Aptahem enters collaboration agreement with Granzer Regulatory Consulting and Services to prepare for clinical stage
Aptahem AB (publ), announce today that the company enters a collaboration agreement with the German company Granzer Regulatory Consulting and Services to prepare for applications to the European Medicines Agency (EMA) and the Food and Drug Administration (FDA). Granzer is a well established consultant company within regulatory support and has expertise in oligionucletides and aptamers for pharmaceutical projects.
By entering this agreement, Aptahem takes the next step to prepare for regulatory documentation leading to clinical trials regarding their lead candidate Apta-1 for the treatment of sepsis. The aim is to submit documentation to EMA and FDA in order to get regulatory scientific advisory meetings with the authorities which is an important step before preparing the clinical trial applications and seek approval to start clinical studies. Granzer Regulatory Consulting and Services have long experience in this area, and have specialists within aptamers.
Dr Ulrich Granzer, CEO of Granzer Regulatory Consulting and Services, says, “we are excited to support Aptahem in the development of a promising treatment option for patients diagnosed with a septic condition in order to prevent organ and tissue damages, associated with high mortality in this patient population with a high unmet medical need.”
“We are very pleased to be able to work together with the reputable consultant company Granzer in this very important step for the company. They will help and support us with the preparations to get regulatory approvals in several continents, and to achieve that they will work in close collaboration with our aptamer expert Thomas Rupp and our COO Ulf Björklund” says Mikael Lindstam, CEO of Aptahem.
For further information:
Aptahem AB
Mikael Lindstam, CEO
Tel: +46 (0)766-33 36 99
E-mail: ml@aptahem.com
About Granzer Regulatory Consulting and Services
Granzer Regulatory Consulting & Services provide clients with unique and tailor-made support to meet European and US regulatory requirements. The company offers expert guidance and know-how to optimise the time to market for their client’s products.
About Aptahem
Aptahem AB (APTA) is a biotechnology company that develops aptamer-based pharmaceuticals for the treatment of life-threatening conditions in which a combination of coagulation and inflammation are involved. The company’s primary pharmaceutical candidate, Apta-1, is being developed with the aim of preventing the high mortality rate caused by organ and tissue damage in sepsis patients, among others. The company possesses patent protection in strategic target markets and actively seeks business development opportunities with potential collaborators.