Archivel Farma looks for partners to start the last stage of development of RUTI® vaccine

  • Archivel has carried out a restructuring of its equipment to facilitate the entry of new partners that can lead the phase III and bring the product to the market.
  • The Catalan company maintains its technological capacity through its pilot plant in Badalona.
  • The prestigious scientific magazine Plos One has just published the good results of the clinical phase II study of the vaccine.

Barcelona, ​​March 28, 2014. After 13 years of research and more than 16 million euros of investment committed by the company’s partners and institutional organizations such as ENISA, the CDTI and the Genoma Spain Foundation (currently integrated into the FECYT), Archivel Farma partners have decided to transfer the leadership of the RUTI® vaccine against tuberculosis to one or more partners that have the necessary financial and operational capacity to end the RUTI®‘s clinical development and to take the vaccine to the market when appropriate approval of the regulatory authorities is obtained.

Archivel, which in 2008 built a GMP pilot plant in Badalona for the manufacturing of sterile injectable products in research, ​​has been restructured to face this new stage. The control on the production process of the vaccine obtained thanks to the GMP plant has allowed the company to obtain a solid product that today is prepared for its industrial scaling.

With a team adjusted to the company’s main objective for 2014 —that is reaching a global agreement or several regional agreements that allow to take RUTI® to the market—, Archivel Farma has signed a collaboration agreement with Trifermed, a service company with 12 years of experience developing and managing international agreements in the life sciences field and with offices in London, Toronto, Mexico, Sant Cugat del Vallès (Barcelona) and Frankfurt (in constitution). With Dr. Sergi Trilla leading the project, the objective of Trifermed is to identify the most appropriate partners to carry out the phase III clinical study to demonstrate the effectiveness of RUTI®. The study will last about two and a half years and will have an estimated cost of 5 million euros. Subsequently, once the results are obtained and their effectiveness is confirmed, the drug registration can be requested before the corresponding agency, based on the marketing strategies of the selected partners.

RUTI® is one of the most advanced therapeutic vaccines worldwide, as reflected in the Global Tuberculosis Report 2013, published by the World Health Organization. A Phase I clinical trial has been carried out in 2008 at the Germans Trias i Pujol University Hospital and a Phase II study in South Africa has been completed in 2011. The good results of Phase II were reviewed by a panel of international experts who confirmed the feasibility of the proposal for progress towards Phase III (final proof of effectiveness).

Last February, the scientific magazine Plos One published an article on the phase II clinical study (“Safety, Tolerability and Immunogenicity of the Novel Antituberculous Vaccine RUTI: Randomized, Placebo – Controlled Phase II Clinical Trial in Patients With Latent Tuberculosis Infection”), which is available in its online version.

Archivel Farma is owned by Archivel Technologies (49.3%), Teodoro García Trabadelo Group (49.3%) and Laboratorios Reig Jofré (1.4%). The inventors of the vaccine, Dr. Pere Joan Cardona and Isabel Amat, are still linked to the project through their participation in Archivel Technologies.