TIDMACPH
Acacia Pharma Launches BYFAVO(TM) (remimazolam) in the United States for
Procedural Sedation in Adults Undergoing Medical Procedures Lasting
30 Minutes or Less
-- Approximately 40 million procedures take place annually in the US that
require the use of procedural sedation
-- BYFAVO is the second Acacia Pharma product approved and launched in the
US in the last year and extends its portfolio of new products targeting
unmet needs in anesthesia
This announcement contains inside information for the purposes of
Article 7 of the Market Abuse Regulation (EU) No 596/2014.
Cambridge, UK and Indianapolis, US -- 28 January 2021: Acacia Pharma
Group plc ("Acacia Pharma", the "Group" or the "Company") (EURONEXT:
ACPH), a hospital pharmaceutical company focused on the development and
commercialization of new products aimed at improving the care of
patients undergoing significant treatments such as surgery, other
invasive procedures or cancer chemotherapy, announces today that
BYFAVO(TM) (remimazolam) has been launched and is now commercially
available in the US for order and delivery to customers through major
wholesalers and specialty distributors.
BYFAVO was approved by the US Food and Drug Administration (FDA) on 2
July 2020 for the induction and maintenance of procedural sedation in
adults undergoing procedures lasting 30 minutes or less. It received its
Schedule IV designation from the US Drug Enforcement Administration
(DEA) on 6 October 2020, finalizing the approval process and clearing
the way for final packaging and shipping to the US.
Acacia Pharma has built critical sales, marketing, medical education and
operational support teams over the past two years to allow it to
directly commercialize both BYFAVO and BARHEMSYS(R) in the US through
its own sales channels. The Company's experienced commercial team is
focused on addressing the combined large market opportunities for
procedural sedation and prevention and treatment of post-operative
nausea & vomiting (PONV), which BYFAVO and BARHEMSYS target,
respectively, that exist in the US hospital market. The initial focus
of the commercial team over the first year of launch is to ensure that
BYFAVO is listed on hospital formularies, based on the unmet needs it
can address and the health economic benefits it can deliver.
"We are delighted to make BYFAVO available to anesthesia providers and
to the millions of patients across the US who require moderate sedation
to undergo medical procedures each year," commented Mike Bolinder,
Acacia Pharma's CEO. "BYFAVO and BARHEMSYS have a clear and shared value
proposition focused on safely and rapidly mobilizing patients after such
procedures, which drives revenues of hospitals and surgical centers in
the US. The launches come at a time when Covid-19 has had a significant
impact on such centers, creating significant patient backlogs and
impacting ongoing revenues. We believe our products can help improve
patient throughput, which is now even more relevant for healthcare
providers and their patients. We believe that the ability to help
address the current backlog of elective surgeries, together with ongoing
shortages for existing drugs in these therapeutic areas, puts Acacia
Pharma in a strong position as the Company enters these markets."
Mr. Bolinder added: "It is a tremendous achievement for our company to
gain approval and launch two new products in the US within the course of
the last year. I would like to thank our partners at PAION as well as
the Acacia Pharma team and our stakeholders who have enabled us to bring
this new and innovative therapeutic to market, particularly given the
challenges caused by the pandemic over the past year."
Dr. Jim Phillips, Chief Executive Officer of PAION AG, stated: "We are
excited to support Acacia in their commercialization process, and we are
delighted by the strong commitment to BYFAVO by our US partner Acacia.
As sales build through the next months and years PAION will be receiving
royalties of between 20--25% in the US. We look forward to a successful
launch of what is a unique new product entering the market."
BYFAVO is now available for ordering in the US through the major
wholesalers and selected specialty distributors, including Cardinal
Health, Amerisource Bergen, Besse, McKesson, McKesson Medsurg, Morris
and Dickson, and Curascript.
###
Contacts
Acacia Pharma Group plc International Media
Mike Bolinder, CEO Mark Swallow, Frazer Hall, David
Gary Gemignani, CFO Dible
+44 1223 919760 / +1 317 505 1280 Citigate Dewe Rogerson
mailto:IR@acaciapharma.com IR@acaciapharma.com +44 20 7638 9571
mailto:acaciapharma@citigatedewerogerson.com
acaciapharma@citigatedewerogerson.com
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US Investors Media in Belgium and the Netherlands
LifeSci Advisors Chris Van Raemdonck
Irina Koffler +32 499 58 55 31
+1 917-734-7387 mailto:chrisvanraemdonck@telenet.be
mailto:ikoffler@lifesciadvisors.com chrisvanraemdonck@telenet.be
ikoffler@lifesciadvisors.com
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About Acacia Pharma
Acacia Pharma is a hospital pharmaceutical company focused on the
development and commercialization of new products aimed at improving the
care of patients undergoing significant treatments such as surgery,
other invasive procedures, or cancer chemotherapy. The Company has
identified important and commercially attractive unmet needs in these
areas that its product portfolio aims to address.
Acacia Pharma's first product, BARHEMSYS(R) (amisulpride injection) is
marketed in the US for the management of postoperative nausea & vomiting
(PONV).
BYFAVO(TM) (remimazolam) for injection, a very rapid onset/offset IV
benzodiazepine sedative is approved and launched in the US for use
during invasive medical procedures in adults lasting 30 minutes or less,
such as colonoscopy and bronchoscopy. BYFAVO is in-licensed from Paion
UK Limited for the US market.
APD403 (intravenous and oral amisulpride), a selective dopamine
antagonist for chemotherapy induced nausea & vomiting (CINV) has
successfully completed one proof-of-concept and one Phase 2 dose-ranging
study in patients receiving highly emetogenic chemotherapy.
Acacia Pharma has its US headquarters in Indianapolis, IN and its R&D
operations are centered in Cambridge, UK. The Company is listed on the
Euronext Brussels exchange under the ISIN code GB00BYWF9Y76 and ticker
symbol ACPH.
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www.acaciapharma.com
About BYFAVO(TM)
BYFAVO (remimazolam) for injection is a very rapid onset/offset
intravenous benzodiazepine sedative for use during invasive medical
procedures in adult patients lasting 30 minutes or less, such as during
colonoscopy and bronchoscopy. Approximately 25 million such procedures
take place annually in the US, of which around 90% use moderate
sedation.
Cosmo in-licensed the US rights to BYFAVO from Paion AG in 2016 and
together they have progressed the product candidate through to
registration. BYFAVO is now approved and launched in the US and is
indicated for the induction and maintenance of procedural sedation in
adults lasting 30 minutes or less.
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www.BYFAVO.com
Important Safety Information for BYFAVO(TM) (remimazolam) Injection
Indications
BYFAVO is a benzodiazepine indicated for the induction and maintenance
of procedural sedation in adults undergoing procedures lasting 30
minutes or less.
Important Safety Information
WARNING: PERSONNEL AND EQUIPMENT FOR MONITORING AND RESUSCITATION
AND RISKS FROM CONCOMITANT USE WITH OPIOID ANALGESICS
Personnel and Equipment for Monitoring and Resuscitation
-- Only personnel trained in the administration of
procedural sedation, and not involved in the conduct
of the diagnostic or therapeutic procedure, should
administer BYFAVO.
-- Administering personnel must be trained in the
detection and management of airway obstruction,
hypoventilation, and apnea, including the maintenance
of a patent airway, supportive ventilation, and
cardiovascular resuscitation.
-- BYFAVO has been associated with hypoxia, bradycardia,
and hypotension. Continuously monitor vital signs
during sedation and during the recovery period.
-- Resuscitative drugs, and age- and size-appropriate
equipment for bag-valve-mask--assisted ventilation
must be immediately available during administration
of BYFAVO.
Risks From Concomitant Use With Opioid Analgesics and Other Sedative-Hypnotics
Concomitant use of benzodiazepines, including BYFAVO, and opioid
analgesics may result in profound sedation, respiratory depression,
coma, and death. The sedative effect of intravenous BYFAVO can
be accentuated by concomitantly administered CNS depressant medications,
including other benzodiazepines and propofol. Continuously monitor
patients for respiratory depression and depth of
sedation.
------------------------------------------------------------------------------
Contraindication
BYFAVO is contraindicated in patients with a history of severe
hypersensitivity reaction to dextran 40 or products containing dextran
40.
Personnel and Equipment for Monitoring and Resuscitation
Clinically notable hypoxia, bradycardia, and hypotension were observed
in Phase 3 studies of BYFAVO. Continuously monitor vital signs during
sedation and through the recovery period. Only personnel trained in the
administration of procedural sedation, and not involved in the conduct
of the diagnostic or therapeutic procedure, should administer BYFAVO.
Administering personnel must be trained in the detection and management
of airway obstruction, hypoventilation, and apnea, including the
maintenance of a patent airway, supportive ventilation, and
cardiovascular resuscitation. Resuscitative drugs, and age- and
size-appropriate equipment for bag-valve-mask--assisted ventilation must
be immediately available during administration of BYFAVO. Consider the
potential for worsened cardiorespiratory depression prior to using
BYFAVO concomitantly with other drugs that have the same potential
(e.g., opioid analgesics or other sedative-hypnotics). Administer
supplemental oxygen to sedated patients through the recovery period. A
benzodiazepine reversal agent (flumazenil) should be immediately
available during administration of BYFAVO.
Risks From Concomitant Use With Opioid Analgesics and Other
Sedative-Hypnotics
Concomitant use of BYFAVO and opioid analgesics may result in profound
sedation, respiratory depression, coma, and death. The sedative effect
of IV BYFAVO can be accentuated when administered with other CNS
depressant medications (eg, other benzodiazepines and propofol). Titrate
the dose of BYFAVO when administered with opioid analgesics and
sedative-hypnotics to the desired clinical response. Continuously
monitor sedated patients for hypotension, airway obstruction,
hypoventilation, apnea, and oxygen desaturation. These cardiorespiratory
effects may be more likely to occur in patients with obstructive sleep
apnea, the elderly, and ASA-PS class III or IV patients.
Hypersensitivity Reactions
BYFAVO contains dextran 40, which can cause hypersensitivity reactions,
including rash, urticaria, pruritus, and anaphylaxis. BYFAVO is
contraindicated in patients with a history of severe hypersensitivity
reaction to dextran 40 or products containing dextran 40.
Neonatal Sedation
Use of benzodiazepines during the later stages of pregnancy can result
in sedation (respiratory depression, lethargy, hypotonia) in the
neonate. Observe newborns for signs of sedation and manage accordingly.
Pediatric Neurotoxicity
Published animal studies demonstrate that anesthetic and sedation drugs
that block NMDA receptors and/or potentiate GABA activity increase
neuronal apoptosis in the developing brain and result in long-term
cognitive deficits when used for longer than 3 hours. The clinical
significance of this is not clear. However, the window of vulnerability
to these changes is believed to correlate with exposures in the third
trimester of gestation through the first several months of life but may
extend out to approximately 3 years of age in humans.
Anesthetic and sedation drugs are a necessary part of the care of
children needing surgery, other procedures, or tests that cannot be
delayed, and no specific medications have been shown to be safer than
any other. Decisions regarding the timing of any elective procedures
requiring anesthesia should take into consideration the benefits of the
procedure weighed against the potential risks.
Adverse Reactions
The most common adverse reactions reported in >10% of patients (N=630)
receiving BYFAVO 5-30 mg (total dose) and undergoing colonoscopy (two
studies) or bronchoscopy (one study) were: hypotension, hypertension,
diastolic hypertension, systolic hypertension, hypoxia, and diastolic
hypotension.
Use in Specific Populations
Pregnancy
There are no data on the specific effects of BYFAVO on pregnancy.
Benzodiazepines cross the placenta and may produce respiratory
depression and sedation in neonates. Monitor neonates exposed to
benzodiazepines during pregnancy and labor for signs of sedation and
respiratory depression.
Lactation
Monitor infants exposed to BYFAVO through breast milk for sedation,
respiratory depression, and feeding problems. A lactating woman may
consider interrupting breastfeeding and pumping and discarding breast
milk during treatment and for 5 hours after BYFAVO administration.
Pediatric Use
Safety and effectiveness in pediatric patients have not been
established. BYFAVO should not be used in patients less than 18 years of
age.
Geriatric Use
No overall differences in safety or effectiveness were observed between
these subjects and younger subjects. However, there is a potential for
greater sensitivity (eg, faster onset, oversedation, confusion) in some
older individuals. Administer supplemental doses of BYFAVO slowly to
achieve the level of sedation required and monitor all patients closely
for cardiorespiratory complications.
Hepatic Impairment
In patients with severe hepatic impairment, the dose of BYFAVO should be
carefully titrated to effect. Depending on the overall status of the
patient, lower frequency of supplemental doses may be needed to achieve
the level of sedation required for the procedure. All patients should be
monitored for sedation-related cardiorespiratory complications.
Abuse and Dependence
BYFAVO is a federally controlled substance (CIV) because it contains
remimazolam which has the potential for abuse and physical dependence.
Please
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click to access full Prescribing Information for BYFAVO.
BYF HCP ISI 10/2020
(c) 2020 Acacia Pharma Group Plc
BYFAVO(TM) is a trademark owned or licensed by Cosmo Technologies Ltd.
About BARHEMSYS(R)
BARHEMSYS is a selective dopamine-2 (D(2) ) and dopamine-3 (D(3) )
receptor antagonist, which Acacia Pharma has developed and protected for
the management of PONV.
BARHEMSYS is indicated in adults for:
-- treatment of PONV in patients who have received antiemetic prophylaxis
with an agent of a different class or who have not received prophylaxis
-- prevention of PONV, either alone or in combination with an antiemetic of
a different class
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www.BARHEMSYS.com
Important Safety Information for BARHEMSYS(R) (amisulpride) Injection
Contraindication
BARHEMSYS is contraindicated in patients with known hypersensitivity to
amisulpride.
QT Prolongation
BARHEMSYS causes dose- and concentration-dependent prolongation of the
QT interval. The recommended dosage is 5 mg or 10 mg as a single
intravenous (IV) dose infused over 1 to 2 minutes.
Avoid BARHEMSYS in patients with congenital long QT syndrome and in
patients taking droperidol.
Electrocardiogram (ECG) monitoring is recommended in patients with
pre-existing arrhythmias/cardiac conduction disorders, electrolyte
abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart
failure, and in patients taking other medicinal products (e.g.,
ondansetron) or with other medical conditions known to prolong the QT
interval.
Adverse Reactions
Common adverse reactions reported in >= 2% of adult patients who
received BARHEMSYS 5 mg (n=748) and at a higher rate than placebo
(n=741) in clinical trials for the prevention of PONV were: chills (4%
vs. 3%), hypokalemia (4% vs. 2%), procedural hypotension (3% vs. 2%),
and abdominal distention (2% vs. 1%).
Serum prolactin concentrations were measured in one prophylaxis study
where 5% (9/176) of BARHEMSYS-treated patients had increased blood
prolactin reported as an adverse reaction compared with 1% (1/166) of
placebo-treated patients.
The most common adverse reaction, reported in >= 2% of adult patients
who received BARHEMSYS 10 mg (n=418) and at a higher rate than placebo
(n=416), in clinical trials for the treatment of PONV was infusion site
pain (6% vs. 4%).
Use in Specific Populations
Lactation
Amisulpride is present in human milk. There are no reports of adverse
effects on the breastfed child and no information on the effects of
amisulpride on milk production.
BARHEMSYS may result in an increase in serum prolactin levels, which may
lead to a reversible increase in maternal milk production. In a clinical
trial, serum prolactin concentrations in females (n=112) increased from
a mean of 10 ng/mL at baseline to 32 ng/mL after BARHEMSYS treatment and
from 10 ng/mL to 19 ng/mL in males (n=61). No clinical consequences due
to elevated prolactin levels were reported.
To minimize exposure to a breastfed infant, lactating women may consider
interrupting breastfeeding and pumping and discarding breast milk for 48
hours after receiving a dose of BARHEMSYS.
Pediatric Use
Safety and effectiveness in pediatric patients have not been
established.
Geriatric Use
No overall differences in safety or effectiveness were observed between
these patients and younger patients, and other reported clinical
experience has not identified differences in responses between the
elderly and younger patients, but greater sensitivity of some older
individuals cannot be ruled out.
Renal Impairment
Avoid BARHEMSYS in patients with severe renal impairment (estimated
glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2). The
pharmacokinetics of amisulpride in patients with severe renal impairment
have not been adequately studied in clinical trials. Amisulpride is
known to be substantially excreted by the kidneys, and patients with
severe renal impairment may have increased systemic exposure and an
increased risk of adverse reactions.
No dosage adjustment is necessary in patients with mild to moderate
renal impairment
(eGFR >= 30 mL/min/1.73 m2).
Drug Interactions
-- BARHEMSYS causes dose- and concentration-dependent QT prolongation. To
avoid potential additive effects, avoid use of BARHEMSYS in patients
taking droperidol.
-- ECG monitoring is recommended in patients taking other drugs known to
prolong the QT interval (e.g., ondansetron).
-- Reciprocal antagonism of effects occurs between dopamine agonists (e.g.,
levodopa) and BARHEMSYS. Avoid using levodopa with BARHEMSYS.
Please
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click to access full Prescribing Information for BARHEMSYS.
Forward looking statements
This announcement includes forward-looking statements, which are based
on current expectations and projections about future events. These
statements may include, without limitation, any statements preceded by,
followed by or including words such as "believe", "expect", "intend",
"may", "plan", "will", "should", "could" and other words and terms of
similar meaning or the negative thereof. Forward-looking statements may
and often do differ materially from actual results. These
forward-looking statements are subject to risks, uncertainties and
assumptions about the Company and its subsidiaries and investments,
including, among other things, the development of its business, trends
in its operating industry, and future capital expenditures and
acquisitions. By their nature, forward-looking statements involve risk
and uncertainty because they relate to future events and circumstances.
Any forward-looking statements reflect the Company's current view with
respect to future events and are subject to risks relating to future
events and other risks, uncertainties and assumptions relating to the
Group's business, results of operations, financial position, prospects,
growth or strategies and the industry in which it operates. Save as
required by law or applicable regulation, the Company and its affiliates
expressly disclaim any obligation or undertaking to update, review or
revise any forward-looking statement contained in this announcement
whether as a result of new information, future developments or
otherwise. Forward-looking statements speak only as of the date they are
made.
(END) Dow Jones Newswires
January 28, 2021 01:00 ET (06:00 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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