Regulatory News:
Ipsen (Euronext: IPN; ADR: IPSEY) today announced the United
States Food and Drug Administration (FDA) has granted the company
Fast Track designation for irinotecan liposome injection (ONIVYDE®)
in study patients with small cell lung cancer (SCLC) who progressed
following a first-line platinum-based regimen, reflecting the unmet
medical need.
ONIVYDE® is currently approved in the United States and in
Europe in combination with fluorouracil (5-FU) and leucovorin (LV)
for the treatment of patients with metastatic adenocarcinoma of the
pancreas after disease progression following gemcitabine-based
therapy. ONIVYDE® is not indicated as a single agent for the
treatment of patients with metastatic adenocarcinoma of the
pancreas.
An ongoing Phase III randomized study (RESILIENT; NCT03088813)
trial is being conducted to assess the efficacy and safety of
investigational irinotecan liposome injection (ONIVYDE®) as a
monotherapy for SCLC study patients who have progressed on or after
a first-line platinum-based regimen.
“The Fast Track designation of ONIVYDE® as a potential treatment
for people living with small cell lung cancer is an extension of
Ipsen’s focus and contribution to the treatment landscape in
oncology,” said Howard Mayer, M.D., Executive Vice President, Head
of Research and Development at Ipsen. “With this aggressive and
often late-stage diagnosed form of lung cancer, we are proud to be
one step closer to making another treatment option available to
patients.”
Lung cancer is the second most common cancer in the United
States. In 2020, the American Cancer Society estimates there to be
about 228,280 new cases of lung cancer in the US (116,300 in men
and 112,520 in women).1 SCLC comprises 10% to 15% of all lung
cancers and is a very aggressive form of cancer with about 70% of
people having metastatic disease when they are diagnosed.2
ONIVYDE® also received Fast Track designation in June 2020 for
first-line irinotecan liposome injection (ONIVYDE®) in combination
with 5- fluorouracil/leucovorin (5-FU/LV) and oxaliplatin (OX)
together, known as NALIRIFOX for study patients with previously
untreated, unresectable, locally advanced and metastatic pancreatic
ductal adenocarcinoma (PDAC). An ongoing Phase 3 randomized study
(NAPOLI-3; NCT04083235) is being conducted to assess the efficacy
and safety of NALIRIFOX in study patients who are not previously
treated for metastatic pancreatic cancer.
Programs with Fast Track designation may benefit from early and
frequent interactions with the FDA over the course of drug
development. In addition, the Fast Track designation program allows
for the eligibility for accelerated approval and priority review if
relevant study criteria are met and enables a company to submit
individual sections of a New Drug Application (NDA) for review on a
rolling-submission basis.
ABOUT ONIVYDE® (irinotecan liposome injection)
Ipsen has exclusive commercialization rights for the current and
potential future indications for ONIVYDE® in the U.S. Servier, an
independent international pharmaceutical company with a strong
international presence in 150 countries, is responsible for the
commercialization of ONIVYDE® outside of the United States and
Taiwan. PharmaEngine is a commercial stage oncology company
headquartered in Taipei and is responsible for the
commercialization of ONIVYDE® in Taiwan.
INDICATION - UNITED STATES
ONIVYDE® is approved by the U.S. FDA in combination with
fluorouracil (5-FU) and leucovorin (LV) for the treatment of
patients with metastatic adenocarcinoma of the pancreas after
disease progression following gemcitabine-based therapy. Limitation
of Use: ONIVYDE® is not indicated as a single agent for the
treatment of patients with metastatic adenocarcinoma of the
pancreas.
IMPORTANT SAFETY INFORMATION - UNITED STATES
BOXED WARNINGS: SEVERE NEUTROPENIA and
SEVERE DIARRHEA
Fatal neutropenic sepsis occurred in
0.8% of patients receiving ONIVYDE®. Severe or
life-threatening neutropenic fever or sepsis occurred in 3% and
severe or life-threatening neutropenia occurred in 20% of patients
receiving ONIVYDE® in combination with 5-FU and LV.
Withhold ONIVYDE® for absolute
neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood
cell counts periodically during treatment.
Severe diarrhea occurred in 13% of
patients receiving ONIVYDE® in combination with 5-FU/LV. Do
not administer ONIVYDE® to patients with bowel obstruction.
Withhold ONIVYDE® for diarrhea of Grade 2–4 severity.
Administer loperamide for late diarrhea of any severity. Administer
atropine, if not contraindicated, for early diarrhea of any
severity.
CONTRAINDICATION
ONIVYDE® is contraindicated in patients who have
experienced a severe hypersensitivity reaction to ONIVYDE®
or irinotecan HCl
Warnings and Precautions
Severe Neutropenia: See Boxed WARNING. In patients
receiving ONIVYDE®/5-FU/LV, the incidence of Grade 3/4 neutropenia
was higher among Asian (18/33 [55%]) vs White patients (13/73
[18%]). Neutropenic fever/neutropenic sepsis was reported in 6% of
Asian vs 1% of White patients
Severe Diarrhea: See Boxed WARNING. Severe and
life-threatening late-onset (onset >24 hours after chemotherapy
[9%]) and early-onset diarrhea (onset ≤24 hours after chemotherapy
[3%], sometimes with other symptoms of cholinergic reaction) were
observed
Interstitial Lung Disease (ILD): Irinotecan HCl can cause
severe and fatal ILD. Withhold ONIVYDE® I patients with new or
progressive dyspnea, cough, and fever, pending diagnostic
evaluation. Discontinue ONIVYDE® in patients with a confirmed
diagnosis of ILD
Severe Hypersensitivity Reactions: Irinotecan HCl can
cause severe hypersensitivity reactions, including anaphylactic
reactions. Permanently discontinue ONIVYDE® in patients who
experience a severe hypersensitivity reaction
Embryo-Fetal Toxicity: ONIVYDE® can cause fetal harm when
administered to a pregnant woman. Advise females of reproductive
potential to use effective contraception during and for 1 month
after ONIVYDE® treatment
Adverse Reactions
- The most common adverse reactions (≥20%) were diarrhea (59%),
fatigue/asthenia (56%), vomiting (52%), nausea (51%), decreased
appetite (44%), stomatitis (32%), and pyrexia (23%)
- The most common Grade 3/4 adverse reactions (≥10%) were
diarrhea (13%), fatigue/asthenia (21%), and vomiting (11%)
- Adverse reactions led to permanent discontinuation of ONIVYDE®
in 11% of patients receiving ONIVYDE®/5- FU/LV; The most frequent
adverse reactions resulting in discontinuation of ONIVYDE® were
diarrhea, vomiting, and sepsis
- Dose reductions of ONIVYDE® for adversereactions occurred in
33% of patients receivingONIVYDE®/5 FU/LV; the most frequent
adverse reactions requiring dose reductions were neutropenia,
diarrhea, nausea, and anemia
- ONIVYDE® was withheld or delayed for adverse reactions in 62%
of patients receiving ONIVYDE®/5- FU/LV; the most frequent adverse
reactions requiring interruption or delays were neutropenia,
diarrhea, fatigue, vomiting, and thrombocytopenia
- The most common laboratory abnormalities (≥20%) were anemia
(97%), lymphopenia (81%), neutropenia (52%), increased ALT (51%),
hypoalbuminemia (43%), thrombocytopenia (41%), hypomagnesemia
(35%), hypokalemia (32%), hypocalcemia (32%), hypophosphatemia
(29%), and hyponatremia (27%)
Drug Interactions
- Avoid the use of strong CYP3A4 inducers, if possible, and
substitute non-enzyme inducing therapies ≥2 weeks prior to
initiation of ONIVYDE®
- Avoid the use of strong CYP3A4 or UGT1A1 inhibitors, if
possible, and discontinue strong CYP3A4 inhibitors ≥1 week prior to
starting therapy
Special Populations
- Pregnancy and Reproductive Potential: See WARNINGS &
PRECAUTIONS. Advise males with female partners of reproductive
potential to use condoms during and for 4 months after ONIVYDE®
treatment
- Lactation: Advise nursing women not to breastfeed during and
for 1 month after ONIVYDE® treatment
Please see full U.S. Prescribing Information including Boxed
WARNING for ONIVYDE®.
About Ipsen
Ipsen is a global specialty-driven biopharmaceutical group
focused on innovation and Specialty Care. The Group develops and
commercializes innovative medicines in three key therapeutic areas
– Oncology, Neuroscience, and Rare Diseases. Ipsen also has a
well-established Consumer Healthcare business. With total sales
over €2.5 billion in 2019, Ipsen sells more than 20 drugs in over
115 countries, with a direct commercial presence in more than 30
countries. Ipsen’s R&D is focused on its innovative and
differentiated technological platforms located in the heart of the
leading biotechnological and life sciences hubs (Paris-Saclay,
France; Oxford, UK; Cambridge, US). The Group has about 5,700
employees worldwide. Ipsen is listed in Paris (Euronext: IPN) and
in the United States through a Sponsored Level I American
Depositary Receipt program (ADR: IPSEY). For more information on
Ipsen, visit www.ipsen.com
Ipsen’s Forward Looking Statement
The forward-looking statements, objectives and targets contained
herein are based on the Group’s management strategy, current views
and assumptions. Such statements involve known and unknown risks
and uncertainties that may cause actual results, performance or
events to differ materially from those anticipated herein. All of
the above risks could affect the Group’s future ability to achieve
its financial targets, which were set assuming reasonable
macroeconomic conditions based on the information available today.
Use of the words "believes", "anticipates" and "expects" and
similar expressions are intended to identify forward-looking
statements, including the Group’s expectations regarding future
events, including regulatory filings and determinations, and the
outcome of this study or other studies. Moreover, the targets
described in this document were prepared without taking into
account external growth assumptions and potential future
acquisitions, which may alter these parameters. These objectives
are based on data and assumptions regarded as reasonable by the
Group. These targets depend on conditions or facts likely to happen
in the future, and not exclusively on historical data. Actual
results may depart significantly from these targets given the
occurrence of certain risks and uncertainties, notably the fact
that a promising product in early development phase or clinical
trial may end up never being launched on the market or reaching its
commercial targets, notably for regulatory or competition reasons.
The Group must face or might face competition from generic products
that might translate into a loss of market share. Furthermore, the
Research and Development process involves several stages each of
which involves the substantial risk that the Group may fail to
achieve its objectives and be forced to abandon its efforts with
regards to a product in which it has invested significant sums.
Therefore, the Group cannot be certain that favorable results
obtained during preclinical trials will be confirmed subsequently
during clinical trials, or that the results of clinical trials will
be sufficient to demonstrate the safe and effective nature of the
product concerned. There can be no guarantees a product will
receive the necessary regulatory approvals or that the product will
prove to be commercially successful. If underlying assumptions
prove inaccurate or risks or uncertainties materialize, actual
results may differ materially from those set forth in the
forward-looking statements. Other risks and uncertainties include
but are not limited to, general industry conditions and
competition; general economic factors, including interest rate and
currency exchange rate fluctuations; the impact of 6 pharmaceutical
industry regulation and health care legislation; global trends
toward health care cost containment; technological advances, new
products and patents attained by competitors; challenges inherent
in new product development, including obtaining regulatory
approval; the Group's ability to accurately predict future market
conditions; manufacturing difficulties or delays; financial
instability of international economies and sovereign risk;
dependence on the effectiveness of the Group’s patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory actions.
The Group also depends on third parties to develop and market some
of its products which could potentially generate substantial
royalties; these partners could behave in such ways which could
cause damage to the Group’s activities and financial results. The
Group cannot be certain that its partners will fulfil their
obligations. It might be unable to obtain any benefit from those
agreements. A default by any of the Group’s partners could generate
lower revenues than expected. Such situations could have a negative
impact on the Group’s business, financial position or performance.
The Group expressly disclaims any obligation or undertaking to
update or revise any forward-looking statements, targets or
estimates contained in this press release to reflect any change in
events, conditions, assumptions or circumstances on which any such
statements are based, unless so required by applicable law. The
Group’s business is subject to the risk factors outlined in its
registration documents filed with the French Autorité des Marchés
Financiers. The risks and uncertainties set out are not exhaustive
and the reader is advised to refer to the Group’s 2019 Universal
Registration Document available on its website (www.ipsen.com).
ONIVYDE® is a registered trademark of Ipsen
Biopharm Limited. All other trademarks are the property of their
respective owners. © 2020 Ipsen Biopharmaceuticals, Inc. All Rights
Reserved. November 2020, ONV-US- 002857
References
- Key Statistics for Lung Cancer. American Cancer Society.
https://www.cancer.org/cancer/lung-cancer/about/key-statistics.html.
Published January 8, 2020. Accessed November 20, 2020.
- What is Lung Cancer. American Cancer Society.
https://www.cancer.org/cancer/lung-cancer/about/what-is.html.
Published October 1, 2019. Accessed November 25, 2020.
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version on businesswire.com: https://www.businesswire.com/news/home/20201130005944/en/
Media Jess Smith Global Corporate Communications +44 (0)
7557 267634 jess.smith@ipsen.com
Financial Community Eugenia Litz Vice President, Investor
Relations +44 (0) 1753 627721 eugenia.litz@ipsen.com
Maryann Quinn North America Product Communications
+1-857-529-1151 Maryann.quinn@ipsen.com
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