Crossject engages Syneos Health for U.S. commercial launch of ZEPIZURE®
January 04 2024 - 11:00AM
Crossject engages Syneos Health for U.S. commercial launch of
ZEPIZURE®
Press Release
Crossject engages Syneos Health
for U.S. commercial launch of
ZEPIZURE®
Crossject expanding market access activities in
preparation for filing for marketing authorization
ZEPIZURE®, previously known as ZENEO® Midazolam,
is separately contracted with BARDA for U.S. advanced regulatory
development and specific supply to the Strategic National
Stockpile
Dijon, France, January 4, 2024, 18:00 CET --
Crossject (ISIN: FR0011716265; uronext: ALCJ), a specialty pharma
company developing needle-free auto-injectors for emergency
situations, has engaged Syneos Health, a leading fully integrated
biopharmaceutical solutions organization, to prepare for the
commercial launch of Crossject’s ZEPIZURE® innovative rescue
therapy for epileptic seizures in the U.S.
Under the agreement, Syneos Health will provide support in all
pre-launch and launch activities for ZEPIZURE®. Syneos Health
brings a strong U.S. presence and significant expertise in
commercializing new therapies for Crossject.
In 2022, Crossject was awarded a contract with the U.S.
Biomedical Advanced Research and Development Authority (BARDA) for
the U.S. advanced regulatory development and procurement of
ZEPIZURE® into the Strategic National Stockpile (SNS), upon
receiving Food and Drug Administration (FDA) authorization. Under
the terms of the contract, BARDA will sponsor the licensure and SNS
stockpiling, and Crossject will sell the therapies directly into
the epilepsy medical market.
“ZEPIZURE® is a unique treatment which could save lives in an
emergency, as it can potentially be administered anywhere and by
anyone, in a matter of seconds,” said Patrick Alexandre, CEO of
Crossject. “We are now focusing on preparing the filing for
marketing authorization with the FDA, and we are pleased to have
such an experienced partner as Syneos Health to guide us through
and launch our commercial activities in the U.S.”
ZEPIZURE® is based on Crossject’s proprietary needle-free device
ZENEO®, which is designed to enable easily administered injections
to be delivered in a fraction of a second in emergency
situations.
“We have reached an advanced stage in development of ZEPIZURE®,
and the approaching regulatory filing is driving a need for local
marketing in the U.S., where we are also expanding Crossject’s
presence. I am looking forward to working closely with Syneos
Health, who will provide important momentum and awareness of our
groundbreaking product and help to ensure it reaches patients in
need in the most efficient manner,” said Daniel Teper, a U.S. based
member of the Crossject Supervisory Board.
“We are pleased to support Crossject on the launch of this
exciting emergency treatment for epilepsy,” said Lee Taurman,
Executive Vice President, Syneos One, Syneos Health. “ZEPIZURE can
be significant for people suffering from epileptic seizures. We
look forward to working closely with Daniel Teper and the rest of
the Crossject team to optimize the launch and commercialization for
this product.”
About Crossject
Crossject SA (Euronext: ALCJ;
www.crossject.com) is an emerging specialty pharma company based in
France and the U.S. It is in advanced regulatory development for
ZEPIZURE®, an epileptic rescue therapy, for which it was awarded a
$60 million contract with the U.S. Biomedical Advanced Research and
Development Authority (BARDA). ZEPIZURE® is based on the Company’s
award-winning needle-free autoinjector ZENEO®, designed to enable
patients and untrained caregivers to easily and instantly deliver
emergency medication via intramuscular injection on bare skin or
even through clothing. The Company’s other products in development
include rescue therapies for allergic shocks, adrenal
insufficiencies, opioid overdose and asthma attacks.
For further information, please contact:
Investors Natasha DrapeauCohesion Bureau+41 76 823
75 27natasha.drapeau@cohesionbureau.com |
MediaSophie BaumontCohesion Bureau+33 6 27 74 74
49sophie.baumont@cohesionbureau.com |
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