Biothera Completes Pharmaceutical Manufacturing Milestone

Eagan, MN – March 28, 2005 – Biothera, the immune health company, has completed an important pharmaceutical manufacturing milestone that is part of the process for filing an Investigational New Drug (IND) application with the FDA for its compound, Imprime PGG.

Biothera has completed development of a multimillion-dollar manufacturing suite in strict compliance with pharmaceutical cGMP (Good Manufacturing Practice) guidelines in Marlboro, Mass. The company has produced non-clinical trial material that is being used in various preclinical studies and a 28-day toxicology study that will support Biothera’s clinical program for this compound. Biothera is scheduled to complete the production of clinical trial material of
Imprime PGG, a cancer therapy, under cGMP conditions in May.

“The rapid completion of this new facility demonstrates the superior ability of our manufacturing processes to produce biologics,” said Richard Mueller, Biothera president and chief executive officer. “We are confident that we can reproduce and scale up production of Imprime PGG under cGMP conditions.”

“At this facility we have validated a new manufacturing process for our drug compound,” said Daniel Conners, Biothera chairman and founder. “The new process is more economical and can be reproduced by a third party licensee.”

In preclinical research, Imprime PGG has worked synergistically with monoclonal antibodies and cancer vaccines. Imprime PGG has a novel mechanism of action that engages immune cells to kill tumor cells they normally fail to recognize as cancer. The discovery of this entirely new cancer killing mechanism represents a technology platform with the potential to dramatically increase survival rates for the vast majority of cancers.

About Biothera, the Immune Health Company
Biothera is a biotechnology company dedicated to improving immune health. The company's primary focus is developing pharmaceuticals whose unique mechanism of action engages immune cells not normally involved in the fight against cancer. In addition, Biothera’s healthcare group manufactures and markets food-grade immune-enhancing ingredients for the nutritional supplement, functional food, cosmetic and the animal feed and nutrition markets.

Contact:
David Walsh
VP, Communications
Biothera, the Immune Health Company
651-256-4606
dwalsh@biotherapharma.com

 


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