Advicenne provides an
update on its activities
followingits Annual General
Meeting
- Introducing Advicenne 2.0, the
Company’s strategy to unlock value
- Poised to partner Sibnayal in dRTA
in Europe following EMA marketing authorization
- Accelerate clinical development of
Sibnayal™ in the US to maximize value creation
- Reinforce the management team to
deliver Advicenne 2.0 goals
PARIS, France,
17:45
p.m. CET, June
15, 2021 – Advicenne
(Euronext: ADVIC), a specialty pharmaceutical company dedicated to
developing and commercializing innovative treatments for those
suffering from rare renal diseases, provides an update on its
activities following its Annual General Meeting, which was held
virtually on June 14, 2021.
During the Annual General Meeting, a majority of
shareholders voted for all resolutions as recommended by the Board
of Directors. 4,379,697 shares were represented in voting,
corresponding to 50,88% of the Company’s 8,607,568 shares. The full
results of the AGM are posted on the Company’s website and can be
found at the following link: https://advicenne.com/investors/.
Over the course of the AGM, attendees were
introduced to Advicenne 2.0, the Company’s new strategy to maximize
value creation for shareholders, details of which can be found
below.
Advicenne 2.0: a clear
strategic pathway
Advicenne aims to capitalize on the recent EU
marketing authorization (MA) for Sibnayal™ (ADV7103) in distal
Renal Tubular Acidosis (dRTA), expanding approved use both
geographically and therapeutically, with strict financial
discipline and capital allocation, and backed by a strong and
highly experienced management team.
The first priority as part of the Advicenne 2.0
strategy is to complete a partnership in Europe to generate
commercial sales of Sibnayal™ in dRTA following its marketing
authorization by the European Medicines Agency (EMA). The company
is identifying the appropriate partners to maximize market
potential in the main European markets and provide its shareholders
with the highest return.
The second priority is to accelerate the
clinical development of Sibnayal™ in the US in two indications:
dRTA and cystinuria. Advicenne has recently received positive
feedback from the US Food and Drug Administration (FDA) on an
amended Phase III study protocol and on a pathway to approval for
Sibnayal™ for the treatment of dRTA. This will enable Advicenne to
resume before the summer its Phase III clinical trial, ARENA 2, in
the US. The right resources will be allocated to run the US
development program in accordance with the FDA requirements and
anticipate a potential first marketing authorization in the US
before the end of 2022. The first approval of Sibnayal™ in the US
would be a major milestone for the Company and a significant value
driver for shareholders.
In parallel, the Company is pursuing the
clinical development of Sibnayal™ in cystinuria both in Europe and
in the US, with a potential approval in first-half 2023 and
second-half 2023, respectively. Sibnayal™ is now a largely
de-risked medicine following its approval by the European
Commission and the clearance of its clinical development in the US
in dRTA.
The decision to prioritize capital allocation to
Sibnayal™ is largely driven by its favorable risk / reward profile
and its peak sales potential. The resources to progress the US
development of Sibnayal™ and unlock shareholder value will partly
come through a partnership to ensure Sibnayal™’s commercial success
in Europe as well as from the license agreement on Ozalin® with
Primex.
Strengthened management to lead
Advicenne 2.0With a clear new strategy and
corporate goals in place, Advicenne has implemented major changes
in management to align the executive team with the Company’s
ambitions. The Chairman of the Board, David Solomon, is taking an
expanded executive role alongside the newly appointed Chief
Executive Officer, Didier Laurens. A highly recognized industry
executive, Didier brings his experience in finance and investor
communications, combined with his 10-year background in marketing
in the pharmaceutical industry. Robbie MacCarthy joined as General
Manager of Advicenne’s US subsidiary bringing extensive knowledge
of the US market, clinical development, and years of experience in
rare diseases and start-up organizations. He has already hired an
experienced team that is committed to restart and progress
ARENA-2.
Advicenne will continue to strengthen its
management team by hiring highly experienced executives in medical
affairs, manufacturing, and commercial operations in the near
term.
Our lead product, Sibnayal™, is ready to launch
and the Company is committed to fully unlock the value of its lead
product both in dRTA and Cystinuria and both in Europe and North
America to the benefit of our shareholders. Advicenne 2.0 marks a
new era for patients and shareholders.
About Advicenne
Advicenne (Euronext: ADVIC) is a pharmaceutical
company founded in 2007, specializing in the development of
innovative treatments in Nephrology. Its lead drug candidate is
currently in late-stage clinical trials for two kidney diseases:
distal renal tubular acidosis and cystinuria. ADV7103 has just
received a Marketing Approval (MAA) for the treatment of dRTA.
Headquartered in Paris, Advicenne has been listed on the Euronext
Paris stock exchange since 2017 and was cross-listed on the
Euronext Brussels stock exchange in 2019.
For additional information see: https://advicenne.com/
CONTACTS
AdvicenneDavid Solomon, ChairmanDidier Laurens,
CEO+33 (0)4 66 05 54 20Email: investors@advicenne.com |
NewCapFinancial communicationsDusan Oresansky,
Emmanuel Huynh+33 (0)1 44 71 94 94Email: advicenne@newcap.eu |
Consilium Strategic CommunicationsMary-Jane
Elliott, Ashley Tapp, Davide Salvi+44 (0)20 3709 5700Email:
advicenne@consilium-comms.com |
Ulysse CommunicationMedia relationsBruno
Arabian+33 (0)6 87 88 47 26Email:
advicenne@ulysse-communication.com |
LEGAL
DISCLAIMERThis press release contains certain
forward-looking statements relating to the business of Advicenne,
which shall not be considered per se as historical facts. Such
statements include projections and estimates, and the 3/3
hypotheses on which these are based, as well as observations
relating to operations, ongoing projects, objectives, the
development of products and their future performance, and
expectations regarding financial results. In some cases,
forward-looking statements can be identified by words such as
"could," "should," "may," "expects," "anticipates," "believes,"
"intends," "estimates," "aims," "targets" or similar words.
Although the management of Advicenne believes that these
forward-looking statements are reasonably made, investors should be
aware that they are subject to a number of known and unknown risks
and uncertainties and other factors that may cause actual results,
performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by
these forward-looking statements. In particular, the expectations
of Advicenne could be affected by, among other things,
uncertainties involved in the placing on the market and
commercialization of Advicenne products or any other risks and
uncertainties developed or identified in any public documents filed
by Advicenne with the French Financial Markets Authority (Autorité
des marchés financiers (AMF)), including those listed in Chapter 4,
“Risk Factors,” of its universal registration document, filed with
the latter on December 22, 2020. Notwithstanding the compliance
with article 223-1 of the General Regulation of the AMF (the
information disclosed must be “accurate, precise and fairly
presented”), Advicenne disclaims any intention or obligation to
publicly update or revise any forward-looking statements, whether
as a result of new information, future events or otherwise.