DSM & Agennix Sign Commercial Manufacturing Agreement

DSM Pharmaceutical Products and Agennix recently announced 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.

“This agreement recognizes intensive collaboration between DSM and Agennix,” said Villaume Kal, Vice President of DSM BioSolutions. “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.”

“We are pleased to continue our productive relationship with DSM,” added Rajesh Malik, MD, Chief Medical Officer and Management Board member of Agennix. “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. No financial terms were disclosed.

Royal DSM is a global science-based company active in health, nutrition, and materials. By connecting its unique competences in Life Sciences and Materials Sciences, DSM is driving economic prosperity, environmental progress, and social advances to create sustainable value for all stakeholders. More information can be found at www.dsmbiosolutions.com and www.dsm.com.

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. For additional information, please visit the Agennix Web site at www.agennix.com.