Key facts and operating structure

Founded in December 2008 by Amedeo Conti, David Lembo, Santo Ladolfo, Claudio Fabris and Enrico Bertino, as a spin-off of the National Research Council and of the University of Torino. Rotalactis srl is based in the BioIndustry Park "Silvano Fumero", located close to Ivrea (TO) in Northern Italy.
Rotalactis has been funded by Eporgen Venture and Piemonte High Technologies, which hold the 51.4% and the 20.6% of the company's shares, respectively, and control its Board of Directors. The total amount invested in Rotalactis to date is €650.000.
Rotalactis is part of the Eporgen Venture portfolio of companies and is benefiting from the support of Eporgen Venture in key functions such as administration, finance, business development, as well as from the Scientific Advisory Board of Eporgen Venture.
Dr Amedeo Conti is the CEO of Rotalactis srl and the Chairman of the Board of Directors. The founding team of Rotalactis is contributing to the scientific work providing their expertise and laboratory facilities. Significant parts of the scientific work (eg. Manufacturing, Toxicology, etc) is contracted out.

The medical need

Rotavirus is a widespread human pathogen transmitted by the oro–faecal route. It is the most important cause of severe gastroenteritis in children under the age of five years.
Rotavirus provokes around 25 million visits to the doctor, 2 million hospitalizations and 500,000 deaths worldwide each year. In Europe, the rotavirus is responsible yearly for around 230 deaths, 87,000 recoveries in hospital, 700,000 visits to the doctor and 2.8 million episodes of illness at home causing high medical and social costs. Currently there are no treatments available and vaccination against rotavirus has serious shortcomings, is not widely practiced and may suffer a low social acceptability in the developed world.
Children which are exclusively breast fed get protection against rotavirus infections thanks to the antiviral components present in the human milk. Infants who aren't exclusively breastfed require a formula or other alternative foods which mostly lack those components. Therefore, formula-fed infants are more susceptible to rotavirus infections than breastfed babies.
In this scenario a preventive option like
RotalactineTM would have a high social acceptability

Key achievements to date

  • Rotalactis scientists have undertaken a proteomic analysis of the equine milk which resulted in the identification of a lactadherin form structurally similar to the human milk counterpart. This protein was completely sequenced and antirotavirus peptides were identified.
  • It was found that an amino acidic motif that is present exclusively in the equine lactadherin confers the highest antiviral activity. The most active peptide, containing this peculiar motif and composed of 20 amino acids, has been selected as lead compound and named RotalactineTM.
  • RotalactineTM's mechanism of antiviral action has been elucidated (it binds to α2β1 integrin and, possibly, to other integrins present on the cell surface and thus reduces the binding of the virus and the subsequent infection), an analytical method for the detection of RotalactineTM in biological fluids by mass spectrometry has been developed and the stability of RotalactineTM in powdered milk as well as its resistance to tryptic digestion have been studied. In silico analysis predicts that RotalactineTM has no allergenic potential.
  • Extensive in vitro studies have demonstrated the anti-viral activity of RotalactineTM

Development strategy

  • The aim is to eventually market RotalactineTM as a (novel) food ingredient/supplement of infant foods to reduce the incidence and the severity of rotavirus gastroenteritis.
  • An alternative development path that considers RotalactineTM as a prescription therapy with documented clinical benefits is also possible and shares some of the initial steps with the food development path.
  • The final selection of the development path will be made following interactions with regulatory authorities in the main markets, which are expected to be completed by the end of 2012. The path that reduces the time to market while maintaining a significant commercial value will be favored.
  • The initial development activities that are common to both development paths include the GMP manufacturing and formulation development of RotalactineTM, its toxicological studies in animals and the first safety and tolerability study of RotalactineTM in healthy adults following single and repeat administration.
  • It is anticipated that GMP manufacturing and formulation development of RotalactineTM should be completed by the end of 2012, the toxicological studies in animals and the subsequent submission of the data to the regulatory authorities will be completed by the end of 2013 and the first safety and tolerability study of RotalactineTM in healthy adults will be initiated and completed during 2014.

Marketing considerations

Depending on the selected development path and based on the current understanding of the regulatory issues, RotalactineTM could enter the market by the end of 2016 the earliest. The assessment of the market potential of RotalactineTM will be undertaken once the regulatory path has been selected and should be available by the end of 2012 or early in 2013.
The world infant milk market was evaluated at 907,000 tons in 2007, worth $9 billion (UBIC Consulting, 2010). Together, Europe and North America represent 33% of the worldwide infant milk market, but the fastest developing area is the Asian market, which is also the largest (53%).

Business development strategy

  • Rotalactis' mission is to advance its innovative RotalactineTM to a pre-clinical proof of concept as an effective anti-rotavirus treatment and then seek partnership with a nutrition (or pharma) franchise leader for the future development and commercialization of the product. The available pre-clinical data constitute a proof-of-concept and therefore Rotalactis' mission can be considered as accomplished.
  • Rotalactis is open to various ways of partnership that include:
    • Financing of the GMP manufacturing, formulation development and preclinical toxicology studies with RotalactineTM towards a regulatory submission and of a safety and tolerability study in healthy subjects. The estimate of the GMP manufacturing and formulation development cost is €700.000, while the estimates of the preclinical and clinical activities cost are €500.000 and €1.000.000 respectively. Considering an additional €500.000 cost for general, administration and IP expenses for the period until the end of 2014, the total financial needs for Rotalactis are in the order of €2.700.000, to be allocated in tranches depending on successful milestones.
    • Licensing of RotalactineTM for further development by the partner with support from Rotalactis as required.