PTC Therapeutics Biologics Facility, Hopewell, New Jersey
PTC Therapeutics biologics facility will be located at the campus of Bristol-Myers Squibb (BMS) in Hopewell, New Jersey, USA.
It is anticipated that the biologics facility will enable the development of gene therapy by PTC.
In August 2019, PTC stepped into a long-term leasing contract with BMS and gained access to around 185,000 square feet (ft2) of Hopewell campus space.
PTC Therapeutics Biologics Facility lease agreement
The international biopharmaceutical company will pay around $88 million for the initial 15-year lease period, beginning in July 2020. The lease duration of the biologics facility of PTC Therapeutics can be extended twice, each for ten years.
As part of the lease agreement, the company will make use of the existing cutting edge biologics production facility at 311 Pennington-Rocky Hill Road and associated research and operation buildings available within the property.
PTC Therapeutics Biologics Facility located at The BMS Hopewell campus
The Hopewell campus of Bristol-Myers Squibb spans over one million ft2, which is being proposed to be transformed into a multi-tenant R&D campus. The campus not only features a state-of-the-art manufacturing facility for biologics but 33 buildings including clinical research, warehouse space and other corporate operations buildings. A fitness center a cafe and multiple conference spaces are also available for use.
The organisation is preparing to move its research activities on the same campus to a newly renovated building. The relocation of research activities is also scheduled for 2020 after the launch of the production of gene therapy.
The purchase would add the expertise of Bristol Myer’s Squibb and trained experts in the biologics process to the portfolio of PTC.
Manufacture of pre-clinical and clinical products
The facility’s cGMP suites will be upgraded to manufacture products for various pre-clinical and clinical programmes. In Bridgewater, New Jersey, it will be an extension to the current pre-clinical trial material production capability of the company.
The organisation may also request the construction of a separate building within the campus area of approximately 75000ft2.
PTC believes that access to best-in-class technology and highly qualified experts in biological operation would allow the company to achieve its aim of becoming a leader in gene therapy.
Gene therapy drugs from PTC Therapeutics
Advanced gene therapy drugs from PTC such as EMFLAZA® (deflazacort), TRANSLARNA™ (ataluren) and TEGSEDI™ (inotersen) will be developed and sold at the facility.
Originally developed by Marathon Pharmaceuticals and later acquired by PTC Therapeutics, the FDA-approved EMFLAZA (deflazacort) is recommended in patients two years of age or older for the treatment of Duchenne muscular dystrophy (DMD). In fact, EMFLAZA is the very first corticosteroid to be approved by the FDA for the treatment of DMD and the first-ever approval of Emflaza for any use in the U.S. It is also the only approved treatment for all patients two and over living with Duchenne, a rare and fatal genetic disorder that results in progressive muscle weakness from early childhood.
EMFLAZA was first approved in February 2017 for the treatment of DMD in patients 5-years and older. In June 2019, PTC Therapeutics announced that the FDA approved the company’s supplemental New Drug Application (sNDA) for EMFLAZA® (deflazacort) to expand its labeling to include patients with Duchenne muscular dystrophy who are between 2- and 5-years-old.
In the first quarter of 2019, TRANSLARNA (ataluren) was approved by the Brazilian Health Regulatory Authority (ANVISA) to extend the presence of PTC in Brazil. The medicine is also approved for the treatment of DMD in the European Union (EU). Translarna is formulated to treat only patients who have DMD or Becker Muscular Dystrophy (BMD), which is a milder version of the disease, caused by a particular type of defect in the DMD gene called a nonsense mutation.
In August 2018 PTC Therapeutics and Akcea Therapeutics, an Ionis Pharmaceuticals affiliate, announced a collaboration under which PTC will commercialise two of Akcea’s rare disease drugs in Latin America: TEGSEDI™ (inotersen) and WAYLIVRA™ (volanesorsen).
TEGSEDI (inotersen), discovered and developed by Ionis Pharmaceuticals, is approved in the United States, Canada and the EU for the treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR) in adults. It is the first and only subcutaneous RNA-targeting drug in the world, designed to reduce the production of human transthyretin (TTR) protein.
hATTR amyloidosis is a progressive, systemic and fatal inherited disease caused by the abnormal formation of the TTR protein and aggregation of TTR amyloid deposits in various tissues and organs throughout the body, including in peripheral nerves, heart, central nervous system, thyroid and bone marrow. TEGSEDI targets the disease at its source by reducing the production of TTR protein. There are an estimated 50,000 patients with hATTR amyloidosis worldwide.
ANVISA has granted the drug priority review and is expected to be recognised by the end of 2019.
In the first quarter of 2019, WAYLIVRA (volanesorsen), indicated for the treatment of family chylomicronemia syndrome (FCS), received the European medical authorities ‘ positive opinion on CHMP.
Upon approval by the European Commission, the organisation plans to launch early access services in Latin America in 2019.
The facility will also support the company’s gene therapy pipeline for central nervous system disorders, which includes the gene therapy programme Friedreich ataxia and Aromatic L-amino acid decarboxylase (AADC).
The relocation of research operations is also planned for 2020 after the start of the production of gene therapy.
More about PTC Therapeutics
PTC Therapeutics, a US-based biopharmaceutical corporation, focuses on researching and developing orally administered medicines that are used in post-transcription control processes.
The research projects set targets in various clinical fields, whereas the main focus of the organisation is to create and market therapies for orphan and ultra-orphan disorders.
The company has purchased Agilis Biotherapeutics and is currently working for the advanced development and implementation of its gene therapy programme with Akcea Therapeutics, Odylia Therapeutics, Roche and Aldevron.
PTC Therapeutics holds no manufacturing or distribution facilities for its candidates for gene therapy drugs and relies solely on third parties for all commercial and medical drug production, packaging, branding and distribution. More than 700 people are currently employed by the company worldwide.
The organisation is sponsored by the Net Operating Loss (NOL) system of the New Jersey Economic Development Authority (NJEDA), which enables future innovation and life science businesses to operate before it begins to make a profit.
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