- Acquisition further strengthens specialty medicines and
respiratory pipeline with camlipixant, a highly selective P2X3
antagonist and potential best-in-class treatment for refractory
chronic cough
- Currently in phase III clinical development with anticipated
regulatory approval and launch in 2026
- Accretive to adjusted EPS from 2027 with significant sales
potential through 2031
GSK plc (LSE/NYSE: GSK) and BELLUS Health Inc. (TSX/NASDAQ: BLU)
today announced that they have entered into an agreement under
which GSK will acquire BELLUS, a Canada-based, late-stage
biopharmaceutical company working to better the lives of patients
suffering from refractory chronic cough (RCC) for US$14.75 per
share of common stock in cash representing an approximate total
equity value of US$2.0 billion (£1.6 billion). The acquisition
provides GSK access to camlipixant, a potential best-in-class and
highly selective P2X3 antagonist currently in phase III development
for the first-line treatment of adult patients with RCC.
It is estimated that 28 million patients suffer from chronic
cough, with 10 million patients globally and 6 million in the
United States (US) and European Union (EU) suffering from RCC for
over a year.1 RCC is defined as a persistent cough for more than
eight weeks that does not respond to treatment for an underlying
condition or is otherwise unexplained.2 RCC significantly impacts
quality of life, with patients suffering from depression (53%),
urinary incontinence (~50%), pain, rib fractures, social
withdrawal, and loss of sleep.3,4 There are no approved medicines
for RCC in the US and EU.
P2X3 is a validated biological target implicated in cough reflex
hypersensitisation, and camlipixant is a highly selective P2X3
antagonist. Current clinical data show that by selectively
inhibiting P2X3 receptors, camlipixant may reduce cough frequency
for patients suffering from RCC with a relatively low incidence of
dysgeusia, the taste disturbance adverse event associated with
other medicines that broadly target the P2X2/3 receptor. These
taste disturbances frequently lead to patients discontinuing
treatment. Notably, low rates of taste-related adverse events were
reported at all doses in the phase IIb trial (≤6.5%).5
Luke Miels, Chief Commercial Officer, GSK, said:
“Patients suffering from severe forms of refractory chronic cough
can experience over 900 coughs daily, resulting in quality-of-life
issues. Camlipixant, a novel, highly selective P2X3 antagonist, has
the potential to be a best-in-class treatment with significant
sales potential. This proposed acquisition complements our
portfolio of specialty medicines and builds on our expertise in
respiratory therapies.”
The acquisition of BELLUS is highly synergistic with GSK’s
expertise in respiratory medicines and is further supported by
GSK’s leading R&D, manufacturing, and commercialisation
capabilities.
Following the anticipated regulatory approval and launch of
camlipixant in 2026, the acquisition is expected to be accretive to
adjusted EPS from 2027 and has the potential to deliver significant
sales through 2031 and beyond.
In December 2021, BELLUS announced positive data from the SOOTHE
phase IIb trial, indicating that it met its primary endpoint for
the 50 mg and 200 mg twice-daily doses. Based on these data, BELLUS
initiated the CALM phase III development programme consisting of
the CALM-1 and CALM-2 trials, with data anticipated in H2 2024 and
2025, respectively. BELLUS is also evaluating a QD (once-daily)
formulation for camlipixant, which is currently in phase I.
Roberto Bellini, Chief Executive Officer of BELLUS, said: “This
acquisition recognises the value of our highly selective P2X3
antagonist camlipixant and validates the hard work and dedication
of all the BELLUS employees in advancing camlipixant to date. As a
leader in respiratory research for over five decades, GSK shares
our commitment to bettering the lives of individuals suffering from
a persistent cough and is the ideal Company to rapidly bring
camlipixant to the millions suffering from refractory chronic cough
around the world.”
The transaction remains subject to regulatory approvals.
Financial Considerations
Under the terms of the agreement, the acquisition will be
effected through a Plan of Arrangement pursuant to the Canada
Business Corporations Act in which the shares of BELLUS outstanding
will be acquired by the Company in consideration of US$14.75 per
share in cash. Subject to customary conditions, including court
approval, the approval of the acquisition by at least 66.67% of the
votes cast at a meeting of BELLUS’ shareholders and a majority of
the votes cast by non-interested shareholders at such meeting, and
approval by the appropriate regulatory agencies, the transaction is
expected to close in the third quarter of 2023 or earlier.
The per-share price represents a premium of approximately 103%
to BELLUS’ closing stock price on April 17th, 2023 and a premium of
approximately 101% to BELLUS’ volume-weighted average price (VWAP)
over the last 30 trading days. BELLUS’ Board of Directors has
unanimously recommended that BELLUS’ shareholders vote in favour of
the approval of the acquisition.
GSK will account for the transaction as a business combination
and expects it to be accretive to adjusted EPS in 2027, the
expected first full year of camlipixant’s sales.
There is no change to GSK’s full-year 2023 guidance or the
medium-term outlook for 2021-2026 of more than 5% sales and 10%
adjusted operating profit CAGR* at CER**.
* CAGR: Compound Annual Growth Rate; **CER: Constant Exchange
Rate
Advisors
PJT Partners is acting as the exclusive financial advisor to
GSK. Paul, Weiss, Rifkind, Wharton & Garrison LLP, and Stikeman
Elliott LLP serve as legal counsel to GSK in connection with the
transaction. Centerview Partners is acting as the exclusive
financial advisor, and Skadden, Arps, Slate, Meagher & Flom
LLP, and Davies Ward Phillips & Vineberg LLP serve as legal
counsel to BELLUS.
About BELLUS
BELLUS is a late-stage biopharmaceutical company working to
better the lives of patients suffering from persistent cough.
About GSK in respiratory
For over 50 years, GSK has led the way in developing medicines
that advance the management of asthma and COPD, from introducing
the world’s first selective short-acting beta agonist in 1969 to
launching six treatments in five years to create today’s
industry-leading respiratory portfolio.
About RCC
RCC is a cough that persists for more than eight weeks despite
optimal treatment of any underlying conditions or where there is no
identifiable underlying cause.6 Cough hypersensitivity syndrome –
excessive coughing, often in response to relatively innocuous
stimuli – is now identified as the primary pathology in RCC. RCC is
a frequent, yet often under-recognised, medical condition with
significant physical, social, and psychological consequences on a
patient’s quality of life. Two-thirds of patients are women
averaging between 50-60 years old.7 There are currently no approved
treatments for this condition in the US or the EU.
About camlipixant
Camlipixant is an investigational, twice-daily oral P2X3
receptor antagonist for the treatment of RCC, which is currently
being evaluated in the CALM phase III clinical development
programme. Given the need for novel and effective medicines for
RCC, camlipixant has the potential to be a breakthrough in the
treatment landscape.
Camlipixant is not currently approved anywhere in the world.
About GSK
GSK is a global biopharma company with a purpose to unite
science, technology, and talent to get ahead of disease together.
Find out more at gsk.com/company.
Cautionary statement regarding forward-looking statements
relating to BELLUS Health
This press release may include “forward-looking statements”
within the meaning of the applicable securities laws, including
with respect to the timing and completion of the arrangement, the
proposed timing of filings, the impact of the proposed transaction
on BELLUS Heath, and the operations of BELLUS Heath
post-transaction. Each forward-looking statement contained in this
press release is based on the current expectations of management
and is subject to known and unknown risks and uncertainties and
other unknown factors that could cause actual results to differ
materially from historical results and those expressed or implied
by such statement. In addition to statements which explicitly
describe such risks and uncertainties, readers are urged to
consider statements labelled with the terms “believes,” “belief,”
“expects,” “intends,” “anticipates,” “will,” or “plans” to be
uncertain and forward-looking. Such statements include, but are not
limited to, the potential of camlipixant to successfully treat RCC
and other hypersensitization-related disorders, the success of
BELLUS Health’s preclinical studies and clinical trials, and the
timing and outcome of anticipated regulatory approvals. Additional
risk factors include, but are not limited to, the impact of general
economic conditions, general conditions in the pharmaceutical
industry, the impact of the COVID-19 pandemic, including impact to
the initiation and completion of clinical trials in a timely manner
or at all, changes in the regulatory environment, supply chain
impacts, fluctuations in costs, changes to the competitive
environment, reliance on third parties to conduct preclinical
studies and clinical trials for camlipixant. Furthermore, the risks
and uncertainties include, among others, the risk that a condition
to closing of the arrangement may not be satisfied, the risk that
any required shareholder, court or applicable regulatory approvals
for the arrangement may not be obtained or be obtained subject to
conditions that are not anticipated, the failure to realize the
anticipated benefits of the transaction, the occurrence of any
event that could give rise to termination of the transaction, and
potential litigation in connection with the transaction or other
settlements or investigations that may affect the timing or
occurrence of the transaction or result in significant costs of
defence, indemnification and liability.
BELLUS Heath cautions investors not to rely on the
forward-looking statements contained in this press release when
making an investment decision in their securities. Investors are
encouraged to read BELLUS Health’s filings available on the SEC
website at www.sec.gov and on the SEDAR website at www.sedar.com,
for a discussion of these and other risks and uncertainties. The
forward-looking statements in this press release speak only as of
the date of this press release and BELLUS Heath undertakes no
obligation to update or revise any of these statements, whether as
a result of new information, future events or otherwise, except as
required by law.
Cautionary statement regarding forward-looking statements
relating to GSK
GSK cautions investors that any forward-looking statements or
projections made by GSK, including those made in this announcement,
are subject to risks and uncertainties that may cause actual
results to differ materially from those projected. Such factors
include, but are not limited to, those described under Item 3.D
'Risk factors” in the company's Annual Report on Form 20-F for
2022, GSK’s Q4 Results for 2022 and any impacts of the COVID-19
pandemic.
Registered in England & Wales: No. 3888792
Registered Office: 980 Great West Road Brentford,
Middlesex TW8 9GS
______________________________________
1 Song et al. The global epidemiology of chronic cough in
adults: a systematic review and meta-analysis. Eur Respir J. 2015;
45: 1479–1481. 2 Meltzer et al. Prevalence and Burden of Chronic
Cough in the United States. J of Allergy Clin Immunol Pract. 2021;
9:4037-44. 3 Dicpinigaitis et al. Prevalence of Depressive Symptoms
Among Patients With Chronic Cough. CHEST. 2006; 130 (6): 1839 – 43.
4 Chamberlain et al. The impact of chronic cough: a cross-sectional
European survey. Lung. 2015 Jun;193(3):401-8. 5 BELLUS Health Inc.
Investor Presentation, Dec 2021. 6 Meltzer et al. Prevalence and
Burden of Chronic Cough in the United States. J of Allergy Clin
Immunol Pract. 2021; 9:4037-44. 7 Morice et al. A worldwide survey
of chronic cough: a manifestation of enhanced somatosensory
response. Eur Respir J. 2014 Nov;44(5):1149-55.
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