Archivel Farma scouts for partners to begin last stage of development of RUTI vaccine against tuberculosis

Following 13 years of research and an investment of more than 16 million euro made by the partners of the company and institutional bodies like ENISA, CDTI and the Fundación Genoma España (currently integrated into FECYT), the partners of Archivel Farma have decided to transfer the leadership of the project of the RUTI vaccine against tuberculosis to one or more partners. They will possess the necessary financial and operative capacity to complete the clinical development of RUTI and carry out the marketing and distribution once the timely approval is obtained from the regulatory authorities.

Archivel, who in 2008 constructed a pilot plant appropriate for the production of sterile injectables under research in Barcelona, has been restructured in order to be able to face this new stage. The control that has been there during all those years over the production process of the vaccine, thanks to the production plant that has been mentioned, has allowed a solid product to be obtained that today is ready for industrial scale-up.

With a team adjusted to the principal objective of the company for 2014, that of arriving at a global agreement or various regional agreements that permit the future access of RUTI to the market, Archivel Farma has signed a collaboration agreement with Trifermed, a service company with 12 years’ experience in the development and management of international agreements in the field of life sciences and with a direct presence in London, Toronto, Mexico, Sant Cugat del Vallès (Barcelona) and Frankfurt (currently being constituted). With Dr Sergi Trilla leading the project, the objective of Trifermed is to identify the ‘partner’ or ‘partners’ most appropriate to carry out the phase III clinical study which will demonstrate the efficacy of RUTI.

The study will have an approximate duration of two and a half years and a minimum estimated cost of 5 million Euros. Thereafter, once the results are obtained and its effectiveness confirmed, the registration of the medicine can be requested from the corresponding agency, depending on marketing strategies of the selected “partners”.

RUTI is one of the most advanced therapeutic vaccines on a global level, as was picked up in the GlobalTuberculosisReport 2013published by the World Health Organization. It reached a phase I clinical trial in 2008 in the Universitari Germans Trias I Pujol Hospital and also completed a phase II clinical trial in South Africa in 2011, with good results that were checked by a panel of international experts who confirmed the viability of the proposal to advance towards phase III (definitive proof of efficacy).

Last February, under the title ‘Safety, Tolerability and Immunogenicity of the Novel Antituberculous Vaccine RUTI: Randomized, Placebo-Controlled Phase II Clinical Trial in Patients with Latent Tuberculosis Infection,’ the scientific journal PLOS ONE has published the article on the phase II clinical study, that is available in its online version.

Archivel Farma is made up at the present time of Archivel Technologies (49.2 per cent), Grupo Teodoro García Trabadelo (49.2 per cent) and Laboratorio Reig Jofré (1.6 per cent). The inventors of the vaccine, Dr Pere Joan Cardona and Isabel Amat, continue to be linked with the project through their participation in Archivel Technologies.

EP News Bureau – Mumbai