WILEX enters into licensing and development partnership for MESUPRON® in China with Link Health Group

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Munich, Germany / Guangzhou, China, 28 March 2014 – WILEX AG (ISIN DE0006614720 / WL6 / FSE) today announced that it has entered into a licensing and development partnership for MESUPRON® with Link Health Co., Guangzhou, China. Link Health will receive the exclusive licensing rights for the development and marketing of MESUPRON® in China, Hong Kong, Taiwan and Macao.

Link Health will be responsible for performing and financing the entire clinical development of MESUPRON® in China in all oncological indications, including HER2-negative metastatic breast cancer and non-metastatic pancreatic cancer, as well as for the regulatory process and product marketing. To receive regulatory approval from the SFDA (Chinese State Food and Drug Administration), the complete clinical development programme from Phase I to Phase III must also be conducted in China, one of the largest pharmaceutical markets with rapid growth rates. The data generated may be used to support potential further development of MESUPRON® in other key markets.

Under the agreement, WILEX will receive a signing fee and milestone payments totalling more than 7 million Euro during clinical development in the first four indications to be developed by Link Health as well as staggered medium single digit royalties. The initial fees received by WILEX under the cooperation will not materially influence the current cash reach of the company.

Prof Olaf G. Wilhelm, CEO of WILEX AG, commented: “Signing the contract with Link Health today is a very important step for us because it means that we will be able to further advance the development of MESUPRON® in one of Asia’s principal markets with an expert partner. Link Health not only has development expertise but also possesses know-how in connection with regulatory approval and the marketing of oncology products. For us, it is a first step, and we will work in parallel on further licensing options.”

Dr Wang, CEO of the Link Health Group, said: “We are proud to be given the opportunity to take over this innovative product for our region and are planning an extensive clinical development programme, initially in two indications. We have high hopes for this innovative product candidate and understand the hitherto development rationale very well.”

The US-based consulting firm Destum Partners Inc., Charlotte, NC, USA, acted as transaction advisor to WILEX for this transaction.

Information on MESUPRON® and the uPA-programme
WILEX has developed with MESUPRON® (INN: Upamostat) a drug candidate to inhibit the Urokinase Plasminogen Activator (uPA) system. The uPA system has been shown to play a key role in tumour cell invasion and metastasis, as well as in primary tumour growth, of various solid tumours. In the Company’s view, the uPA inhibitor MESUPRON® of WILEX can be considered as a promising new non-cytotoxic approach in cancer therapy to prolong progression free survival and to specifically block tumour metastasis in solid cancers. Data from two Phase IIa trials (proof of concept) in locally advanced pancreatic cancer (2010) and metastatic breast cancer (2012) indications show the safety and activity of the drug candidate in combination with chemotherapeutic agents.

About WILEX
WILEX AG is a biopharmaceutical company based in Munich, Germany. Focused on oncology, the Company’s portfolio includes diagnostic and therapeutic product candidates for the specific detection and targeted treatment of various types of cancer based on antibodies and small molecules. Our aim is out-licensing these clinical projects. The subsidiary Heidelberg Pharma GmbH in Ladenburg, Germany, offers preclinical contract research services and an antibody drug conjugate (ADC) technology platform. 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.

About Link Health Group
Link Health Group is a high-quality Healthcare Service company focused on providing registration, licensing and regulatory consulting services in the Greater China area. Founded in 2009 as a spin-off from a public pharmaceutical company, Link Health is now an independent company. Based on eight years’ experience in the pharmaceutical industry, Link Health created a strong team to provide solutions for regulatory, (pre)clinical research, licensing, partnering and communications (IND, NDA applications) with the SFDA (Chinese State Food and Drug Administration), among others. Link Health Group has expertise in the licensing and co-development of INDs or devices at clinical stage.

Operating from the Chinese market, Link Health Group specialises in linking businesses from different markets to the mutual benefit of each other. The professional teams target and screen the best innovations in medical industry with the aim of creating market value in China with local partners. More information can be found at: www.healthinlink.com

Contact
WILEX AG
Sylvia Wimmer
Tel.: +49 (0)89-41 31 38-29
Email: investors[at]wilex.com
Grillparzerstr. 10, 81675 Munich, Germany 

Link Health Group
Song Yan, PhD
VP, BD and licensing
Link Health Group12/F, Tower A, G.T. Plaza, No85 Huacheng Avenue Tianhe District, Guangzhou
Tel: +86 20 28017293
E-Mail:
y.song[at]healthinlink.com

For press enquiries
MC Services AG
Katja Arnold (CIRO)
Tel.: +49-89-210 228-40
Mobil: +49 160 9360 3022
E-Mail: 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 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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