Ferring Pharmaceuticals and SK pharmteco enter into commercial gene therapy manufacturing deal
- Biopharmaceutical contract manufacturer SK pharmteco commits to production, testing, and release of Ferring’s U.S. approved Adstiladrin® (nadofaragene firadenovec-vncg)
- The deal assures diversity of supply to meet future long-term plans for expanded availability of the gene therapy
- Two additional state-of-the-art manufacturing facilities for Adstiladrin® are near completion in Finland and the U.S.
Saint-Prex, Switzerland and King of Prussia, Pa, U.S.– 18 April, 2024 – Ferring Pharmaceuticals and SK pharmteco today announced an agreement to scale up commercial manufacturing capacity for the drug substance of Ferring’s intravesical gene therapy Adstiladrin® (nadofaragene firadenovec-vncg) for ensuring long-term future supply. Following technology transfer, SK pharmteco, a contract development manufacturing organisation (CDMO), will be qualified as another source for manufacturing, testing, and release of the medicine, subject to regulatory approval by the U.S. Food and Drug Administration (FDA).
Adstiladrin® was approved by the FDA in December 2022 for adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
This additional scale up and diversification of drug substance capacity demonstrates Ferring’s commitment to securing future long-term supply of Adstiladrin® to meet the projected commercial growth of its non-replicating gene therapy. In addition to this contract manufacturing agreement, dedicated capacity expansion of Adstiladrin® is well underway at state-of-the-art facilities in Ferring’s existing site in Finland and its U.S. campus in Parsippany, New Jersey. Ferring will provide updates on the progress of these near-term projects later in 2024.
“Ferring takes its responsibilities to patients with high-risk BCG-unresponsive NMIBC very seriously – especially when pioneering in the emerging field of gene therapy commercial manufacturing,” said Bipin Dalmia, Global Head, Uro-Oncology Franchise, Ferring Pharmaceuticals. “Following our January announcement of full availability of Adstiladrin® across the U.S. and expansion of our clinical trials program, this agreement with SK pharmteco comes alongside major investments in our own manufacturing capabilities to assure the breadth of our long-term supply base. Stable and sustainable supply is a vital part of our mission to fill this unmet clinical need for the patients we serve.”
The need to scale up supply of strategically important medicines for bladder cancer across geographies is demonstrated by the trend of increased disease prevalence worldwide. The World Bladder Cancer Patient Coalition has reported that bladder cancer became the ninth most common cancer in the world (a rise from tenth) according to new data published in February 2024 (IARC GLOBOCAN 2022)1. In the United States, it is the seventh most common cancer, fourth among men, 2-3 and 75% of bladder cancer presents as NMIBC.4
“SK pharmteco is proud to partner with Ferring Pharmaceuticals as a manufacturer of the breakthrough gene therapy Adstiladrin®,” said Joerg Ahlgrimm, Chief Executive Officer for SK pharmteco. “Our integrated approach, incorporating customizable clinical and commercial GMP manufacturing solutions with comprehensive in-process testing, quality control, and lot release programs, provides unparalleled support to our partners throughout their product lifecycle and is in perfect alignment with our mission of expediting the delivery of potentially life-saving therapies to patients across the globe.”
SK pharmteco was selected based on their competencies and alignment on core values across the two companies following a thorough assessment of potential CDMOs with gene therapy development and GMP manufacturing capabilities.
About Adstiladrin
Adstiladrin® (nadofaragene firadenovec-vncg) is a gene therapy developed as a treatment for adult patients with BCG-unresponsive NMIBC. It is a non-replicating adenovirus vector-based gene therapy containing the gene encoding interferon alfa-2b protein, administered by catheter into the bladder once every three months. The vector enters the cells of the bladder wall, releasing the interferon gene. The internal cell machinery translates the interferon DNA sequence, resulting in the cells secreting high quantities of interferon alfa-2b protein, a recombinant analog of the naturally occurring protein the body uses to fight cancer. This novel gene therapy approach thereby turns the patient’s own bladder wall cells into interferon microfactories, enhancing the body’s natural defenses against the cancer. Nadofaragene firadenovec-vncg has been studied in a clinical trial program that includes 157 patients with high-grade, BCG-unresponsive NMIBC who had been treated with adequate BCG previously and did not see benefit from additional BCG treatment (full inclusion criteria published on clinicaltrials.gov: NCT02773849).
Nadofaragene firadenovec-vncg has been studied in a clinical trial program that includes 157 patients with high-grade, BCG-unresponsive NMIBC who had been treated with adequate BCG previously and did not see benefit from additional BCG treatment (full inclusion criteria published on clinicaltrials.gov: NCT02773849).4
INDICATION
Adstiladrin® is a non-replicating adenoviral vector-based gene therapy indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS: Adstiladrin® is contraindicated in patients with prior hypersensitivity reactions to interferon alfa or to any component of the product.
WARNINGS AND PRECAUTIONS:
- Risk with delayed cystectomy: Delaying cystectomy in patients with BCG-unresponsive CIS could lead to development of muscle invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after 3 months or if CIS recurs, consider cystectomy.
- Risk of disseminated adenovirus infection: Persons who are immunocompromised or immunodeficient may be at risk for disseminated infection from Adstiladrin® due to low levels of replication-competent adenovirus. Avoid Adstiladrin® exposure to immunocompromised or immunodeficient individuals.
DOSAGE AND ADMINISTRATION: Administer Adstiladrin® by intravesical instillation only. Adstiladrin® is not for intravenous use, topical use, or oral administration.
USE IN SPECIFIC POPULATIONS: Advise females of reproductive potential to use effective contraception during Adstiladrin® treatment and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during Adstiladrin® treatment and for 3 months after the last dose.
ADVERSE REACTIONS: The most common (>10%) adverse reactions, including laboratory abnormalities (>15%), were glucose increased, instillation site discharge, triglycerides increased, fatigue, bladder spasm, micturition (urination urgency), creatinine increased, hematuria (blood in urine), phosphate decreased, chills, pyrexia (fever), and dysuria (painful urination).
You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.FDA.gov/medwatch or call 1-800-332-1088. You may also contact Ferring Pharmaceuticals at 1-888-FERRING.
Please click to see the full Prescribing Information.
About Ferring Pharmaceuticals
Ferring Pharmaceuticals is a privately owned, research-driven, specialty biopharmaceutical group committed to building families and helping people live better lives. We are leaders in reproductive medicine and maternal health, and in areas of gastroenterology and urology. We are at the forefront of innovation in microbiome-based therapeutics and uro-oncology intravesical gene therapy. Ferring was founded in 1950 and employs more than 7,000 people worldwide. The company is headquartered in Saint-Prex, Switzerland, and has operating subsidiaries in more than 50 countries which markets its medicines in over 100 countries.
Learn more at www.ferring.com, or connect with us on LinkedIn, Instagram, YouTube, Facebook and Twitter
About SK pharmteco
SK pharmteco is a global contract development and manufacturing organization (CDMO) with 13 offices and manufacturing facilities across the U.S., Europe, and Korea. The company partners with biopharmaceutical companies of all sizes to manufacture Active Pharmaceutical Ingredients (API) and intermediates, cell and gene therapy technologies, registered starting materials, and analytical services for the biopharmaceutical industry worldwide. SK pharmteco is a subsidiary of SK Inc. (KRX: 034730) (SK), the strategic investment company for SK Group, South Korea’s second-largest conglomerate.
Learn more at www.skpharmteco.com, or connect with us on LinkedIn.
References
- World Bladder Cancer Patient Coalition GLOBOCAN 2022 press release. https://worldbladdercancer.org/news_events/globocan-2022-bladder-cancer-is-the-9th-most-commonly-diagnosed-worldwide/ , page last accessed: March 2024
- European Association of Urology. Guidelines for non-muscle-invasive bladder cancer (TaT1 and CIS). Available at https://uroweb.org/guidelines/non-muscle-invasive-bladder-cancer
- Boorjian SA, Alemozaffar M, Konety BR, et al. Intravesical nadofaragene firadenovec gene therapy for BCG-unresponsive non-muscle-invasive bladder cancer: a single-arm, open-label, repeat-dose clinical trial. Lancet Oncol 2021; 22:107–17.
- ADSTILADRIN in Patients With High Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC). Gov Identifier: NCT02773849. https://clinicaltrials.gov/ct2/show/NCT02773849.
For more information, please contact
SK pharmteco
Keith Bowermaster
Modig Group
(+01) 770-891-9247
Keith@ModigGroup.com
Ferring Pharmaceuticals
Matthew Worrall
Director of Corporate Communications
(+44) 7442 271 811
Matthew.Worrall@ferring.com
