- Clementia’s late-stage drug
candidate, palovarotene, has rare pediatric disease and
breakthrough therapy designations for the treatment of an
ultra-rare bone disorder and a path to approval in 2020
- Acquisition to transform Ipsen’s
Rare Disease portfolio by leveraging Clementia’s expertise and
Ipsen’s global commercial footprint to provide life-altering
treatments to patients with unmet medical needs
- Ipsen to acquire all outstanding
shares of Clementia for a purchase price of US$25.00 per share in
cash upfront plus a contingent value right (CVR) of US$6.00 per
share related to the multiple osteochondromas indication for a
total transaction value of up to US$1.31 billion
- Ipsen to host conference call today
at 2:00pm CET
Regulatory News:
Ipsen (Euronext: IPN; ADR: IPSEY) and Clementia Pharmaceuticals
(NASDAQ: CMTA) today announced that they have entered into an
agreement for Ipsen to acquire Clementia Pharmaceuticals, including
its key late-stage clinical asset palovarotene, an investigational
retinoic acid receptor gamma (RARγ) selective agonist, for the
treatment of fibrodysplasia ossificans progressiva (FOP), multiple
osteochondromas (MO) and other diseases. The acquisition will
proceed by way of a court-approved plan of arrangement pursuant to
the Canada Business Corporations Act.
Continuing the transformation of Ipsen:
- Accelerating a global Rare Disease
organization with the mission to bring treatment options for
ultra-orphan diseases to patients worldwide
- Executing on a key strategic objective
to increase the value of the pipeline with innovative
first-in-class or best-in-class assets
- Acquiring a near-term launch
opportunity of a largely de-risked asset with limited competition
which enhances sustainable growth of the company with significant
upside potential from additional indications
Palovarotene inhibits excess bone morphogenetic protein (BMP)
signaling which is linked to the progression of FOP and MO, two
well-characterized, ultra-rare/rare and severely-disabling bone
disorders for which there are currently no treatment options
available.
A New Drug Application (NDA) for palovarotene for episodic
flare-up treatment of FOP is expected to be submitted to the U.S.
Food and Drug Administration (FDA) in the second half of 2019, and
subject to FDA approval, a first commercial launch is expected in
mid-2020. A Phase 3 registrational trial evaluating a chronic
dosing regimen for FOP, a Phase 2 trial for MO, and a Phase 1 trial
for dry eye disease are also ongoing. Palovarotene has received
Orphan Drug designation for FOP and MO from the FDA and the
European Medicines Agency (EMA), and Fast Track, Breakthrough
Therapy and Rare Pediatric Disease designations for FOP from the
FDA.
David Meek, Chief Executive Officer of Ipsen, commented,
“The acquisition of Clementia Pharmaceuticals accelerates the
ongoing transformation of Ipsen as we are successfully executing on
our external innovation strategy to identify and acquire innovative
medicines to serve patients with unmet medical needs. Through this
transaction, we will gain scientific expertise, exceptional talent,
and a cornerstone ultra-rare disease drug candidate with rare
pediatric disease and breakthrough therapy designations, potential
U.S. approval in 2020 and additional indications to follow. We look
forward to working closely with Clementia to successfully integrate
two companies that share a similar patient-centric culture and the
ambition to deliver new treatments to patients with unmet medical
needs.”
Dr. Clarissa Desjardins, Chief Executive Officer of
Clementia, commented, “I am proud of the entire Clementia team,
whose tireless efforts have rapidly advanced palovarotene towards a
planned NDA submission, and we are all grateful for the dedication
of the patient community and our clinical trial investigators who
have supported us along the way. Ipsen’s global commercial presence
and capabilities will expedite our shared vision of bringing
palovarotene to patients around the world as quickly as possible.
We anticipate a smooth transition of our operations into the Ipsen
organization that will continue Clementia’s vision of delivering
palovarotene to patients worldwide.”
Under the terms of the agreement, Ipsen will pay US$25.00 per
share in cash upfront on completion of the transaction, for an
initial aggregate consideration of US$1.04 billion, plus deferred
payments on the achievement of a future regulatory milestone in the
form of a contingent value right (CVR) of US$6.00 per share upon
FDA acceptance of the NDA filing for palovarotene for the treatment
of MO, representing an additional potential payment of US$263
million. The initial cash consideration represents a premium of 77%
to Clementia’s 30-day volume-weighted average stock price.
The transaction will be fully financed by Ipsen’s existing cash
and lines of credit and significantly increase the level of net
debt. It is expected to have a limited dilutive impact on Ipsen’s
core operating margin for 2019 and 2020 given the costs of the
ongoing clinical trials and preparation for the commercial launch
of palovarotene. Consequently, Ipsen is updating its 2019 financial
objectives and now expects:
- Sales growth of greater than 13.0% at
current exchange rates (unchanged)
- Core operating margin of around 30.0%
of net sales (previous guidance of around 31.0% of net sales),
excluding other potential investments in pipeline expansion
initiatives
The transaction will also be dilutive at the Consolidated Net
Income level.
The Boards of Directors of both companies have approved the
transaction. Completion of the transaction is anticipated to occur
in the second quarter of 2019, subject to satisfaction of all
closing conditions. The acquisition will proceed by way of a
court-approved plan of arrangement pursuant to the Canada Business
Corporations Act and will require, at the special meeting of
Clementia shareholders expected to be held on or about
April 9, 2019, the approval of at least 66 2/3% of the votes
cast by Clementia's shareholders present in person or represented
by proxy as well as the approval of a majority of the votes cast by
Clementia's disinterested shareholders present in person or
represented by proxy. A proxy circular relating to the special
meeting of shareholders of Clementia and containing further details
regarding the Arrangement and the agreement will be mailed to
Clementia’s shareholders and made available on SEDAR and EDGAR.
The Board of Directors of Clementia, acting on the unanimous
recommendation of the transaction committee comprised of
independent directors and after having received an opinion from its
financial advisor to the effect that the consideration to be
received by Clementia shareholders pursuant to the plan of
arrangement is fair from a financial point of view, has unanimously
approved the arrangement. OrbiMed Private Investments IV, LP,
Clementia’s largest shareholder with approximately 27.5% of
Clementia’s total shares outstanding (on a non-diluted basis) as of
the date hereof, has entered into a support and voting agreement
with Ipsen pursuant to which it has agreed to vote its Clementia
shares in favor of the transaction. In addition, directors and
officers of Clementia holding an aggregate of approximately 3.2% of
the Clementia shares (on a non-diluted basis) as of the date hereof
have entered into support and voting agreements with Ipsen.
In addition to shareholders’ and court approval, the arrangement
is also subject to other customary conditions. The arrangement
agreement is subject to customary “fiduciary out” provisions, and a
right in favor of Ipsen to match any superior proposal. A
termination fee is payable to Ipsen in certain specified
circumstances, including if it fails to exercise its right to match
in the context of a superior proposal supported by Clementia.
Centerview Partners is acting as exclusive financial advisor to
Ipsen and Goodwin Procter LLP and Davies Ward Phillips &
Vineberg LLP are acting as U.S. and Canadian legal counsel to
Ipsen, respectively.
Morgan Stanley & Co. LLC is acting as exclusive financial
advisor to Clementia and Skadden, Arps, Slate, Meagher & Flom
LLP and Stikeman Elliott LLP are acting as U.S. and Canadian legal
counsel to Clementia, respectively.
Conference Call
Ipsen will host a conference call and web conference (available
at www.ipsen.com) today to discuss this announcement. Participants
should dial in approximately 5 to 10 minutes prior to the start. No
reservation is required to participate in the conference call.
Date: February 25, 2019 Time: 2:00pm CET/ 8:00am EST France
and continental Europe +33 (0) 1 7670 0794 UK +44 (0) 2071 928 000
United States +1 (631) 510-7495 Conference ID: 8476676
A replay will be available on Ipsen’s website: www.ipsen.com
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 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 timing and completion of the arrangement, the
proposed timing of filings and submissions with the FDA for
palovarotene and the impact of the proposed 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 risk that a condition to closing of the
arrangement may not be satisfied, the risk that any required
shareholder, court or applicable regulatory approvals for the
arrangement may not be obtained or be obtained subject to
conditions that are not anticipated, 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/20190224005148/en/
Ipsen:MediaKarla
MacDonald – North AmericaVice President, NA Communications+ 1
(857) 332-3467Karla.macdonald@ipsen.comFinancial CommunityEugenia LitzVice
President, Investor Relations+44 (0) 7879 627
205eugenia.litz@ipsen.comChristian Marcoux – EuropeSenior
Vice-President, Global Communication+33 (0) 1 58 33 67
94Christian.marcoux@ipsen.comMyriam KoutchinskyInvestor
Relations Manager+33 (0)1 58 33 51
04myriam.koutchinsky@ipsen.comClementia:MediaMonique
AllairePresident, THRUST Strategic Communications+ 1 (781)
631-0759monique@thrustsc.comFinancial
CommunityJoseph WalewiczEVP, Business and
Corporate Development+1 (514)
940-1080investors@clementiapharma.com
Clementia Pharmaceuticals Inc. (NASDAQ:CMTA)
Gráfica de Acción Histórica
De May 2024 a Jun 2024
Clementia Pharmaceuticals Inc. (NASDAQ:CMTA)
Gráfica de Acción Histórica
De Jun 2023 a Jun 2024