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UCB Agrees to Acquire Ra Pharmaceuticals: Joining Forces to Improve Treatment Options for People Living With Myasthenia Gravis and Other Rare Diseases

Geschrieben am 10-10-2019

- Will enhance UCB's leadership potential in myasthenia gravis by
adding zilucoplan, a peptide inhibitor of complement component 5 (C5)
currently in phase 3, to the UCB pipeline alongside to UCB's
rozanolixizumab, an FcRn targeting antibody also in phase 3

- Will enrich UCB's pipeline; zilucoplan is a novel, potentially
best-in-class investigational molecule also being evaluated in other
complement-mediated diseases including amyotrophic lateral sclerosis
(ALS) and immune-mediated necrotizing myopathy (IMNM). UCB will
develop and, if approved, launch zilucoplan worldwide, accelerating
and diversifying company growth

- Will accelerate UCB's long-term innovation capabilities through
the addition of Ra Pharmaceuticals ExtremeDiversity(TM) technology
platform

- Plan to maintain productive and innovative Ra Pharma unit in
Cambridge, MA, to complement UCB's research hubs

- The acquisition will enable accelerated top and bottom line
growth from 2024 onwards

- Total transaction value of approximately US$ 2.1 billion / EUR
2.0 billion (net of Ra Pharma cash) based on US$ 48 in cash per Ra
Pharmaceuticals share (approximately US$ 2.5bn / EUR 2.2bn)

- This acquisition will not impact UCB's 2019 financial guidance.
It would be dilutive to UCB's mid-term earnings level and hence move
the mid-term target of UCB reaching a rEBITDA ratio (to revenue) of
31% to 2022 from 2021 as previously guided

Brussels and Cambridge, Massachusetts (ots/PRNewswire) -

Regulated Information - Inside Information -

UCB and Ra Pharmaceuticals Inc. (NASDAQ: RARX, Ra Pharma)
announced today their entry into a merger agreement pursuant for
which UCB will acquire Ra Pharma. Under the terms of the agreement,
Ra Pharma shareholders will receive US$ 48 in cash for each Ra Pharma
share at closing. The Boards of Directors of both companies have
unanimously approved the transaction, which remains subject to
approval by Ra Pharma shareholders and to obtaining antitrust
clearance and other customary closing conditions.

Ra Pharma is a clinical-stage biopharmaceutical company leveraging
a proprietary peptide chemistry platform to develop novel
therapeutics for the treatment of serious diseases caused by
excessive or uncontrolled activation of the complement system, a
critical component of the innate immune system. The company was
founded in 2008 and is headquartered in Cambridge, MA, U.S. The
company's ExtremeDiversity(TM) platform enables the production of
synthetic macrocyclic peptides combining the diversity and
specificity of antibodies with the pharmacological properties of
small molecules.

Ra Pharma's phase 3 product candidate, zilucoplan, is a once-daily
self-administered, subcutaneous peptide inhibitor of C5. In December
2018, Ra Pharma announced positive top-line results from a phase 2
trial of zilucoplan in patients with generalized myasthenia gravis
(gMG), achieving clinically meaningful and statistically significant
reductions in both primary and key secondary endpoints. Zilucoplan is
currently being tested in phase 3 for the treatment of gMG with
top-line results expected in early 2021. Further indications that are
potentially addressable by zilucoplan include immune-mediated
necrotizing myopathy (IMNM), amyotrophic lateral sclerosis (ALS) and
other tissue-based complement-mediated disorders with high unmet
medical need. Ra Pharma is also developing an extended release
formulation of zilucoplan, as well as a potential first-in-class oral
small molecule C5 inhibitor.

Jean-Christophe Tellier, CEO UCB, said: "Ra Pharma is an excellent
strategic fit addressing multiple areas of UCB's patient value growth
strategy. Upon closing, the acquisition will add to our strong
internal growth opportunities - six potential product launches in the
next five years, strengthening our neurology and immunology
franchises with late and early-stage pipeline projects. In addition,
the combination will provide us with the opportunity to become a
leader in treating people living with myasthenia gravis, an
auto-antibody mediated neurological orphan disease with high unmet
medical need, as well as adding a highly productive technology
platform to our innovation engine."

Strategic Rationale

The proposed acquisition is part of UCB's strategic growth path,
namely the "Accelerate and Expand" phase since January 2019. The
addition of Ra Pharma's 'pipeline in a product' investigational
peptide C5 inhibitor zilucoplan alongside UCB's anti-FcRn
rozanolixizumab, could create an opportunity to provide more people
living with myasthenia gravis with better treatment options. Beyond
myasthenia gravis, this acquisition has the potential to enable UCB
to offer new treatment opportunities for several rare diseases in
neurology and immunology as well as different delivery forms,
including extended release and orally available product. The combined
portfolio may also offer synergies in the outreach to people with
rare diseases and the health care market.

Additionally, UCB would gain access to a proprietary technology
platform to produce synthetic macrocyclic peptides. The platform,
known as ExtremeDiversity(TM), is based on messenger ribonucleic acid
(mRNA) display and combines the diversity, specificity and high
affinity of therapeutic antibodies with the attractive
pharmacological properties of small molecules. It has the potential
to augment UCB's drug discovery capabilities and provide access to Ra
Pharma's proven expertise and talent in this area. UCB will also
further strengthen its presence in the U.S., in particular the
innovation hub in the Boston, Massachusetts area (U.S.).

Doug Treco, Ph.D., President and Chief Executive Officer of Ra
Pharmaceuticals, commented: "UCB shares our commitment to the rare
disease patient community and our goal of developing novel,
accessible, and cost-effective therapies in the areas of immunology
and neurology. I firmly believe it is the right partner for us to
advance new treatment options from our unique early and late stage
pipeline to patients. Ra Pharma's technology platform is an ideal
addition to UCB's leading innovation capabilities, and our scientists
are looking forward to working with the entire team at UCB."

Transaction Terms, Approvals and Timing to Close

Upon closing, Ra Pharma shareholders will receive US$48.00 in cash
for each Ra Pharma share (approximately US$2.5bn/EUR2.2bn), which
represents a transaction value of approximately US$ 2.1 billion /
EUR2.0 billion, net of Ra Pharma cash. The cash consideration
represents an approximately 93% premium to Ra Pharma shareholders
based on the 30-day volume weighted average closing stock price of Ra
Pharma prior to signing. The transaction has been unanimously
approved by the Boards of Directors of both, UCB and Ra Pharma and
remains subject to approval by Ra Pharma shareholders, obtaining
anti-trust clearance and other customary closing conditions. UCB and
Ra Pharma expect to complete the transaction by the end of Q1 2020.

Funding

The acquisition of Ra Pharma will be financed by a combination of
existing cash resources and new bank term loans, arranged and
underwritten by BNP Paribas Fortis and Bank of America Merrill Lynch.
Pro-forma for this acquisition, UCB's new net debt / rEBITDA ratio
would be in the range between 1.5 and 2.0 times with rapid
de-leveraging expected allowing UCB to maintain significant balance
sheet flexibility.

Financial Guidance

This acquisition will not impact UCB's 2019 financial guidance.
The acquisition would be dilutive to UCB's mid-term earnings level
due to R&D investments. As a result, the mid-term target of UCB
reaching a rEBITDA ratio (to revenue) of 31% would move to 2022 from
2021 as previously guided. The acquisition is expected to be core EPS
accretive from 2024 onwards and would enable accelerated top and
bottom line growth for UCB from 2024 onwards.

Advisors

Bank of America Merrill Lynch and Lazard are acting as financial
advisors to UCB in relation to the transaction. Covington & Burling
LLP is acting as legal advisor to UCB on this transaction.

Centerview Partners is acting as exclusive financial advisor to Ra
Pharma on this transaction. Latham & Watkins LLP is acting as legal
advisor to Ra Pharma on this transaction.

Conference call

Today, at 9:00am (EDT) / 2:00pm (BST) / 15:00 (CEST), UCB will
host a conference call for the financial community. The login details
can also be found on: https://www.ucb.com/investors/.

US: +1-6467224916; UK: +442071943759; Belgium: +3224035816;
France: +33 172727403

PIN: 20542874#

About Generalized Myasthenia Gravis (gMG)

Generalized myasthenia gravis is an unpredictable, chronic
auto-immune condition in which auto-antibodies attack specific
proteins in the neuro-muscular junction. This disrupts the way that
nerves can communicate with muscles, resulting in muscle weakness and
fatigue. Both men and women are impacted equally, and it can occur at
any age and in any race. Myasthenia Gravis is a rare disease
impacting almost 200,000 patients in the US, EU and Japan (Gilhus N,
N Engl J Med 2016;375:2570-812015). Those living with gMG can
experience a variety of symptoms, including drooping eyelids and
double vision as well as severe muscular weakness that can result in
life threatening weakness of muscles of respiration.

About Immune-Mediated Necrotizing Myopathy (IMNM)

Immune-mediated necrotizing myopathy (IMNM) is a rare, serious,
progressive neurological condition marked by severe proximal (for
example hip and shoulder) muscle weakness. Auto-immune myopathies
have a prevalence of around 15 cases per 100,000 with IMNM about
10-15% of all IMM cases. This suggests that there are more than 6,000
patients in each of the US and EU. (Anquetil et al. Autoimmunity
Reviews 18 (2019) 223-230) IMNM is only recently understood to be a
distinct entity within the broad group of idiopathic inflammatory
myopathies and as of yet there are no approved therapies.

Amyotrophic Lateral Sclerosis (ALS) is a rare and progressive
degenerative disease of the motor neurons affecting more than 200,000
people globally (30,000 in the US alone) in the central nervous
system (brain and spinal cord) involved in muscle movement, leading
to muscle weakness and ultimately paralysis. For more information,
please visit www.ALS.org

Zilucoplan is a macrocyclic peptide designed to bind complement C5
with sub-nanomolar affinity and allosterically inhibit its cleavage
into C5a and C5b upon activation of the classical, alternative, or
lectin pathways and block the membrane attack complex (MAC) assembly.
Zilucoplan is in clinical development at Ra Pharmaceuticals and is
not approved in any region of the world. In addition to a
recently-initiated phase 3 study in gMG and an upcoming phase 2 study
in IMNM, zilucoplan was selected as one of the first drugs to be
tested in a multi-center ALS platform study sponsored by the Sean M.
Healey & AMG Center for ALS at Mass General.

About Ra Pharmaceuticals Inc.

Ra Pharma is a clinical-stage biopharmaceutical company focused on
leading the field of complement biology to bring innovative and
accessible therapies to patients with rare diseases. Ra Pharma
discovers and develops peptides and small molecules to target key
components of the complement cascade. For more information, please
visit: www.RaPharma.com.

About UCB

UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical
company focused on the discovery and development of innovative
medicines and solutions to transform the lives of people living with
severe diseases of the immune system or of the central nervous
system. With more than 7 500 people in approximately 40 countries,
UCB generated revenue of EUR 4.6 billion in 2018. UCB is listed on
Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news

Forward looking statements UCB

This press release contains forward-looking statements based on
current plans, estimates and beliefs of management. All statements,
other than statements of historical fact, are statements that could
be deemed forward-looking statements, including estimates of
revenues, operating margins, capital expenditures, cash, other
financial information, expected legal, political, regulatory or
clinical results and other such estimates and results. By their
nature, such forward-looking statements are not guarantees of future
performance and are subject to risks, uncertainties and assumptions
which could cause actual results to differ materially from those that
may be implied by such forward-looking statements contained in this
press release. Important factors that could result in such
differences include: changes in general economic, business and
competitive conditions, the inability to obtain necessary regulatory
approvals or to obtain them on acceptable terms, costs associated
with research and development, changes in the prospects for products
in the pipeline or under development by UCB, effects of future
judicial decisions or governmental investigations, product liability
claims, challenges to patent protection for products or product
candidates, changes in laws or regulations, exchange rate
fluctuations, changes or uncertainties in tax laws or the
administration of such laws and hiring and retention of its
employees.

Additionally, information contained in this document shall not
constitute an offer to sell or the solicitation of an offer to buy
any securities, nor shall there be any offer, solicitation or sale of
securities in any jurisdiction in which such offer, solicitation or
sale would be unlawful prior to the registration or qualification
under the securities laws of such jurisdiction. UCB is providing this
information as of the date of this document and expressly disclaims
any duty to update any information contained in this press release,
either to confirm the actual results or to report a change in its
expectations.

There is no guarantee that new product candidates in the pipeline
will progress to product approval or that new indications for
existing products will be developed and approved. Products or
potential products which are the subject of partnerships, joint
ventures or licensing collaborations may be subject to differences
between the partners. Also, UCB or others could discover safety, side
effects or manufacturing problems with its products after they are
marketed.

Moreover, sales may be impacted by international and domestic
trends toward managed care and health care cost containment and the
reimbursement policies imposed by third-party payers as well as
legislation affecting biopharmaceutical pricing and reimbursement.

Forward-Looking Statements of Ra Pharmaceuticals

Certain statements contained in this press release may be
considered forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the Securities
Exchange Act of 1934, as amended, including without limitation
statements regarding the merger and the ability to consummate the
merger. These forward-looking statements generally include statements
that are predictive in nature and depend upon or refer to future
events or conditions, and include words such as "believes," "plans,"
"anticipates," "projects," "estimates," "expects," "intends,"
"strategy," "future," "opportunity," "may," "will," "should,"
"could," "potential," or similar expressions. Statements that are not
historical facts are forward-looking statements. Forward-looking
statements are based on current beliefs and assumptions that are
subject to risks and uncertainties. Forward-looking statements speak
only as of the date they are made, and Ra Pharma undertakes no
obligation to update any of them publicly in light of new information
or future events. Actual results could differ materially from those
contained in any forward-looking statement as a result of various
factors, including, without limitation: (1) Ra Pharma may be unable
to obtain shareholder approval as required for the merger; (2)
conditions to the closing of the merger may not be satisfied and
required regulatory approvals may not be obtained; (3) the merger may
involve unexpected costs, liabilities or delays; (4) Ra Pharma's
business may suffer as a result of uncertainty surrounding the
merger; (5) the outcome of any legal proceedings that may arise
related to the merger; (6) Ra Pharma may be adversely affected by
other economic, business, and/or competitive factors; (7) the
occurrence of any event, change or other circumstances that could
give rise to the termination of the merger agreement; and (8) the
ability to recognize benefits of the merger; (9) risks that the
merger disrupts current plans and operations and the potential
difficulties in employee retention as a result of the merger; and
(10) other risks to consummation of the merger, including the risk
that the merger will not be consummated within the expected time
period or at all. If the merger is consummated, Ra Pharma
shareholders will cease to have any equity interest in Ra Pharma and
will have no right to participate in its earnings and future growth.
Additional factors that may affect the future results of Ra Pharma
are set forth in its filings with the SEC, including its Annual
Report on Form 10-K for the year ended December 31, 2018, which is
available on the SEC's website at www.sec.gov. Readers are cautioned
not to place undue reliance on these forward-looking statements,
which speak only as of the date thereof.

ots Originaltext: UCB Pharma
Im Internet recherchierbar: http://www.presseportal.de

Contact:
+32-2-559-9178
france.nivelle@ucb.com

Laurent Schots
Media Relations
UCB
T: +32-2-559-92-64
Laurent.schots@ucb.com

UCB - Investor Relations: Antje Witte
Investor Relations
UCB
T: +32-2-559-94-14
antje.witte@ucb.com

Isabelle Ghellynck
Investor Relations
UCB
T: +32-2-559-9588
isabelle.ghellynck@ucb.com

Ra Pharmaceuticals, Inc.: Investors: Ra Pharmaceuticals, Inc.
Natalie Wildenradt
617-674-9874
nwildenradt@rapharma.com

Media: Argot Partners
David Rosen
212-600-1902 david.rosen@argotpartners.com

Allyson Funk
Head of U.S. Communications and Public Affairs
770-970-8338
allyson.funk@ucb.com

Original-Content von: UCB Pharma, übermittelt durch news aktuell


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