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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

2019 Super Penguin Celebrity Game Sees a Successful Completion

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Ginóbili and Parker Lead the Highest-standard Game

SHANGHAI–(BUSINESS WIRE)–On September 21st, 2019 (Beijing time), the 2019 Super Penguin Celebrity Game completed successfully at the Shanghai Oriental Sports Center. NBA legendaries Manu Ginóbili and Tony Parker joined hands with Li Chen, Zheng Kai, Xiao Jingteng and other celebrities, and presented a cross-border basketball game for the audience. The game ended at 45-56, team Red Force took the prize from team Blue Energy. YeZhou won the MVP with his excellent performance.

ESPN live broadcasted the game in various countries and regions including Australia, Brazil, Japan, Mexico, New Zealand, Singapore, and the United States. It has spread the fascination of the game to every continent except the Antarctic.

The Super Penguin Celebrity Game is a celebrity basketball event that brings together professional basketball players and hottest entertainment celebrities. Initiated by Tencent Sports (SEHK: 700) in 2016, the Super Penguin Celebrity Game has been successfully held for four consecutive years, attracting more than 160 basketball players and entertainment celebrities, including NBA legends such as Tracy McGrady, Allen Iverson, Paul Pierce, Ray Allen and Chris Bosh, and entertainment stars like Kris Wu, Bai Jingting, Xiao Jingteng.

In fact, the Super Penguin Celebrity Game is composed of a basketball reality show and a basketball game. The basketball reality show involves 32 entertainment stars, which are divided into 16 teams. With the professional guidance from NBA legend Manu Ginóbili and world-renowned trainer Ganon Baker, the players boosted their egos through the tough training and intense competitions lasting 8 weeks. The show has attracted more than 30 million individual users, among who female viewers account for more than 40%, making the show a pioneer in breaking the boundary between sports and entertainment.

Through 4 years of exploration, the Super Penguin Celebrity Game has developed from a single event to a matrix of contents comprising variety shows and sports events. It has become an exemplary IP integrating sports and entertainment, while it also has built the presence of basketball among the mass public.

Contacts

David Andrew

davidandrew@foxmail.com

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IRI to Discuss Advertising Campaign Data Analytics Strategies in Three Sessions at Advertising Week New York

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–(BUSINESS WIRE)–IRI:

WHO:

At the “ The State of AI” session, presenters will be:

 

Nishat Mehta, President, Media Center of Excellence, IRI®

 

Jocelyn Lee, Head of AI, Heat

Nate Rackiewicz, Chairman and Co-Founder, METEOR NOW

 

Sara Robertson, Global Vice President, Product and Engineering, Xaxis

 

At the “So Much Data…So Little Time” session, presenters will be:

JP Beauchamp, Senior Vice President, Media Center of Excellence, IRI

Christine Frohlich, Vice President Product Marketing, Experian

 

Duncan McCall, Founder and Chief Executive Officer, PlaceIQ

 

Elliott Easterling, Co-Founder and Chief Executive Officer, TrueData

 

 

At the “Measurement on Demand” session, presenters will be:

Vijoy Gopalakrishnan, Senior Vice President, Media Center of Excellence, IRI

Abishake Subramanian, Director, Digital Advertising, Media Sales and Strategy, Sam’s Club

Adam Gitlin, Head of Data, Annalect

Lisa Hill, Brand Manager, Starbucks At Home Coffee/Personalized Marketing, Nestlé Coffee Partners

 

Maciej Szczepaniak, Global Brand Measurement, Lead Google

 

 

WHAT:

On September 23, IRI’s Nishat Mehta will participate on a panel with the Heat’s Jocelyn Lee, METEOR NOW’s Nate Rackiewicz and Xaxis’ Sara Robertson to discuss the use of AI in technology and measurement mechanisms, the effect on creative and talent resources and risks in brand safety and fraud, during their session titled, “The State of AI.

 

Later that day, IRI’s JP Beauchamp will serve on a panel with Experian’s Christine Frohlich, PlaceIQ’s Duncan McCall and TrueData’s Elliott Easterling that will cover the endless amounts of data available to brands. The panel will provide advice to brand managers on top methods to integrating online and offline data, executing omnichannel campaigns, reducing media waste through better targeting strategies as well as measuring campaigns effectively, during their session titled, “So Much Data…So Little Time.

 

 

On September 26, IRI’s Vijoy Gopalakrishnan will take the stage with Sam’s Club’s Abishake Subramanian, Annalect’s Adam Gitlin, Nestlé Coffee Partners’ Lisa Hill and Google’s Maciej Szczepaniak to discuss the longstanding challenge faced by marketers — on demand advertising effectiveness measurement. The panel will review tools available to marketers such as in-flight optimization, better and less expensive measurement techniques and connecting advertising effectiveness to bottom of the funnel metrics, during their session titled, “Measurement on Demand.

 

WHY:

 

 

Brands are faced with an immense amount of data, and it is now the job of marketers to decipher the data to find the best product lines, advertising campaigns or social media influencers that most align with that company. In today’s data-focused world, brands must be able to utilize artificial intelligence and machine learning techniques to interpret vast data sets in order to create quality products and target the right customers.

 

WHEN:

The State of AI

 

Monday, September 23, 2019

9:15 a.m. – 10:00 a.m. ET

 

So Much Data…So Little Time

 

Monday, September 23, 2019

10:45 a.m. – 11:30 a.m. ET

 

Measurement on Demand

 

Thursday, September 26, 2019

4:30 p.m. – 5:15 p.m. ET

 

WHERE:

Advertising Week New York

AMC Lincoln Square Campus

1998 Broadway

 

New York City, NY 10023

About IRI

IRI is a leading provider of big data, predictive analytics and forward-looking insights that help CPG, OTC health care organizations, retailers, financial services and media companies grow their businesses. A confluence of major external events — a change in consumer buying habits, big data coming into its own, advanced analytics and personalized consumer activation — is leading to a seismic shift in drivers of success in all industries. With the largest repository of purchase, media, social, causal and loyalty data, all integrated on an on-demand, cloud-based technology platform, IRI is empowering the personalization revolution, helping to guide its more than 5,000 clients around the world in their quests to remain relentlessly relevant, capture market share, connect with consumers, collaborate with key constituents and deliver market-leading growth. For more information, visit www.iriworldwide.com.

Contacts

IRI:

Victoria Guimarin

UPRAISE Marketing + PR for IRI

Email: iri@upraisepr.com
Phone: +1 415.397.7600

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Spirit of Wipro Run Brings Together Participants from 110 Cities Across 34 Nations

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EAST BRUNSWICK, N.J. & BANGALORE, India–(BUSINESS WIRE)–#FurtherTogether–Wipro Limited (NYSE: WIT) (BSE: 507685) (NSE: WIPRO), a leading global information technology, consulting and business process services company, today organized the 14th edition of the ‘Spirit of Wipro’ (SOW) Run in 110 cities across 34 countries.

The theme for this year’s Run was “#FurtherTogether”, which celebrated the spirit of camaraderie and several thousands of Wipro employees, their friends and families, alumni, customers, partners and suppliers came together for the event.

The SOW Run reinforces the core values of the organization-

  • Be passionate about clients’ success,
  • Treat each person with respect,
  • Be global and responsible and
  • Unyielding integrity in everything we do.

This annual global event has people stepping forward together as a community to bring about progressive change in the society.

Commenting on the run, Abidali Z Neemuchwala, Chief Executive Officer and Managing Director, Wipro Limited said, “The SOW Run is our annual, global tradition. This year’s theme of ‘FurtherTogether’ is aimed to inspire everyone to go the extra mile and is a reminder that anyone can achieve anything if they put their mind to it. We celebrate the collective spirit of Wiproites across the world on this special day and appreciate their contributions towards social causes globally.”

Saurabh Govil, President and Chief Human Resources Officer, Wipro Limited said, “The SOW Run celebrates the people of Wipro. Over the years, this annual run has become one of the largest employee engagement events in the world. Every year the run brings together our employees, their families and friends, clients, partners and suppliers. It is a great testament of what the spirit of togetherness and genuine collaboration can achieve.”

The SOW Run 2019 was organized in New Jersey, Portland, Mountain View, Atlanta, Tampa, Boston, Austin, Dallas, Reading, Perth, Melbourne, Sydney, Edmonton, Ottawa, Dublin, Yokohama, Kuala Lumpur, Curitiba, Guadalajara, Mexico City, Cebu, Manila, Doha, Dubai, Dalian, Singapore, Johannesburg, and Zurich among other cities.

In India, the SOW Run 2019 was held in 15 cities, including Bangalore, Delhi, Mumbai, Chennai, Pune and Kolkata. The event saw an officially timed 21K or half marathon in Bangalore, Chennai, Pune and Hyderabad. This apart, timed 10K was held in Bangalore, Pune, Chennai, Delhi, Mumbai and Hyderabad.

Each year the proceeds from the SOW Run are used towards social causes identified by the locations, globally. The funds raised by the runners globally are matched 100% by Wipro Limited and are utilized by Wipro Cares, the community initiatives arm of Wipro Limited. In the United States, where Wipro has a significant presence, the funds will be used to support educational programmes in underserved communities. In India, the 2019 edition of the Run is supporting the educational needs of underprivileged and disadvantaged children.

About Wipro Limited

Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO) is a leading global information technology, consulting and business process services company. We harness the power of cognitive computing, hyper-automation, robotics, cloud, analytics and emerging technologies to help our clients adapt to the digital world and make them successful. A company recognized globally for its comprehensive portfolio of services, strong commitment to sustainability and good corporate citizenship, we have over 175,000 dedicated employees serving clients across six continents. Together, we discover ideas and connect the dots to build a better and a bold new future.

Forward-looking and Cautionary Statements

Certain statements in this release concerning our future growth prospects are forward-looking statements, which involve a number of risks, and uncertainties that could cause actual results to differ materially from those in such forward-looking statements. The risks and uncertainties relating to these statements include, but are not limited to, risks and uncertainties regarding fluctuations in our earnings, revenue and profits, our ability to generate and manage growth, intense competition in IT services, our ability to maintain our cost advantage, wage increases in India, our ability to attract and retain highly skilled professionals, time and cost overruns on fixed-price, fixed-time frame contracts, client concentration, restrictions on immigration, our ability to manage our international operations, reduced demand for technology in our key focus areas, disruptions in telecommunication networks, our ability to successfully complete and integrate potential acquisitions, liability for damages on our service contracts, the success of the companies in which we make strategic investments, withdrawal of fiscal governmental incentives, political instability, war, legal restrictions on raising capital or acquiring companies outside India, unauthorized use of our intellectual property, and general economic conditions affecting our business and industry. Additional risks that could affect our future operating results are more fully described in our filings with the United States Securities and Exchange Commission. These filings are available at www.sec.gov. We may, from time to time, make additional written and oral forward-looking statements, including statements contained in the company’s filings with the Securities and Exchange Commission and our reports to shareholders. We do not undertake to update any forward-looking statement that may be made from time to time by us or on our behalf.

Contacts

Wipro Media Contact:
Shraboni Banerjee

Wipro Limited

shraboni.banerjee@wipro.com

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