WILEX Inc. and IBL-America sign non-exclusive marketing and distribution agreement for USA

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Munich, Germany / Minneapolis, USA, 31 January 2013. WILEX AG (ISIN DE0006614720/ WL6 / FSE) today announced that its US subsidiary WILEX Inc., Cambridge, MA, USA, entered into a non-exclusive marketing and distribution agreement with Immuno-Biological Laboratories Inc., Minneapolis, MN, USA, (IBL-America) for the commercialization of the complete diagnostic portfolio in the USA. IBL-America is a distributor of high quality diagnostic assays in various areas including autoimmunity, endocrinology, infectious disease, oncology and neuroscience and offers technical laboratory services as well. Financial terms were not disclosed.

WILEX Inc. is a specialist in serum based oncoprotein diagnostics and offers tests for In Vitro Diagnostic (IVD) and Research Use Only (RUO) under the brand Oncogene Science. WILEX Inc. provides the only FDA-cleared through 510(k) IVD ELISA test for the measurement of serum HER-2/neu in the management and monitoring of women with metastatic breast cancer. This microtiter based test enables laboratories to measure the level of HER-2/neu in serum in a cost-efficient and validated manner. This test is reimbursed by insurance companies and has a unique CPT code 83950. In addition, WILEX Inc. also offers a CAIX IHC Class 1 IVD test for the pathology market and CAIX RUO ELISA for measuring this hypoxia biomarker in serum or plasma. CAIX is highly overexpressed in renal cell cancer and several other major cancers. The portfolio also includes RUO ELISA kits for the detection of oncoproteins in serum including targets like uPA, PAI-1, TIMP-1 and EGFR.

The 2011 signed exclusive distribution contract between WILEX Inc. and American Laboratory Products Company Inc., Salem, NH, USA, (ALPCO Diagnostics) for the co-marketing and distribution of the Serum HER-2/neu ELISA test in USA and Canada was terminated recently by mutual agreement.

Professor Olaf G. Wilhelm, CEO of WILEX Inc. and WILEX AG, commented: “As the American market is quite fragmented we decided to terminate our exclusive distribution agreement and to open up the business for IBL-America. With more than 16 years of hands-on experience and existing sales in oncology, we believe that IBL-America is an ideal partner to successfully market and distribute our portfolio of biomarker tests.”

Mark A. Kowal, President and CEO of IBL-America said: “We believe the Oncogene Science diagnostic tests are an attractive addition to our existing product portfolio. Especially the Serum HER-2/neu ELISA offers an important diagnostic application for improving breast cancer patient care. We already have a well-established distribution network to gynecologists and labs for our HE4 assay to monitor recurrence or progressive disease in patients with epithelial ovarian cancer and will use this distribution channel to promote the Oncogene Serum HER-2/neu ELISA as well.”

About IBL-America. IBL-America is a privately owned US corporation located in Minneapolis, MN, and since 1997 has been an established provider of in-vitro diagnostic assays to major US laboratories and hospitals. With annual sales of $4MM+ IBL-America continues to provide the diagnostic community with the products and technical service required to meet today’s high quality standards and regulations. Additionally IBL-America supplies research assays as well as antibodies and proteins to thousands of laboratories across North and South America. Through their sister company, KMI Diagnostics, Inc., IBL-America can also provide testing services for endocrinology and research projects. More information is available at www.ibl-america.com and www.kmidiagnostics.com.

About WILEX Inc. WILEX Inc. is a wholly owned US subsidiary of WILEX AG, Munich, Germany and manufactures, markets and sells serum based oncoprotein diagnostics and various biomarker tests under the brand name Oncogene Science. The product portfolio includes Enzyme-linked ImmunoSorbent Assays (ELISA) and immunohistochemical (IHC) assays. With the aim of supporting treatment regimens for cancer patients worldwide WILEX Inc. offers biomarker tests for measuring oncogenes, growth factor receptors (HER-2/neu, EGFr), proteases and protease inhibitors (uPA,
PAI-1, TIMP-1), as well as markers of hypoxia (CAIX). In addition to the new CAIX IHC which is a class 1 IVD test, WILEX Inc. provides the only FDA-cleared IVD ELISA that measures the serum HER-2/neu level for the management and monitoring of patient care for women with metastatic breast cancer. WILEX Inc. is based in Cambridge, MA, USA and also provides GMP and ISO certified manufacturing services. More information is available on www.oncogene.com.

WILEX AG is a biopharmaceutical company based in Munich, Germany. Focused on oncology, the Company develops diagnostic and therapeutic product candidates for the specific detection and targeted treatment of various types of cancer based on antibodies and small molecules. Beside the manufacturing and marketing of the biomarker tests from WILEX Inc. the subsidiary Heidelberg Pharma GmbH offers preclinical contract research services and an antibody drug conjugate (ADC) technology platform. The business model comprises research and product development as well as the commercialisation of its activities. Our customers and partners include leading international pharmaceutical companies. WILEX AG is listed at the Frankfurt Stock Exchange. ISIN DE0006614720 / WKN 661472 / Symbol WL6. More information is available on www.wilex.com.

Contact WILEX AG

Corporate Communications
Katja Arnold (CIRO)
Grillparzerstr. 10
81675 Munich, Germany
Tel.: +49 (0)89-41 31 38-126
Fax: +49 (0)89-41 31 38-99
Email: investors@wilex.com

IBL-America 
Immuno-Biological Laboratories Inc.
Mark A. Kowal President / CEO
8201 Central Ave NE, Suite P Minneapolis,
Minnesota 55432
Tel: 1-763-780-2955
Fax: 1-763-780-2988
Email: mkowal@ibl-america.com

This communication contains certain forward-looking statements relating to the Company’s business, which can be identified by the use of forward-looking terminology such as “estimates”, “believes”, “expects”, “may”, “will” “should” “future”, “potential” or similar expressions or by a general discussion of the Company’s strategy, plans or intentions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results of operations, financial position, earnings, achievements, or industry results, to be materially different from any future results, earnings or achievements expressed or implied by such forward-looking statements. Given these uncertainties, prospective investors and partners are cautioned not to place undue reliance on such forward-looking statements. We disclaim any obligation to update any such forward-looking statements to reflect future events or developments.

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