Celltrion and MediGene Announce Co-development of Anti-L1 Monoclonal Antibody Therapeutic for Treating Cancer

Incheon--(뉴스와이어)--Celltrion, Inc. and MediGene AG signed a binding Memorandum of Understanding for the co-development and commercialization of an anti-L1 monoclonal antibody (“L1 MAb”) for the treatment of cancer in humans covering major cancer indications. Under the terms of the agreement, the companies will share responsibilities for development and commercialization of the L1 MAb. Celltrion will conduct process development and manufacturing of the product and will have exclusive responsibility for development and commercialization of the L1 MAb in Asia, including Japan. Celltrion will also have an option for global manufacturing rights to supply Phase III and commercial material. MediGene retains the rights for the development and commercialization of the product in Europe, USA and the remaining areas.

MediGene previously entered into an option and license agreement with German Cancer Research Center (Deutsches Krebsforschungszentrum, “DKFZ”) and initiated the development of a monoclonal antibody against the tumor marker L1. During the period of cooperation MediGene will have the right to exercise an option to acquire an exclusive worldwide license on the application of the anti-L1 monoclonal antibody in anti-tumor therapy.

“MediGene and Celltrion have a shared vision for the development and commercialization of the L1 MAb in a range of potential cancer indications, with the lead indication being ovarian cancer,” said Peter Heinrich, Ph.D., Chief Executive Officer of MediGene. “We are confident in the potential of this product as a novel means of treating cancer in humans - an area where there is still a high unmet medical need. Celltrion as one of the leading biopharmaceutical manufacturing companies worldwide will be an excellent partner for this highly innovative drug candidate.”

“We are pleased to establish this alliance with MediGene, a company with a strong expertise in the development of cancer drugs,” said Jung-Jin Seo, Chairman and Chief Executive Officer of Celltrion. “This alliance will serve as a stepping stone to strengthen our business partnerships in the biopharmaceutical industry and to build a marketing and sales organization at Celltrion. MediGene shares our enthusiasm and commitment to developing this first-in-class molecule and to bring the L1 MAb more quickly to patients.”

About L1

The L1 protein highly specifically occurs on the cell surfaces of malignant ovarian and endometrial tumors (ovarian and uterine cancer), whereas it is not found in the respective healthy tissue or benign tumors. For this reason, this protein is especially suited as a new tumor marker in diagnostics and therapy.

About Celltrion

Celltrion, established in 2002, is a contract manufacturing organization located in South Korea with about 240 employees, and 50,000L of mammalian cell culture capacity. Celltrion is an emerging leader in the biopharmaceutical industry, dedicated to providing high quality services to accelerate product development and manufacturing capabilities for our clients and business partners focused on the treatment and prevention of human diseases. Celltrion is currently evolving into a fully integrated biotechnology company through the research and development of its own products as well as co-development of biopharmaceutical products via in-licensing deals with reputable biopharmaceutical companies in the USA and Europe.

About MedGene

MediGene is a publicly quoted (Frankfurt: Prime Standard: MDG) biotechnology company located in Martinsried/Munich, Germany, with subsidiaries in Oxford, UK and San Diego, USA. MediGene is the first German biotech company with a drug on the market. Another drug obtained marketing authorization for the USA and a further drug is currently undergoing the European approval procedures. Furthermore MediGene has several drug candidates for the treatment of various types of cancer and autoimmune diseases in clinical development, and possesses innovative platform technologies for drug development.

This press release contains forward-looking statements that involve risks and uncertainties. The forward-looking statements contained herein represent the judgment of MediGene as of the date of this release. These forward-looking statements are no guarantees for future performance, and the forward-looking events discussed in this press release may not occur. MediGene disclaims any intent or obligation to update any of these forward-looking statements. MediGeneTM is a trademark of MediGene AG

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