Ad hoc announcement pursuant to Art. 53
LR
- Royalty Pharma to pay Ferring $300 million upfront and a
potential $200 million milestone payment in exchange for royalties
on the sales of Ferring’s intravesical gene therapy Adstiladrin®
(nadofaragene firadenovec-vncg)
- Transaction provides Ferring with significant non-dilutive
capital to support the manufacturing capacity expansion,
commercialization and further clinical development of Adstiladrin
for bladder cancer patients in the United States
Royalty Pharma plc (Nasdaq: RPRX) and Ferring Pharmaceuticals
today announced that Royalty Pharma has acquired a synthetic
royalty on US net sales of Ferring’s Adstiladrin® (nadofaragene
firadenovec-vncg) for up to US $500 million comprised of an upfront
payment of US $300 million and a US $200 million milestone payment.
The milestone payment is contingent on certain manufacturing goals
that are expected to be achieved in 2025 for the FDA-approved
intravesical gene therapy that Ferring will make available next
month through an early experience program 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.
Under the terms of the agreement, Royalty Pharma is acquiring a
5.1% percentage royalty on net sales of Adstiladrin in the United
States, which will increase to 8.0% upon payment of the
manufacturing-related milestone. The royalty is expected to end in
the early to mid-2030s.
“This major investment by Royalty Pharma, the largest buyer of
biopharmaceutical royalties and a leading funder of innovation, is
yet another demonstration of the value and confidence in our gene
therapy Adstiladrin to address significant unmet medical needs for
patients. It also highlights its significant potential as a key
growth driver for Ferring, and our commitment to Uro-Oncology,”
said Jean-Frédéric Paulsen, Executive Chairman of Ferring
Pharmaceuticals.
Bladder cancer is the sixth most common cancer in the United
States, with NMIBC representing approximately 75% of all new
bladder cancer cases.1 Adstiladrin is a non-replicating adenovirus
vector-based gene therapy for the treatment of adult patients with
high-risk BCG-unresponsive NMIBC. Although BCG remains the
first-line standard of care for people living with high-grade
NMIBC, more than 50% of patients who receive initial treatment with
BCG will experience disease recurrence and progression within one
year, with many developing BCG-unresponsive disease.2 In April
2023, the FDA approved a Prior-Approval Supplement (PAS) to the
Biologics License Application (BLA) for the therapy which enabled
the scale-up of drug substance manufacturing process.
“After several decades of little progress in the field,
Adstiladrin brings a major innovation to patients with high-risk
NMIBC who no longer respond to current first-line treatment and
have few other good options. Our ambition is for Adstiladrin to
become the new standard of care and the backbone therapy for these
patients and to drive research in other urothelial cancers. This
agreement positions us well for continued significant and sustained
investment to further advance Adstiladrin as the foundation of our
leadership drive in Uro-Oncology,” said Bipin Dalmia, Global Head,
Uro-Oncology Franchise of Ferring Pharmaceuticals.
“We are delighted to partner with Ferring, a research-driven,
global specialty biopharmaceutical company. This investment is
consistent with our strategy of acquiring royalties on innovative
therapies in areas of high unmet patient need,” said Pablo
Legorreta, founder and Chief Executive Officer of Royalty Pharma.
“Adstiladrin is the first gene therapy in our diversified royalty
portfolio. We believe it has blockbuster potential and we are
pleased to provide funding to support the launch of Adstiladrin and
help Ferring reach as many patients as possible with this important
therapy in the United States.”
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).
US FDA approval of Adstiladrin on December 16, 2022 was based on
results of the Phase 3 clinical trial, which met its primary
endpoint with more than half (51%, n=50 of 98; 95% CI 41 to 61) of
patients with carcinoma in situ with or without concomitant
high-grade Ta or T1 disease (CIS ± Ta/T1) achieving a complete
response (CR) by three months. Of the patients who achieved an
initial CR, 46% (n=23 of 50) continued to remain free of high-grade
recurrence at 12 months.
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 hypersensitivity to interferon alfa or 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.
About Royalty Pharma plc Founded in 1996, Royalty Pharma
is the largest buyer of biopharmaceutical royalties and a leading
funder of innovation across the biopharmaceutical industry,
collaborating with innovators from academic institutions, research
hospitals and non-profits through small and mid-cap biotechnology
companies to leading global pharmaceutical companies. Royalty
Pharma has assembled a portfolio of royalties which entitles it to
payments based directly on the top-line sales of many of the
industry’s leading therapies. Royalty Pharma funds innovation in
the biopharmaceutical industry both directly and indirectly -
directly when it partners with companies to co-fund late-stage
clinical trials and new product launches in exchange for future
royalties, and indirectly when it acquires existing royalties from
the original innovators. Royalty Pharma’s current portfolio
includes royalties on more than 35 commercial products, including
Vertex’s Trikafta, Kalydeco, Orkambi and Symdeko, Biogen’s Tysabri,
AbbVie and Johnson & Johnson’s Imbruvica, Astellas and Pfizer’s
Xtandi, GSK’s Trelegy, Novartis’ Promacta, Pfizer’s Nurtec ODT,
Johnson & Johnson’s Tremfya, Roche’s Evrysdi, Gilead’s
Trodelvy, and 11 development-stage product candidates.
About Ferring Pharmaceuticals Ferring Pharmaceuticals is a
research-driven, specialty biopharmaceutical group committed to
helping people around the world build families and live better
lives. Headquartered in Saint-Prex, Switzerland, Ferring is a
leader in reproductive medicine and women’s health, and in
specialty areas within gastroenterology and urology. Ferring has
been developing treatments for mothers and babies for over 50 years
and has a portfolio covering treatments from conception to birth.
Founded in 1950, privately owned Ferring now employs around 7,000
people worldwide, has its own operating subsidiaries in more than
50 countries, and markets its products in 100 countries.
Learn more at www.ferring.com, or connect with us on Twitter,
Facebook, Instagram, LinkedIn and YouTube.
Advisors Goodwin Procter LLP and Fenwick & West LLP
acted as legal advisors to Royalty Pharma. Orrick, Herrington &
Sutcliffe LLP acted as legal advisor to Ferring.
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set forth herein does not purport to be complete or to contain all
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For further information, please reference Royalty Pharma’s
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References: 1 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 2
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.
# # #
US-ADST-2300225
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For more information, please contact Royalty Pharma Investor
Relations and Communications +1 (212) 883-6772
ir@royaltypharma.com Ferring Europe Matthew Worrall +44
7442271811 Matthew.Worrall@ferring.com Ferring US Carol
Ready +1 973 7657307 Carol.Ready@ferring.com
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