DGAP-News: WILEX AG:
DGAP-News: WILEX AG / Key word(s): Strategic Company Decision/Disposal
06.09.2013 / 18:51
Nuclea Biotechnologies Inc. acquires WILEX Inc. and extends their
cooperation with WILEX AG
- Nuclea purchased all shares of WILEX Inc. (Oncogene Science)
- Development and financing of an automated CAIX in vitro diagnostic by
Munich, Germany / Pittsfield, USA / Cambridge, USA, 06 September 2013.
WILEX AG (ISIN DE0006614720/ WL6 / FSE) and Nuclea Biotechnologies, Inc.,
Pittsfield, MA, USA, (Nuclea) today signed a share deal agreement under
which Nuclea acquires all shares of WILEX Inc., Cambridge, MA, USA,
(Oncogene Science), a wholly owned US subsidiary of WILEX AG. Under the
terms of the deal, Nuclea will assume all the assets of WILEX Inc. and will
also assume responsibility for repayment of USD 2.5 million under an
intercompany loan between WILEX Inc. and WILEX AG. In addition, WILEX AG is
eligible for single-digit royalties on net sales on the HER-2/neu and CAIX
Concurrently and as essential part of the overall deal, WILEX AG and Nuclea
entered into a development agreement under which Nuclea will develop an
automated CAIX IVD IHC assay ('CAIX Dx') to be submitted for FDA allowance
under the investigational device exemption ('IDE'). This CAIX Dx is
intended to be used for patient stratification in a planned pivotal study
with RENCAREX(R) and as a potential future companion diagnostic in the
adjuvant treatment of clear cell renal cell carcinoma. Nuclea will bear the
costs for the development of this CAIX Dx as a contribution in kind which
will lead to savings of at least USD 2.5 million for WILEX AG.
WILEX Inc. (Oncogene Science) specialises in serum based oncoprotein
diagnostics and provides the only FDA cleared and CE marked IVD ELISA test
for the measurement of serum HER-2/neu in the management and monitoring of
patients with metastatic breast cancer. In addition, the company listed the
CAIX IHC kit as a Class I 510(k)-exempt medical device with the FDA. This
immunohistochemistry (IHC) kit is used to identify the antigen Carbonic
Anhydrase IX (CAIX) which plays an important role in various types of
cancer. Beside these important assays other Oncogene Science biomarker
tests (e.g. TIMP-1 ELISA, EGFR ELISA and uPA ELISA) currently used as
research use only (RUO) complement Nuclea's wide range of products and
Nuclea identifies biomarkers and develops proprietary diagnostic assays
under the brand Decision Dx(TM) that can help predict which courses of
treatments will be effective for specific patients, based on their genetic
makeup. Nuclea performs in vitro diagnostic (IVD) assays in the area of
oncology in a certified laboratory (CLIA) and also has access through its
business relationships with hospitals and research institutions to patients
in need of such tests. One such assay is Nuclea's Decision Dx(TM) Fatty
Acid Synthase for use in a variety of cancers.
Nuclea and WILEX Inc. have been partners in marketing the serum HER-2/neu
ELISA since early 2013 and had identified several synergies. The agreement
includes the transfer to Nuclea of numerous distribution and marketing
agreements for the marketed Oncogene Science tests and Nuclea will acquire
the GMP (Good Manufacturing Practice) facility in Cambridge.
'This deal is a major step for Nuclea,' said Patrick J. Muraca, President &
CEO of Nuclea. 'This acquisition presented us with an opportunity to
strengthen Nuclea's portfolio and continue to move into the commercial
realm. The commercial platform and the GMP facility acquired through this
transaction will serve as a catalyst for the adoption of Nuclea's Decision
Dx(TM) Fatty Acid Synthase, which is currently available as a CLIA
validated assay, used in clinical trials and under regulatory review. With
our expertise and existing relationships, I'm confident that these
additions will expand our footprint in the field of personalized medicine.'
Professor Olaf G. Wilhelm, CEO of WILEX Inc. and WILEX AG, commented: 'The
acquisition of Oncogene Science was driven by the CAIX assets. The future
development of RENCAREX(R) requires now a companion diagnostic based on
CAIX for patient stratification. This transaction delivers not only a
partner to develop and commercialise the CAIX Dx but also further cost
savings and allows WILEX to focus on its late stage drug pipeline and ADC
Nuclea Biotechnologies, Inc. is headquartered in Pittsfield, Massachusetts
with additional operations in Worcester, Massachusetts. Nuclea has
developed and is commercializing unique diagnostic tests for colon, breast,
leukaemia, lung and prostate cancer. Nuclea also performs research leading
to novel molecular oncology companion diagnostics for the pharmaceutical
and biotechnology industries. www.nucleabio.com
About WILEX Inc.
WILEX Inc. is a wholly owned US subsidiary of WILEX AG, Munich, Germany.
The team of 11 employees has many years' experience in developing and
manufacturing biomarker tests for oncology, which are marketed under the
brand name Oncogene Science. The product portfolio includes enzyme-linked
immunosorbent assays (ELISA) and immunohistochemical (IHC) assays for in
vitro diagnostic (IVD) and research use only (RUO). 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). WILEX Inc. is based in Cambridge, MA,
USA and also provides GMP and ISO certified manufacturing services. More
information is available at 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. 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 at www.wilex.com.
WILEX AG Nuclea Biotechnologies Inc.
Corporate Communications Media Relations
Katja Arnold (CIRO) & Sylvia Wimmer Greg D'Agostino
Tel.: +49 (0)89-41 31 38-29 Cell +1 617.388.6477
Mobil: +49 (0)160 93 60 30 22 Office +1 617.695.0369
Email: investors[at]wilex.com Email: email@example.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.
End of Corporate News
06.09.2013 Dissemination of a Corporate News, transmitted by DGAP - a
company of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
Company: WILEX AG
Phone: +49 (0)89 41 31 38 - 0
Fax: +49 (0)89 41 31 38 - 99
Listed: Regulierter Markt in Frankfurt (Prime Standard);
Freiverkehr in Berlin, Düsseldorf, München, Stuttgart
End of News DGAP News-Service
Press spacebar to pause and continue. Press esc to stop.