Ipsen completes acquisition of Albireo, expanding the scope of its
Rare Disease portfolio
Ipsen completes acquisition of
Albireo, expanding
the scope of its
Rare
Disease
portfolio
- Bringing medicines to patients with
rare liver disease, a growth opportunity for Ipsen
- Lead asset Bylvay® (odevixibat) is the
first approved treatment in progressive familial intrahepatic
cholestasis, with two
additional investigational indications in rare,
pediatric liver diseases
- Acquisition adds novel bile-acid
modulators and an innovative pipeline to the existing rare liver
portfolio
PARIS,
FRANCE, 3
March 2023 –
Ipsen (Euronext: IPN: ADR: IPSEY) today announced it has completed
the acquisition of Albireo Pharma, Inc., a leading innovator in
bile-acid modulators to treat rare liver conditions. The
acquisition enriches Ipsen’s Rare Disease portfolio, with promising
therapeutics for pediatric and adult rare cholestatic-liver
diseases, innovative pipeline potential, as well as scientific and
commercial capabilities. Pursuant to the transaction, Ipsen
acquires all the issued and outstanding shares at a price of $42.00
per share in cash plus one non-transferable contingent value right
(CVR) of $10.00 per share.
“The acquisition of Albireo will greatly
strengthen our portfolio in rare diseases,” said David Loew, Chief
Executive Officer of Ipsen. “I am excited to welcome new colleagues
to Ipsen, who led the innovation on the development of novel bile
acid modulators, like Bylvay, to treat rare liver diseases in
children and adults. With Ipsen’s global presence, together we will
be able to bring the full potential of the approved medicines to
patients around the world.”
Lead medicine, Bylvay, is a potent once-daily
ileal bile acid transport inhibitor (IBATi) that received
regulatory approvals in 2021 in the U.S. for the treatment of
pruritus in patients three months of age and older with progressive
familial intrahepatic cholestasis (PFIC) 1 and in the E.U. for the
treatment of PFIC in patients aged six months or older.2
In addition to the lead indication, Bylvay was
accepted for Priority Review by the U.S. FDA for pediatric and
adult Alagille syndrome (ALGS) in February 2023 with a Prescription
Drug User Fee Act (PDUFA) action date of June 15, 2023. A variation
seeking authorization for ALGS was also submitted to the EMA in
2022, which has been validated for review. In a third indication,
the rare pediatric cholestatic liver disease, biliary atresia (BA),
Bylvay is in late-stage development with the Phase III BOLD
(Biliary atresia and the use of Odevixibat in
treating Liver Disease) trial. This is the first,
prospective, double-blind clinical trial in this patient
population. Bylvay has orphan exclusivity for the approved
indications in PFIC in the U.S. and E.U., and orphan drug
designations have been granted in both ALGS and BA indications in
the U.S. and E.U.
As part of the transaction, Ipsen has also
acquired A3907 and A2342, two clinical-stage assets in Albireo’s
pipeline. A3907 is a novel oral systemic apical sodium-dependent
bile-acid transporter inhibitor currently in Phase II clinical
development for primary sclerosing cholangitis (PSC).3 A2342 is an
oral systemic sodium-taurocholate co-transporting peptide (NTCP)
inhibitor being evaluated for viral and cholestatic diseases in a
Phase I trial.
As of 2 March 2023, close of business, Albireo’s
common stock will cease to be traded on the NASDAQ Capital Market
and will be subsequently deregistered.
ENDS
About
Bylvay®
(odevixibat)
Bylvay is a potent, non-systemic ileal bile-acid
transport inhibitor (IBATi). It is approved in the U.S. for the
treatment of pruritus in patients three months of age and older
with PFIC1, where it has orphan exclusivity. Bylvay was launched in
the U.S. in 2021, where it is supported by a program designed to
assist with access to treatment and patient support. Bylvay is also
approved in the E.U. for the treatment of PFIC in patients aged six
months or older.2 It has launched in over nine countries and has
secured public reimbursement across several major markets including
Germany, Italy, the U.K., France and Belgium.
View full E.U. prescribing information here:
Bylvay, INN-odevixibat (europa.eu)View full U.S. prescribing
information here: label (fda.gov)
About BOLDBOLD (NCT04336722) is
a double-blind, randomized, placebo-controlled trial to evaluate
the efficacy and safety of Bylvay (odevixibat) in children who have
biliary atresia and have undergone a Kasai procedure before age
three months. Children in the treatment arm receive Bylvay 120
μg/kg orally once daily for 24 months. The primary efficacy
endpoint is improvement in the proportion of patients who are alive
and have not undergone a liver transplant after two years of
treatment compared to placebo, and secondary outcome measures
include time to onset of any sentinel events, total bilirubin
levels and sBA levels.
About PFICPFIC is a spectrum4-7
of autosomal recessive genetic disorders in which cholestasis may
lead to end-stage liver disease.8 The estimated global incidence of
PFIC is 1 in 100,000 live births.8 Currently in the U.S., it is
estimated that there are 500 PFIC patients who may be eligible for
IBATi treatment. Subtypes PFIC1, PFIC2 and PFIC3 are the most
common.8 In addition, other rare forms of PFIC exist with varying
degrees of cholestasis.9 Patients with PFIC have impaired bile
flow, or cholestasis, and the resulting bile build-up in liver
cells causes liver disease and symptoms. The most debilitating
symptom of PFIC is pruritus (itching), which may be so severe that
it leads to skin mutilation, loss of sleep, irritability, poor
attention and impaired school performance.7 Up to 80% of PFIC
patients suffer from severe pruritus, associated with abrasions,
skin mutilation, hemorrhage or scarring.10
About ALGSALGS
is an inherited rare, genetic disorder that can affect multiple
organ systems in the body including the liver, heart, skeleton,
eyes and kidneys. Liver damage may result from having fewer than
normal, narrowed or malformed bile ducts, which leads to toxic bile
acid build-up, which in turn can cause scarring and progressive
liver disease.11 Approximately 95% of patients with the condition
present with chronic cholestasis, usually within the first three
months of life and as many as 88% also present with severe,
intractable pruritus.12,13 The estimated global incidence of ALGS
is 3 in 100,000 live births.14 Currently in the U.S., it is
estimated that there are 1,300 patients who may be eligible for
IBATi treatment.
About BABA is
a rare pediatric liver disease. Symptoms typically develop about
two to eight weeks after birth and there are no approved
pharmacological therapies. Damaged or absent bile ducts outside the
liver result in bile and bile acids being trapped inside the liver,
quickly resulting in cirrhosis and liver failure requiring liver
transplantation. At the time of diagnosis, a hepatic
portoenterostomy (HPE) called Kasai procedure is performed to
create a conduit allowing biliary drainage. The rate of success in
re-establishing bile flow is dependent on the age of the infant
when the HPE is performed. Kasai procedure is not curative and most
patients who have BA have progressive disease, with at least 80%
requiring liver transplantation by age 20 years.15 Of those who
survive into the third decade after birth, almost all have portal
hypertension or other complications of cirrhosis.16 New therapies
are therefore needed to delay or avoid the need for liver
transplantation following Kasai procedure.17 There are currently no
approved pharmacological treatments for biliary atresia. There is
an estimated incidence of 5-6 per 100,000 live births worldwide
with BA.18 Currently in the U.S., it is estimated that there are
750 patients who may be eligible for IBATi treatment.
About Ipsen Ipsen is a
global, mid-sized biopharmaceutical company focused on
transformative medicines in Oncology, Rare Disease and
Neuroscience. With total sales of €3.0bn in FY 2022, Ipsen sells
medicines in over 100 countries. Alongside its
external-innovation strategy, the Company’s research and
development efforts are focused on its innovative and
differentiated technological platforms located in the heart of
leading biotechnological and life-science hubs: Paris-Saclay,
France; Oxford, U.K.; Cambridge, U.S.; Shanghai, China. Ipsen has
around 5,000 colleagues worldwide and is listed in Paris (Euronext:
IPN) and in the U.S. through a Sponsored Level I American
Depositary Receipt program (ADR: IPSEY). For more information,
visit ipsen.com
For further information:
Ipsen
ContactsInvestors |
|
Craig
MarksVice President, Investor Relations+44 (0)7584 349
193 |
|
Media |
|
Anna
GibbinsGlobal Head of Franchise Communications,Rare
Disease+44 (0)7717801900 Amy WolfVP, Head
of Corporate Brand Strategy & Communications+41 79 576 07 23
|
Ioana
PiscociuSenior ManagerGlobal
Media Relations+33 6 69 09 12 96 |
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- label (fda.gov)
- Bylvay, INN-odevixibat (europa.eu)
- Safety and Tolerability of A3907 in Primary Sclerosing
Cholangitis - Full Text View - ClinicalTrials.gov (last accessed 21
February 2023)
- Henkel S. World J Hepatol. 2019;11(5):450-463
- Schatz B. Hepatol Commun. 2018;2(5):504-514
- Aldrian D. J Clin Med. 2021;10(3):481
- Folmer D E. Hepatology 2009;50(5):1597-1605
- Davit-Spraul A. Orphanet J Rare Dis. 2009;4:1
- Amirneni S World J Gastroenterol. 2020;26(47):7470- 7484
- Baker A. Clin Res Hepatol Gastroenterol. 2019;43(1):20-36
- U.S. Department of Health and Human Services. Alagille
syndrome- about the disease. Genetic and rare diseases information
center.
https://rare-diseases.info.nih.gov/diseases/804/alagille-syndrome
- Singh S P.Euroasian J Hepatogastroenterol.
2018;8(2):140-147
- Feldman A G. Neoreviews 2013;14 (2): e63–e73
- Leonard L. European Journal of Human Genetics. 2014;
22:435
- Lykavieris P. Heptology. 2005;4 (2):366-371
- Jain V. Hepatology. 2001;73 (1); 93-98
- Efficacy and Safety of Odevixibat in Children with Biliary
Atresia Who Have Undergone a Kasai HPE (BOLD) - Full Text View -
ClinicalTrials.gov
- Hopkins P J Pediatr. 2017;187:253-257. doi:
10.1016/j.jpeds.2017.05.006. Epub 2017 Jun 1.
- Ipsen completes acquisition of Albireo - Press Release -
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