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EANS-News: Epigenomics AG and NextPharma Sign Global Manufacturing Deal for Colorectal Cancer Blood Test
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Company Information/Molecular diagnostics
Berlin, Germany and Surrey, United Kingdom, 6th October, 2010 (euro adhoc) - The cancer molecular diagnostics company Epigenomics AG and NextPharma Technologies, the leading European provider of product development, contract manufacturing and cold chain and logistics outsourcing services to the pharmaceutical and biotechnology industries, today announced that the companies have signed a global manufacturing contract for Epigenomics´ Epi proColon product. Epi proColon, currently marketed in Europe, is the world´s first in-vitro diagnostic test for the detection of colorectal cancer in a simple blood draw.
Under the terms of the agreement between the companies, NextPharma will manufacture Epigenomics´ CE-marked Epi proColon test kit for European and other markets according to the ISO 13485 for medical devices and will manufacture a cGMP-compliant version for the US market that is currently under development. Epigenomics plans to submit a marketing application to the US Food and Drug Administration (FDA) for the Epi proColon test in 2011.
"In NextPharma we have found the ideal contract manufacturing partner to satisfy the increasing demand for our Epi proColon test kit in Europe," commented Dr. Uwe Staub, Senior Vice President Product Development at Epigenomics. "With its high quality standards and depth of experience in medical device manufacturing NextPharma is also ideally positioned to manufacture our future US product."
NextPharma will manufacture the Epi proColon test kits at its US facility based in San Diego, California. This operation serves small to large corporations worldwide in the biotechnology, pharmaceutical, diagnostic, and medical device industries. Its aseptic area has multiple clean room suites offering Class 10,000 (Class 7 or Class C) formulation rooms and Class 100 (Class 5 or Class A) filling hoods or rooms. This facility is FDA licensed for pharmaceutical manufacturing and medical devices and is ISO 13485 certified for medical device manufacturing.
NextPharma´s medical device capabilities include in-vitro diagnostic reagents and kit preparation, custom procedure pack preparation as well as research analytical agents and research reagent kit preparation. In addition NextPharma is capable of performing prototype and pilot manufacturing of Class I/II Medical Devices.
"We are delighted to work alongside Epigenomics in manufacturing this innovative diagnostic test for the early detection of colorectal cancer for the global market" commented Bill Wedlake, Chief Executive Officer, NextPharma Technologies. "This is a testament to our skill, flexibility and speed in delivering this very important product through a combination of our medical device team´s significant experience combined with the utilization of our cutting edge technologies at our San Diego site."
The Epi proColon colorectal cancer blood test is designed to be convenient and patient friendly to overcome one of the biggest hurdles in colorectal cancer detection: patients´ lack of acceptance of currently available screening options. With the Epi proColon test, patients simply provide a blood sample in the doctor´s office, which can be part of a regular health check-up. The blood sample is then shipped to a laboratory where it is tested for the presence of methylated DNA of the Septin9 gene (mSEPT9). Detection of mSEPT9 in blood plasma has been demonstrated to be a reliable indicator of the presence of colorectal cancer in multiple case control studies with CRC patients and colonoscopy-verified negative controls as well as through a prospective population based study ("PRESEPT") of more than 7,900 subjects.
Current colorectal cancer screening methods - including fecal occult blood tests (FOBT) and colonoscopy - are perceived to be inconvenient and laborious and are infrequently used by individuals aged 50 and older who should be screened at regular intervals. As a consequence, the majority of cancers are detected at an advanced stage when the chance of survival is greatly diminished. The blood-based Epi proColon test may provide an opportunity for more people to participate in early cancer detection schemes and as a result those diagnosed with colon cancer may have a better prognosis.
Epigenomics is a molecular diagnostics company with a focus on the development of novel products for cancer. Using DNA methylation biomarkers, Epigenomics´ tests on the market and in development aim at detecting cancer before symptoms occur and thereby potentially reducing mortality from this disease.
Epigenomics´ product portfolio contains the CE-marked IVD test Epi proColon, the world´s first regulatory cleared molecular diagnostic test for the detection of colorectal cancer in blood that is based on the biomarker Septin9, and further proprietary DNA methylation biomarkers and IVD products at various stages of development and commercialization for colorectal, lung and prostate cancer. For development and global commercialization of IVD test products, Epigenomics pursues a dual business strategy in which direct commercialization of proprietary diagnostic test products is combined with non-exclusive licensing to diagnostic industry players with broad customer access. Strategic diagnostics industry partners include Abbott Molecular, Sysmex Corporation,Quest Diagnostics Incorporated, and ARUP Laboratories, Inc. for diagnostics test products and services, and QIAGEN N.V. for sample preparation solutions and research products. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary, Epigenomics Inc., in Seattle, WA, USA. For more information, please visit Epigenomics´ website at www.epigenomics.com.
NextPharma Technologies, headquartered in the UK and founded in 2000, is a world class outsourcing partner to the pharmaceutical and biotechnology industry.
NextPharma offers a full range of services from early phase product development, through clinical trial packaging (Phases I through III) to high volume commercial manufacturing for New Chemical Entities (NCEs)/New Biological Entities (NBEs) and generic products. The company is a world leader in lyophilization, sterile fill finish and pellet technologies and in specialist product manufacturing including cytotoxics, hormones, penicillins, cephalosporins and controlled drugs. Its sterile development and production offers a full range of drug delivery technologies including pre-filled syringes, vials and ampoules. Additionally NextPharma has significant expertise in paediatric drug formulation, development and manufacture. NextPharma offers `one-stop´ logistics solutions tailored to meet the needs of the global pharmaceutical industry under the rigid standards of cGSP/GDP regulations.
NextPharma operates globally with seven product development centers, seven manufacturing plants and six temperature controlled storage and distribution sites across Europe and North America, supplying customers in North America, Europe and Japan.
NextPharma has 1,200 employees dedicated to serving over 200 customers worldwide and a customer base, which includes many of the world´s leading pharmaceutical, specialty pharma and biotech companies.
NextPharma has a proven track record in almost all pharmaceutical technologies and product forms and in addition to the specialist areas above have capabilities in solids, semi-solids, liquids, sprays and dry dosage form technologies.
All of its sites are either FDA inspected, in the process of upgrade for inspection or targeted for upgrade for inspection.
Epigenomics´ legal disclaimers. This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale by Epigenomics in the United States of America. The analytical and clinical performance characteristics of any product based on this technology which may be sold at some future time in the USA have not been established.
Contact NextPharma Contact Epigenomics AG Bill Wedlake Dr. Achim Plum Chief Executive Officer Sen. VP Corporate Development NextPharma Technologies Epigenomics AG Holding Limited Tel +44 (0) 1483 479 121 Tel +49 (0) 30 24345 368 www.nextpharma.com email@example.com www.epigenomics.com
end of announcement euro adhoc --------------------------------------------------------------------------------
Further inquiry note:
Dr. Achim Plum
Sen. VP Corporate Development
Tel: +49 30 24345 368
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