Switzerland, and Singapore, 4 May 2022 – Juniper
Biologics Pte Ltd , a science-led healthcare company focused on researching,
developing and commercializing novel therapies, and Helsinn Group, a fully integrated, global biopharma company with a diversified
pipeline of innovative oncology assets and strong track-record of commercial
today the signing of an exclusive license agreement to develop and
commercialise infigratinib (INN) in Australia, New Zealand, Southeast Asia and
certain markets in the Middle East and Africa (see full list below) for the
treatment of adults with previously treated, unresectable locally advanced or
metastatic cholangiocarcinoma (CCA) with a fibroblast growth factor receptor 2
(FGFR2) fusion or other rearrangement.
2021 infigratinib obtained accelerated approval from the U.S. Food and Drug
Administration (FDA) under the brand name “TRUSELTIQ”® for the
treatment of adults with previously treated, unresectable locally advanced or
metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2)
fusion or other rearrangement as detected by an FDA-approved test. This
indication is based on overall response rate and duration of response. Additionally, infigratinib received
conditional approval by Health Canada and provisional approval by the
Therapeutics Goods Association in Australia for the treatment of adults with
previously treated, unresectable locally advanced or metastatic
cholangiocarcinoma with a FGFR2 fusion or other rearrangement. Continued
approval in the U.S., Canada and Australia for this indication may be contingent
upon verification and description of clinical benefit in confirmatory trial(s).
is not FDA-, Health Canada- or Therapeutics Goods Association-approved for any
other indication in the United States, Canada and Australia, and is not approved
for use by any other health authority.
Raman Singh, CEO of Juniper Biologics, commented: “The
acquisition of infigratinib is an important addition to our oncology
portfolio and a much-needed treatment for patients whose cancer has spread or cannot
be removed by surgery. Our mission is to increase access to proven treatments
and we trust that infigratinib will help advance the treatment of
patients in markets, where there remains an unmet patient need.”
Giorgio Calderari, Helsinn CEO commented: “This
agreement with Juniper is another example of our Fully Integrated Targeted
Therapy (FITT) Strategy in action as we continue to widen our network of
partners for infigratinib. Helsinn’s renewed strategic focus is on developing highly
innovative oncology assets to address unmet needs, and this license agreement
with our trusted partner, Juniper Biologics, will ensure that this important
treatment is accessible to patients in Australia, Southeast Asia and certain
markets in Middle East and Africa.”
*The full list of countries covered by the license
agreement includes: Algeria, Angola, Australia, Bahrain, Brunei, Cambodia,
Egypt, India, Indonesia, Ivory Coast, Jordan, Kenya, Kuwait, Laos, Lebanon,
Libya, Malaysia, Mauritius, Morocco, Myanmar, Nepal, New Zealand, Nigeria,
Oman, Pakistan, Philippines, Qatar, Saudi Arabia, Seychelles, Singapore, South
Africa, South Korea, Taiwan, Tanzania, Thailand, Tunisia, Sri Lanka, United
Arab Emirates, Vietnam, Zimbabwe.
is an orally administered, selective, ATP‐competitive, kinase inhibitor of FGFR 1, 2, and 3.
The therapy is currently under investigation as a potential first-line
treatment for individuals with unresectable locally advanced or metastatic
cholangiocarcinoma (bile duct cancer) with FGFR2 fusion/rearrangement
and in the adjuvant setting for individuals with invasive urothelial carcinoma (bladder
cancer) with susceptible FGFR3 genetic alterations.
represents an aggressive group of malignancies that form in the bile ducts.
Although rare in most countries (with a worldwide estimated incidence of <6
per 100,000 people), the incidence of this malignancy is increasing worldwide.
Because the disease is usually asymptomatic at early-stages, diagnosis may be
delayed until advanced stages, when CCA typically presents as locally advanced
or metastatic disease. Despite continuing advances in treatments, the prognosis
for this disease remains poor, with a 5-year survival rate of <20%. FGFR2 genetic
alterations are present in approximately 15% to 20% of CCA patients and
represent potential targets for treatments.1,2
U.S. Indication and Important
Safety Information for TRUSELTIQ®
TRUSELTIQ® (infigratinib) is indicated for the treatment
of adults with previously treated, unresectable, locally advanced or metastatic
cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or
other rearrangement as detected by an FDA-approved test.
approval was granted based on overall response rate and duration of response.
Continued approval for this indication may be contingent upon verification of
clinical benefit in confirmatory trial(s).
recommended dosage of TRUSELTIQ is 125 mg (one 100 mg capsule and one 25 mg
capsule) orally once daily for 21 consecutive days followed by 7 days off
therapy, in 28-day cycles.
Warnings and precautions
Ocular toxicity: Retinal
pigment epithelial detachment (RPED), which may cause blurred vision,
occurred in 11% of 351 patients treated with TRUSELTIQ, including patients with
asymptomatic RPED, with a median onset of 26 days. Perform comprehensive
ophthalmological exam including optical coherence tomography prior to
initiating, at 1 month, at 3 months, and then every 3 months during treatment
with TRUSELTIQ. Urgently evaluate patients for onset of visual symptoms and
follow up every 3 weeks until resolved or TRUSELTIQ is discontinued. Withhold
TRUSELTIQ as recommended. Dry eye occurred in 29% of 351 patients;
treat with ocular demulcents as needed
Hyperphosphatemia and soft tissue
mineralization: Hyperphosphatemia, which can lead to soft
tissue mineralization, cutaneous calcinosis, non-uremic calciphylaxis, vascular
calcification, and myocardial calcification, occurred in 82% of 351 patients
treated with TRUSELTIQ, with a median time to onset of 8 days (range 1-349);
83% of 351 patients treated with TRUSELTIQ received phosphate binders. Monitor
for hyperphosphatemia throughout treatment. Initiate phosphate-lowering therapy
for serum phosphate >5.5 mg/dL; withhold TRUSELTIQ and initiate
phosphate-lowering therapy for serum phosphate >7.5 mg/dL; withhold, reduce
the dose, or permanently discontinue TRUSELTIQ based on duration and severity
Embryo-fetal toxicity: TRUSELTIQ
can cause fetal harm. Advise pregnant women of the potential risk to the fetus;
advise females of reproductive potential and men who are partnered with women
of reproductive potential to use effective contraception during treatment with
TRUSELTIQ and for 1 month after the final dose.
Most common adverse
reactions (incidence ≥20%, all grades): nail
toxicity, stomatitis, dry eye, fatigue, alopecia, palmar-plantar
erythrodysesthesia syndrome, arthralgia, dysgeusia, constipation, abdominal
pain, dry mouth, eyelash changes, diarrhea, dry skin, decreased appetite,
blurred vision, and vomiting.
Most common laboratory
abnormalities (incidence ≥20%, all grades): increased
creatinine, increased phosphate, decreased phosphate, increased alkaline
phosphatase, decreased hemoglobin, increased alanine aminotransferase,
increased lipase, increased calcium, decreased lymphocytes, decreased sodium,
increased triglycerides, increased aspartate aminotransferase (AST), increased
urate, decreased platelets, decreased leukocytes, decreased albumin, increased
bilirubin, and decreased potassium.
CYP3A inhibitors: Avoid
use with strong and moderate CYP3A inhibitors
CYP3A inducers: Avoid
use with strong and moderate CYP3A inducers
Gastric acid–reducing agents: Avoid
coadministration with proton pump inhibitors, histamine-2 receptor antagonists
(H2RA), and locally acting antacids. If coadministration of H2RA or locally
acting antacids cannot be avoided, separate TRUSELTIQ administration
H2RA: Take TRUSELTIQ 2 hours before or 10
Locally-acting antacid: Take TRUSELTIQ 2 hours
before or 2 hours after
Prior to initiating TRUSELTIQ: Confirm
FGFR2 fusion or rearrangement; perform comprehensive ophthalmic exam including
OCT; confirm negative pregnancy test in females of reproductive potential.
Starting dose: Take
TRUSELTIQ orally once daily on Days 1-21 of 28-day cycles; continue treatment
until disease progression or unacceptable toxicity. Take TRUSELTIQ on an empty
stomach with a glass of water at least 1 hour before or 2 hours after food at
approximately the same time each day.
No renal or hepatic impairment
125 mg (one 100 mg capsule and one 25 mg capsule)
Mild and moderate renal impairment (creatinine
clearance 30-89 mL/min)
100 mg (one 100 mg capsule)
Mild hepatic impairment (total bilirubin >upper
limit of normal [ULN] to 1.5 x ULN or AST > ULN)
100 mg (one 100 mg capsule)
Moderate hepatic impairment (total bilirubin
>1.5 to 3 x ULN with any AST)
75 mg (three 25 mg capsules)
Dose modification: Consult
the TRUSELTIQ full Prescribing Information for dose modifications and
monitoring recommendations for RPED, hyperphosphatemia, and other Grades 3-4
Helsinn is a fully integrated, global biopharma company
headquartered in Lugano, Switzerland. It is focused on improving the lives of
cancer patients all over the world with a leading position in cancer supportive
care and an innovative pipeline of cancer therapeutics.
Helsinn is a third-generation family-owned company, that since
1976 has been focused on improving the lives of patients, guided by core values
of respect, integrity and quality. It operates a unique licensing business
model with integrated drug development and manufacturing capabilities. Helsinn
has a commercial presence in 190 countries either directly, with operating
subsidiaries in the U.S. and China, or via its network of long-standing trusted
partners. Helsinn also has a fully integrated supply chain and product
development through its subsidiary in Ireland, Helsinn Birex Pharmaceuticals
Helsinn plays an active and central role in promoting social
transformation in favor of people and the environment. Corporate social
responsibility is at the heart of everything we do, which is reinforced in the
company’s strategic plan by a commitment to sustainable growth.
Backed by The Sylvan Group, Juniper Biologics is a science-led healthcare company focused
on delivering novel therapies to improve the health and quality of life of
patients, by building a growing presence in Oncology, Rare/Orphan Diseases and
Gene Therapy. It was founded on a vision to provide treatments for
unmet medical needs focused on specialist therapy areas in which it can
make the most difference. Through bold and transformative science, Juniper
Biologics is committed to creating possibilities that have the potential to
become the next generation of life-changing medicines for patient communities
in China, Japan, Asia, Australia, New Zealand, Middle East and Africa.
1Banales, J., Cardinale, V., Carpino, G. et al.
Cholangiocarcinoma: current knowledge and future perspectives consensus statement
from the European Network for the Study of Cholangiocarcinoma (ENS-CCA). Nat
Rev Gastroenterol Hepatol 13, 261–280 (2016).
2Banales, J.M., Marin, J.J.G., Lamarca, A. et al.
Cholangiocarcinoma 2020: the next horizon in mechanisms and management. Nat Rev
Gastroenterol Hepatol 17, 557–588 (2020).
For more information:
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Tel: +41 (0) 91 985 21 21
Juniper Biologics Contact:
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