24/7 BIOPHARMA - issue 1 / October 2024

CORDENPHARMA

Through this integrated peptide-injectable offer, customers will benefit from: - One CDMO relationship with a single contract, including quality agreement and project management. - API route selection, salt and solubility studies, API characterisation, reference standard qualification (RABS). - Formulation development, analytical method development and validation (27.9m 2 , 15 shelves). - Technical writing for the IND/IMPD submission.

Peptide platform receives record

investment for expansions in small to large scale peptide production.

This is the result of rapidly increasing demand in the Diabetes and Obesity Glucagon-like Peptide 1 (GLP-1) agonist medications market and comes off the back of multiple, long-term, multi-year contracts totalling ~€3 billion, with potential upsides. The European expansion centres on the construction of a new state-of-the-art greenfield facility in Switzerland, with the aim of creating additional Peptide capacity to serve customers from initial early clinical to late-stage commercial manufacturing. The new site will be fully integrated within CordenPharma’s existing facility network. In addition to enhanced large-scale manufacturing, our multi-pronged approach to becoming the #1 peptide CDMO supplier extends to small-scale capabilities at our Peptide Centre of Excellence in Frankfurt, Germany, with the commissioning of new GMP capacities to manufacture early clinical phase peptide APIs for pharma and biotech customers. The investment will be fully operational and authorised by German authorities in Q4 of 2024. The Frankfurt site will add 1000 m 2 of manufacturing space, including two fully equipped lines comprised of a Solid Phase Peptide Synthesizer (SPPS), High Pressure Liquid Chromatography (HPLC), Liquid Phase (LP), isolation equipment and quality control laboratories, including In Process Control (IPC), starting material batch release and GMP stabilities. The GMP manufacturing area is designed to produce peptide APIs from gram to kilogram range for clinical phase 1 and 2 requirements. Moreover, the GMP expansion supports the launch of an integrated service offering between CordenPharma Frankfurt (for Peptide Drug Substance) and CordenPharma Caponago, Italy, (for Injectable Drug Products) to deliver fully customisable technical, manufacturing and regulatory support that is specifically targeted to enable efficient IND/IMPD filings, with all the necessary materials needed to initiate customers’ First-In-Human (FIH) clinical trials.

Oligonucleotide platform addresses largest gaps in oligo market.

After an initial exit of the oligo market in 2018 due to shifting CapEx investments, CordenPharma was pleased to announce in 2023 that we have re-entered the oligonucleotide manufacturing space with an initial ~$25 million budget in two phases, backed by record year-over-year sales growth and reinforced with new Private Equity owners Astorg and scientific strategies to support innovative, complex modalities. Phase one of the program, the reconditioning of existing laboratory space, purchase of development equipment and the hiring of an expert team to set up process and analytical development capabilities, was successfully completed in the Summer of 2024. Phase two includes the redesign of existing manufacturing space to create a fully GMP-compliant manufacturing area housing synthesis, cleavage, downstream processing and lyophilisation at 10-160 mmol scale. These manufacturing assets will provide early to mid phase clinical trial supply for customer demands and are envisioned to come on stream in mid-2026. Future expansions are being investigated to cover increased capacity and scale capability strategically designed to supply customers with validation and commercial supply solutions to address the largest gaps in the oligonucleotide market. As a stand-alone service offering for customers in the early clinical phases, we believe this two-phased approach will have great benefit. However, when taken in combination with our recently-expanded sterile injectable filling capability, full Lipid NanoParticle (LNP) formulation development and manufacturing services,

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TWENTYFOURSEVENBIOPHARMA Issue 1 / October 2024