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Austrianova And Miltenyi Biotec, Inc. Announce Strategic Partnership To Manufacture World's First Allogeneic Product To Combat Pancreatic Cancer


10/19/2005 5:13:19 PM

The Viennese company Austrianova Biotechology has entered into a strategic alliance with the German biotechnological manufacturer Miltenyi Biotec (Bergisch Gladbach) to establish a manufacturing process for NovaCaps®. Austrianova's lead-product, NovaCaps®, is the first somatic cell therapy worldwide to be established for the treatment of pancreatic cancer and will enter a pivotal phase III clinical trial at the end of 2006. Austrianova received "Orphan Drug" designation for NovaCaps® from the European Medicines Agency (EMEA) in July 2003 and, thus, is the only Austrian biotechnology company to have an "Orphan Drug" designation.

The cooperation will allow Austrianova to move from the research and development arena to become a producer of biological products. This move will be aided by Miltenyi Biotec's extensive know-how in the area of GMP production of biologics.

A new challenge: the encapsulation of living cells "In Miltenyi Biotec, we have found a specialist who can help us produce our somatic cell therapy product in an industrial scale. The challenge we face is how to upscale a functioning laboratory process - that has never been upscaled before - whilst adhering to the requirements of large-scale manufacture" explained Managing Partner Brian Salmons who is responsible for Research and Development at Austrianova. The industrial scale production of NovaCaps® is a prerequisite before the company can begin its final clinical studies at the end of 2006 that are aimed at European market approval.

The Vienna based biotech company will both finance and develop the product, whilst Miltenyi Biotec will contribute its production capacity, know-how, and laboratories to accelerate the large-scale GMP production of NovaCaps®.

Stefan Miltenyi, Managing Director of Miltenyi Biotec, sees interesting new possibilities as a result of the cooperation: "We are pleased to support the development of Austrianova's product with both our know-how and our manufacturing capabilities. The encapsulation of cells for therapeutic applications is a novel and innovative technology with immense potential for the future."

On the way to the market place: a pivotal phase III study Austrianova's primary goal is to obtain market approval for NovaCaps® in Europe as soon as possible. Currently plans are on track and the start of the multicentre pivotal phase III study on 200 patients with inoperable pancreatic cancer is scheduled for late 2006. If the trial is successful, it should be possible to obtain market approval in 2009. As a result of the "Orphan Drug" designation, Austrianova would also obtain up to 10 years market exclusivity concomitantly to market approval.

Expansion at Austrianova As a result of the activities leading up to the large-scale manufacture and clinical testing of NovaCaps®, Austrianova is one of the few European biotech companies currently actively recruiting new product development, regulatory, and medical staff. "The exciting challenge of helping to develop the first allogeneic cell therapy product worldwide for this devastating disease, in the setting of a young and fast-moving biotech company, makes us an attractive choice for people seeking a new paradigm in the drug development world" commented Brian Salmons.

High demand for effective cancer treatment options According to the WHO, 125,000 patients are diagnosed with pancreatic cancer every year in the industrial nations, 50,000 of these within the EU. Thomas Fischer, Austrianova's Financial Director estimates an annual market volume in the EU of around 300 million Euro.

2005-10-03

Austrianova Biotechnology GmbH

Austrianova Biotechnology GmbH is a biotech company based at the University of Veterinary Medicine in Vienna specialising in the development of cell and gene based therapies for the treatment of solid tumours. The company was founded in 2001 by Thomas Fischer, Walter H. Günzburg, and Brian Salmons and is now regarded as one of the leading Austrian biotech companies. Its lead-product, NovaCaps®, has received "Orphan Drug" designation for pancreatic cancer in the EU. Austrianova has a close cooperation with the Research Institute for Virology and Biomedicine, and together they employ more than 60 people from more than 10 nations.

Further information can be found at www.austrianova.com

For individual questions, please contact: Mag. Thomas Fischer, Managing Director Finance & Administration Austrianova Biotechnology GmbH Veterinaerplatz 1, A-1210 Vienna, Austria Telephone: +43 1 250 77 2601, e-mail: fischer@austrianova.com

Miltenyi Biotec GmbH Employing more than 750 people worldwide, Miltenyi Biotec is one of Germany's most successful biotech companies. As premier provider of magnetic cell separation technology, Miltenyi Biotec has its expertise in the areas of cell separation, cell analysis, cell culture, cell therapy, and molecular biology. Miltenyi Bioprocess, a division of Miltenyi Biotec, offers services in the area of GMP manufacturing of pharmaceutical products. This includes process development, qualification, and validation of recombinant proteins from prokaryotic and eukaryotic cells, the development and GMP production of affinity chromatography matrices, the coupling of protein conjugates to superparamagnetic carriers, and the production of cell culture media. Miltenyi Biotec's portfolio is rounded off by independent departments for quality control, quality assurance, and regulatory matters.

Further information can be found at www.miltenyibiotec.com

For individual questions, please contact: Dr. Reinhard Kuske, Contract Manufacturing Manager Miltenyi Bioprocess, a division of the Miltenyi Biotec GmbH Friedrich-Ebert-Straße 68, D-51429 Bergisch Gladbach, Germany Telephone: +49 2204 8306 3175, e-mail: reinhardk@miltenyibiotec.de


Read at BioSpace.com

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