Biologics manufacturing facility
PTC Therapeutics’ biologics facility will be located within the Bristol-Myers Squibb (BMS) campus in Hopewell, New Jersey, US.
PTC entered a long-term lease agreement with BMS, gaining access to approximately 185,000 square feet (ft2) of space within the campus. The company will pay approximately $88m for the initial rental term of 15 years, starting from July 2020. The rental period of the PTC Therapeutics’ biologics facility can be extended twice for ten years each.
The company will make use of the existing state-of-the-art biologics production facility and associated research and operations buildings available within the space, as part of the lease agreement. The biologics facility is expected to support PTC’s gene therapy production.
The Bristol-Myers Squibb’s Hopewell campus spans over one million ft2, which is proposed to be converted to a multi-tenant research and development campus.
The campus features a state-of-the-art biologics manufacturing facility, as well as associated buildings for research and other administrative operations.
The company proposes to shift its research operations to a newly renovated building on the same campus. The relocation of research operations, following the start of gene therapy production, is also planned for 2020.
The acquisition will add Bristol Myer’s Squibb’s technology and qualified biologics operation professionals to PTC’s portfolio.
The cGMP suites of the facility will be renovated to produce materials for various pre-clinical and clinical programmes. It will be an addition to the company’s existing pre-clinical trials material production capacity in Bridgewater, New Jersey. The company may also request to construct a separate approximately 75000ft2 building within the campus area.
Access to best-in-class technology and highly qualified biologics operation specialists will enable PTC to meet its goal of becoming a leader in gene therapy.
PTC’s advance gene therapy products such as Emflaza (deflazacort), Translarna (ataluren), and Tegsedi (inotersen) will be developed and commercialised in the facility. The FDA-approved Emflaza (deflazacort) is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients two years or older. PTC is awaiting approval over a supplemental new drug application (sNDA) submitted for the drug in July 2019.
Translarna (ataluren) received approval from the Brazilian health regulatory authority (ANVISA) in the first quarter of 2019, expanding PTC’s footprint in Brazil. The drug is also approved in the European Union (EU) for the treatment of DMD.
Tegsedi (inotersen), indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR) in adults, is approved in the US, Canada and EU. The drug received priority review from ANVISA and is anticipated to be approved by the end of 2019.
Waylivra™ (volanesorsen), indicated for the treatment of familial chylomicronemia syndrome (FCS), secured a positive CHMP opinion from the European medical authorities in the first quarter of 2019. The company plans to start early access programmes in Latin America in 2019, following ratification by the European Commission.
The facility will also support the company’s gene therapy pipeline for central nervous system disorders, which includes Friedreich ataxia programme and Aromatic L-amino acid decarboxylase (AADC) deficiency gene therapy programme. Gene therapy development for the treatment of Angelman syndrome and other cognitive disorders are in the early stage of development.
PTC Therapeutics, a biopharmaceutical company in the US, focuses on research and development of orally administered drugs used in post-transcriptional control processes. The discovery programmes direct the targets in multiple therapeutic areas, while the company’s main focus is on developing and commercialising treatments for orphan and ultra-orphan disorders.
The company acquired Agilis Biotherapeutics and is currently collaborating with Akcea Therapeutics, Odylia Therapeutics, Roche and Aldevron for advancing its gene therapy platform.
PTC Therapeutics does not own any manufacturing or distribution facilities for their gene therapy product candidates and relies only on third-parties for all the manufacturing, packaging, labelling and distribution of the commercial and clinical products. The company currently employs more than 700 people worldwide.
The company is backed by the New Jersey Economic Development Authority’s (NJEDA) net operating loss (NOL) programme, which enables potential technologies and life sciences companies to sustain competition before it starts making a profit.
Vibalogics announced the development of a late-phase clinical and commercial virotherapy manufacturing facility in Boston, Massachusetts, US, in November 2020.…
Thermo Fisher Scientific (Thermo Fisher) will establish a new pharmaceutical services facility for integrated biologics and sterile drug development and…
Arranta Bio is constructing a new multi-product, commercial-ready manufacturing facility in Watertown, Massachusetts, US. Watertown facility will be used for…
Berkshire Sterile Manufacturing (BSM) is expanding its manufacturing facility in Lee, Massachusetts (MA), US. The company began preparations for the…