Crossject provides strategic update on priorities for 2024
February 06 2024 - 11:30AM
Focusing on regulatory filings and accelerating
U.S. commercialization efforts
Contract of up to $155 million with BARDA for
U.S. stockpiling continues to advance
Dijon, France February 6, 2024 –530 pm CET Crossject
(ISIN: FR0011716265; Euronext: ALCJ), a specialty pharma company
developing needle-free auto-injectors for emergency
situations, provides a summary of recent milestones
reached and an update on its strategic priorities for 2024.
In January 2024, Crossject engaged Syneos
Health, a leading fully integrated biopharmaceutical solutions
organization, to prepare for the commercial launch of its
ZENEO-midazolam autoinjector, proposed name ZEPIZURE®, an
innovative rescue therapy for epileptic seizures, including those
caused by nerve agent exposure, in the United States. Syneos Health
has a strong U.S. presence and significant expertise in
commercializing new therapies for Crossject, as it approaches
filing for regulatory approval.
Crossject is also advancing its licensing and
commercialization efforts for ZEPIZURE® in other strategic markets
and signed in 2023 a licensing agreement with AFT Pharmaceuticals
for Australia and New Zealand and a new commercialization agreement
for northern Europe.
In 2024, Crossject will especially focus on
regulatory approvals for ZEPIZURE® and accelerating market access
efforts in the United States. Crossject has a senior team in the
U.S. and is working in close collaboration with Syneos Health to
ensure a smooth and rapid launch of ZEPIZURE® upon receiving
regulatory approval.
The Company previously signed a $92 million
contract with the Biomedical Advanced Research and Development
Authority (BARDA), part of the Administration for Strategic
Preparedness and Response (ASPR) in the U.S. Department of Health
and Human Services (HHS), under contract number 75A50122C00031. The
contract includes $32 million to advance the development of
ZEPIZURE®, through U.S. Food and Drug Administration (FDA) approval
for status epilepticus. The agreement also includes procurement of
$60 million of ZEPIZURE®, which will be delivered to the U.S.
government (USG), once it is authorized for emergency use by the
FDA. Delivery of ZEPIZURE will fulfill a USG requirement for an
improved anticonvulsant to treat status epilepticus seizures caused
by nerve agent exposure. According to the contract terms, BARDA
also has options for post-marketing commitment activities and
procurement of additional ZEPIZURE® units for up to $63 million.
The total contract value, if all options are exercised, is $155
million. The Company is actively engaged with BARDA and the FDA,
and discussions are fully focused on ensuring fulfillment of
requirements to file for Emergency Use Authorization (EUA) of
ZEPIZURE®.
Crossject cashed in early 2023 €8 million, in
addition to €4 million at the end of 2022, from a combined
non-dilutive financial transaction of €14 million to accelerate the
company's development. The transaction includes various loans
granted by its long-standing banks (Caisse d'Epargne and BNP),
Société Générale and BPI, with amortization periods ranging from 5
to 10 years.
The company also secured a total sum of around
EUR 5 million over several years through the leaseback of several
of its buildings.
According to the BARDA agreement terms,
Crossject was reimbursed $3.2 million for the advanced US
regulatory development expenses in the first half of 2023, an
increase from $1.8 million in 2022. The company has continued its
monthly regulatory development billing for this matter.
Henri de Parseval is leaving his position as
Chief Operating Officer of Engineering & Industry at Crossject,
with a strong organization in place to support the company’s drive
for approvals and commercialization of ZEPIZURE®. Didier Morin, who
joined Crossject in mid-2023 as Industrial Director, assumes those
responsibilities.
“Crossject is starting 2024 with strong momentum
as our discussions with FDA related to the requirements necessary
for Emergency Use Authorization of ZEPIZURE® continue moving
forward on a good track. In parallel, we are preparing for
regulatory filings of ZEPIZURE®, our unique treatment which can be
administered by anyone in seconds, to save lives in emergencies. We
are working closely with our strategic partners market access
activities in the US,” said Patrick Alexandre, CEO of
Crossject.
“I would like to thank Henri de Parseval for his contributions
to Crossject, providing a strong foundation for our future work,
and I wish him all the best for the future.”
About Crossject
Crossject SA (Euronext: ALCJ;
www.crossject.com) is an emerging specialty pharma company. It is
in advanced regulatory development for ZEPIZURE®, an epileptic
rescue therapy, for which it was awarded a $92 million contract
with the U.S. Biomedical Advanced Research and Development
Authority (BARDA) for the FDA Approval and procurement of ZEPIZURE®
for the US government.
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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- 2024-02-06 -ENG final - Press release Crossject 2024
Priorities
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