the potential to substantially improve the length and quality of life of critically ill patients in areas of major unmet medical need. The Company's most advanced program is talactoferrin, a first-in class oral Dendritic Cell Mediated Immunotherapy (DCMI). Talactoferrin is currently in Phase III clinical trials in non-small cell lung cancer. Other clinical development programs include RGB-286638, a multi-targeted kinase inhibitor in Phase I testing for cancer, and a topical gel form of talactoferrin for diabetic foot ulcers. Agennix's registered seat is in Heidelberg, Germany. The Company has three sites of operation: Planegg/Munich, Germany; Princeton, New Jersey and Houston, Texas. For additional information, please visit the Agennix Web site at www.agennix.com.
This press release contains forward-looking statements, which express the current beliefs and expectations of the management of Agennix AG. Such statements are based on current expectations and are subject to risks and uncertainties, many of which are beyond our control, that could cause future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Actual results could differ materially depending on a number of factors, and we caution investors not to place undue reliance on the forward-looking statements contained in this press release. The achievement of positive results in early stage clinical studies does not ensure that later stage or large scale clinical studies will be successful. Even if the results from our later stage trials with talactoferrin, including the ongoing FORTIS-M trial in non-small cell lung cancer, are considered positive, there can be no guarantee that they will be sufficient to gain marketing approval in the United States or any other country, and regulatory authorities may require additional information, data and/or further pre-clinical or clinical studies to support approval. In such event, there can be no guarantee that the Company will have or be able to obtain the financial resources to conduct any such additional studies or that such studies will yield results sufficient for approval. Forward-looking statements speak only as of the date on which they are made and Agennix undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future.
Agennix™ is a trademark of the Agennix group.