The Pfenex- Agila venture
May 23, 2013: With an increasing awareness and extensive exploration in the realm of biosimilars, yet another pharmaceutical collaboration of importance is the one between Pfenex and Agila, which was formally announced in April 2013.
Biosimilars are biological agents which are synthesized by living organisms such as E. coli, by employing DNA recombinant techniques, such that a desired trait is expressed.
Agila Biotech, based in Bengaluru will be the major stake holder, amounting to 51% of the share. Their primary and most promising product in the series is Interferon beta- 1b, which is indicated in the management of secondary and rapid progressing variants of multiple sclerosis. After positive results in the preclinical studies, Phase 1 clinical studies on this biosimilar are expected to commence by September, this year.
According to the terms of the agreement, Pfenex is in charge of optimization of the culture strains and microorganism, fine-tuning the manufacturing parameters, and designing the methods of analyses for the finished product.
Agila biotech is expected to conduct the initial clinical trials, develop the product based on the results of the trial, and the final manufacturing of the biosimilar.
Large scale production of this Interferon beta would be at Agila’s new 150 acre biotechnology plant, which is currently under construction in Malaysia.
Upon successful launch of the first product, the focus would shift to the other biosimilars which are in Agila’s pipeline.
Agila Biotech, owned by Strides Acrolabs is an emerging pharmaceutical firm, which has its manufacturing centers in 6 countries, and operations in over 70 countries. Pfenex Inc, headquartered in San Diego, CA is a pioneer in recombinant DNA products, vaccines, and high throughput parallel strain screening techniques. Their patented Pfenex Expression Technology using the microbe Pseudomonas fluorescens is the basis of their research on protein expression.
The new collaboration of Pfenex and Agila with an impressive product portfolio and research teams shows immense promise.
Dr. Jay Shinde