-- Expands Ipsen’s Rare Diseases portfolio
to include BLU-782, a highly selective investigational ALK2
inhibitor for the treatment of FOP --
-- Accelerates global development of BLU-782
through Ipsen’s clinical expertise in rare diseases and global
infrastructure --
-- Blueprint Medicines is eligible to
receive up to $535 million, including a $25 million upfront payment
and up to $510 million in potential development, regulatory and
sales-based milestones and other payments, plus tiered percentage
royalties –
Regulatory News:
Ipsen (Euronext: IPN; ADR: IPSEY) and Blueprint Medicines
Corporation (NASDAQ: BPMC) today announced Ipsen, through its
subsidiary Clementia Pharmaceuticals, and Blueprint Medicines have
entered into an exclusive, worldwide license agreement for the
development and commercialization of BLU-782, an oral, highly
selective investigational ALK2 inhibitor being developed for the
treatment of fibrodysplasia ossificans progressiva (FOP).
The agreement enhances Ipsen’s Rare Diseases portfolio and
advances Blueprint Medicines’ goal of rapidly and efficiently
developing BLU-782 as a potential treatment for patients with FOP.
Ipsen has demonstrated its commitment to leadership in this complex
ultra-rare genetic disorder through the ongoing late-stage clinical
development of palovarotene, an investigational retinoic acid
receptor gamma (RARγ) agonist. With the addition of BLU-782, which
recently completed dosing in a Phase 1 study in healthy volunteers,
Ipsen has the potential to offer the broadest possible suite of
treatment options for patients with FOP.
“Our strategy has been to build a leading Rare Diseases
franchise, and through the recent acquisition of Clementia, we
gained a first-in-class asset in palovarotene. Now, with the
addition of Blueprint Medicines’ BLU-782, we have two strong
complementary drug candidates. We will continue to develop and
deliver valuable treatments for patients around the world living
with FOP and other rare diseases,” said David Meek, CEO, Ipsen.
“We admire Ipsen’s track record of successful global clinical
development in this complex, ultra-rare genetic disorder and
believe this expertise, combined with Ipsen’s global infrastructure
and commitment to transforming the treatment of FOP, will
accelerate the development of BLU-782 globally,” said Jeff Albers,
CEO, Blueprint Medicines. “We are inspired by the FOP community,
including the patients, families, clinicians and advocacy groups we
have had the fortune to work with, as we have advanced this program
from an idea to BLU-782, the first investigational therapy
targeting ALK2, the genetic driver of FOP, to enter clinical
development. We are also grateful for the dedication and drive of
our team at Blueprint Medicines whose tireless commitment has
brought BLU-782 this far.”
Subject to the terms of the license agreement, Blueprint
Medicines will be eligible to receive up to $535 million in
upfront, milestone and other payments, including an upfront cash
payment of $25 million and up to $510 million in potential
milestone payments related to specified development, regulatory and
sales-based milestones for licensed products in up to two
indications, including FOP. In addition, Ipsen will pay Blueprint
Medicines tiered percentage royalties ranging from the low- to
mid-teens on worldwide aggregate annual net sales of licensed
products, subject to adjustment in specified circumstances under
the license agreement.
About BLU-782
BLU-782 was designed by Blueprint Medicines to selectively
target mutant ALK2, the underlying cause of FOP, using Blueprint
Medicines’ proprietary scientific platform. Blueprint Medicines
recently completed dosing in a Phase 1 clinical trial of BLU-782 in
healthy volunteers and reported preliminary data at the American
Society of Bone and Mineral Research Annual Meeting in September
2019, which showed that BLU-782 was well-tolerated at all doses
tested. Previously reported preclinical data in a
well-characterized, genetically accurate FOP model showed that
BLU-782 prevented injury- and surgery-induced heterotopic
ossification, reduced edema and restored healthy tissue response to
muscle injury. The FDA has granted a rare pediatric disease
designation, orphan drug designation and fast track designation to
BLU-782.
About fibrodysplasia ossificans progressiva (FOP)
FOP is a rare, severely disabling genetic disorder characterized
by progressive heterotopic ossification (HO), or the abnormal
transformation of muscle, ligaments and tendons into bone. HO may
be spontaneous or associated with painful episodic disease
flare-ups that are usually precipitated by soft tissue injury. As
the disease progresses, extra-skeletal bone increasingly restricts
joints, resulting in severe disability and loss of mobility,
compromised respiratory function and increased risk of early death.
FOP is caused by a mutation in the gene for ALK2, which is known as
ACVR1, leading to inappropriate activation of the bone
morphogenetic pathway.
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 Blueprint Medicines
Blueprint Medicines is a precision therapy company striving to
improve human health. With a focus on genomically defined cancers,
rare diseases and cancer immunotherapy, we are developing
transformational medicines rooted in our leading expertise in
protein kinases, which are proven drivers of disease. Our uniquely
targeted, scalable approach empowers the rapid design and
development of new treatments and increases the likelihood of
clinical success. We are currently advancing three investigational
medicines in clinical development, along with multiple research
programs. For more information, visit www.BlueprintMedicines.com
and follow us on Twitter (@BlueprintMeds) and LinkedIn.
Ipsen—Cautionary Note Regarding Forward-Looking
Statements
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. 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 pre-clinical 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 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 2018 Registration
Document available on its website (www.ipsen.com).
Blueprint Medicines—Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, including, without limitation, statements
regarding Ipsen’s plan to develop and commercialize BLU-782 or any
other licensed products under the license agreement; potential
payments under the license agreement, including the upfront payment
and any milestone or royalty payments; potential benefits of the
license agreement between Blueprint Medicines and Ipsen; the
potential benefits of BLU-782 or any other licensed product in
treating patients, including patients with FOP; and Blueprint
Medicines' strategy, goals and anticipated milestones, business
plans and focus. The words "may," "will," "could," "would,"
"should," "expect," "plan," "anticipate," "intend," "believe,"
"estimate," "predict," "project," "potential," "continue," "target"
and similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words. Any forward-looking statements in this
press release are based on management's current expectations and
beliefs and are subject to a number of risks, uncertainties and
important factors that may cause actual events or results to differ
materially from those expressed or implied by any forward-looking
statements contained in this press release, including, without
limitation, risks and uncertainties related to the delay of any
current or planned clinical trials or the development of Blueprint
Medicines' drug candidates or the licensed products, including
BLU-782; the ability of the Blueprint Medicines and Ipsen to
terminate the license agreement under specified circumstances;
preclinical and clinical results for BLU-782 that may not support
further development of such drug candidate, including expectations
that such results may be predictive of the results in future
clinical trials; actions of regulatory agencies, which may affect
the initiation, timing and progress of clinical trials or the
regulatory pathway for the licensed products; and Ipsen’s ability
to successfully develop and commercialize the licensed products.
These and other risks and uncertainties are described in greater
detail in the section entitled "Risk Factors" in Blueprint
Medicines' filings with the Securities and Exchange Commission
(SEC), including Blueprint Medicines' most recent Quarterly Report
on Form 10-Q and any other filings that Blueprint Medicines has
made or may make with the SEC in the future. Any forward-looking
statements contained in this press release represent Blueprint
Medicines' views only as of the date hereof and should not be
relied upon as representing its views as of any subsequent date.
Except as required by law, Blueprint Medicines explicitly disclaims
any obligation to update any forward-looking statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20191015006093/en/
Ipsen investor contact Financial Community Eugenia Litz
Vice President, Investor Relations +44 (0) 1753 627721
eugenia.litz@ipsen.com
Myriam Koutchinsky Investor Relations Manager +33 (0) 1 58 33 51
04 Myriam.koutchinsky@ipsen.com
Ipsen media contact Christian Marcoux, M.Sc. SVP, Global
Communications +33 (0) 1 58 33 67 94
christian.marcoux@ipsen.com
David Caruba Global Communications +1 857-998-7036
david.caruba@ipsen.com
Fanny Allaire Global Communications + 33 (0) 1 58 33 58 96
fanny.allaire@ipsen.com
Blueprint Medicines investor contact Kristin Hodous
Senior Manager, Investor Relations 617-714-6674
ir@blueprintmedicines.com
Blueprint Medicines media contact Jim Baker Vice
President, Corporate Affairs 617-844-8236
media@blueprintmedicines.com
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