Algenex and FATRO announce positive CVMP opinion for CrisBio-based vaccine for Rabbit Viral Haemorrhagic Disease

PRESS RELEASE

Algenex and FATRO announce positive CVMP opinion for CrisBio-based vaccine for Rabbit Viral Haemorrhagic Disease

Madrid (Spain) and Bologna (Italy), June 21, 2021 – Algenex SL, a biotech company backed by Cleon Capital and Columbus Ventures delivering disruptive technologies for recombinant biologics production, and FATRO S.p.A, a leader in the field of veterinary pharmaceutical products, today announce that The Committee for Medical Products for Veterinary Use (CVMP) of the European Medicines Agency (EMA) has recommended FATRO’S CrisBio®-based vaccine for Rabbit Haemorrhagic Disease (RHD) for marketing authorization in the European Union. The final decision of the European Commission on the marketing authorisation of FATROVAX RHD is expected in the coming months. Klifovet advised the applicant in the regulatory submission.

FATROVAX RHD is a patent-protected recombinant subunit RHDV1 and RHDV2 vaccine that was developed and will be manufactured using CrisBio®, Algenex’ proprietary and patent protected Baculovirus vector-mediated expression platform that harnesses the power of insects to act as natural single-use bioreactors. CrisBio® represents a new paradigm in biologics production, offering a quick, linearly scalable solution to meet the global demand for recombinant protein production without significant capex investment.

Rabbit Haemorrhagic Disease Virus, with its variants RHDV and RHDV2, is endemic in most parts of the world, and causes a highly contagious, acute and fatal disease. The virus does not replicate in vitro and the production of protective antigens by recombinant baculovirus avoids the need to use live rabbits in the manufacture of RHD vaccines.

“The positive opinion of the EMA’s CVMP represents a significant regulatory validation for Algenex’s CrisBio® technology and a major milestone for the Company. The submission by FATRO was a first for our technology and its success further reinforces the potential of CrisBio® to provide a versatile and robust alternative to bioreactor-based expression technologies across multiple applications in human and animal health,” said Claudia Jiménez, CEO of Algenex.

“Today’s news signals a further expansion of our portfolio of vaccines for veterinary use,” stated Dr. Francesco Meliota, vice president responsible for IVMPs at FATRO. “Our collaboration with Algenex has played an important part in enabling us to develop this new product and we have since worked with the Company on a second vaccine. We remain convinced that CrisBio® offers a highly practical and effective means of manufacturing recombinant vaccines and can support innovative product development.”

For further information, please contact:

Algenex contact Fatro contact
Claudia Jiménez Silvana Dal Magro
CEO President
T: +34 91 452 4941 T: +39 051 6512711
cjimenez@algenex.com fatro@fatro.it

About Algenex

Algenex is a biotechnology company backed by Cleon Capital and Columbus Ventures developing disruptive baculovirus-based technologies for the production of recombinant biologics. Algenex´ first two platforms, TopBac® and CrisBio®, are based on baculovirus-based expression systems and have demonstrated their capacity to transform recombinant protein production through a process that provides almost unlimited and immediate linear scalability of manufacturing, production flexibility, simplicity and versatility while being extremely cost efficient. The Company’s technology is highly applicable across a wide range of commercial product classes in both human and animal health.

Algenex has successfully produced >200 molecules in collaboration with public and private partners, including multiple international pharmaceutical companies, including VLPs, monomeric vaccines, single domain antibodies, hormones, enzymes, growth factors and diagnostic reagents.

For more information, please visit http://www.algenex.com

About FATRO S.p.A

Founded in 1947, FATRO is a pharmaceutical company that has always concentrated its activities exclusively in the veterinary medicine sector.

The beating heart of its research laboratories and its main production plants are located in Italy. FATRO has its own subsidiary companies in Poland, Spain, Greece, Czech Republic, Argentina, Uruguay, India and exports its products to over 90 Countries. Currently, the Group employs over 700 people worldwide.

FATRO invests continuously in research in the ethical drugs and veterinary vaccines sectors, with the aim of developing new products and production technologies.

For more information, please visit http://www.fatro.com