Aptahem signs agreement with new contract manufacturer
Aptahem (publ) announced today that the company has signed an agreement with a GMP-certified (Good Manufacturing Practice) contract manufacturer, LGC Group. LGC Group will manufacture the company’s lead candidate, Apta-1, for the concluding toxicological studies and the production is expected to commence during the third quarter of 2019.
LGC Group is a globally leading contract manufacturer with extensive experience in GMP-certified manufacturing of oligonucleotides, i.e. the short RNA sequences that aptamers consist of, and therapeutic nucleic acids, in particular of the size and with the chemical composition that Apta-1 consists of. Preparations ahead of Apta-1’s production began immediately after the contract was signed and according to the communicated timeline, the manufacturing will commence during the third quarter of 2019.
“We are very pleased with the impression that LGC has given and the competence that they have demonstrated in aptamer manufacturing. It’s a very well-established and experienced company that was not available for our type of aptamer when we previously sought a contract manufacturer. Thanks to purposeful expansion, LGC has now expanded its manufacturing capacity and we are very pleased to be able to start this collaboration, which ensures delivery of Apta-1 and advances the regulatory program,” commented Mikael Lindstam, CEO of Aptahem.
Aptahem has previously announced that a delay had occurred in Apta-1’s development program following technical difficulties associated with the manufacturing. Meanwhile, Aptahem has, as previously communicated, sought alternative solutions to get Apta-1 manufactured. Now, the company chooses to sign an agreement with a second contract manufacturer in order to limit the delay to Apta-1's development program to the extent possible. Aptahem will update the market with more information regarding the timeline for Apta-1's continued development shortly.
For further information:
Mikael Lindstam, CEO
Tel: 0766-33 36 99
This information is information that Aptahem AB is obliged to make public according to the EU Market Abuse Regulation. The information was provided through the agency of the contact persons above, for publication on July 4, 2019.
This communication contains forward-looking statements, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as of the date they are made and are, by their nature, as is research and development work in the biotechnology segment, associated with risk and uncertainty. With this in mind, the actual outcome may deviate significantly from the scenarios as described in this press release.
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.