REGULATED INFORMATION - INSIDE
INFORMATION
GHENT, Belgium, 30 April 2018 - Ablynx [Euronext Brussels and
Nasdaq: ABLX] today announced that it has successfully
completed patient recruitment in the Phase IIb RESPIRE dose-ranging
efficacy study of ALX- 0171, the Company's novel inhaled drug
candidate to treat respiratory syncytial virus (RSV)
infections.
A total of 180 infants (aged 1-24
months) diagnosed with RSV and hospitalised for a lower respiratory
tract infection have been enrolled. The study consists of a
sequential dose escalation part which enrolled 36 infants, followed
by a parallel part in which 144 infants were randomly assigned to
one of three dose groups of inhaled ALX-0171 or placebo. The study
drug is administered once daily for three consecutive days.
Data from this Phase IIb study are
expected to be reported in the second half of 2018.
Dr Robert K.
Zeldin, Chief Medical Officer at Ablynx, commented:
"Completing study recruitment is
an important step in the development of our inhaled anti-RSV
Nanobody and we look forward to reporting the data later this year.
Recruiting 180 infants with RSV younger than two years of age in
just over 16 months confirms the urgent need for effective
therapies in RSV. We thank everyone involved in this trial for
their contribution and enabling us to evaluate ALX-0171 as a
potential therapeutic for RSV infections, which today impact
millions of infants and young children and place a significant
burden on their families."
About RSV
RSV is the most common cause of
lower respiratory tract infections and the leading viral cause of
severe lower respiratory tract disease in infants and young
children worldwide. It is the primary cause of infant
hospitalisation and virus-associated deaths in infants, with
estimated global annual infection of 33 million infants and young
children and the resulting hospitalisation of 3-4
million[1]. RSV is
associated with an estimated 3,000-8,500 deaths in infants <2
years globally per year[2], and it has
been linked to an increased risk of asthma development later in
life[3].
Current treatment of RSV
infections is primarily focused on symptomatic relief, hence the
need for an effective and specific anti-RSV therapeutic.
About
ALX-0171
ALX-0171 is a wholly-owned
trivalent Nanobody that binds to the F-protein of RSV, thereby
inhibiting viral replication and neutralising RSV activity by
blocking virus uptake into cells. The physical robustness of the
Nanobody allows administration via inhalation directly to the site
of infection, i.e. the respiratory tract. ALX-0171 has shown a
potent anti-viral effect against a broad range of RSV strains
in vitro and it has demonstrated a marked
therapeutic effect following administration via nebulisation in a
neonatal animal model for infant RSV infection[4].
Repeated daily inhalation of
ALX-0171 was proven to be well-tolerated in multiple Phase I
clinical studies in adults and a Phase I/IIa study in 53
hospitalised infants (aged 1-24 months) with a RSV infection. In
addition, repeated daily inhalation of ALX-0171 had an immediate
and significant impact on viral replication and an encouraging
initial therapeutic effect in the Phase I/IIa study.
The randomised, double-blind,
placebo-controlled, international, multi-centre dose-ranging Phase
IIb RESPIRE study is evaluating three different doses of inhaled
ALX-0171 in 180 hospitalised infants (aged 1-24 months) with a RSV
infection. The sequential dose escalation part, which enrolled 36
infants, was completed in July 2017, after which the Data
Monitoring Committee recommended to continue the study without
changes to the protocol. The parallel dose part of the study in 144
infants was initiated in August 2017. The primary endpoint of the
trial is to evaluate the anti-viral effect of treatment measured in
samples taken by nasal swabs. Secondary endpoints include safety,
pharmacokinetics and clinical activity determined by assessment of
the composite Global Severity Score. Topline results from the
RESPIRE trial are expected in H2 2018.
A randomised, double-blind,
placebo-controlled, multi-centre Phase II study of ALX-0171 in 60
Japanese infants (aged 1-24 months) diagnosed with RSV and
hospitalised for a lower respiratory tract infection is also
ongoing since March 2018, with topline results expected in H2
2019.
About
Ablynx
Ablynx is a biopharmaceutical
company engaged in the development of Nanobodies, proprietary
therapeutic proteins based on single-domain antibody fragments,
which combine the advantages of conventional antibody drugs with
some of the features of small-molecule drugs. Ablynx is dedicated
to creating new medicines which will make a real difference to
society. Today, the Company has more than 45 proprietary and
partnered programmes in development in various therapeutic areas
including inflammation, haematology, immuno-oncology, oncology and
respiratory disease. The Company has collaborations with multiple
pharmaceutical companies including AbbVie; Boehringer Ingelheim;
Eddingpharm; Merck & Co., Inc., Kenilworth, New Jersey, USA;
Merck KGaA; Novo Nordisk; Sanofi and Taisho Pharmaceuticals. The
Company is headquartered in Ghent, Belgium. More information can be
found on www.ablynx.com.
On 29 January 2018, Sanofi made an
offer to acquire all of Ablynx's outstanding ordinary shares
(including shares represented by American Depository Shares (ADSs),
warrants and convertible bonds) at a price of €45 per share, which
represents an aggregate equity value of approximately €3.9 billion.
The proposed transaction was unanimously approved by both the
Sanofi and Ablynx Board of Directors. The offer is comprised of two
separate but concurrent tender offers: (i) a tender offer
under the laws of Belgium for all of the outstanding shares,
warrants and convertible bonds of Ablynx (the "Belgian Offer") and (ii) a tender offer under the
laws of the U.S. for all of the outstanding shares held by U.S.
holders and ADSs held by holders, wherever located (the "U.S. Offer"). The initial acceptance period of the
tender offers commenced on 4 April 2018 and will expire at 5:00
p.m. ET / 11:00 p.m. CET on 4 May 2018, subject to extension.
For more
information, please contact
Ablynx:
Dr Edwin Moses
CEO
t: +32 (0)9 262 00 07
m: +32 (0)473 39 50 68
e: edwin.moses@ablynx.com
Lies Vanneste
Director Investor Relations
t: +32 (0)9 262 01 37
m: +32 (0)498 05 35 79
e: lies.vanneste@ablynx.com
Follow us on Twitter @AblynxABLX
Ablynx media
relations:
Consilium Strategic Communications
Mary-Jane Elliott, Philippa Gardner, Sukaina Virji
t: +44 (0)20 3709 5700
e: ablynx@consilium-comms.com
Joele Frank,
Wilkinson Brimmer Katcher
Dan Katcher or Joseph Sala
t: +1 212-355-4449
Disclaimer
Certain statements, beliefs and opinions in this press release are
forward-looking, which reflect the Company or, as appropriate, the
Company directors' current expectations and projections about
future events. By their nature, forward-looking statements involve
a number of risks, uncertainties and assumptions that could cause
actual results or events to differ materially from those expressed
or implied by the forward-looking statements. These risks,
uncertainties and assumptions could adversely affect the outcome
and financial effects of the plans and events described herein. A
multitude of factors including, but not limited to, changes in
demand, competition and technology, can cause actual events,
performance or results to differ significantly from any anticipated
development. Forward looking statements contained in this press
release regarding past trends or activities should not be taken as
a representation that such trends or activities will continue in
the future. As a result, the Company expressly disclaims any
obligation or undertaking to release any update or revisions to any
forward-looking statements in this press release as a result of any
change in expectations or any change in events, conditions,
assumptions or circumstances on which these forward-looking
statements are based. Neither the Company nor its advisers or
representatives nor any of its parent or subsidiary undertakings or
any such person's officers or employees guarantees that the
assumptions underlying such forward-looking statements are free
from errors nor does either accept any responsibility for the
future accuracy of the forward-looking statements contained in
this press release or the actual occurrence of the forecasted
developments. You should not place undue reliance on
forward-looking statements, which speak only as of the date of this
press release.
Additional
information on the Belgian Offer
An electronic version of the
prospectus (including the forms) can be found on the websites of
the Receiving & Paying Agents (for BNP Paribas Fortis NV/SA,
https://www.bnpparibasfortis.be/epargneretplacer (French and
English) and https://www.bnpparibasfortis.be/sparenenbeleggen
(Dutch and English); for KBC Securities NV/SA in cooperation with
KBC Bank NV/SA,
https://www.kbcsecurities.com/prospectus-documents-overviews/prospectus-overview,
https://www.kbc.be, https://www.cbc.be and https://www.bolero.be),
Sanofi (https://www.sanofi.com/en/investors/tender-offers-ablynx
and https://www.sanofi.com/fr/investisseurs/offres-ablynx) and
Ablynx (http://www.ablynx.com/investors/sanofi-takeover-bid/). The
Prospectus can also be obtained in hard copy free of charge
(i) at the counters of the Receiving & Paying Agents or
(ii) by contacting the Receiving & Paying Agents at
+32 (0)2 433 41 13 (BNP Paribas
Fortis NV/SA), +32 (0)78 15 21 53 (KBC Bank NV/SA, Dutch &
English), +32 (0) 800 92 020 (CBC Banque NV/SA, French
& English) or +32 32 83 29 81 (Bolero by KBC
Securities NV/SA, Dutch, French & English). The Prospectus
is available in English and Dutch. The summary of the prospectus is
also available in French.
The Response Memorandum is annexed
to the prospectus. The Response Memorandum can also be obtained in
hard copy free of charge at the registered office of Ablynx
(Technologiepark 21, 9052 Zwijnaarde (Belgium)). The Response
Memorandum is available in English and Dutch.
Additional
Information on the U.S. Offer
The tender offer for the outstanding ordinary shares ("Shares"),
American Depositary Shares issued by J.P. Morgan Chase Bank, N.A.,
acting as depositary ("ADSs"), warrants ("Warrants") and
convertible bonds of Ablynx ("Bonds" and, together with the Shares,
ADSs and Warrants, the "Securities") has commenced. This
communication is for informational purposes only and is neither a
recommendation, an offer to purchase nor a solicitation of an offer
to sell any Securities of Ablynx.
Sanofi has filed a tender offer
statement on Schedule TO with the SEC and Ablynx has filed a
solicitation/recommendation statement on Schedule 14D-9 with
respect to the U.S. Offer. Ablynx stockholders and other investors
should read the tender offer statement (including the offer to
purchase, related letter of transmittal and other offer documents)
and the solicitation/recommendation statement carefully because
they contain important information, including the terms and
conditions of the U.S. Offer.
The offer to purchase, the related
letter of transmittal and certain other tender offer documents, as
well as the solicitation/recommendation statement, are available to
all holders of Securities of Ablynx at no expense to them. These
documents are available for free at the SEC's website at
www.sec.gov. Additional copies may be obtained for free by
contacting Sanofi at ir@Sanofi.com or on Sanofi's website at
https://en.Sanofi.com/investors. Stockholders and other investors
should read the filings made by Sanofi and Ablynx with the SEC
carefully before making a decision concerning the U.S. Offer.
[1] Shi
et al, Lancet 2017
[2] Byington
et al, Pediatric 2014
[3] Sigurs
et al, Thorax 2010; Backman et al, Acta Pediatr 2014
[4] Oral
presentation at the 9th
International RSV Symposium, November 2014
pdf version of the press
release
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responsible for the content, accuracy and originality of the
information contained therein.
Source: Ablynx via Globenewswire
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