Bachem and ISA Pharmaceuticals have 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 Medicine¹, ISA Pharmaceuticals has now 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 of marketing and sales at Bachem, 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 synthetic long peptide (SLP®) 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. Furthermore, Bachem will provide the necessary analytical and regulatory support required for phase III.
¹ Gemma G Kenter et al., New England Journal of Medicine, 361, 12 (2009) – Vaccination against HPV-16 Oncoproteins for Vulvar Intraepithelial Neoplasia.