Civica Rx and Xellia Pharmaceuticals Join Forces to Reduce Chronic Drug Shortages

Xellia becomes Civica’s first supplier partner and will produce
essential
antibiotics in short supply in U.S. hospitals

LEHI, Utah & BUFFALO GROVE, Ill.–(BUSINESS WIRE)–Civica Rx (Civica, Inc.) and Xellia Pharmaceuticals today announced they
have signed a product supply agreement under which Xellia will
manufacture essential antibiotics, including Vancomycin and Daptomycin,
for Civica’s member health systems. Shortages of these anti-infective
medications are impacting patient care in hospitals across the United
States.

Today marks the first time that Civica is announcing the production of
generic drugs – and the initial medications to be supplied – since the
company was established to address chronic drug shortages. It has
committed to partnering with suppliers to deliver 14 essential generic
medications this year.

Xellia, headquartered in Copenhagen, Denmark, is expanding its
manufacturing and sales capabilities within the U.S. and has a
long-standing heritage of manufacturing with an emphasis on quality and
security of supply. The company produces its own active pharmaceutical
ingredients, as well as finished injectable drug products for serious
and often life-threatening bacterial and fungal infections.

“We thank Xellia for helping to lead the way in efforts to reduce
chronic generic drug shortages in the U.S., including treatments for
serious infections caused by bacteria that are resistant to other
antibiotics,” said Martin VanTrieste, President and CEO of Civica. “By
helping to stabilize the supply of Vancomycin and Daptomycin, we will
have a direct impact on patient safety and public health by providing
consistent access to antibiotics that are important treatment options in
the management of difficult-to-treat and life-threatening infections.”

The partnership with Xellia will help avoid drug shortages and enable
the supply security Civica and its member health systems are seeking.
Xellia will make medications for Civica under Xellia’s Abbreviated New
Drug Application (ANDA) and Civica labeling and New Drug Code (NDC).

“We are honored to work with Civica, an innovator in addressing generic
drug shortages,” said Carl-Aake Carlsson, CEO Xellia Pharmaceuticals.
“Our collaboration also supports Xellia’s long-term ambition of
mitigating anti-infective drug shortages across the U.S.”

###

About Civica Rx
Civica was established in 2018 to reduce
chronic generic drug shortages in the U.S. and exists in the public
interest as a non-profit, non-stock corporation committed to stabilizing
supply of essential generic medications in a hospital setting. Civica’s
membership includes a Governing
Board and Founding
and Partnering
Members.

Civica will act in the best interest of patients to eliminate
uncertainty in the generic drug supply chain through long-term contracts
with health system members as well as its manufacturing partners. Civica
is committed to transparency and will offer fair and sustainable prices
to its member hospitals. It will also ensure it has dedicated
manufacturing capacity for the medications that are most desperately
needed in hospitals across the country through redundant manufacturing
and strategic stockpiling of medications to prevent drug shortages in
the future.

Civica aims to stabilize the supply of antibiotics, anesthetics, cardiac
medications, pain management medications, and other essential sterile
injectable medicines used in hospitals daily. It is actively pursuing a
three-pronged product
supply strategy:

• Working with multiple generic drug manufacturers (with Xellia as its
  first) that have the US FDA approved manufacturing facilities and
  capacity to produce Civica labeled generic drugs, allowing
  manufacturers to re-enter the market or increase existing capacity
• Developing and acquiring Abbreviated New Drug Applications (ANDAs) for
  generic drugs and working with contract manufacturing organizations to
  produce Civica medications
• Acquiring and building Civica manufacturing facilities using Civica’s
  ANDAs

More information about Civica can be found at www.civicarx.org
and https://civicarx.org/media/.

About Xellia Pharmaceuticals
Xellia Pharmaceuticals
(“Xellia”) is a specialty pharmaceutical company developing,
manufacturing and commercializing anti-infective treatments against
serious and often life-threatening bacterial and fungal infections.

With over 100 years of experience, Xellia is a world-leading trusted
supplier of several important established anti-infective drugs,
comprising active pharmaceutical ingredients as well as injectable
products. Continuing the Company’s evolution, Xellia is generating an
innovative pipeline of value-added anti-infective medicines intended to
enhance patient care, providing convenience and ease-of-use for
healthcare professionals.

Headquartered in Copenhagen, Denmark, Xellia has a global footprint with
R&D, manufacturing and commercial operations across Europe, Asia and
North America and is investing significantly to expand its sales and
manufacturing capabilities within the United States. Xellia is wholly
owned by Novo Holdings A/S and employs a dedicated team of over 1,600
people.

Further information about Xellia can be found at: www.xellia.com.

About Vancomycin and Daptomycin
Vancomycin is an antibiotic
administered by an intravenous (IV) infusion over at least 60 minutes.
It is used for serious infections caused by bacteria that are resistant
to certain other antibiotics, including methicillin resistant
Staphylococcus aureus (MRSA). Vancomycin can treat infections throughout
the body including: pneumonia (lungs), cellulitis (skin and skin
structures), septicemia (blood), osteomyelitis (bone), and endocarditis
(inner lining of the heart).

Daptomycin is an antibiotic administered by an intravenous (IV) bolus
injection or infusion over 2-30 minutes, respectively. It is used to
treat complicated infections of the skin and skin structures caused by
susceptible isolates of the Gram-positive bacteria including methicillin
resistant Staphylococcus aureus (MRSA). Daptomycin is also used to treat
infections of the bloodstream and infective endocarditis (an infection
of the inner lining of the heart) caused by methicillin-susceptible and
methicillin-resistant S. aureus bacteria.

Contacts

Enquiries:
Civica Rx
Debbi Ford
Tel: +1
(970) 227-3991
Email: [email protected]

Xellia
Pharmaceuticals ApS
Carl-Åke Carlsson, CEO
Tel: +45 32 64
55 00

Xellia Pharmaceuticals USA, LLC
Craig Boyd
/ Shawn Olsson
Tel: +1 630 776 9357

Instinctif
Partners (Xellia’s international media relations)
Eileen Paul /
Rozi Morris / Melanie Toyne-Sewell
Tel: +44 (0) 20 7457 2020
Email:
[email protected]