2023
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
(BUSINESS WIRE)--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.
Royalty Pharma Forward-Looking Statements
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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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Contacts
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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