Xellia Pharmaceuticals Receives US FDA Approval for Premixed Vancomycin Injection

First Room Temperature Stable Vancomycin Injection Premix

Now offering Vancomycin in 500 mg in 100 mL, 1 g in 200 mL, 1.5 g in
300 mL, and 2 g in 400 mL, Ready-to-Use (RTU) bags in the US Market

COPENHAGEN, Denmark & BUFFALO GROVE, IL.–(BUSINESS WIRE)–Xellia Pharmaceuticals (‘Xellia’), a global leader in the manufacturing
of specialty anti-infective treatments, announced today it has received
U.S. Food and Drug Administration (FDA) approval for Premixed Vancomycin
Injection in a Ready-to-Use (RTU) bag in the United States market. This
approval follows Qualified Infectious Disease Product (QIDP) designation
from the FDA in February 2018.

“In 2014 we started on a journey to develop a pipeline of innovative,
novel anti-infective therapies focused on unmet medical needs and
centered on advanced formulation improvements for marketed drugs from
our core portfolio. This first approval is a significant milestone for
Xellia and an important validation of our strategy,”
said Carl-Åke
Carlsson, Xellia’s CEO.

It is a testament to our science, formulation and medical expertise
that enabled us to successfully overcome the long standing industry
challenge of stabilizing Vancomycin in solution at room temperature for
an extended time, 16 months. We are continuing innovative R&D efforts
with the goal to further broaden our portfolio of novel anti-infective
therapies aimed at enhancing patient care and improving convenience and
ease of use for healthcare professionals
.” said Dr. Aleksandar
Danilovski, Xellia’s CSO.

Craig Boyd, Xellia’s North American President said, “Vancomycin is a
critical World Health Organization (WHO) designated essential medicine.
With this approval, US healthcare professionals will now have access to
multiple presentations (500 mg in 100 mL, 1 g in 200 mL, 1.5 g in 300 mL
and 2 g in 400 mL) of the first room temperature stable Vancomycin
Injection Premix with 16 months of shelf life. In addition, this should
move the product closer to the patients which may reduce time to
delivery in urgent, emergency needs.”

Full prescribing information for Vancomycin Injection Premix RTU can be
found at www.xellia.com/us

About Vancomycin Injection

Vancomycin Injection, Ready to use (RTU) is a proprietary formulation of
vancomycin, provided as a premixed solution in single-dose flexible
bags, stable at room temperature (up to 25 °C) for 16 months.

Vancomycin Injection RTU is provided as 100 mL, 200 mL, 300 mL or 400 mL
solution containing 500 mg, 1 g, 1.5 g or 2 g vancomycin, respectively.
Each 100 mL of solution contain 1.8 mL polyethylene glycol 400, 1.36 g
N-acetyl-D-alanine, and 1.26 g L-lysine hydrochloride (monochloride) in
water for injection. Hydrochloric acid and sodium hydroxide are used for
pH adjustment.

Vancomycin Injection is a glycopeptide antibacterial indicated in adult
and pediatric patients (1 month and older) for the treatment of:
septicaemia, infective endocarditis, skin and skin structure infections,
bone infections and lower respiratory tract infections.

The FDA approval of this novel vancomycin formulation was obtained on
the basis of more than 60 non-clinical experiments, including studies to
confirm that the new formulation does not adversely impact the efficacy
profile of the active ingredient, vancomycin. The product safety profile
has been extensively evaluated in vitro and in vivo, including 5 repeat
dose toxicity studies of the novel vancomycin formulation in rats and
dogs with dosing up to 13 weeks, in addition to full safety
qualification of excipient N-acetyl-D-alanine including safety
pharmacology and repeat dose toxicity studies in 2 animal species with
dosing up to 13 weeks, and animal reproduction studies of
N-acetyl-D-alanine and polyethylene glycol 400.

IMPORANT SAFETY INFORMATION
WARNING: RISK OF
EMBRYO-FETAL TOXICITY DUE TO EXCIPIENTS

This formulation of
Vancomycin Injection is not recommended for use during pregnancy because
it contains the excipients polyethylene glycol (PEG 400) and N-acetyl
D-alanine (NADA), which caused fetal malformations in animal
reproduction studies. If use of vancomycin is needed during pregnancy,
use other available formulations of vancomycin. (5.1, 8.1)

WARNINGS AND PRECAUTIONS

  • Infusion Reactions: Hypotension,
    including shock and cardiac arrest, wheezing, dyspnea, urticaria,
    muscular and chest pain and “red man syndrome” which manifests as
    pruritus and erythema that involves the face, neck and upper torso may
    occur with rapid intravenous administration. To reduce the risk of
    infusion reactions, administer Vancomycin Injection over a period of
    60 minutes or greater and also prior to intravenous anesthetic agents.
    (2.1, 5.2)
  • Nephrotoxicity: Systemic vancomycin
    exposure may result in acute kidney injury (AKI) including acute renal
    failure, mainly due to interstitial nephritis or less commonly acute
    tubular necrosis. Monitor serum vancomycin concentrations and renal
    function. (5.3)
  • Ototoxicity: Ototoxicity has occurred in
    patients receiving vancomycin. Monitor for signs and symptoms of
    ototoxicity during therapy. Monitor serum vancomycin concentrations
    and renal function. Assessment of auditory function may be appropriate
    in some instances. (5.4)
  • Clostridium Difficile-Associated Diarrhea:
    Evaluate patients if diarrhea occurs. (5.5).
  • Neutropenia: Periodically monitor
    leukocyte count. (5.7)
  • Phlebitis: To reduce the risk of local
    irritation and phlebitis administer Vancomycin Injection by a secure
    intravenous route of administration. (5.8)
  • Development of Drug-Resistant Bacteria:
    Prescribing Vancomycin Injection in the absence of a proven or
    strongly suspected bacterial infection is unlikely to provide benefit
    to the patient and increases the risk of the development of drug
    resistant bacteria. (5.9)

ADVERSE REACTIONS

The common adverse reactions are anaphylaxis, “red man syndrome”, acute
kidney injury, hearing loss, neutropenia. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Xellia Pharmaceuticals
USA, LLC at 1-833-295-6953 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.

DRUG INTERACTIONS

  • Anesthetic Agents: Concomitant
    administration of vancomycin and anesthetic agents has been associated
    with erythema and histamine-like flushing. (2.1, 7.1)
  • Piperacillin/Tazobactam: Increased
    incidence of acute kidney injury in patients receiving concomitant
    piperacillin/tazobactam and vancomycin as compared to vancomycin
    alone. Monitor kidney function in patients (7.2)

Please see full Prescribing Information, including Boxed WARNING (1).

References

1. Vancomycin Injection Full Prescribing Information (U.S.). Feb 2019,
Xellia Pharmaceuticals ApS.

ENDS

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 drug
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.

Contacts

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

Xellia Pharmaceuticals USA, LLC
Craig
Boyd / Ben Pettit
Tel: +1 248 953 2435

Instinctif
Partners (International media relations)

Eileen Paul / Rozi
Morris / Melanie Toyne-Sewell
Tel: +44 (0) 20 7457 2020
Email: xellia@instinctif.com

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