Heidelberg Pharma AG

Regulatory Filings • Jan 16, 2017

News Details

Ad-hoc | 16 January 2017 09:05

WILEX AG: WILEX signs antibody license agreement with Telix Pharmaceuticals Limited

WILEX AG / Key word(s): Alliance

16-Jan-2017 / 09:05 CET/CEST
Disclosure of an inside information acc. to Article 17 MAR, transmitted by
DGAP - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

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Ad-hoc announcement

Inside information according to Article 17 MAR

WILEX signs antibody license agreement with Telix Pharmaceuticals Limited

Munich, Germany, 16 January 2017 - WILEX AG (ISIN DE000A11QVV0 / WL6 / FSE)
and Australian biopharmaceutical company Telix Pharmaceuticals Limited
("Telix"), today announced that they have concluded a worldwide license
agreement for the development and commercialization of the imaging agent
REDECTANE(R), a radiolabeled form of the monoclonal antibody Girentuximab.
WILEX successfully completed a first Phase III trial with REDECTANE(R) in
ccRCC.

WILEX has granted Telix the worldwide licensing rights to further develop
and commercialize the REDECTANE(R) molecular imaging program. Under the
agreement, Telix will, as a first step, invest in an improved manufacturing
process for the antibody. Under the terms of the agreement, WILEX is
eligible to receive up-front and milestone payments totaling USD 3.7
million. In addition, WILEX is eligible to receive significant royalties on
global net sales of REDECTANE(R), commensurate with a Phase III asset.
Telix will be responsible for all development costs, as well as
manufacturing and commercialization costs.

Telix will also develop a therapeutic radioimmunoconjugate program based on
Girentuximab. Early clinical data suggests that 177Lu-labeled Girentuximab
has disease stabilizing effects in patients with advanced staged metastatic
renal cancer. Telix is evaluating the use of CAIX targeting therapeutic
agents with both beta- and alpha-emitting radionuclides for a variety of
malignancies. Under the terms of the agreement, if a therapeutic product
developed by Telix is ultimately granted marketing approval, WILEX will
receive single-digit royalties.

+++ End of the release +++

About REDECTANE(R) and the Phase III REDECT Study
REDECTANE(R) (INN: 124I-Girentuximab) is a radiolabeled form of the
monoclonal antibody Girentuximab, which binds to the Carbonic Anhydrase-9
(CAIX) antigen, expressed on the surface of cancer cells of the clear-cell
phenotype. Accumulation of this antibody in tumor tissue can be visualized
by means of molecular imaging using Positron Emission Tomography (PET).
Additional anatomical information provided by computer tomography (CT) can
be used to localize the accumulation of the antibody. REDECTANE(R) has the
potential to fundamentally change therapy planning for renal cancer
patients, including the avoidance of unnecessary surgery. Furthermore,
REDECTANE(R) may also prove suitable for the diagnosis, staging and
treatment response assessment in other kinds of cancers, such as lung and
ovarian cancer.

The Phase III REDECT trial demonstrated that REDECTANE(R) can differentiate
between clear cell and non-clear cell renal cell cancer and that PET/CT
molecular imaging with REDECTANE(R) was superior to CT alone. In order to
obtain market authorization from the US Food and Drug Administration (FDA),
REDECTANE(R) requires a second Phase III confirmatory study. WILEX has been
granted a special protocol assessment (SPA) from the FDA for the planned
confirmatory study (REDECT 2).

About WILEX
WILEX AG is a biopharmaceutical company based in Munich, Germany, that
serves as a parent and holding company. The Company's research and
development work is conducted by its subsidiary Heidelberg Pharma GmbH in
Ladenburg. Heidelberg Pharma is the first company to develop the toxin
Amanitin into cancer therapies using its proprietary Antibody Targeted
Amanitin Conjugate (ATAC) technology and to advance the biological mode of
action of the toxin as a novel therapeutic principle. This proprietary
technology platform is being applied to develop the company's own
therapeutic ATACs as well as in third-party collaborations to create a
variety of ATAC candidates. The proprietary lead candidate is a BCMA ATAC
for multiple myeloma. WILEX's clinical assets MESUPRON(R) and REDECTANE(R)
have been partnered, while RENCAREX(R) is available for out-licensing and
further development. WILEX is listed on the Frankfurt Stock Exchange: ISIN
DE000A11QVV0 / WKN A11QVV / Symbol WL6. More information is available at
http://www.wilex.com/.

Contact IR/PR-­support
WILEX AG MC Services AG
Sylvia Wimmer Katja Arnold (CIRO)
Corporate Communications Managing Director & Partner
Tel.: +49 (0)89-41 31 38-29 Tel.: +49 (0)89-210 228-40
Email: investors[at]wilex.com Mobile: +49 (0)160 9360 3022
Grillparzerstr. 18, 81675 Munich Email: katja.arnold[at]mc-services.eu

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 condition, performance, or achievements, or industry results, to
be materially different from any future results, performance 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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Language: English
Company: WILEX AG
Grillparzerstr. 18
81675 München
Germany
Phone: +49 (0)89 41 31 38 - 0
Fax: +49 (0)89 41 31 38 - 99
E-mail: info@wilex.com
Internet: www.wilex.com
ISIN: DE000A11QVV0
WKN: A11QVV
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated
Unofficial Market in Berlin, Dusseldorf, Munich,
Stuttgart, Tradegate Exchange

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