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Sage Therapeutics Announces U.S. Drug Enforcement Administration Scheduling of ZULRESSO™ (brexanolone) Injection

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On track for full commercial launch in the U.S. in late June

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Sage Therapeutics (NASDAQ: SAGE), a biopharmaceutical company developing
novel medicines to treat life-altering central nervous system (CNS)
disorders, today announced that the U.S. Drug Enforcement Administration
(DEA) has placed ZULRESSO™ (brexanolone) injection into Schedule IV of
the Controlled Substances Act. ZULRESSO, which was approved by the U.S.
Food and Drug Administration (FDA) on March 19, 2019, is the first and
only treatment specifically approved for postpartum depression (PPD),
the most common medical complication of childbirth.


With this decision, the product label for ZULRESSO will be finalized.
The Company expects to launch ZULRESSO in late June as planned. ZULRESSO
is administered via continuous intravenous (IV) infusion for 2.5 days
under the supervision of healthcare providers in sites of care certified
under the ZULRESSO Risk Evaluation and Mitigation Strategy (REMS)
program. The one-time infusion offers the potential for rapid resolution
of depressive symptoms of PPD.

“Historically, women suffering from PPD may have avoided seeking help
because of the stigma, lack of a specifically approved treatment and the
complicated journey to care – challenges that have been difficult for
women with PPD and their families to overcome,” said Mike Cloonan, chief
business officer at Sage. “Sage is taking on those challenges and
creating a family-centric approach to ZULRESSO availability by enabling
pathways to care including building our patient support organization,
where we will provide a range of meaningful support resources to women
with PPD and their families to help navigate the ZULRESSO treatment
journey. We also continue to activate Centers of Excellence across the
country with the goal of supporting a positive patient experience and
broad availability to ZULRESSO for women with PPD.”

The Company continues to focus on identifying and activating Centers of
Excellence (COE) and other healthcare settings capable of administering
ZULRESSO to women with PPD. The key criteria for identifying a potential
COE or other sites of care include: a PPD healthcare provider champion;
the ability to secure appropriate payer reimbursement for ZULRESSO; and
the capability to meet the requirements for certification under the
ZULRESSO REMS, which includes monitoring by qualified trained staff,
adherence to specific protocols and the maintenance of a patient
registry. The Company continues to execute against its planned
go-to-market strategy with a focus on the commercial launch of ZULRESSO
in late June.

For more information on ZULRESSO, including the final product label,
visit www.sagerx.com.

About Postpartum Depression
Postpartum depression (PPD) is
the most common medical complication of childbirth. PPD is a distinct
and readily identified major depressive episode that can occur during
pregnancy or after giving birth. Expert opinions vary as to the timing
of the onset of PPD, ranging from onset during pregnancy up to 4-weeks
postpartum and onset during pregnancy up to 12-months postpartum. PPD
may have devastating consequences for a woman and for her family, which
may include significant functional impairment, depressed mood and/or
loss of interest in her newborn, and associated symptoms of depression
such as loss of appetite, difficulty sleeping, motor challenges, lack of
concentration, loss of energy and poor self-esteem. PPD can be a
life-threatening condition due to the risk of suicide, a leading cause
of maternal death following childbirth. PPD is estimated to affect
approximately one in nine women who have given birth in the U.S. and
400,000 women annually. More than half of these cases may go undiagnosed
without proper screening.

About ZULRESSO™ (brexanolone) injection
ZULRESSO, the first
medicine specifically approved by the U.S. Food and Drug
Administration (FDA) for the treatment of postpartum depression (PDD) in
adults, is a positive allosteric modulator of both synaptic and
extrasynaptic GABAA receptors. Allosteric modulation of
neurotransmitter receptor activity results in varying degrees of desired
activity rather than complete activation or inhibition of the receptor.

What is ZULRESSO?

ZULRESSO™ (brexanolone) CIV is a prescription medicine used in adults to
treat a certain type of depression called Postpartum Depression.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about ZULRESSO?

ZULRESSO can cause serious side effects, including:

  • Excessive sedation and sudden loss of consciousness. ZULRESSO
    may cause you to feel very sleepy (excessive sedation) or pass out
    (loss of consciousness). Your healthcare provider should check you for
    symptoms of excessive sleepiness every 2 hours while you are awake.

    • During your ZULRESSO infusion, tell your healthcare provider right
      away if you feel like you cannot stay awake during the time you
      are normally awake or if you feel like you are going to pass out.
      Your healthcare provider may lower your dose or stop the infusion
      until symptoms go away.
    • You must have a caregiver or family member with you to help care
      for your child(ren) during your ZULRESSO infusion.
  • Because of the risk of serious harm resulting from excessive sedation
    or sudden loss of consciousness, ZULRESSO is only available through a
    restricted program called the ZULRESSO REMS.

Before receiving ZULRESSO, tell your healthcare provider about all
your medical conditions, including if you:

  • drink alcohol
  • have kidney problems
  • are pregnant or think you may be pregnant. It is not known if ZULRESSO
    will harm your unborn baby.

    • There is a pregnancy registry for females who are exposed to
      ZULRESSO during pregnancy. The purpose of the registry is to
      collect information about the health of females exposed to
      ZULRESSO and their baby. If you become pregnant during treatment
      with ZULRESSO, talk to your healthcare provider about registering
      with the National Pregnancy Registry for Antidepressants at
      1-844-405-6185 or visit https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/
  • are breastfeeding or plan to breastfeed. ZULRESSO passes into breast
    milk. Talk to your healthcare provider about the risks and benefits of
    breastfeeding and about the best way to feed your baby while receiving
    ZULRESSO.

Tell your healthcare provider about all the medicines you take, including
prescription and over-the-counter medicines, vitamins, and herbal
supplements.

ZULRESSO and some medicines may interact with each other and cause
serious side effects.

Especially tell your healthcare provider if you take other
antidepressants, opioids, or Central Nervous System (CNS) depressants
(such as benzodiazepines).

Know the medicines you take. Keep a list of them to show your healthcare
provider and pharmacist when you get a new medicine. Your healthcare
provider will decide if other medicines can be taken with ZULRESSO.

How will I receive ZULRESSO?

ZULRESSO is given to you by continuous intravenous (IV) infusion into
your vein. The infusion will last for a total of 60 hours (2.5 days).

What should I avoid while receiving ZULRESSO?

  • ZULRESSO may make you feel dizzy and sleepy. Do not drive a car or do
    other dangerous activities after your ZULRESSO infusion until your
    feeling of sleepiness has completely gone away. See “What is the
    most important information I should know about ZULRESSO?
  • Do not drink alcohol while receiving ZULRESSO.

What are the possible side effects of ZULRESSO?

ZULRESSO can cause serious side effects, including:

  • See “What is the most important information I should know about
    ZULRESSO?
  • Increased risk of suicidal thoughts or actions. ZULRESSO and
    other antidepressant medicines may increase suicidal thoughts and
    actions in some people 24 years of age and younger. Depression or
    other serious mental illnesses are the most important causes of
    suicidal thoughts or actions.

How can I watch for and try to prevent suicidal thoughts and actions?

  • Pay close attention to any changes, especially sudden changes in mood,
    behavior, thoughts, or feelings, or if you develop suicidal thoughts
    or actions.
  • Tell your healthcare provider right away if you have any new or sudden
    changes in mood, behavior, thoughts, or feelings.
  • Keep all follow-up visits with your healthcare provider as scheduled.
    Call your healthcare provider between visits as needed, especially if
    you have concerns about symptoms.

Tell your healthcare provider right away if you have any of the
following symptoms, especially if they are new, worse, or worry you:

  • Attempts to commit suicide, thoughts about suicide or dying, new or
    worse depression, other unusual changes in behavior or mood

The most common side effects of ZULRESSO include:

  • Sleepiness, dry mouth, passing out, flushing of the skin or face.

These are not all the side effects of ZULRESSO.

Call your doctor for medical advice about side effects. You may report
side effects to FDA at 1-800-FDA-1088.

Please see Full
Prescribing Information including Boxed Warning
and Medication
Guide
for ZULRESSO™ and discuss any questions you may have with
your healthcare provider.

About Sage Therapeutics
Sage Therapeutics is a
biopharmaceutical company committed to developing novel medicines to
transform the lives of patients with life-altering CNS disorders.
ZULRESSO™ (brexanolone) injection is a rapidly acting GABA modulator now
approved by the U.S. Food and Drug Administration as the first and only
treatment specifically indicated for postpartum depression. Sage is
developing a portfolio of novel product candidates targeting critical
CNS receptor systems, including SAGE-217, which is in Phase 3
development in major depressive disorder and postpartum depression. For
more information, please visit www.sagerx.com.

Forward-Looking Statements
Various statements in this
release concern Sage’s future expectations, plans and prospects,
including without limitation: our expectations regarding the timing of
availability and launch of ZULRESSO in the treatment of PPD; our plans
regarding commercial activities and patient support; our expectations
regarding availability of REMS-certified sites of care for the
administration of ZULRESSO; our expectations regarding access to
treatment for women with PPD; our statements regarding the potential
benefit of ZULRESSO in the treatment of PPD; our estimates as to the
number of women who suffer from PPD; and other statements regarding the
potential and our plans and expectations for ZULRESSO and our other
programs and business.
These statements constitute
forward-looking statements as that term is defined in the Private
Securities Litigation Reform Act of 1995. These forward-looking
statements are neither promises nor guarantees of future performance,
and are subject to a variety of risks and uncertainties, many of which
are beyond our control, which could cause actual results to differ
materially from those contemplated in these forward-looking statements,
including the risks that: availability and launch of ZULRESSO may not
occur on the timelines we expect; we may encounter issues or other
challenges in launching and commercializing ZULRESSO, including issues
related to market acceptance by healthcare providers, healthcare
settings and women with PPD, issues related to availability of sites of
care,
challenges with reimbursement, other issues related to
limitations on the site of administration of ZULRESSO to REMS-certified
supervised healthcare settings and the other requirements of the REMS,
and challenges associated with execution of our marketing, sales and
patient support activities, which in each case could limit the potential
of ZULRESSO; results achieved with use of ZULRESSO in the treatment of
PPD once we have launched the product may be different than observed in
clinical trials, and may vary among patients; the number of women with
PPD or the unmet need for additional treatment options may be
significantly smaller than we expect; we may encounter unexpected safety
or tolerability issues with ZULRESSO or any of our product candidates;
we may encounter supply issues with respect to ZULRESSO or any of our
product candidates; we may not be successful in our development of any
of our current or future product candidates in any indication we are
currently pursuing or may in the future pursue; success in early stage
clinical trials may not be repeated or observed in ongoing or future
studies of any of our product candidates; ongoing and future clinical
results may not support further development or be sufficient to gain
regulatory approval of our product candidates; we may decide that a
development pathway for one of our product candidates in one or more
indications is no longer feasible or advisable or that the unmet need no
longer exists; the FDA may decide that the development program for any
of our product candidates, even if positive, is not sufficient for a new
drug application filing or approval; and we may encounter technical and
other unexpected hurdles in the commercialization of ZULRESSO or in the
development of our product candidates; as well as those risks more fully
discussed in the section entitled “Risk Factors” in our most recent
report filed with the Securities and Exchange Commission (SEC), and
discussions of potential risks, uncertainties, and other important
factors in our subsequent filings with the SEC. In addition, any
forward-looking statements represent our views only as of today, and
should not be relied upon as representing our views as of any subsequent
date. We explicitly disclaim any obligation to update any
forward-looking statements.

Contacts

Investor Contact:
Maren Killackey, 617-949-4113
maren.killackey@sagerx.com

Media
Contact:

Alexis Smith, 617-588-3740
alexis.smith@sagerx.com

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Business Wire

Acquia Unveils Faster, Easier Personalization for Marketers

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Announced at Acquia Engage Europe; the Only Personalization Tool
Optimized for Drupal Helps Marketers Build and Launch No-Code
Personalizations for Superior Digital Experiences

LONDON–(BUSINESS WIRE)–Acquia
today announced the all-new Acquia
Lift
, the only personalization tool optimized for Drupal,
now available as a no-code application to help marketers quickly and
easily optimize customer experiences. The new product was unveiled at Acquia
Engage Europe
, where attendees got a first look at Acquia’s
data-driven personalization solution.

To meet customer expectations, marketers recognize the need to offer
more personalized experiences. However, research
shows nearly three-fourths (74 percent) of marketers globally feel like
technology has made it harder, not easier, to do this.

The latest release of Acquia Lift addresses this challenge head-on with
a unified and marketer-ready interface, allowing users to execute all
profile management, segmentation, and personalization activities in a
single place. Anyone — regardless of technical acumen — can point,
click, and personalize without any code.

“In this competitive, fast-paced market, we know how important it is for
businesses to be agile enough to quickly deliver relevant, customized
content to users,” said Shareen Campbell, Head of Global Partnerships &
Alliances, EPAM. “As an Acquia Global Select Partner, we’re excited to
leverage Acquia Lift’s new capabilities and continue to enhance our
clients’ digital platforms and customer experiences through
personalization.”

“As a non-profit health system with more than 200 sites of care and
affiliates, we pride ourselves on offering convenient access to
exceptional healthcare services, where and when patients need them—in
hospitals, health pavilions and doctor’s offices, as well as workplaces,
schools and homes,” said Debbie Kenemer, Executive Director, Digital
Marketing at Community
Health Network
. “Our digital properties have to be equally focused
on our patients and their needs. Acquia Lift helps us better understand
our site visitors and put more relevant and specific information and
services in front of them, increasing the opportunities that help them
live healthier while also securing the care and information that’s
important.”

New key capabilities for Acquia Lift include:

  • Simple campaign creation — enabling marketers to create
    complex personalization campaigns in three simple steps
  • Testing and targeting with no code — powering the creation and
    launch of website personalization without technical skill
  • Clearly defined personalization campaign types — users can
    launch A/B tests, target personalizations to specific audiences, or
    recommend content across a series of sessions to deliver the best
    possible experience
  • Enhanced scheduling — helping marketing teams align
    personalizations to events, promotions, sales, and press activities
  • Real-time dashboards and advanced analytics — providing the
    ability to quickly review activities and metrics for both optimizing
    and validating marketing investment

“In today’s world, personalization is at the core of successful customer
experiences. As a result, we have seen rapid adoption of Acquia Lift,
which is now used by leading brands like Wendy’s, Bayer, and BlueCross
BlueShield,” said Dries Buytaert, Acquia co-founder and CTO. “Most
organizations know that personalization is no longer optional, but put
it off because it can be difficult. Acquia Lift, in combination with our
other solutions, solves that. It provides a powerful, yet easy-to-use,
platform that drives real business results – helping you understand your
customers, and improve engagement with relevant, personalized content.”

Resources:

About Acquia
Acquia is the open source digital experience
company. We provide the world’s most ambitious brands with technology
that allows them to embrace innovation and create customer moments that
matter. At Acquia, we believe in the power of community – giving our
customers the freedom to build tomorrow on their terms. To learn more,
visit acquia.com.

All logos, company and product names are trademarks or registered
trademarks of their respective owners.

Contacts

Jenny Radloff or Kate Lavoie-Mayer
PAN Communications
acquia@pancomm.com
+1
617 502 4300

Kaitlyn Ethier
Acquia
pr@acquia.com
+1
978 578 0480

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Business Wire

Temenos Successfully Delivers a Single, State-of-the-Art Digital Platform for ABN AMRO’s Private and Corporate Banking Business

Business Wire

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Dutch banking giant goes live with Temenos’ award-winning WealthSuite
to achieve improved cost/income ratio and faster time to market with one
rationalized product menu across all countries

GENEVA–(BUSINESS WIRE)–Temenos (SIX: TEMN), the banking software company, today announced that
ABN AMRO has gone live with Temenos’ WealthSuite digital banking
platform, which will power the bank’s international operations for
private and corporate banking. The shift to a single shared digital
banking platform will allow ABN AMRO to reduce IT operational costs and
achieve an improved cost/ income ratio. The open digital banking
platform will future-proof ABN AMRO’s growth and enable the bank to
deliver innovative and personalized products and services faster to
market.

Belgium is the first international branch to go live with the Temenos
solution under ABN AMRO’s rollout plan, which will see the bank migrate
two additional countries on the new platform in the coming years.

ABN AMRO joins the growing list of top tier banks that have deployed
Temenos WealthSuite to transform their wealth management operations.
With Temenos WealthSuite, ABN AMRO will deploy an end-to-end, highly
scalable and configurable platform that will allow the bank to benefit
from considerable efficiency gains. This will be achieved by automating
and simplifying processes and streamlining IT and business operations.

Cognizant, a global Temenos partner, has been providing consulting and
system integration services for the project. By using a single core
banking system, the bank can now launch a new corporate bank within nine
month, as recently seen in Australia.

ABN AMRO has been a pioneer in digital banking and a Temenos client for
over a decade. Temenos and ABN AMRO have a proven record of
co-innovation. ABN AMRO implemented Temenos T24 Core Banking platform –
the forerunner to Temenos T24 Transact – to transform its corporate
banking activities in 2009 and serve the needs of its international
business in nine countries. ABN AMRO also uses Temenos Payments. The
bank recently selected
the Temenos Continuous Deployment
product to speed up its software
delivery and rapidly launch new innovations.

Friso Westra, Head of IT Development Core Banking International of
ABN AMRO said:
We selected Temenos as our technology partner to
future-proof the ongoing growth of our private bank. Working closely
with Temenos and our implementation partner, Cognizant we experienced a
smooth go-live. I am excited as this is a big step for ABN AMRO in
harmonizing our IT infrastructure and speeding up digitization. We run
our corporate and part of our private banking operations now from one
single digital platform. We expect IT costs savings and efficiencies
from the standardization of processes and products. With Temenos
WealthSuite we are confident of achieving our ambition in offering the
most innovative wealth management products and services in the industry.”

Max Chuard, Chief Executive Officer, stated: We are proud to
support ABN AMRO, one of the largest and most innovative banks in
Europe, with its digital transformation journey. ABN AMRO will have a
single, state- of- the- art banking platform and benefit from massive
economies of scale, reduced IT operational costs and personalized
customer experience. The platform will support traditional and digitized
interactions, process automation and standardization of products, which
means faster time to market and increased business agility. Our
cloud-native, cloud-agnostic and advanced open API software enables ABN
AMRO to drastically reduce transformation time and cost.”

Santosh Thomas, President, Global Growth Markets, Cognizant, said:
We are excited to be working on ABN AMRO’s digital transformation
project with Temenos, a long-standing strategic partner. The digital
banking platform, based on Temenos software, will enable ABN AMRO to
streamline processes across its corporate and private banking business,
benefit from cost efficiencies in IT and business operations and serve
customers in a faster, more cost effective way.”

Temenos WealthSuite provides multi-channel, 24/7 real-time capability to
support wealth managers in delivering superior service to clients, while
allowing advisors to automate time-consuming compliance and back-office
functions. WealthSuite currently helps advisors manage $12trillion
assets under management.

– Ends –

About ABN AMRO
ABN AMRO is a Dutch bank for retail,
corporate and private banking clients. We are a relationship-driven,
knowledgeable and digitally savvy bank, active in Northwest Europe and
with expertise in selected sectors globally. Our purpose is Banking for
better, for generations to come. Headquartered in Amsterdam, ABN AMRO
employs around 19,000 people worldwide.

Please visit us at www.abnamro.com

About Temenos
Temenos AG (SIX: TEMN), headquartered in
Geneva, is the world’s leader in banking software, partnering with banks
and other financial institutions to transform their businesses and stay
ahead of a changing marketplace. Over 3,000 firms across the globe,
including 41 of the top 50 banks, rely on Temenos to process both the
daily transactions and client interactions of more than 500 million
banking customers. Temenos offers cloud-native, cloud-agnostic front
office and core banking, payments, fund management and wealth management
software products enabling banks to deliver both consistent,
frictionless customer journeys and gain operational excellence. Temenos
customers are proven to be more profitable than their peers: over a
seven-year period, they enjoyed on average a 31% higher return on
assets, a 36% higher return on equity and an 8.6 percentage point lower
cost/income ratio than banks running legacy applications. For more
information please visit www.temenos.com.

Contacts

Jessica Wolfe
Temenos Global Public Relations
Tel: +1
610 232 2793
Email : press@temenos.com

Alistair Kellie & Andrew Adie
Newgate Communications on
behalf of Temenos
Tel: +44 20 7680 6550
Email: allnewgatetemenos@newgatecomms.com

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Business Wire

Acquia Delivers 316% ROI According to Total Economic Impact Study

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Independent study evaluates the financial impact of deploying Acquia
Cloud Site Factory and Acquia Lift together for seamless content
management and personalization

LONDON–(BUSINESS WIRE)–Acquia
today unveiled the results of an independent commissioned Total
Economic Impact (TEI™) study
conducted by Forrester Consulting on
behalf of Acquia that examines the potential return on investment (ROI)
enterprises may realize by deploying Acquia
Cloud Site Factory
and Acquia
Lift
in tandem. Forrester Consulting director of research Jon
Erickson will present key findings from the study today at Acquia
Engage Europe 2019
, the company’s marquee customer and partner
conference taking place at the Royal Garden Hotel, Kensington, London.

To understand the business benefits and cost savings of Acquia’s
products for enterprises, Forrester interviewed several customers with
years of experience using Acquia Cloud Site Factory in conjunction with
Acquia Lift to streamline site creation and management while also
delivering engaging and personalized content. Forrester’s financial
analysis found that customers quantified key benefits from investment in
Acquia, resulting in benefits of $8.3 million over three years.

The study found that Acquia customers experience:

  • 85 percent faster time to market of new sites and features,
  • 60 percent more productive digital marketing teams, and
  • 3 percent improved customer retention from increased audience
    engagement

“Forrester’s analysis is consistent with what we hear from our customers
— that they find a material return on investment when they deploy our
products, and the returns come both on the top line and the bottom
line,” said Mike Sullivan, Acquia CEO.

Acquia’s portfolio empowers today’s businesses to challenge the customer
experience (CX) status quo through unparalleled content management
capabilities, comprehensive digital insights, and limitless integration.
Its open source foundation allows enterprises to gain the deep and
holistic customer insights they need to create experiences that matter
and act upon them at the speed of the market, unfettered and on their
own terms.

“Prior to using Acquia Cloud Site Factory and Acquia Lift, the
interviewed organizations were typically managing their websites across
many different legacy systems and working with multiple agencies, with
no consistent or unified process in place to manage and update their
sites,” stated the June 2019 Forrester Consulting report ‘The Total
Economic Impact of Acquia Cloud Site Factory and Acquia Lift.’ “These
organizations were frustrated with the expense, time, and resources it
took to manage and create their sites and lacked the insights required
to create personalized experiences. These organizations looked for a
solution to help them create a centralized view of their content and
customer data.“

The full study is available
for download from Acquia
.

About Acquia

Acquia is the open source digital experience company. We provide the
world’s most ambitious brands with technology that allows them to
embrace innovation and create customer moments that matter. At Acquia,
we believe in the power of community – giving our customers the freedom
to build tomorrow on their terms. To learn more, visit acquia.com.

All logos, company and product names are trademarks or registered
trademarks of their respective owners.

Contacts

Jenny Radloff or Kate Lavoie-Mayer
PAN Communications
acquia@pancomm.com
+1
617 502 4300

Kaitlyn Ethier
Acquia
pr@acquia.com
+1
978 578 0480

Continue Reading

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