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Bionaturis out-licenses its Leishmaniasis vaccine for Argentina and Paraguay
Bionaturis has signed an exclusive development, manufacturing, registration, and commercialization license of its Leishmaniasis vaccine with the company Biotandil for Argentina and Paraguay
Bionaturis will receive 50% of the profits resulting of the commercialization.
Jerez de la Frontera, April 25, 2017. Bionaturis has signed an exclusive development, manufacturing, registration, and commercialization license of its Leishmaniasis lead vaccine (BNT005) with the company Laboratorio Biologico de Tandil (Biotandil) for Argentina and Paraguay as the Territory. According to the terms of the license, Biotandil will be responsible for the manufacturing, development, registration, and commercialization of the vaccine in the territory. In exchange Bionaturis will receive 50% of the profits resulting of the commercialization.

Visceral Canine Leishmaniasis is a so called neglected tropical disease transmitted by the bite of the phlebotomine sandfly that acts as a vector. One of its main reservoir –spread through the Mediterranean countries and LATAM – are dogs, and therefore their immunization is crucial to minimize zoonosis episodes. According to WHO, in humans between 700.000 and 1.000.000 new cases, with 3% of deaths, are registered annually worldwide[1]. In Argentina, there is in place a Leishmaniasis National Programme led to track its progress in the country and promoting control and eradication measures.
This specific license of our Leishmaniasis vaccine candidate means a significant milestone because LATAM is one of the most affected regions by this disease, being recorded a steady growth in Argentine and Paraguay lately. Besides, getting the market authorization in Argentina could pave the way for its registration in other Latin American markets”, the chief of biological developments in Bionaturis, Juan Jose Infante, has stated.

According to Biotandil CEO, Enrique Lucchesi, “the prevalence of Visceral Canine Leishmaniasis in Argentina and Paraguay is rising in recent years so control and vaccination measures in the reservoirs are essential. Besides ensuring the welfare of our bellowed pets, this recombinant vaccine launched between Bionaturis and Biotandil will definitely contribute to fight people infection in this region, where children count for one third of the cases. Thus we will be also protecting the public health of our community”.
Research partners in this project

The following research partners are having a key role on BNT005 development: “Lopez Neyra” Institute of Parasitology and Biomedicine of the National Research Council of Spain (CSIC), Faculty of Veterinary Sciences (University of Murcia) and Pablo de Olavide University (Seville).

The development project has received funds from several public and private institutions, such as the Spanish National Agency of Innovation of the Ministry of Economy and Competitiveness (RETOS program 2015 cofounded by ERDF and ‘Innpacto’ program 2012), Andalusian Technology Corporation (2016-2018 and 2011-2013) and the Agency of Innovation and Development of Andalusia IDEA (2011-2013).
About Biotandil

Biotandil (Laboratorio Biologico de Tandil) is an Argentinian company founded in 1983 and devoted to develop, produce, and commercialize products for Animal Health. Regarding parasitic-cause diseases such as leishmaniasis, back in 2004 Biotandil registered in Argentina the vaccine TRICOVAC to combat Bovine Trichomoniasis, leading the market for this indication since then.

Further information about Biotandil on its website

About Bionaturis Group

Bionaturis Group offers premium solutions for human and animal health; it comprises four companies (Bionaturis, Biobide, ZIP Solutions, and BNT Pacific) and two subsidiaries (Biobide USA and BNT China Biosciences) in six different locations around the world. Bionaturis lists on the Spanish stock exchange for SMEs (trading code BNT).
About future statements

The Market and investors are informed that the Company’s developments are subject to significant risks and uncertainties, that include, but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Bionaturis’ ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Bionaturis’ patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Currently, there are no guarantees that the development product will receive the necessary regulatory approvals or that they will prove to be commercially successful.