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UCB [BE0003739530 / UCB]

UCB agrees to acquire Ra Pharmaceuticals: Joining forces to improve treatment options for people living with myasthenia gravis and other rare diseases

INFORMATION REGLEMENTEE


[10/10/2019 | 07:02]
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** UCB agrees to acquire Ra Pharmaceuticals: Joining forces to improve trea=
tment options for people living with myasthenia gravis and other rare disea=
ses
------------------------------------------------------------

=C2=B7 Will enhance UCB=E2=80=99s leadership potential in myasthenia gravis=
by adding zilucoplan, a peptide inhibitor of complement component 5 (C5) c=
urrently in phase 3, to the UCB pipeline alongside to UCB=E2=80=99s rozanol=
ixizumab, an FcRn targeting antibody also in phase 3
=C2=B7 Will enrich UCB=E2=80=99s pipeline; zilucoplan is a novel, potential=
ly best-in-class investigational molecule also being evaluated in other com=
plement-mediated diseases including amyotrophic lateral sclerosis (ALS) and=
immune-mediated necrotizing myopathy (IMNM). UCB will develop and, if appr=
oved, launch zilucoplan worldwide, accelerating and diversifying company gr=
owth
=C2=B7 Will accelerate UCB=E2=80=99s long-term innovation capabilities thro=
ugh the addition of Ra Pharmaceuticals ExtremeDiversity=E2=84=A2 technology=
platform
=C2=B7 Plan to maintain productive and innovative Ra Pharma unit in Cambrid=
ge, MA, to complement UCB=E2=80=99s research hubs=C2=A0
=C2=B7 The acquisition will enable accelerated top and bottom line growth f=
rom 2024 onwards
=C2=B7 Total transaction value of approximately US$ 2.1 billion / =E2=82=AC=
2.0 billion (net of Ra Pharma cash) based on US$ 48 in cash per Ra Pharmac=
euticals share (approximately US$ 2.5bn / =E2=82=AC 2.2bn)
=C2=B7 This acquisition will not impact UCB=E2=80=99s 2019 financial guidan=
ce. It would be dilutive to UCB=E2=80=99s mid-term earnings level and hence=
move the mid-term target of UCB reaching a rEBITDA ratio (to revenue) of 3=
1% to 2022 from 2021 as previously guided.

Brussels (Belgium) and Cambridge, Mass U.S.=C2=A010 October 2019 =E2=80=93 =
7:00 (CEST) - regulated information =E2=80=93 inside information =E2=80=93 =
UCB and Ra Pharmaceuticals Inc. (NASDAQ: RARX, Ra Pharma) announced today t=
heir entry into a merger agreement pursuant for which UCB will acquire Ra P=
harma. Under the terms of the agreement, Ra Pharma shareholders will receiv=
e US$ 48 in cash for each Ra Pharma share at closing. The Boards of Directo=
rs of both companies have unanimously approved the transaction, which remai=
ns 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 propri=
etary peptide chemistry platform to develop novel therapeutics for the trea=
tment of serious diseases caused by excessive or uncontrolled activation of=
the complement system, a critical component of the innate immune system. T=
he company was founded in 2008 and is headquartered in Cambridge, MA, U.S. =
The company=E2=80=99s ExtremeDiversity=E2=84=A2 platform enables the produc=
tion of synthetic macrocyclic peptides combining the diversity and specific=
ity of antibodies with the pharmacological properties of small molecules.=
=C2=A0

Ra Pharma=E2=80=99s 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 ziluc=
oplan in patients with generalized myasthenia gravis (gMG), achieving clini=
cally 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. Fu=
rther potential indications that are potentially addressable by zilucoplan =
include immune-mediated necrotizing myopathy (IMNM), amyotrophic lateral sc=
lerosis (ALS) and other tissue-based complement-mediated disorders with hig=
h unmet medical need. Ra Pharma is also developing an extended release form=
ulation of zilucoplan, as well as a potential first-in-class oral small mol=
ecule C5 inhibitor.

Jean-Christophe Tellier, CEO UCB said: =E2=80=9CRa Pharma is an excellent s=
trategic fit addressing multiple areas of UCB=E2=80=99s patient value growt=
h strategy. Upon closing, the acquisition will add to our strong internal g=
rowth opportunities =E2=80=93 six potential product launches in the next fi=
ve years, strengthening our neurology and immunology franchises with late a=
nd 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 wi=
th high unmet medical need, as well as adding a highly productive technolog=
y platform to our innovation engine.=E2=80=9D

Strategic Rationale=C2=A0

The proposed acquisition is part of UCB=E2=80=99s strategic growth path, na=
mely the =E2=80=9CAccelerate and Expand=E2=80=9D phase since January 2019. =
The addition of Ra Pharma=E2=80=99s =E2=80=98pipeline in a product=E2=80=99=
investigational peptic C5 inhibitor zilucoplan alongside UCB=E2=80=99s ant=
i-FcRn rozanolixizumab, could create an opportunity to provide more people =
living with myasthenia gravis with better treatment options. Beyond myasthe=
nia gravis, this acquisition has the potential to enable UCB to offer new t=
reatment opportunities for several rare diseases in neurology and immunolog=
y as well as different delivery forms, including extended release and orall=
y available products. The combined portfolio may also offer synergies in th=
e 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 ExtremeDive=
rsity=E2=84=A2, is based on messenger ribonucleic acid (mRNA) display and c=
ombines the diversity, specificity and high affinity of therapeutic antibod=
ies with the attractive pharmacological properties of small molecules. It h=
as the potential to augment UCB=E2=80=99s drug discovery capabilities and p=
rovide access to Ra Pharma=E2=80=99s proven expertise and talent in this ar=
ea. UCB will also further strengthen its presence in the U.S., in particula=
r the innovation hub in the Boston, Massachusetts area (U.S.).

Doug Treco, Ph.D., President and Chief Executive Officer of Ra Pharmaceutic=
als commented: =E2=80=9CUCB shares our commitment to the rare disease patie=
nt community and our goal of developing novel, accessible, and cost-effecti=
ve 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 uniqu=
e early and late stage pipeline to patients. Ra Pharma=E2=80=99s technology=
platform is an ideal addition to UCB=E2=80=99s leading innovation capabili=
ties, and our scientists are looking forward to working with the entire tea=
m at UCB.=E2=80=9D

Transaction Terms, Approvals and Timing to Close=C2=A0
Upon closing, Ra Pharma shareholders will receive US$48.00 in cash for each=
Ra Pharma share (approximately US$ 2.5 billion / =E2=82=AC 2.2 billion), w=
hich represents a transaction value of approximately US$ 2.1 billion / =E2=
=82=AC 2.0 billion, net of Ra Pharma cash at June 30, 2019 of approximately=
US$315 million. The cash consideration represents an approximately 93% pre=
mium 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 e=
xpect to complete the transaction by the end of Q1 2020.=C2=A0

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 Pa=
ribas Fortis and Bank of America Merrill Lynch. Pro-forma for this acquisit=
ion, UCB=E2=80=99s new net debt / rEBITDA ratio would be in the range betwe=
en 1.5 and 2.0 times with rapid de-leveraging expected allowing UCB to main=
tain significant balance sheet flexibility.

Financial Guidance
This acquisition will not impact UCB=E2=80=99s 2019 financial guidance. The=
acquisition would be dilutive to UCB=E2=80=99s mid-term earnings level due=
to R&D investments. As a result, the mid-term target of UCB reaching a rEB=
ITDA ratio (to revenue) of 31% would move to 2022 from 2021 as previously g=
uided. The acquisition is expected to be core EPS accretive from 2024 onwar=
ds and would enable accelerated top and bottom line growth for UCB from 202=
4 onwards.

Advisors
Bank of America Merrill Lynch and Lazard are acting as financial advisors t=
o 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 o=
n this transaction. Latham & Watkins LLP is acting as legal advisor to Ra P=
harma on this transaction.

Conference call
Today, at 9:00am (EDT) / 2:00pm (BST) / 15:00 (CEST), UCB will host a confe=
rence call for the financial community. The login details can also be found=
on: https://u7061146.ct.sendgrid.net/wf/click?upn=3DG62jSYfZdO-2F12d8lSllQ=
B7X3kY45D7w88RKNKEbAnX3z-2B0lHRIdKimZI6veH9fqo_-2B-2Ft0TnE1oEbVIWS8vHM8JK8e=
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bjyVZ-2FeXi2kIrv1GGK8mo4q1cS2TaqV-2BhEBL0ElBQq2jf64SkzCuLIw3emolQ-3D

US: +1 6467224916; =C2=A0 =C2=A0 UK: +442071943759; =C2=A0 =C2=A0 Belgium: =
+3224035816; =C2=A0 =C2=A0 France: +33 172727403
PIN: 20542874#

About Generalized Myasthenia Gravis (gMG)
Generalized myasthenia gravis is an unpredictable, chronic auto-immune cond=
ition in which auto-antibodies attack specific proteins in the neuro-muscul=
ar 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 exp=
erience a variety of symptoms, including drooping eyelids and double vision=
as well as severe muscular weakness that can result in life threatening we=
akness of muscles of respiration.=C2=A0

About Immune-Mediated Necrotizing Myopathy (IMNM)=C2=A0
Immune-mediated necrotizing myopathy (IMNM) is a rare, serious, progressive=
neurological condition marked by severe proximal (for example hip and shou=
lder) muscle weakness. Auto-immune myopathies have a prevalence of around 1=
5 cases per 100,000 with IMNM about 10-15% of all IMM cases. This suggests =
that there are=C2=A0more than 6,000 patients in each of the US and EU. (Anq=
uetil et al. Autoimmunity Reviews 18 (2019) 223=E2=80=93230) IMNM is only r=
ecently understood to be a distinct entity within the broad group of idiopa=
thic inflammatory myopathies and as of yet there are no approved therapies.=
=C2=A0

Amyotrophic Lateral Sclerosis (ALS) is a rare and progressive degenerative =
disease of the motor neurons affecting more than 200,000 people globally (3=
0,000 in the US alone). in the central nervous system (brain and spinal cor=
d) involved in muscle movement, leading to muscle weakness and ultimately p=
aralysis. 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 C5=
b upon activation of the classical, alternative, or lectin pathways and blo=
ck the membrane attack complex (MAC) assembly. Zilucoplan is in clinical de=
velopment at Ra Pharmaceuticals and is not approved in any region of the wo=
rld. In addition to a recently-initiated phase 3 study in gMG and an upcomi=
ng 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 therapie=
s to patients with rare diseases. Ra=C2=A0Pharma discovers and develops pep=
tides and small molecules to target key components of the complement cascad=
e. 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 soluti=
ons to transform the lives of people living with severe diseases of the imm=
une system or of the central nervous system. With more than 7 500 people in=
approximately 40 countries, UCB generated revenue of =E2=82=AC 4.6 billion=
in 2018. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Tw=
itter: @UCB_news

For further information=C2=A0

UCB Corporate Communications
France Nivelle =C2=A0
Global Communications, UCB
T +32.2.559.9178 france.nivelle@ucb.com

Laurent Schots=C2=A0
Media Relations, UCB =C2=A0
T+32.2.559.92.64 =C2=A0Laurent.schots@ucb.com=C2=A0

UCB Investor Relations
Antje Witte =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0
Investor Relations, UCB
T +32.2.559.94.14 antje.witte@ucb.com

Isabelle Ghellynck,
=C2=A0Investor Relations, UCB
T+32.2.559.9588, isabelle.ghellynck@ucb.com=C2=A0

Ra Pharmaceuticals, Inc.

Investors:
Ra Pharmaceuticals, Inc.
Natalie Wildenradt, 617-674-9874
nwildenradt@rapharma.com=C2=A0

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

Forward looking statements UCB
This press release contains forward-looking statements based on current pla=
ns, estimates and beliefs of management. All statements, other than stateme=
nts of historical fact, are statements that could be deemed forward-looking=
statements, including estimates of revenues, operating margins, capital ex=
penditures, cash, other financial information, expected legal, political, r=
egulatory or clinical results and other such estimates and results. By thei=
r nature, such forward-looking statements are not guarantees of future perf=
ormance and are subject to risks, uncertainties and assumptions which could=
cause actual results to differ materially from those that may be implied b=
y such forward-looking statements contained in this press release. Importan=
t factors that could result in such differences include: changes in general=
economic, business and competitive conditions, the inability to obtain nec=
essary regulatory approvals or to obtain them on acceptable terms, costs as=
sociated with research and development, changes in the prospects for produc=
ts in the pipeline or under development by UCB, effects of future judicial =
decisions or governmental investigations, product liability claims, challen=
ges to patent protection for products or product candidates, changes in law=
s or regulations, exchange rate fluctuations, changes or uncertainties in t=
ax laws or the administration of such laws and hiring and retention of its =
employees.=C2=A0

Additionally, information contained in this document shall not constitute a=
n 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 jurisdi=
ction in which such offer, solicitation or sale would be unlawful prior to =
the registration or qualification under the securities laws of such jurisdi=
ction. UCB is providing this information as of the date of this document an=
d expressly disclaims any duty to update any information contained in this =
press release, either to confirm the actual results or to report a change i=
n its expectations.

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

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

Forward-Looking Statements of Ra Pharmaceuticals
Certain statements contained in this press release may be considered forwar=
d-looking statements within the meaning of the Private Securities Litigatio=
n 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, includi=
ng without limitation statements regarding the merger and the ability to co=
nsummate the merger. =C2=A0These forward-looking statements generally inclu=
de statements that are predictive in nature and depend upon or refer to fut=
ure events or conditions, and include words such as =E2=80=9Cbelieves,=E2=
=80=9D =E2=80=9Cplans,=E2=80=9D =E2=80=9Canticipates,=E2=80=9D =E2=80=9Cpro=
jects,=E2=80=9D =E2=80=9Cestimates,=E2=80=9D =E2=80=9Cexpects,=E2=80=9D =E2=
=80=9Cintends,=E2=80=9D =E2=80=9Cstrategy,=E2=80=9D =E2=80=9Cfuture,=E2=80=
=9D =E2=80=9Copportunity,=E2=80=9D =E2=80=9Cmay,=E2=80=9D =E2=80=9Cwill,=E2=
=80=9D =E2=80=9Cshould,=E2=80=9D =E2=80=9Ccould,=E2=80=9D =E2=80=9Cpotentia=
l,=E2=80=9D or similar expressions. =C2=A0Statements that are not historica=
l facts are forward-looking statements. =C2=A0Forward-looking statements ar=
e based on current beliefs and assumptions that are subject to risks and un=
certainties. =C2=A0Forward-looking statements speak only as of the date the=
y are made, and Ra Pharma undertakes no obligation to update any of them pu=
blicly in light of new information or future events. =C2=A0Actual results c=
ould differ materially from those contained in any forward-looking statemen=
t as a result of various factors, including, without limitation: (1) Ra Pha=
rma 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 requ=
ired regulatory approvals may not be obtained; (3) the merger may involve u=
nexpected costs, liabilities or delays; (4) Ra Pharma=E2=80=99s business ma=
y 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 Phar=
ma may be adversely affected by other economic, business, and/or competitiv=
e factors; (7) the occurrence of any event, change or other circumstances t=
hat 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 dis=
rupts current plans and operations and the potential difficulties in employ=
ee retention as a result of the merger; and (10) other risks to consummatio=
n of the merger, including the risk that the merger will not be consummated=
within the expected time period or at all. =C2=A0If the merger is consumma=
ted, Ra Pharma shareholders will cease to have any equity interest in Ra Ph=
arma and will have no right to participate in its earnings and future growt=
h. =C2=A0Additional 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 S=
EC=E2=80=99s website at www.sec.gov. =C2=A0Readers are cautioned not to pla=
ce undue reliance on these forward-looking statements, which speak only as =
of the date thereof.
=C2=A0
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UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . B - 1070 Belgium=