Poxel Regains Imeglimin Rights From Metavant
14 Janvier 2021 - 05:45PM
Business Wire
POXEL SA (Euronext: POXEL -
FR0012432516), a biopharmaceutical company focused on the
development of innovative treatments for metabolic disorders,
including type 2 diabetes and non-alcoholic steatohepatitis (NASH),
today announced that, as part of the previously communicated
decision by Metavant not to advance Imeglimin into a Phase 3
program for strategic reasons, its partnership agreement with
Metavant will be terminated, effective January 31, 2021. Metavant
will return all rights to Imeglimin to Poxel, as well as all data,
materials, and information, including FDA regulatory filings,
related to the program. Metavant is not entitled to any payment
from Poxel as part of the return of the program.
“We remain convinced of Imeglimin’s value as an innovative new
drug for type 2 diabetes. A New Drug Application in Japan (J-NDA)
is currently advancing through regulatory review with our partner
Sumitomo Dainippon Pharma, and a target product launch is
anticipated in fiscal year 20211. Moving forward, we are
considering various options to advance Imeglimin in the US, Europe
and other countries not covered by our agreement with Sumitomo
Dainippon Pharma and we are looking forward to updating the market
on our progress. In the meantime, we continue to remain focused on
the further development of our metabolic disease pipeline,” said
Thomas Kuhn, CEO of Poxel.
About Poxel SA
Poxel is a dynamic biopharmaceutical company that uses
its extensive expertise in developing innovative drugs for
metabolic diseases, with a focus on type 2 diabetes and
non-alcoholic steatohepatitis (NASH). In its
mid-to-late-stage pipeline, the Company is currently advancing
three drug candidates as well as earlier-stage opportunities.
Imeglimin, Poxel’s first-in-class lead product, targets
mitochondrial dysfunction. Poxel has a strategic partnership with
Sumitomo Dainippon Pharma for Imeglimin in Japan, China, South
Korea, Taiwan and nine other Southeast Asian countries. A Japanese
new drug application (J-NDA) is under review by the Pharmaceuticals
and Medical Devices Agency (PMDA) to request approval for the
manufacturing and marketing of Imeglimin for the treatment of type
2 diabetes. After successfully completing a Phase 2a
proof-of-concept trial for the treatment of NASH, which met its
primary endpoint and study objectives, for PXL770, a
first-in-class direct adenosine monophosphate-activated protein
kinase (AMPK) activator, Poxel plans to initiate a Phase 2b program
in the second half of 2021. PXL770 could also have the potential to
treat additional metabolic diseases. PXL065
(deuterium-stabilized R-pioglitazone), a MPC inhibitor, is in a
streamlined Phase 2 trial for the treatment of NASH. Poxel also has
additional earlier-stage programs from its AMPK activator and
deuterated TZD platforms targeting chronic and rare metabolic
diseases. The Company intends to generate further growth through
strategic partnerships and pipeline development. Listed on Euronext
Paris, Poxel is headquartered in Lyon, France, and has subsidiaries
in Boston, MA, and Tokyo, Japan. For more information, please
visit: www.poxelpharma.com.
In the context of the COVID-19 outbreak, which was declared a
pandemic by the World Health Organization (WHO) on March 12, 2020,
the Company is regularly reviewing the impact of the outbreak on
its business.
As of the date of this press release, and based on publicly
available information, the Company has not identified the
occurrence of any material negative effect on its business due to
the COVID-19 pandemic that remains unresolved. However, the Company
anticipates that the COVID-19 pandemic could have further material
negative impact on its business operations. The worldwide impact of
COVID-19 may notably affect the Company’s internal organization and
efficiency, particularly in countries where it operates and where
confinement measures are implemented by the authorities. In
addition, COVID-19 may impact market conditions and the Company’s
ability to seek additional funding or enter into partnerships.
Particularly, delays in the supply of drug substance or drug
products, in the initiation or the timing of results of preclinical
and/or clinical trials, as well as delays linked to the
responsiveness of regulatory authorities could occur, which could
potentially have an impact on the Company’s development programs
and partnered programs. The Company will continue to actively
monitor the situation.
All statements other than statements of historical fact included
in this press release about future events are subject to (i) change
without notice and (ii) factors beyond the Company’s control. These
statements may include, without limitation, any statements preceded
by, followed by or including words such as “target,” “believe,”
“expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,”
“project,” “will,” “can have,” “likely,” “should,” “would,” “could”
and other words and terms of similar meaning or the negative
thereof. Forward-looking statements are subject to inherent risks
and uncertainties beyond the Company’s control that could cause the
Company’s actual results or performance to be materially different
from the expected results or performance expressed or implied by
such forward-looking statements.
________________ 1 Year noted is Fiscal Year from April 2021 to
March 2022, which is Sumitomo Dainippon Pharma’s Fiscal Year.
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Poxel SA Aurélie Bozza Investor Relations &
Communication Director aurelie.bozza@poxelpharma.com +33 6 99 81 08
36
Investor relations / Media - EU/US Trophic Communications
Stephanie May or Valeria Fisher may@trophic.eu or fisher@trophic.eu
+49 171 185 56 82 or +49 175 804 1816
Investor relations / Media - France NewCap Emmanuel Huynh
or Arthur Rouillé poxel@newcap.eu +33 1 44 71 94 94
Poxel (EU:POXEL)
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