PolyTherics Moves Lead Candidate Into Development and Manufacturing With DSM BioSolutions

DELFT, Netherlands, Sept. 7 /PRNewswire/ -- DSM BioSolutions (“DSM”), DSM’s microbial fermentation CMO business unit and PolyTherics Limited (“PolyTherics”), an innovator in precision engineering of proteins, today announced that they have entered into an agreement for the process development and manufacture of PolyTherics’ lead biobetter product, HiPEG IFN alpha-2a.

PolyTherics has applied its HiPEG site-specific PEGylation technology to interferon alpha to produce a product (HiPEG IFN alpha-2a) that has eight-fold higher activity than a marketed PEGylated interferon in vitro and a comparable half-life in a preclinical study.

HiPEG specifically attaches poly(ethylene) glycol (PEG) to a histidine tag at the end of the protein; histidine tags are commonly used to improve protein stability and to facilitate the purification of proteins. PolyTherics is seeking partners for the development of HiPEG IFN alpha-2a for hepatitis C.

DSM has successfully started development, scale-up and manufacture of the recombinant his-tagged IFN alpha-2a. PolyTherics will transfer its proprietary HiPEG PEGylation method to DSM so that the process can also be scaled-up. The companies intend to develop a robust process to produce sufficient material for preclinical development and then for cGMP production of HiPEG IFN alpha-2a for clinical development.

Keith Powell, CEO of PolyTherics, stated that, “The transfer of the production of our lead product to a contract manufacturer is a major milestone for PolyTherics and is the beginning of the development stage of its first biobetter drug.”

Villaume Kal, Vice-President of DSM BioSolutions stated, “We are delighted to work with PolyTherics on this promising biobetter compound. Our technology, operational excellence, and outstanding cGMP and compliance record with the EMA and FDA allows us to serve this important customer and to develop, scale-up and manufacture their preclinical and clinical material”.

No financial terms will be disclosed.

PolyTherics Limited

PolyTherics is a biopharmaceutical company that applies precision chemistry to develop improved protein and peptide-based drugs. It received investment of 2.3 million pounds Sterling from Imperial Innovations Group plc, Longbow Capital LLP and The Capital Fund in June 2007 and a further 3.0 million pounds Sterling investment from the same syndicate in February 2010.

PolyTherics has developed three proprietary technologies for attaching the polymer poly(ethylene glycol) (PEG) to any therapeutic peptide or protein in a targeted fashion. PEGylation slows elimination from the body, thereby improving half-life and potentially reducing drug treatment frequency, decreasing side effects and improving patient compliance.

PEGylated products derived from PolyTherics’ technologies are more homogeneous than those derived from traditional methods, resulting in reduced complexity of downstream processing, more consistent product quality and cost-effective manufacture. PEGylation is an established method for improving drugs and nine PEGylated products are already approved for therapeutic use worldwide.

For more information, please visit: www.polytherics.co.uk

DSM BioSolutions Microbial Fermentation

DSM BioSolutions, part of the DSM Pharma cluster, offers a wide range of customer services ranging from process development to large scale production, all in the field of microbial fermentation. Expertise covers microbial strain construction and improvement, fermentation process development and product recovery and purification. DSM’s production infrastructure for fermentation and associated product recovery and purification is based in a multipurpose facility in Capua, Italy, which currently produces pharmaceutical intermediates and APIs (with the exception of beta-lactams) and food/nutrition-related products. In the Pharma area, production lines are available for cGMP manufacturing of small molecules and pharmaceutical proteins. The facilities comply with all relevant regulations and are regularly inspected by the respective authorities (e.g. EMA and FDA).

For more information, please visit www.dsmbiosolutions.com

DSM the Life Sciences and Materials Sciences Company

Royal DSM N.V. creates solutions that nourish, protect and improve performance. Its end markets include human and animal nutrition and health, personal care, pharmaceuticals, automotive, coatings and paint, electrical and electronics, life protection and housing. DSM manages its business with a focus on the triple bottom line of economic performance, environmental quality and social responsibility, which it pursues simultaneously and in parallel. DSM has annual net sales of about euro 8 billion and employs some 22,700 people worldwide. The company is headquartered in the Netherlands, with locations on five continents. DSM is listed on Euronext Amsterdam.

For more information, please visit www.dsm.com

Forward-looking statements

This press release may contain forward-looking statements with respect to DSM’s future (financial) performance and position. Such statements are based on current expectations, estimates and projections of DSM and information currently available to the company. DSM cautions readers that such statements involve certain risks and uncertainties that are difficult to predict and therefore it should be understood that many factors can cause actual performance and position to differ materially from these statements. DSM has no obligation to update the statements contained in this press release, unless required by law.

SOURCE DSM BioSolutions