Lonza and Agennix Sign Development and Manufacturing Deal for Production of Talactoferrin
- Contract covers the commercial production of talactoferrin, an oral Dendritic Cell Mediated Immunotherapy (DCMI) under investigation for the treatment of non-small cell lung cancer (NSCLC)
- Lonza will manufacture talactoferrin at its microbial facility in Kou?im, Czech Republic
Basel (Switzerland), Planegg/Munich (Germany), Princeton, NJ and Houston, TX (USA) – 12 April 2012 – Lonza and Agennix AG (Frankfurt Stock Exchange: AGX) announced today an agreement for the production of Agennix’s first-in-class oral Dendritic Cell Mediated Immunotherapy (DCMI), talactoferrin, currently in Phase III testing for the treatment of non-small cell lung cancer (NSCLC). Under the agreement, Lonza will produce commercial material at its microbial manufacturing facility in Kou?im, Czech Republic. This agreement initiates the process needed to be able to ultimately seek approval for Lonza as a second manufacturer of talactoferrin after the initial commercial launch.
“We are committed to supporting emerging therapeutics through clinical trial milestones,” said Dr. Stephan Kutzer, COO Lonza Custom Manufacturing. “Our partnership with Agennix is an example of this commitment and demonstrates Lonza’s ability to offer access to our development and manufacturing expertise at an early stage of production.”
Rajesh Malik, M.D., Chief Medical Officer and Management Board member of Agennix, said: “We are pleased to enter this agreement with Lonza, which has extensive experience manufacturing biologics on a commercial scale. In anticipation of positive Phase III data and a potential product approval, it is important that we have more than one manufacturer in place to ensure we can meet anticipated commercial demand and that we have security of supply.”
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.
Lonza is one of the world's leading suppliers to the pharmaceutical, healthcare and life science industries. Products and services span its customers’ needs from research to final product manufacture. It is the global leader in the production and support of active pharmaceutical ingredients both chemically as well as biotechnologically. Biopharmaceuticals are one of the key growth drivers of the pharmaceutical and biotechnology industries. Lonza has strong capabilities in large and small molecules, peptides, amino acids and niche bioproducts which play an important role in the development of novel medicines and healthcare products. Lonza is also the world leader in microbial control providing innovative, chemistry-based and related solutions to destroy or to selectively inhibit the growth of harmful microorganisms. Its activities encompass the areas of water treatment, personal care, health and hygiene, industrial preservation, materials protection, and wood treatment. In addition, Lonza is a leader in cell-based research, endotoxin detection and cell therapy manufacturing. Furthermore, the company is a leading provider of value chemical and biotech ingredients to the nutrition and agro markets.
Lonza is headquartered in Basel, Switzerland and is listed on the SIX Swiss Exchange and secondary listed on the Singapore Exchange Securities Trading Limited (“SGX-ST”). Lonza is not subject to the SGX-ST’s continuing listing requirements. Lonza is subject to the listing rules of the SIX Swiss Exchange, which do not have specific requirements equivalent to the listing rules of the SGX-ST in respect of interested person transactions, acquisition and realizations, and delisting. In 2011, the company had sales of CHF 2.69 billion. Further information can be found at www.lonza.com.