Pipeline
Products approved
Gencebok®
Caffeine citrate
10 mg/ml
1 ml ampoule
Solution for Infusion
Route of administration : Intravenous infusion and oral administration
Therapeutic indication : treatment of primary apnoea of premature newborns.
This formulation is more suitable for maintenance doses applied by NICU.
The development of Gencebok® has been performed in 2019 and its evaluation by the European Medicine Agency (EMA) has been completed. The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Gencebok® on 25 June 2020. On 19 August 2020, Gencebok® received a centrally Marketing Authorisation valid throughout the EU. Gencebok® is now available through the 27 countries being part of the European Union.
Apnoea in preterm infants is common in babies born at less than 34 weeks gestation due to the baby’s breathing centers in the brain not being fully developed. The active substance caffeine citrate is a stimulant of the nervous system and treat primary apnoea in premature newborns. Primary means that the apnoea has no obvious cause.
Caffeine citrate is an ‘antagonist’ of adenosine, a substance that blocks the activity of some parts of the brain, including the part responsible for controlling breathing. Caffeine citrate works in apnoea by blocking the receptors that adenosine normally attaches to. This reduces the effect of adenosine, stimulating the brain to resume breathing.
Food for Special Medical Purposes
DADFMS (Denrées alimentaires diététiques destinées à des fins médicales spéciales)
ProPrems®
1.109 CFU per stick
Sticks of 0.5 g
Powder to be reconstituted
<400 mOsm/kg (with 1.2ml water)
Indication : For preterm infants nutritional need with the objective to support microbiota by balancing microbial flora and facilitating colonization of preterm gut microbiota.
Oral administration route
Composition : 3 microbiotic strains: Bifidobacterium longum subsp. infantis, Streptococcus thermophilus et Bifidobacterium animalis subsp. lactis for a total of one billion CFU (colony forming unit) per stick.
This formulation is manufactured according to GMP (Good Manufacturing Practices – for European Pharmaceutical products ) and HACCP (Hazard Analysis Critical Control Point – for European Nutritional products) regulations.
ProPrems® is a Neobiomics’ proprietary product. Neobiomics and Gennisium Pharma have entered into a License Agreement under which Gennisium has the exclusive rights to register, market and sell ProPrems® in France.
A marketing declaration has been managed in January 2023 to French authorities (DGCCRF).Therefore, ProPrems® can be distributed to any Neonatal Intensive Care Units in France by Gennisium Pharma.
Products in development
Gennisium works every day to develop suitable formulations for preterm infants.
New products for neonatal indications are under development : Respiratory distress, metabolism disorders…