Bachem to supply ISA Pharmaceuticals with finished dosage forms immunotherapeutic HPV-SLP® for phase III clinical trials
Bubendorf, Switzerland and Leiden, Netherlands,
Bachem (SIX: BANB) and ISA Pharmaceuticals B.V. today announced the conclusion of an agreement for the manufacture of the active ingredients and the supply of finished dosage forms of ISA Pharmaceutical’s immunotherapeutic HPV-SLP® product. The company has successfully concluded a clinical phase II study with this product in patients suffering from human papillomavirus type 16 (HPV16) associated (pre-) malignant disorders. To date, ISA Pharmaceuticals had commissioned peptide production for clinical trials to its partner Leiden University Medical Center. Subsequent to the positive phase II results published in the New England Journal of Medicine*, ISA Pharmaceuticals now has chosen Bachem as a manufacturing and supply partner for the upcoming phase III program and the subsequent market introduction.
Gerard Platenburg, CEO of ISA Pharmaceuticals, commented: “When entering phase III with our lead product, we want to work with the best in class to assure optimal technical and regulatory support in order to get our therapeutic HPV product to the market as soon as possible. Bachem is our partner of choice since it has a proven track record, as well as the skills and the range of services we need.”
Anne-Kathrin Stoller, Vice President Marketing and Sales of Bachem AG, added: “We are very proud of having been selected by ISA Pharmaceuticals for this challenging project now entering phase III. It does not only prove our competence in manufacturing peptides but also the benefit of our Clinalfa® brand with its offer of finished dosage forms for clinical trials.”
ISA’s therapeutic HPV product is based on the company’s proprietary SLP® (Synthetic Long Peptide) concept and is indicated against Vulvar Intraepithelial Neoplasia (VIN) with Cervical Intraepithelial Neoplasia (CIN), and cervical carcinoma as first follow up indications. In the frame of the agreement, Bachem will manufacture and provide to ISA Pharmaceuticals both the peptides as well as the Clinalfa® products. Further, Bachem will provide the necessary analytical and regulatory support required for phase III. * Gemma G. Kenter et al., New England Journal of Medicine, 361, 12 (2009) – Vaccination against HPV-16 Oncoproteins for Vulvar Intraepithelial Neoplasia.
Bachem is an independent, technology-based, public biochemicals company providing full service to the pharma and biotech industry. Bachem is specialized in the process development and the manufacturing of peptides and complex organic molecules as active pharmaceutical ingredients (APIs), as well as innovative biochemicals for research purposes. With headquarters in Bubendorf, Switzerland, and affiliates in Europe and the US, Bachem works on a global scale and holds a leading position in the field of peptides. For more information about Bachem, please visit www.bachem.com.
Clinalfa® is Bachem’s brand name for its sterile products to be used in approved clinical studies. The products are manufactured and released based on the requirements laid down in the relevant European Commission Directives. Clinalfa® products contain active substances manufactured and released according to ICH Q7.
ISA Pharmaceuticals is dedicated to fighting cancer and infectious diseases by providing novel immunotherapeutics based on its proprietary SLP® technology to activate and employ the patient’s own immune system. Its most advanced product is a highly efficacious therapeutic product against HPV-induced lesions. The company was founded in 2004 by Aglaia Oncology Fund and has its roots in the ground-breaking research performed by the group of the internationally renowned tumor immunologist Professor Kees Melief. R&D is performed in close collaboration with the Leiden University Medical Center, the Netherlands. For more information about ISA, please visit www.isa-pharma.com.