The new facility will make small molecule active pharmaceutical ingredients (APIs) and is set to become AbbVie’s first manufacturing operations in Asia when it begins production in 2016. The acquisition, details of which were not disclosed, is located in Singapore's Tuas Biomedical Park on the same site where AbbVie announced earlier this year it is building a bulk biologics manufacturing facility.
Company spokesperson Adelle Infante told Biopharma-Reporter.com “both the biologics facility under construction and the small molecule facility purchased, will support AbbVie’s oncology and immunology pipeline and platform technologies such as antibody-drug conjugates (ADCs).”
An ADC comprises of a small molecule highly potent cytotoxic drug linked to a cancer-cell targeting monoclonal antibody (or an antibody fragment), and despite there only being two ADCs on the market – Seattle Genetics’ Adcetris and Genentech’s Kadcyla – about 45 molecules are in clinical development.
AbbVie has one ADC in development, ABT-414, an anti-epidermal growth factor receptor ADC being developed to target malignant brain tumours. ABT-414 was recently granted orphan status by the EMA and US FDA and in a conference call discussing Q3 results CEO Rick Gonzalez said the firm is “moving aggressively to start a Phase II study” of the candidate early next year.
Big Biopharma and Singapore
AbbVie expanded a partnership in January this year, paying $25m to access Seattle Genetics’ pyrrolobenzodiazepine (PBD) dimer ADC technology and EC-mAb site-specific conjugation technology, but the company is far from the only Big Biopharma firm interested in such technology, with AstraZeneca, Pfizer, Eli Lilly, Novartis, and Roche all having invested in ADCs over the past 18 months.
But while an industry report on the Antibody Drug Conjugates Market 2014-24 published in August reported 70-80% of ADC manufacturing is performed by a third-party, AbbVie’s investment in Singapore shows intent to keep such operations in-house, according to Infante.
“This investment expands AbbVie’s manufacturing network and builds capacity to support pipeline products for patients globally,” she told us. “Singapore is supportive of manufacturing and offers an educated workforce [and this investment] provides geographic balance in our manufacturing network to ensure continuity of supply.”
Last week, fellow biologics maker Amgen announced it had completed construction of a $200m manufacturing facility also in Tuas, while Novartis is currently building a $500m cell-culture based plant in the Biomedical Park.