GENTICEL : Genticel licenses Vaxiclase platform to Serum Institute of India for use in pertussis vaccines

information fournie par Actusnews •02/02/2015 à 19:30

• Serum Institute of India, world's largest producer of vaccines, to evaluate Vaxiclase for use in multivalent vaccines containing pertussis antigens
• Preclinical stage license agreement entitles Genticel to up to $57 million in upfront & milestones payments plus single digit royalties on net sales

GENTICEL (Euronext Paris and Brussels: FR0011790542 - GTCL), a French biotechnology company and leading developer of therapeutic vaccines, today announces that it has licensed its Vaxiclase technology to Serum Institute of India Ltd. (SIIL), for use as a component in acellular multivalent combination vaccines including pertussis antigens.

The license granted by Genticel to SIIL provides the Vaxiclase platform for inclusion in multivalent vaccines that also protect against Bordetella pertussis , the causative agent of whooping cough. The license covers all countries of the world except major pharmaceutical markets, in particular the USA, Canada, New Zealand, Australia, Japan, Israel, Turkey and greater Europe.

In exchange for the access and use of Vaxiclase in the licensed indication, Genticel is eligible for up to $ 57 million in upfront, development & sales milestone payments from SIIL, as well as single digit royalties on net sales. Detailed financial terms of the agreement are not disclosed.

Furthermore, the deal provides the two partners with additional options to extend their partnership to a global territory.

Adar C. Poonawalla, CEO and Executive Director of Serum Institute of India, commented: “ We have been closely monitoring the challenges related to resurgence of pertussis especially in the countries utilizing acellular pertussis components based combination vaccine. Based on our analysis, we are sure the collaboration with Genticel and use of Vaxiclase will play a key role in improving the acellular pertussis component based combination vaccine. ”

Benedikt Timmerman, Genticel's Chief Executive officer said, “ We are very satisfied with our partnership with Serum Institute of India, the largest vaccine producer in the world. This deal opens an entirely new field of applications for Vaxiclase, which complements our core activities in the HPV field. Besides this deal's commercial interest, we are proud to be associated with a development program that may lead to one of the most widely supplied combination vaccines worldwide .”

Mr Timmerman added, “ Moreover, the deal will also provide Genticel with access to improved production methods that the Serum Institute may implement to our Vaxiclase platform. Given Serum's extensive experience and track record in this area, this is of strategic value to Genticel .”

About Genticel
Genticel is a French biopharmaceutical company specialized in the development of therapeutic vaccines aimed at eliminating, at an early stage, the human papillomavirus (HPV) responsible for cervical cancer.

Genticel's most advanced candidate therapeutic vaccine, ProCervix, is currently in a Phase 2 clinical trial. ProCervix is designed to induce the elimination of cervical cells infected with HPV 16 and/or HPV 18.

Genticel is based in Paris and Toulouse and was awarded “Prix Biotech d'Avenir” (Most Promising Biotech) in the SW France category of the Deloitte Technology Fast 50 Benchmark in 2014.

Since April 4, 2014, Genticel shares have been listed on the regulated Euronext markets in Paris and Brussels.

For more information, please visit www.genticel.com

About Vaxiclase
The company has also established Vaxiclase, a technology platform ideally adapted for use in immunotherapies against multiple infectious or cancerous diseases. This platform is already being used by Genticel to develop a second therapeutic HPV vaccine candidate, now in its preclinical stage. This drug candidate targets six of the most pertinent HPV strains that cause approximately 85% of all cervical cancers world-wide.

About Serum Institute of India Ltd. (SIIL)
Serum Institute of India Ltd. ( 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. Serum Institute's products have been used in 140 countries. Serum Institute of India Ltd. 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 SIIL.

About Whooping Cough
Pertussis (whooping cough) is a major cause of infant death worldwide and continues to be a public health concern even in countries with high vaccination coverage. Estimates from WHO suggest that, in 2008, about 16 million cases of pertussis occurred worldwide, 95% of which were in developing countries, and that about 195 000 children died from the disease.

Following an incubation period of 9–10 days (range 6-20 days), patients develop catarrhal symptoms including cough. In the course of 1–2 weeks, coughing paroxysms may occur, ending in the characteristic whoop.

For several decades, infant immunization programmes using pertussis vaccines of documented quality have been highly successful in preventing severe pertussis in infants all over the world. The main aim of pertussis vaccination is to reduce the risk of severe pertussis in infancy. At least 90% coverage of infants with 3 doses of high quality pertussis vaccines remains a priority worldwide, particularly where pertussis still poses a serious health problem in infants and young children ( http://www.who.int/immunization/topics/pertussis/en/ ). In recent years evidence has shown that the immunity induced by acellular pertussis vaccines wanes over time, leading to insufficient protection against Whooping Cough. Development of better acellular pertussis vaccines would address this newly emerged medical need (Tartof et al., Pediatrics, vol. 131 N°4, April 1, 2013).