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UCB Media Room: Collaboration with Roche to develop antibody treatment

INFORMATION REGLEMENTEE


[29/07/2020 | 07:02]
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** UCB enters into collaboration with Roche to develop antibody treatment f=
or people living with Alzheimer=E2=80=99s Disease
------------------------------------------------------------

=C2=B7 UCB to provide to Roche and Genentech exclusive, world-wide license =
to UCB=E2=80=99s UCB0107, an innovative anti-Tau antibody treatment
=C2=B7 UCB will receive an initial upfront payment and, after positive comp=
letion of proof-of-concept in Alzheimer=E2=80=99s Disease, is eligible to r=
eceive further potential payments with a total potential consideration appr=
oaching US $2 billion upon receipt of certain regulatory approvals and sati=
sfying certain milestones.
=C2=B7 UCB to fund and perform initial proof-of-concept study in Alzheimer=
=E2=80=99s Disease. Upon completion and availability of results, Genentech =
has the right to proceed with clinical development or return full rights ba=
ck to UCB.=C2=A0

Brussels (Belgium) 29 July 2020 =E2=80=93 7:00 (CEST) - UCB today announced=
an agreement to enter into a world-wide, exclusive license agreement with =
Roche and Genentech, a member of the Roche Group, for the global developmen=
t and commercialization of UCB0107 in Alzheimer=E2=80=99s Disease (AD). The=
transaction remains subject to obtaining antitrust clearance and other cus=
tomary closing conditions.

Charl van Zyl, Executive Vice President UCB and Head of Neurology said: =E2=
=80=9CWe are excited that Roche and Genentech, with their deep and wide-ran=
ging expertise, capacity and know-how in Alzheimer=E2=80=99s Disease, will =
collaborate with UCB on UCB0107 with a shared ambition to offer people livi=
ng with Alzheimer=E2=80=99s Disease a new treatment option. Our science dri=
ven, patient centric development approach, and leading experience in neurol=
ogical diseases provides a uniquely holistic view towards the unmet needs a=
nd the potential for an effective anti-Tau antibody in the treatment of neu=
rodegenerative diseases like Alzheimer=E2=80=99s Disease and progressive su=
pranuclear palsy. In-line with our ongoing and longstanding commitment to t=
he neurodegeneration community, this partnership represents an important st=
ep in the potential development of this exciting new medicine.=E2=80=9D

James Sabry, Global Head of Roche Pharma Partnering said: =E2=80=9CIn Alzhe=
imer=E2=80=99s Disease, we are continuing to explore new molecules that add=
ress the key pathways of this complex disease. We are pleased to embark on =
this journey together with UCB to help expand our efforts on tau. Our commi=
tment remains strong on exploring multiple approaches with the hope that ou=
r research and development, including this collaboration with UCB, will lea=
d to a disease-modifying medicine that could positively impact millions of =
people with Alzheimer=E2=80=99s Disease.=E2=80=9D =C2=A0

UCB0107 is an investigational monoclonal antibody drug being developed by U=
CB as a potential treatment for patients with tauopathies such as progressi=
ve supranuclear palsy (PSP) and Alzheimer=E2=80=99s Disease.=C2=A0

UCB will provide an exclusive, world-wide license to Roche and Genentech to=
develop and commercialize UCB0107 in AD. In return, UCB will receive an in=
itial upfront payment of US $120 million. UCB will fund and perform a proof=
-of-concept study in AD and, upon availability of the results of that study=
, Genentech has the right to progress with the development or return full r=
ights back to UCB. After Genentech=E2=80=99s decision to proceed with furth=
er clinical development, UCB will be eligible to receive further potential =
cost reimbursement, development and sales milestone payments as well as roy=
alties with a total potential consideration approaching US $2 billion upon =
receipt of certain regulatory approvals and satisfying certain clinical and=
sales milestones.=C2=A0

This license agreement does not impact UCB=E2=80=99s 2020 financial outlook.

UCB continues to develop UCB0107 in progressive supranuclear palsy (PSP), w=
ith a confirmatory phase 3 study due to commence in Q2 2021.

About UCB0107=C2=A0
UCB0107 is a recombinant, humanized, full-length IgG4 monoclonal antibody, =
targeting a central Tau epitope, which is being developed to block/reduce t=
he spread of Tau pathology.

Tau is a microtubule-associated protein expressed in the central nervous sy=
stem, which supports the assembly and stabilization of neuronal microtubule=
s.^1 In tauopathies, Tau becomes pathogenic, forming tangles, which cause c=
ell damage and ultimately neuronal death.^1,2,3 It is hypothesised that the=
spread of Tau protein from neuron to neuron underpins disease progression =
in tauopathies^4 providing the rationale for antibody therapies.

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 4.9 billion=
in 2019. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Tw=
itter: @UCB_news

For further information UCB:

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

Forward looking statements UCB=C2=A0
This press release may contain forward-looking statements including, withou=
t limitation, statements containing the words =E2=80=9Cbelieves=E2=80=9D, =
=E2=80=9Canticipates=E2=80=9D, =E2=80=9Cexpects=E2=80=9D, =E2=80=9Cintends=
=E2=80=9D, =E2=80=9Cplans=E2=80=9D, =E2=80=9Cseeks=E2=80=9D, =E2=80=9Cestim=
ates=E2=80=9D, =E2=80=9Cmay=E2=80=9D, =E2=80=9Cwill=E2=80=9D, =E2=80=9Ccont=
inue=E2=80=9D and similar expressions. These forward-looking statements are=
based on current plans, estimates and beliefs of management. All statement=
s, other than statements of historical facts, are statements that could be =
deemed forward-looking statements, including estimates of revenues, operati=
ng margins, capital expenditures, cash, other financial information, expect=
ed legal, arbitration, political, regulatory or clinical results or practic=
es and other such estimates and results. By their nature, such forward-look=
ing statements are not guarantees of future performance and are subject to =
known and unknown risks, uncertainties and assumptions which might cause th=
e actual results, financial condition, performance or achievements of UCB, =
or industry results, to differ materially from those that may be expressed =
or implied by such forward-looking statements contained in this press relea=
se. Important factors that could result in such differences include: the gl=
obal spread and impact of COVID-19, changes in general economic, business a=
nd competitive conditions, the inability to obtain necessary regulatory app=
rovals or to obtain them on acceptable terms or within expected timing, cos=
ts associated with research and development, changes in the prospects for p=
roducts in the pipeline or under development by UCB, effects of future judi=
cial decisions or governmental investigations, safety, quality, data integr=
ity or manufacturing issues; potential or actual data security and data pri=
vacy breaches, or disruptions of our information technology systems, produc=
t liability claims, challenges to patent protection for products or product=
candidates, competition from other products including biosimilars, changes=
in laws or regulations, exchange rate fluctuations, changes or uncertainti=
es in tax laws or the administration of such laws, and hiring and retention=
of its employees. There is no guarantee that new product candidates will b=
e discovered or identified in the pipeline, will progress to product approv=
al or that new indications for existing products will be developed and appr=
oved. Movement from concept to commercial product is uncertain; preclinical=
results do not guarantee safety and efficacy of product candidates in huma=
ns. So far, the complexity of the human body cannot be reproduced in comput=
er models, cell culture systems or animal models. The length of the timing =
to complete clinical trials and to get regulatory approval for product mark=
eting has varied in the past and UCB expects similar unpredictability going=
forward. Products or potential products which are the subject of partnersh=
ips, joint ventures or licensing collaborations may be subject to differenc=
es disputes between the partners or may prove to be not as safe, effective =
or commercially successful as UCB may have believed at the start of such pa=
rtnership. UCB=E2=80=99 efforts to acquire other products or companies and =
to integrate the operations of such acquired companies may not be as succes=
sful as UCB may have believed at the moment of acquisition. Also, UCB or ot=
hers could discover safety, side effects or manufacturing problems with its=
products and/or devices after they are marketed. The discovery of signific=
ant problems with a product similar to one of UCB=E2=80=99s products that i=
mplicate an entire class of products may have a material adverse effect on =
sales of the entire class of affected products. Moreover, sales may be impa=
cted by international and domestic trends toward managed care and health ca=
re cost containment, including pricing pressure, political and public scrut=
iny, customer and prescriber patterns or practices, and the reimbursement p=
olicies imposed by third-party payers as well as legislation affecting biop=
harmaceutical pricing and reimbursement activities and outcomes. Finally, a=
breakdown, cyberattack or information security breach could compromise the=
confidentiality, integrity and availability of UCB=E2=80=99s data and syst=
ems.=C2=A0
Given these uncertainties, you should not place undue reliance on any of su=
ch forward-looking statements. There can be no guarantee that the investiga=
tional or approved products described in this press release will be submitt=
ed or approved for sale or for any additional indications or labelling in a=
ny market, or at any particular time, nor can there be any guarantee that s=
uch products will be or will continue to be commercially successful in the =
future.
UCB is providing this information, including forward-looking statements, on=
ly as of the date of this press release and it does not reflect any potenti=
al impact from the evolving COVID-19 pandemic, unless indicated otherwise. =
UCB is following the worldwide developments diligently to assess the financ=
ial significance of this pandemic to UCB. UCB expressly disclaims any duty =
to update any information contained in this press release, either to confir=
m the actual results or to report or reflect any change in its forward-look=
ing statements with regard thereto or any change in events, conditions or c=
ircumstances on which any such statement is based, unless such statement is=
required pursuant to applicable laws and regulations.=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.

References:=C2=A0
1.=C2=A0=C2=A0 =C2=A0Courade J-P et al. Acta Neuropathol. 2018;136(5):729=
=E2=80=9345.=C2=A0
2.=C2=A0=C2=A0 =C2=A0Albert M et al. Brain. 2019; 142:1736=E2=80=9350.
3.=C2=A0=C2=A0 =C2=A0Fontaine S et al. Cell Mol Life Sci. 2015;72(10):1863=
=E2=80=9379.=C2=A0
4.=C2=A0=C2=A0 =C2=A0Ling H. J Mov Disord. 2016;9(1):3=E2=80=9313.=C2=A0

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