The clinical trial program in patients with bladder cancer has proceeded successfully, showing significant treatment effects and low toxicity in treated patients. Large-scale manufacturing of Alpha1H at Good Manufacturing Practice (GMP) quality has been established since the start of the clinical program, with an increase in volumes and technical adjustments during successive phases of the program.

A Phase III trial requires increased production capacity, and advanced technical and drug quality control programs must be in place. Drug production at Phase III quality is therefore costly and extremely demanding. Hamlet BioPharma has completed the production of a first batch of Alpha1H at Phase III quality. The batch is now undergoing final evaluation steps, before release for clinical use.  

To meet the increased demand for Phase III-grade material, Hamlet BioPharma is expanding its production of the Alpha1 peptide, which is the first step in the production process. The company has indentified Porton Pharmaceutical Chemicals GmbH as an advanced and cost effective pharmaceutical manufacturing infrastructure. The Alpha1 peptide production technology has been adjusted by Porton to meet the requirements of a Phase III trial and the production site has been extensively audited for alignment with international market requirements.

To manufacture the final product, Hamlet BioPharma collaborates with Rechon Life Science AB - a manufacturer approved for pharmaceutical supply worldwide, including the US. Rechon are responsible for the final formulation and release of Alpha1H and have already established large scale processes for Alpha1H production and distribution to clinical trial sites.

The timing of Phase III adjusted manufacturing is essential to secure a rapid and robust supply of Alpha1H to the clinic, which benefits Hamlet BioPharma's shareholders and patients, who will receive Alpha1H treatment.

`'We are impressed with the competence and precision of our manufacturing partners `' says Hans Wännman, Liansa AB, CMC specialist and consultant to Hamlet BioPharma. 

" Our strategy is to ensure that the drug is ready and available for clinical use, as we prepare for later-stage developments," says Catharina Svanborg, CEO

For further information, please contact

Hans Wännman, CMC Specialist and Consultant, Liansa AB, +46 707 28 01 89

hans.wannman@liansa.se

Catharina Svanborg, CEO, Hamlet BioPharma AB, +46 709 42 65 49,

catharina.svanborg@hamletpharma.com

www.hamletbiopharma.com