Ferring Pharmaceutical, a global life sciences company specializing in reproductive medicine, uro-oncology and specialty areas within orthopaedics, and gastroenterology, including microbiome therapeutics, held a ribbon-cutting ceremony yesterday for its new 12,000-square-foot gene therapy manufacturing facility located within its US headquarters in Parsippany.
The new facility is producing ADSTILADRIN, the first and only FDA-approved gene therapy delivered directly to the bladder for high-risk, non–muscle-invasive bladder cancer (NMIBC). The treatment is given to patients when Bacillus Calmette-Guérin (BCG) is no longer effective.
ADSTILADRIN is delivered via a catheter and is given every three months, unlike many gene therapies which are one-and-done treatments.
According to Bipin Dalmia, senior vice president, global head, uro-oncology franchise at Ferring, the idea for ADSTILADRIN is to turn high-risk bladder cancer into a manageable chronic disease. People who become cancer-free can continue taking their quarterly dose, but, he said, “people may stop after three to five years or so.” He added that phase three clinical studies of ADSTILADRIN were five years long.
Ferring’s vision for ADSTILADRIN production is for the company’s manufacturing facilities in Finland to develop the therapy’s drug substance (the active ingredient) globally, while the Parsippany location will be the primary site for the drug product (the finished dosage) globally.
While Ferring did not disclose how much it cost to build the new manufacturing facility, Dalmia said that, overall, the company has invested more than $1 billion in developing ADSTILADRIN over a 10-year period. This included nearly $500 million in manufacturing investments.
According to Dalmia, “The strategy is to manage three things: One is capacity, because we expect a lot of global demand for the product; second is risk balance by diversifying our manufacturing footprint – Ferring is a large manufacturer and anytime a product is expected to be big, we want dual sources [drug substance and product]; third, we want to address costs, which for gene therapies, can be very high.”
The patient use of ADSTILADRIN was approved by the FDA in December 2022. This past April, the FDA approved the Parsippany manufacturing plant for production. Meanwhile, Ferring has filed to get approval for therapy usage in the European Union, Canada, and Israel. It also plans to file with four other countries this year, and a Phase 3 study is ongoing in Japan.
As of now, ADSTILADRIN is the only gene therapy being produced at the Parsippany site, but Dalmia said the location can become a multiproduct facility in the future.
Currently, the facility employs 23 people, with the expectation of increasing the head count to 67. Overall, there are 600 full-time and 200 contingent workers at the 25-acre Parsippany headquarters, which opened in 2014.
Ferring’s world headquarters are in St. Prex, Switzerland. The company employs more than 6,000 people across the globe and reaches millions patients in more than 100 countries.
Article sourced from New Jersey Business Magazine.