New drug manufacturing and laboratory and office facilities
Verona, Wisconsin, US
Up to $250m
Arrowhead Pharmaceuticals, a biopharmaceutical company based in the US, is developing a new good manufacturing practice (GMP) plant and associated laboratory and office facilities in Verona, Wisconsin, to strengthen its process development and analytical activities.
The new campus will facilitate the advancement of the manufacturing process for the growing pipeline of the company, including commercial-scale manufacturing of the Targeted RNA interference Molecule (TRiM™) platform and lead RNAi-based drug candidates.
The facilities will be constructed with an investment between $200m and $250m, which will generate approximately 250 jobs in the area. The laboratory and office space are expected to be completed in the first quarter of 2023, while the manufacturing facility will be completed by the fourth quarter of 2023.
New campus location and details
The new campus will be built on 13.06 acres of land located at the east end of John P. Livesey Boulevard in the Verona Technology Park in Wisconsin. The site was purchased by Arrowhead in December 2021.
The campus will feature a 140,000ft2 drug manufacturing facility and a three-story building accommodating about 115,000ft2 of laboratory and office space.
The site will also have a stormwater management facility and parking space for 236 vehicles.
Arrowhead Pharmaceuticals’ RNAi therapeutics
RNAi are short oligonucleotide molecules that trigger silencing of gene expression, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics target and shut down specific disease-causing genes by leveraging the natural pathway of gene silencing.
The mechanism offers many potential advantages in the development of disease therapies, including the ability to target a broad range of genes and proteins with high specificity, and target disease pathways that have proven difficult to inhibit with conventional small molecule and biologic therapeutics.
TRiMTM platform details
Arrowhead’s proprietary TRiMTM platform is structurally simple and uses a ligand-mediated delivery strategy for tissue-specific targeting and rapid development of optimal RNAi therapies.
The platform comprises a potent RNA trigger with components such as a high-affinity targeting ligand, multiple linkers and chemistries, highly potent RNAi triggers with sequence-specific stabilisation chemistries, and structures to enhance pharmacokinetics, for each drug candidate.
The therapeutics developed using the platform offer advantages including simplified manufacturing at reduced costs, multiple routes of administration, and the potential for improved safety with fewer metabolites from smaller molecules, thereby reducing the risk of intracellular accumulation.
The key project team members of Arrowhead’s Verona campus development include: Eppstein Uhen Architects (EUA); DPS Group, D’Onofrio Kottke & Associates); Smocke & Associates); Cresa Madison); and Vogel Bros. Building (Vogel).
Marketing commentary on Arrowhead Pharmaceuticals
Arrowhead Pharmaceuticals is developing an array of drugs to treat intractable diseases, using a broad portfolio of RNA chemistries and efficient modes of delivery to trigger the RNA interference mechanism, resulting in rapid, deep and durable knockdown of target genes.
The drug candidates developed using the TRiMTM platform include ARO-HBV targeting chronic hepatitis B infection, ARO-AAT targeting alpha-1 antitrypsin deficiency liver disease, as well as ARO-APOC3 and ARO-ANG3 targeting hypertriglyceridemia.
ARO-XDH, an investigational RNAi therapeutic, is being developed by Arrowhead under a collaboration and license agreement with Horizon Therapeutics to target xanthine dehydrogenase as a potential treatment for people with uncontrolled gout.
JNJ-75220795, an investigational siRNA therapeutic, is being developed using the TRiMTM platform to minimise expression in the liver of patatin-like phospholipase domain containing 3 (PNPLA3) as a potential treatment for patients with non-alcoholic steatohepatitis (NASH).