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UCB Media Room: zilucoplan in immune-mediated necrotizing myopathy (IMNM)

INFORMATION REGLEMENTEE


[22/04/2021 | 20:04]
https://mb.cision.com/Public/18595/logo/86a99b25f755738d_org.jpg

** UCB=E2=80=99s zilucoplan shows no relevant effect in immune-mediated nec=
rotizing myopathy (IMNM)
------------------------------------------------------------

=C2=B7 In phase 2, zilucoplan did not show a meaningful effect in immune-me=
diated necrotizing myopathy (IMNM)=C2=A0
=C2=B7 No unexpected safety findings and no relevant safety differences bet=
ween zilucoplan and placebo were identified
=C2=B7 Phase 3 headline results for generalized myasthenia gravis (gMG) are=
unchanged expected in Q4 2021

Brussels (Belgium) 22=C2=A0April 2021 =E2=80=93 20:00 (CEST) =E2=80=93 Base=
d on the initial results of a Phase 2 study investigating zilucoplan in imm=
une-mediated necrotizing myopathy (IMNM), UCB today announced that UCB has =
decided to not move forward with its IMNM development program.=C2=A0

The phase 2 study with zilucoplan, a peptide inhibitor of complement compon=
ent 5 (C5), in immune-mediated necrotizing myopathy (IMNM) did not show a m=
eaningful effect of zilucoplan for people living with IMNM. No unexpected s=
afety findings and no relevant safety differences between zilucoplan and pl=
acebo were identified.=C2=A0

=E2=80=9CWe are very thankful to the patients, their caregivers and the inv=
estigators for their study participation and their efforts=E2=80=9D, said P=
rof. Dr. Iris Loew-Friedrich, Chief Medical Officer, UCB. =E2=80=9CWhile th=
is result is disappointing, we are satisfied to have conducted a high-quali=
ty Phase 2 study which provides a clear read-out and direction on the path =
forward - despite the challenging environment during the pandemic, which ha=
d no material impact on results. This result in IMNM in no way affects our =
confidence in zilucoplan in the other indications we are pursuing given the=
uniqueness of each of the diseases and the way that complement inhibition =
may affect the specific immune pathology in each of them. We are looking fo=
rward to our upcoming Phase 3 headline results in the generalized myastheni=
a gravis (gMG) study, expected in Q4 2021.=E2=80=9D

In December 2019, Ra Pharma started the Phase 2 clinical trial of zilucopla=
n for the treatment of immune-mediated necrotizing myopathy (IMNM). Ra Phar=
ma pioneered C5 inhibition in IMNM, an untested, new indication based on a =
sound scientific hypothesis and supportive non-clinical data, with the goal=
to provide a treatment to patients with a significant unmet need.=C2=A0

The results of this study indicate that complement activation is less relev=
ant in the disease biology of IMNM than hypothesized. UCB anticipates prese=
nting this data at an upcoming scientific meeting to further inform future =
IMNM research and to contribute towards better understanding about the dise=
ase pathogenesis.

The appropriate impairment assessment of the decision, to not move forward =
with the IMNM development program, will be performed for the Half Year Resu=
lts 2021, due 29 July 2021. This decision does not impact the financial gui=
dance for 2021.

About Zilucoplan - The phase 3 product candidate, zilucoplan, is a once-dai=
ly self-administered, subcutaneous peptide inhibitor of C5 and is currently=
being tested in phase 3 for the treatment of gMG with top-line results exp=
ected in Q4 2021. Further indications that are potentially addressable by z=
ilucoplan include amyotrophic lateral sclerosis (ALS) and other tissue-base=
d complement-mediated disorders with high unmet medical need. Zilucoplan wa=
s selected as one of the first drugs to be tested in a multi-center amyotro=
phic lateral sclerosis (ALS) platform study sponsored by the Sean M. Healey=
& AMG Center for ALS at Mass General. Zilucoplan is in clinical developmen=
t and is not approved in any region of the world.=C2=A0

About immune-mediated necrotizing myopathy (IMNM) - IMNM is a rare, severe,=
inflammatory myopathy characterized by necrosis of skeletal muscle fibers.=
This manifests as proximal limb weakness. IMNM is a relatively newly defin=
ed inflammatory myopathy, a group of diseases that also includes polymyosit=
is, dermatomyositis, inclusion body myositis, and other, less well-defined =
myopathies. The prevalence of IMNM is estimated at approximately 16,000 pat=
ients in the US, Europe, and Japan (Pinal-Fernandez et al, 2018; Smoyer-Tom=
ic et al, 2012; Anquetil et al, 2019).=C2=A0

About Generalized Myasthenia Gravis (gMG) - Generalized myasthenia gravis i=
s 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 a=
ny age and in any race. Myasthenia Gravis is a rare disease impacting almos=
t 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 wea=
kness that can result in life threatening weakness of muscles of respiratio=
n.=C2=A0

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 7 600 people in=
approximately 40 countries, UCB generated revenue of =E2=82=AC 5.3 billion=
in 2020. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Tw=
itter: @UCB_news

For further information =E2=80=93=C2=A0

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,
Investor Relations, UCB
T+32.2.559.9588, isabelle.ghellynck@ucb.com=C2=A0

Brand Communications
Jim Baxter,=C2=A0
Rare Disease Communications, UCB
T+32.2.473.78.85.01 jim.baxter@ucb.com=C2=A0

Corporate Communications
Laurent Schots=C2=A0
Media Relations, UCB =C2=A0
T+32.2.559.92.64 =C2=A0Laurent.schots@ucb.com=C2=A0
=C2=A0=C2=A0 =C2=A0
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=
delay, divert or change any of them this year and the next several years, =
that are difficult to predict, may be beyond UCB=E2=80=99s control and coul=
d cause UCB=E2=80=99s actual future financial results, goals, plans and obj=
ectives to differ materially from those that may be expressed in, or implie=
d by, such forward-looking statements contained in this press release. Impo=
rtant factors that could result in such differences include: the global spr=
ead and impact of COVID-19, changes in general economic, business and compe=
titive conditions, the inability to obtain necessary regulatory approvals o=
r to obtain them on acceptable terms, costs associated with research and de=
velopment, changes in the prospects for products in the pipeline or under d=
evelopment by UCB, effects of future judicial decisions or governmental inv=
estigations, product liability claims, challenges to patent protection for =
products or product candidates, changes in laws or regulations, exchange ra=
te fluctuations, changes or uncertainties in tax 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.
The updated financial guidance above does not reflect any potential impacts=
from the evolving COVID-19 pandemic. The company is following the developm=
ent diligently to assess the financial significance of this pandemic to UCB=
.=C2=A0

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