- Ipsen’s Rare Diseases portfolio
significantly enhanced with late-stage drug candidate,
palovarotene, for the treatment of rare bone disorders in adult and
pediatric patients
- Transaction reinforces Ipsen’s
strong commitment to providing life-altering treatments to patients
with high unmet medical needs
Regulatory News:
Ipsen (Euronext: IPN; ADR: IPSEY) and Clementia Pharmaceuticals
(NASDAQ: CMTA) today announced the closing of Ipsen’s acquisition
of Clementia following approval of the arrangement by Clementia
shareholders and the Quebec Superior Court. Pursuant to the
arrangement, Clementia shareholders will receive US$25.00 per share
in cash upfront and one contingent value right (CVR) per share
entitling them to receive US$6.00 per CVR upon the U.S. Food and
Drug Administration's (FDA) acceptance of the regulatory filing for
palovarotene for the treatment of multiple osteochondromas
(MO).
Clementia’s key late-stage clinical asset palovarotene is an
investigational retinoic acid receptor gamma (RARγ) selective
agonist, for the treatment of two rare bone disorders,
fibrodysplasia ossificans progressiva (FOP) and multiple
osteochondromas (MO), and other diseases.
The palovarotene regulatory submission for the prevention of
heterotopic ossification (HO) in patients with FOP in the U.S. is
expected for the second half of 2019. The submission will be based
on Phase 2 clinical data from greater than 100 imaged flare-ups and
indicated that treatment with palovarotene resulted in a greater
than 70% reduction of new heterotopic ossification (HO), or bone
formation, across all three dosing levels.
Dr. Alexandre Lebeaut, Chief Scientific Officer of Ipsen,
commented, “We are encouraged by compelling and consistent clinical
data from the extensive Phase 2 program as well as fast-track,
breakthrough therapy, orphan drug and rare pediatric diseases
designations from the FDA. We are focused on the successful
regulatory submission of palovarotene as a first-in-class
therapeutic solution for patients with episodic flare-up treatment
of fibrodysplasia ossificans progressiva in the second half of
2019.”
Dr. Clarissa Desjardins, Chief Executive Officer of
Clementia, added, “I am extremely grateful for the hard-working
and dedicated team at Clementia, the patient community and the
clinical trial investigators who have helped advance the
palovarotene program. Going forward, we are confident that Ipsen,
with its shared patient-centric culture, proven development
capabilities and global commercial footprint, will fulfill our
ambition of delivering palovarotene to patients worldwide as
quickly as possible.”
About Fibrodysplasia Ossificans Progressiva (FOP)
FOP is an ultra-rare, severely disabling disorder characterized
by heterotopic ossification (HO), or bone that forms outside the
normal skeleton, in muscles, tendons or soft tissue. In FOP, HO
progressively restricts movement by locking joints, leading to a
cumulative loss of function, progressive disability, and increased
risk of early death. FOP is caused by a mutation in the ACVR1 gene,
resulting in excess signaling in the bone morphogenetic pathway, a
key pathway controlling bone growth and development, by way of both
ligand-dependent and independent mechanisms. The prevalence of FOP
is approximately 1.3 individuals per million lives, or
approximately 9,000 patients globally. There are currently no
approved treatments for FOP.
About Multiple Osteochondromas (MO)
MO, also called multiple hereditary exostoses (MHE) is a rare,
severely disabling, progressive, chronic disease in which multiple
benign bone tumors, also known as osteochondromas (OCs) or
osteocartilaginous exostoses, develop on bones. MO is typically
diagnosed in early childhood when OCs become visible with a median
age at diagnosis of four years. Because of their development around
joints, children develop limb deformity and restricted movement as
they grow. Today, the only available treatments for MO are surgery
and palliative care, and many patients will undergo surgery, some
as many as 30 surgeries, before adulthood. MO is estimated to
affect 20 individuals per million lives, or approximately 150,000
globally. MO is among the most common inherited bone disorders with
multiple family members in multiple generations affected.
About Palovarotene
Palovarotene is an RARγ agonist being developed as a treatment
for patients with ultra-rare/rare and debilitating bone diseases,
including fibrodysplasia ossificans progressiva (FOP) and multiple
osteochondromas (MO), as well as other diseases. Palovarotene was
in-licensed from Roche Pharmaceuticals, where it was previously
evaluated in more than 800 subjects, including 450 patients treated
for up to two years. Palovarotene has received Orphan Drug status
for FOP and MO from the U.S. Food and Drug Administration (FDA) and
the European Medicines Agency (EMA). In addition, palovarotene has
been granted Fast Track, Breakthrough Therapy and Rare Pediatric
Disease designations for FOP from the FDA.
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. Its commitment to
Oncology is exemplified through its growing portfolio of key
therapies for prostate cancer, neuroendocrine tumors, renal cell
carcinoma and pancreatic cancer. Ipsen also has a well-established
Consumer Healthcare business. With total sales over €2.2 billion in
2018, 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.
About Clementia Pharmaceuticals Inc.
Clementia is a clinical-stage company innovating treatments for
people with ultra-rare bone disorders and other diseases with high
medical need. The company is preparing for a 2019 new drug
application (NDA) submission to the FDA to seek approval of its
lead product candidate, palovarotene, a novel RARγ agonist, for the
prevention of heterotopic ossification (HO) associated with flare
up symptoms in adults and children with fibrodysplasia ossificans
progressiva (FOP). The ongoing Phase 3 MOVE Trial is evaluating an
additional dosing regimen of palovarotene for the treatment of FOP.
Palovarotene is also in a Phase 2 trial, the MO-Ped Trial, for the
treatment of multiple osteochondromas (MO, also known as multiple
hereditary exostoses, or MHE). In addition, Clementia has commenced
a Phase 1 trial for an eye drop formulation of palovarotene for the
potential treatment of dry eye disease and is also investigating
other conditions that may benefit from RARγ therapy. For more
information, please visit www.clementiapharma.com and connect with
us on Twitter @ClementiaPharma.
Forward Looking Statement
This press release may include “forward-looking statements”
within the meaning of the applicable securities laws, including
with respect to the proposed timing of filings and submissions with
the FDA for palovarotene and the impact of the transaction on Ipsen
and Clementia, the operations of Ipsen and Clementia
post-transaction and the amounts potentially payable under the
CVRs. Each forward-looking statement contained in this press
release is subject to known and unknown risks and uncertainties and
other unknown factors that could cause actual results to differ
materially from historical results and those expressed or implied
by such statement. In addition to statements which explicitly
describe such risks and uncertainties, readers are urged to
consider statements labeled with the terms “believes,” “belief,”
“expects,” “intends,” “anticipates,” “will,” or “plans” to be
uncertain and forward-looking. Applicable risks and uncertainties
include, among others, the outcome of the FDA approval of
palovarotene product candidate for the treatment of multiple
osteochondromas (MO), Clementia’s ability to successfully complete
in a timely manner the studies required to be completed in order to
submit the NDA, Clementia’s ability to generate revenue and become
profitable, the risks related to its heavy reliance on
palovarotene, its only current product candidate, the risks
associated with the development of palovarotene and any future
product candidate, including the demonstration of efficacy and
safety, Ipsen's and Clementia’s dependence on licensed intellectual
property, including the ability to source and maintain licenses
from third-party owners; as well as the risks identified in Ipsen's
registration documents filed with the French Autorité des Marchés
Financiers and Clementia’s public filings with the SEC and the
Québec Autorité des Marchés Financiers. Ipsen and Clementia caution
investors not to rely on the forward-looking statements contained
in this press release when making an investment decision in their
securities. Investors are encouraged to read Ipsen's filings
available on its website (www.ipsen.com) as well as Clementia’s filings with
the SEC or on SEDAR, available at www.sec.gov or www.sedar.com, for
a discussion of these and other risks and uncertainties. The
forward-looking statements in this press release speak only as of
the date of this press release, and Ipsen and Clementia undertake
no obligation to update or revise any of these statements, whether
as a result of new information, future events or otherwise, except
as required by law.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190417005962/en/
For further information
MediaKarla MacDonald –
North AmericaVice President, NA Communications+ 1 (857)
332-3467Karla.macdonald@ipsen.com
Monique AllairePresident, THRUST Strategic
Communications+ 1 (781)
631-0759monique@thrustsc.com
Christian Marcoux – EuropeSenior
Vice-President, Global Communication+33 (0) 1 58 33 67
94Christian.marcoux@ipsen.com
Joseph WalewiczEVP, Business and Corporate Development+1
(514) 940-1080investors@clementiapharma.com
Financial
CommunityEugenia LitzVice President, Investor
Relations+44 (0) 7879 627
205eugenia.litz@ipsen.com
Myriam KoutchinskyInvestor Relations Manager+33 (0)1 58
33 51 04myriam.koutchinsky@ipsen.com
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