Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma”) and Nuance
Pharma Limited (“Nuance Pharma”), today announce that the companies
have entered into an agreement granting Nuance Pharma, a
Shanghai-based specialty pharmaceutical company, the rights to
develop and commercialize ensifentrine in Greater China (mainland
China, Taiwan, Hong Kong and Macau). Ensifentrine is an
investigational, first-in-class, inhaled, dual inhibitor of the
enzymes phosphodiesterase 3 and 4 (“PDE3” and “PDE4”). This dual
inhibition enables it to combine both bronchodilator and
anti-inflammatory effects in one compound. Verona Pharma is
currently conducting a global Phase 3 program evaluating
ensifentrine for the maintenance treatment of chronic obstructive
pulmonary disease (“COPD”), with sites in the US, Europe and South
Korea.
“We are extremely excited about the formation of
this strategic partnership with Nuance Pharma to further the
development and future commercialization of ensifentrine in Greater
China,” said David Zaccardelli, Pharm. D., President and CEO of
Verona Pharma. “Nuance Pharma’s highly talented leadership team has
deep experience developing and commercializing respiratory products
across China and we look forward to working with them to bring
ensifentrine to this important market.”
“Ensifentrine is an ideal fit for Nuance
Pharma’s portfolio, given our focus on developing and
commercializing innovative products for the Chinese market,”
commented Mark G. Lotter, CEO and Co-Founder of Nuance Biotech.
“With proven expertise in developing and commercializing global
brands, including many leading respiratory products, I have
confidence in the Nuance Pharma team’s ability to develop and
commercialize ensifentrine in Greater China.”
Under the terms of the agreement, Verona Pharma
has granted Nuance Pharma the exclusive rights to develop and
commercialize ensifentrine in Greater China. In return, Verona
Pharma will receive an upfront payment of $25 million in cash and
an equity interest currently valued at $15 million in Nuance
Biotech, the parent company of Nuance Pharma. Verona Pharma is
eligible to receive future milestone payments of up to $179 million
that are triggered upon achievement of certain clinical,
regulatory, and commercial milestones. Verona Pharma is also
entitled to tiered double-digit royalties as a percentage of net
sales in Greater China.
Nuance Pharma will be responsible for all costs
related to clinical development and commercialization in Greater
China. A joint steering committee will be established to ensure
ensifentrine’s clinical development in the region aligns with
Verona Pharma’s overall global development and commercialization
strategy. Nuance Pharma intends to file a Clinical Trial
Application with the China Food and Drug Administration later this
year and begin clinical studies for the treatment of COPD in
Greater China thereafter.
For further information please contact:
Verona Pharma plc |
US Tel: +1-833-417-0262UK Tel: +44 (0)203 283 4200 |
Victoria Stewart, Director of Communications |
info@veronapharma.com |
|
|
Argot Partners(US Investor Enquiries) |
Tel: +1-212-600-1902verona@argotpartners.com |
Kimberly Minarovich / Michael Barron |
|
|
|
Optimum Strategic Communications(International
Media and European Investor Enquiries) |
Tel: +44 (0)203 950 9144verona@optimumcomms.com |
Mary Clark / Eva Haas / Shabnam Bashir |
|
About Ensifentrine
Ensifentrine (RPL554) is an investigational,
first-in-class, inhaled, dual inhibitor of the enzymes
phosphodiesterase 3 and 4 (“PDE3” and “PDE4”). This dual inhibition
enables it to combine both bronchodilator and anti-inflammatory
effects in one compound. Ensifentrine also activates the Cystic
Fibrosis Transmembrane Conductance Regulator (“CFTR”), which is
beneficial in reducing mucous viscosity and improving mucociliary
clearance. Ensifentrine’s mechanism of action has the potential to
alleviate respiratory symptoms such as breathlessness and cough and
work against inflammation associated with COPD or inflammation
triggered by viruses.
Ensifentrine has demonstrated significant and
clinically meaningful improvements in both lung function and
symptoms, including breathlessness, in Verona Pharma’s Phase 2
clinical studies in patients with moderate to severe Chronic
Obstructive Pulmonary Disease (“COPD”). In addition, nebulized
ensifentrine showed further improved lung function and reduced lung
volumes in COPD patients taking standard short- and long-acting
bronchodilator therapy, including maximum bronchodilator treatment
with dual/triple therapy. Ensifentrine has been well tolerated in
clinical trials involving more than 1,300 subjects to date.
About Verona Pharma
Verona Pharma is a clinical-stage
biopharmaceutical company focused on developing and commercializing
innovative therapies for the treatment of respiratory diseases with
significant unmet medical needs. If successfully developed and
approved, Verona Pharma’s product candidate, ensifentrine, has the
potential to be the first therapy for the treatment of respiratory
diseases that combines bronchodilator and anti-inflammatory
activities in one compound. The Company is evaluating nebulized
ensifentrine in its Phase 3 clinical program ENHANCE (“Ensifentrine
as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance
treatment. Two additional formulations of ensifentrine are in Phase
2 development for the treatment of COPD: dry powder inhaler (“DPI”)
and pressurized metered-dose inhaler (“pMDI”). Ensifentrine has
potential applications in cystic fibrosis, asthma and other
respiratory diseases. For more information, please visit
www.veronapharma.com.
About Nuance Pharma
Nuance Pharma is a Shanghai-based late
clinical-stage biopharmaceutical company focused on licensing,
developing and commercializing globally innovative therapies with
the mission of addressing critical unmet medical needs
in China and other emerging Asia
Pacific markets. Its world-class clinical and regulatory
teams, visionary approach to business development and integrated
commercial platforms enable Nuance Pharma to continuously
accelerate the access of innovative treatments to patients. Since
its inception in 2014, Nuance Pharma has assembled a portfolio of
promising clinical-stage drug candidates for respiratory, pain and
iron deficiency anemia. The company has targeted these therapeutic
areas based on the severity of the unmet medical needs, the size of
the at-risk patient population, and the emergence of innovative
products worldwide.
Forward-Looking Statements
This press release contains forward-looking
statements. All statements contained in this press release that do
not relate to matters of historical fact should be considered
forward-looking statements, including, but not limited to,
statements regarding milestone payments, royalties and other
financial terms of the collaboration agreement with Nuance Pharma,
our and Nuance Pharma’s ability to bring ensifentrine to market in
China, the timing of Nuance Pharma filing a Clinical Trial
Application with the China Food and Drug Administration and
beginning clinical studies for the treatment of COPD in China, and
the potential of ensifentrine in the treatment of COPD, cystic
fibrosis, asthma and other respiratory diseases.
These forward-looking statements are based on
management's current expectations. These statements are neither
promises nor guarantees, but involve known and unknown risks,
uncertainties and other important factors that may cause our actual
results, performance or achievements to be materially different
from our expectations expressed or implied by the forward-looking
statements, including, but not limited to, the following: our
limited operating history; our need for additional funding to
complete development and commercialization of ensifentrine, which
may not be available and which may force us to delay, reduce or
eliminate our development or commercialization efforts; the
reliance of our business on the success of ensifentrine, our only
product candidate under development; economic, political,
regulatory and other risks involved with international operations;
the lengthy and expensive process of clinical drug development,
which has an uncertain outcome; serious adverse, undesirable or
unacceptable side effects associated with ensifentrine, which could
adversely affect our ability to develop or commercialize
ensifentrine; potential delays in enrolling patients, which could
adversely affect our research and development efforts and the
completion of our clinical trials; we may not be successful in
developing ensifentrine for multiple indications; our ability to
obtain approval for and commercialize ensifentrine in multiple
major pharmaceutical markets; misconduct or other improper
activities by our employees, consultants, principal investigators,
and third-party service providers; our future growth and ability to
compete depends on retaining our key personnel and recruiting
additional qualified personnel; material differences between our
“top-line” data and final data; our reliance on third parties,
including clinical research organizations, clinical investigators,
manufacturers and suppliers, and the risks related to these
parties’ ability to successfully develop and commercialize
ensifentrine; and lawsuits related to patents covering ensifentrine
and the potential for our patents to be found invalid or
unenforceable; changes in our tax rates, unavailability of certain
tax credits or reliefs or exposure to additional tax liabilities or
assessments could affect our profitability, and audits by tax
authorities could result in additional tax payments for prior
periods; and our vulnerability to natural disasters, global
economic factors and other unexpected events, including health
epidemics or pandemics like the COVID-19 pandemic, which has and
may continue to adversely impact our business. These and other
important factors under the caption “Risk Factors” in our Annual
Report on Form 10-K for the year ended December 31, 2020, and our
other reports filed with the SEC, could cause actual results to
differ materially from those indicated by the forward-looking
statements made in this press release. Any such forward-looking
statements represent management's estimates as of the date of this
press release. While we may elect to update such forward-looking
statements at some point in the future, we disclaim any obligation
to do so, even if subsequent events cause our views to change.
These forward-looking statements should not be relied upon as
representing our views as of any date subsequent to the date of
this press release.
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