16.01.2017
WILEX AG DE000A11QVV0
DGAP-News: WILEX AG: WILEX signs antibody license agreement with Telix Pharmaceuticals Limited
DGAP-News: WILEX AG / Key word(s): Alliance
WILEX AG: WILEX signs antibody license agreement with Telix Pharmaceuticals
Limited
16.01.2017 / 09:29
The issuer is solely responsible for the content of this announcement.
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PRESS RELEASE
WILEX signs antibody license agreement with Telix Pharmaceuticals Limited
- Telix receives exclusive worldwide rights for the development and
commercialization of diagnostic agent REDECTANE(R) (INN: 124I-
Girentuximab)
- Telix also receives development rights to Girentuximab for use with
therapeutic radionuclides, such as 177Lu (Lutetium)
- Telix is responsible for the manufacturing of Girentuximab for both
diagnostic and therapeutic applications
- WILEX to receive upfront payment plus potential clinical and regulatory
milestone payments and attractive royalties
Munich, Germany / Melbourne, Australia, 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. Girentuximab binds to Carbonic Anhydrase-9 (CAIX),
an antigen highly expressed on clear cell renal cell carcinoma (ccRCC)
cells. Targeting and accumulation of radiolabeled-antibodies in tumor
tissue can be visualized by molecular imaging with Positron Emission
Tomography (PET) and has significant diagnostic and staging value in the
management of renal (kidney) cancer. WILEX has 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.
Dr Jan Schmidt-Brand, CEO / CFO of WILEX AG, said: "We are pleased to sign
this licensing agreement for this promising Phase III product candidate.
Telix is one of the few firms, globally, that has the experience and
capability to effectively address the dual technical challenge of
radiochemistry and biologics development. Telix is an ideal partner to
leverage the potential of Girentuximab-based diagnostic and therapeutic
radiopharmaceuticals. With this agreement, WILEX will be able to share in
the future success of REDECTANE(R) and potentially other downstream
products. This agreement also represents another important step in our
strategic realignment and enables us to further focus on our innovative
ATAC technology."
Telix CEO, Dr Christian Behrenbruch, stated: "We are delighted to have
partnered with WILEX to complete the development of REDECTANE(R). This is a
very promising product that has the potential to have a major impact on the
way patients with renal cancer are diagnosed, staged and managed. We are
confident of the clinical data supporting the final development and
commercialization of REDECTANE(R) and we are pleased to add such an
advanced-stage candidate to our portfolio of products."
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
www.wilex.com.
About Telix
Telix Pharmaceuticals Limited is a clinical-stage biopharmaceutical company
headquartered in Melbourne, Australia. Telix is developing an advanced
portfolio of clinical-stage products that address significant unmet medical
needs in renal, prostate and brain (glioblastoma) cancers. Telix's pipeline
consists of "theranostic" radiopharmaceuticals, agents that are able to be
used both diagnostically (via PET imaging) and therapeutically for patient
benefit. Telix is an unlisted public company. For more information go to
www.telixpharma.com.
Contact IR/PR-Contact WILEX AG MC Services AG Corporate Communications Katja Arnold (CIRO) Sylvia Wimmer Managing Director & Partner Tel.: +49 (0)89-41 31 38-29 Tel.: +49-89-210 228-40 Email: investors[at]wilex.com Mobil: +49 160 9360 3022 Email: katja.arnold[at]mc-services.euTelix Pharmaceuticals Limited Dr Christian Behrenbruch Tel.: +61 (0)406063247 Email: [email protected] 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. --------------------------------------------------------------------------- 16.01.2017 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement. The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Archive at www.dgap.de --------------------------------------------------------------------------- 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: [email protected] 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 End of News DGAP News Service --------------------------------------------------------------------------- 536551 16.01.2017
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