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Genkyotex Expands License Agreement for Vaxiclase Platform with Serum Institute of India


Regulatory News:

Genkyotex (GKTX.PA) (GKTX.PA) (Euronext Paris & Brussels: FR00011790542 – GKTX), a biopharmaceutical company and the leader in NOX therapies, today announces that it has expanded the license agreement for its Vaxiclase platform with the Serum Institute of India (SIIPL), the world's largest vaccine manufacturer, to include the developed world in their addressable markets. The initial agreement, signed in 2015, covered emerging pharmaceutical markets.

Since the beginning of the agreement, Genkyotex has received a total of $1.3 million in upfront payment and from the achievement of a pre-specified development milestone in November 2016. According to the terms of the initial agreement, Genkyotex is eligible to receive $57 million. Following the expansion of the agreement to the developed world territories, Genkyotex becomes eligible to receive additional €100 million bringing the overall agreement to approximately €150 million* in upfront payment, development and commercial milestones. Genkyotex is also eligible to receive single digit royalties on sales. The new territories covered in the expanded agreement include the U.S., Canada, EU member states, and the UK. Vaxiclase is a technology platform ideally suited for immunotherapies against multiple infectious diseases or cancers and SIIPL is utilizing it to develop a pertussis vaccine.

“In the past three years since our initial agreement, we are increasingly confident in the potential for the Vaxiclase platform to play an important role in the development of a pertussis vaccine,” said Adar C. Poonawalla, CEO and Executive Director of SIIPL. “We look forward to expand our agreement to the developed world, which has become a key strategic priority for our company. Pertussis remains an indication with significant unmet needs worldwide, and we believe a substantial market opportunity exists for an improved acellular pertussis component-based combination vaccine.”

“We are extremely pleased to further monetize our Vaxiclase technology,” said Elias Papatheodorou, CEO of Genkyotex. “As SIIPL is the world’s largest vaccine manufacturer, we view our relationship as a validation of this platform and its significant potential for the development of various immunotherapies. Genkyotex remains focused in the development of its lead asset GKT831 in fibrotic indications as well as other future candidates targeting the NOX enzymes. Our trial with GKT831 in primary biliary cholangitis (PBC) is progressing and we are happy to report that till today we have not had any serious adverse events, liver related events or any drop outs. We still guide for interim data in the fall of 2018 and final data in H1 2019.”

*The overall amount of this agreement is provided in euros for information purposes and is based on the €/$ currency rate as at the signature date of the restated agreement.

About Serum Institute of India Private Ltd. (SIIPL)
Serum Institute of India (www.seruminstitute.com) is the world’s largest producer of the Measles and DTP group of vaccines. Approximately two of every three children immunized globally are vaccinated by a vaccine manufactured by Serum Institute of India. Serum Institute of India’s products have been used in 140 countries. Serum Institute of India was founded in 1966 by Dr. C.S. Poonawalla with the vision of manufacturing life-saving immune-biologicals in shortage in the country. Thereafter, several life-saving biologicals were manufactured in abundance at prices affordable to the common man.

Through Serum Institute, India was made self-sufficient for Tetanus Anti-toxin and Anti-snake Venom serum, followed by the DTP (Diphtheria, Tetanus and Pertussis) group of vaccines and later, for the MMR (Measles, Mumps and Rubella) group of vaccines. The Philanthropic philosophy of Serum Institute has since been expanded to also provide newer vaccines such as Hepatitis-B vaccine, Rabies vaccine and Combination vaccines.

Today, not only Indians, but all under-privileged children of the world in more than 140 countries are protected from birth onwards by vaccines provided by SIIPL.

About Genkyotex
Genkyotex is the leading biopharmaceutical company in NOX therapies, listed on the Euronext Paris and Euronext Brussels markets. A leader in NOX therapies, its unique therapeutic approach is based on a selective inhibition of NOX enzymes that amplify multiple disease processes such as fibrosis, inflammation, pain processing, cancer development, and neurodegeneration.

Genkyotex’s platform enables the identification of orally available small-molecules that selectively inhibit specific NOX enzymes. Genkyotex is developing a pipeline of first-in-class product candidates targeting one or multiple NOX enzymes. The lead product candidate, GKT831, a NOX1 and NOX4 inhibitor is evaluated in a phase II clinical trial in primary biliary cholangitis (PBC, a fibrotic orphan disease) and in an investigator-initiated Phase II clinical trial in Type 1 Diabetes and Kidney Disease (DKD). This product candidate may also be active in other fibrotic indications. Its second product candidate, GKT771, is a NOX1 inhibitor targeting multiple pathways in angiogenesis, pain processing, and inflammation, currently undergoing preclinical testing.

Genkyotex also has a versatile platform well-suited to the development of various immunotherapies (Vaxiclase). A partnership covering the use of Vaxiclase as an antigen per se (GTL003) has been established with Serum Institute of India Ltd (Serum Institute), the world’s largest producer of vaccine doses, for the development by Serum Institute of cellular multivalent combination vaccines against a variety of infectious diseases. This partnership could generate approximately €150 million in future revenues for Genkyotex, before royalties on sales.

For further information, please go to www.genkyotex.com.

This press release and the information it contains does not constitute an offer or solicitation to buy, sell or hold Genkyotex shares in any country, in particular any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration, exemption from registration or other qualification under the securities laws of any such jurisdiction.

This press release may contain forward-looking statements by the company with respect to its objectives. Such statements are based upon the current beliefs, estimates and expectations of Genkyotex’s management and are subject to risks and uncertainties such as the company's ability to implement its chosen strategy, customer market trends, changes in technologies and in the company's competitive environment, changes in regulations, clinical or industrial risks and all risks linked to the company's growth. These factors as well as other risks and uncertainties may prevent the company from achieving the objectives outlined in the press release and actual results may differ from those set forth in the forward-looking statements, due to various factors. Without being exhaustive, such factors include uncertainties involved in the development of Genkyotex’s products, which may not succeed, or in the delivery of Genkyotex’s products marketing authorizations by the relevant regulatory authorities and, in general, any factor that could affects Genkyotex’s capacity to commercialize the products it develops. No guarantee is given on forward-looking statements which are subject to a number of risks, notably those described in the registration document (document de reference) registered by the French Markets Authority (the AMF) on 27 April 2018 under number R.18-037., and those linked to changes in economic conditions, the financial markets, or the markets on which Genkyotex is present. Genkyotex products are currently used for clinical trials only and are not otherwise available for distribution or sale.

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