Lonza and Agennix Sign Development and Manufacturing Deal for Production of Talactoferrin

April 12,2012
  • 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 Kouřim, 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 Kouřim, 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.”  

About Talactoferrin
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.   

About Agennix
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.  

Further Information

Lonza Group AG
Head of Corporate Communications
Dominik Werner
Tel +41 61 316 8798 
Fax +41 61 316 9798

Lonza Group AG
Investor Relations
Dirk Oehlers
Tel +41 61 316 8540 
Fax +41 61 316 9540

Lonza Group AG
Media Relations
Melanie Disa
Tel +1 201 316 9413
Fax +1 201 696 3533

Agennix Information

Barbara Mueller
Manager, Investor Relations & Corporate Communications 
Phone: +49 (0)89 8565 2693               

In the U.S.: Laurie Doyle
Senior Director, Investor Relations & Corporate Communications
Phone: +1 609 524 5884

Additional media contact - Europe:
MC Services AG    
Raimund Gabriel
Phone: +49 (0) 89 210 228 0               

Additional investor contact - Europe:
Trout International LLC       
Lauren Williams, Senior Vice President           
Phone: +44 207 936 9325    

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