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ACADIA Pharmaceuticals to Present Phase 2 CLARITY Results for Pimavanserin as an Adjunctive Treatment in Major Depressive Disorder at the 2019 American Psychiatric Association Annual Meeting

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SAN DIEGO–(BUSINESS WIRE)–ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD), a biopharmaceutical company
focused on the development and commercialization of innovative medicines
to address unmet medical needs in central nervous system disorders,
today announced it will present data from its Phase 2 CLARITY study,
which evaluated the efficacy, safety, and tolerability of pimavanserin
as an adjunctive treatment for major depressive disorder (MDD) at the
2019 American Psychiatric Association Annual Meeting in San Francisco,
May 18 – 22, 2019.

Poster Presentation
Poster:
#P8-049
Date/Time: Tuesday, May 21, 2:00 p.m. – 4:00 p.m. Pacific
Time
Title: CLARITY: A Phase 2 Double-blind, Placebo-controlled
Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in
Major Depressive Disorder

The Phase 2 CLARITY study was a 10-week, randomized, double-blind,
placebo-controlled, multi-center, two-stage sequential parallel
comparison design study that evaluated the efficacy, safety, and
tolerability of pimavanserin (34 mg once daily). Pimavanserin was
administered as an adjunctive treatment in patients with MDD who had an
inadequate response to a stable dose of standard antidepressant therapy
with either a selective serotonin reuptake inhibitor (SSRI) or a
serotonin norepinephrine reuptake inhibitor (SNRI). The study randomized
207 patients across 27 clinical research centers in the U.S. and was
conducted in collaboration with the Massachusetts General Hospital (MGH)
Clinical Trials Network and Institute.

There is a significant need for new therapies for the majority of
patients suffering from major depressive disorder who do not respond to
initial antidepressant therapy,” said Professor Maurizio Fava, M.D.,
Executive Vice Chair, Department of Psychiatry, MGH, Director of the
Division of Clinical Research of the MGH Research Institute, and
Associate Dean for Clinical & Translational Research, Harvard Medical
School. “The results observed in the Phase 2 CLARITY study combined with
a favorable tolerability profile provides evidence that adjunctive
treatment with pimavanserin may provide meaningful benefit to those MDD
patients who have an inadequate response to either a SSRI or a SNRI
therapy.”

In the trial, pimavanserin met the overall primary endpoint of the
weighted average results of Stage 1 and Stage 2 by significantly
reducing the 17-item Hamilton Depression Rating Scale total score
compared to placebo (p=0.039). On the key secondary endpoint,
pimavanserin demonstrated statistically significant reductions compared
to placebo in the Sheehan Disability Scale score (p=0.004). Positive
results were also observed for seven other secondary endpoints,
including improvement in daytime sleepiness as measured by the
Karolinska Sleepiness Scale and improvement in sexual function as
measured by the Massachusetts General Hospital Sexual Functioning Index.

In this Phase 2 study of pimavanserin as an adjunctive treatment for
MDD, we found patients treated with pimavanserin experienced significant
reduction in their depression symptoms in addition to improvement in
daytime sleepiness and sexual function when compared to placebo,” said
Serge Stankovic, M.D., M.S.P.H., ACADIA’s President. “These results are
encouraging for patients with MDD who may experience challenges with
their current treatment options. We look forward to further evaluating
pimavanserin as an adjunctive treatment in our ongoing Phase 3 CLARITY
program.”

On April 25, ACADIA
announced
it had initiated its Phase 3 CLARITY program for
pimavanserin as an adjunctive treatment for MDD. The CLARITY-2 study
will be based in the U.S. and has already initiated enrollment and the
CLARITY-3 study will be based outside the U.S. and will initiate
enrollment in the upcoming months. Both studies are six-week,
parallel-designed, randomized, double-blind, placebo-controlled,
multi-center studies designed to evaluate the efficacy and safety of
pimavanserin as adjunctive treatment in patients with MDD who have an
inadequate response to standard antidepressant therapy with either a
SSRI or a SNRI.

About Major Depressive Disorder
According to the National
Institute of Mental Health, MDD affects approximately 16 million adults
in the U.S.1, with approximately 2.5 million adults treated
with adjunctive therapy.2,3 MDD is a condition characterized
by depressive symptoms such as a depressed mood or a loss of interest or
pleasure in daily activities for more than two weeks, as well as
impaired social, occupational, or other important functioning. The
majority of people who suffer from MDD do not respond adequately to
initial antidepressant therapy.4

About Pimavanserin
Pimavanserin is a selective serotonin
inverse agonist and antagonist preferentially targeting 5-HT2A
receptors. These receptors are thought to play an important role in
depression, psychosis, and other neuropsychiatric disorders. ACADIA is
evaluating pimavanserin in an extensive clinical development program
across multiple indications with significant unmet need including
dementia-related psychosis, schizophrenia inadequate response,
schizophrenia-negative symptoms, and MDD. Pimavanserin was approved for
the treatment of hallucinations and delusions associated with
Parkinson’s disease psychosis by the U.S. Food and Drug Administration
in April 2016 under the trade name NUPLAZID®. NUPLAZID is not
approved for the adjunctive treatment of patients with MDD.

About ACADIA Pharmaceuticals
ACADIA is a
biopharmaceutical company focused on the development and
commercialization of innovative medicines to address unmet medical needs
in central nervous system disorders. ACADIA has developed and
commercialized the first and only medicine approved for the treatment of
hallucinations and delusions associated with Parkinson’s disease
psychosis. ACADIA also has ongoing clinical development efforts in
additional areas with significant unmet need, including dementia-related
psychosis, schizophrenia inadequate response, schizophrenia-negative
symptoms, major depressive disorder, and Rett syndrome. This press
release and further information about ACADIA can be found at: www.acadia-pharm.com.

Forward-Looking Statements
Statements in this press release
that are not strictly historical in nature are forward-looking
statements. These statements include, but are not limited to, statements
related to: the potential benefits of pimavanserin as adjunctive
treatment for MDD or other central nervous system disorders as well as
the potential results of clinical trials of pimavanserin in other
indications. These statements are only predictions based on current
information and expectations and involve a number of risks and
uncertainties. Actual events or results may differ materially from those
projected in any of such statements due to various factors, including
the risks and uncertainties inherent in drug development, approval and
commercialization, and the fact that past results of clinical trials may
not be indicative of future trial results. For a discussion of these and
other factors, please refer to ACADIA’s annual report on Form 10-K for
the year ended December 31, 2018 as well as ACADIA’s subsequent filings
with the Securities and Exchange Commission. You are cautioned not to
place undue reliance on these forward-looking statements, which speak
only as of the date hereof. This caution is made under the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995. All
forward-looking statements are qualified in their entirety by this
cautionary statement and ACADIA undertakes no obligation to revise or
update this press release to reflect events or circumstances after the
date hereof, except as required by law.

Important Safety Information and Indication for
NUPLAZID (pimavanserin)

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS

  • Elderly patients with dementia-related psychosis treated with
    antipsychotic drugs are at an increased risk of death.
  • NUPLAZID is not approved for the treatment of patients with
    dementia-related psychosis unrelated to the hallucinations and
    delusions associated with Parkinson’s disease psychosis.
  • Contraindication: NUPLAZID is contraindicated in patients with
    a history of a hypersensitivity reaction to pimavanserin or any of its
    components. Rash, urticaria, and reactions consistent with angioedema
    (e.g., tongue swelling, circumoral edema, throat tightness, and
    dyspnea) have been reported.
  • QT Interval Prolongation: NUPLAZID prolongs the QT interval.

    • The use of NUPLAZID should be avoided in patients with known QT
      prolongation or in combination with other drugs known to prolong
      QT interval including Class 1A antiarrhythmics or Class 3
      antiarrhythmics, certain antipsychotic medications, and certain
      antibiotics.
    • NUPLAZID should also be avoided in patients with a history of
      cardiac arrhythmias, as well as other circumstances that may
      increase the risk of the occurrence of torsade de pointes and/or
      sudden death, including symptomatic bradycardia, hypokalemia or
      hypomagnesemia, and presence of congenital prolongation of the QT
      interval.
  • Adverse Reactions: The most common adverse reactions (≥2% for
    NUPLAZID and greater than placebo) were peripheral edema (7% vs 2%),
    nausea (7% vs 4%), confusional state (6% vs 3%), hallucination (5% vs
    3%), constipation (4% vs 3%), and gait disturbance (2% vs <1%).
  • Drug Interactions:

    • Coadministration with strong CYP3A4 inhibitors (e.g.,
      ketoconazole) increases NUPLAZID exposure. Reduce NUPLAZID dose to
      10 mg taken orally as one tablet once daily.
    • Coadministration with strong or moderate CYP3A4 inducers reduces
      NUPLAZID exposure. Avoid concomitant use of strong or moderate
      CYP3A4 inducers with NUPLAZID.

Indication: NUPLAZID is indicated for the treatment of
hallucinations and delusions associated with Parkinson’s disease
psychosis.

Dosage and Administration: Recommended dose: 34 mg capsule taken
orally once daily, without titration.

NUPLAZID is available as 34 mg capsules and 10 mg tablets.

Please see the full Prescribing
Information
including Boxed WARNING for NUPLAZID.

References
1National Institute of Mental Health.
(2017). Major Depression. Retrieved from http://www.nimh.nih.gov/health/statistics/major-depression.shtml.

2IMS NSP, NPA, NDTI MAT-24 month data through Aug-2017.

3PLOS One, Characterization of Treatment Resistant Depression
Episodes in a Cohort of Patients from a US Commercial Claims
Database, Oct 2013, Vol 8, Issue 10.

4Rush AJ, et al. (2007) Am J. Psychiatry 163:11, pp.
1905-1917 (STAR*D Study).

Contacts

Investor Contact:
ACADIA Pharmaceuticals Inc.
Mark
Johnson, CFA
(858) 261-2771
ir@acadia-pharm.com

Media Contact:
ACADIA Pharmaceuticals Inc.
Maurissa
Messier
(858) 768-6068
media@acadia-pharm.com

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Business Wire

EZShield® and IdentityForce® combine Under New Parent Company: Sontiq™

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Sontiq is Two Identity Security Powerhouses, EZShield and IdentityForce, Now Working as One Delivering Intelligent Identity Security

NOTTINGHAM, Md.–(BUSINESS WIRE)–#BecomeLessVulnerableEZShield, the best-in-class digital Identity Theft Protection and Mobile Cybersecurity provider that pioneered fraud restoration, and IdentityForce, the #1 consumer-rated service that pioneered personal information security, today announced that their brands have aligned under a new company: Sontiq.

Sontiq will unite both companies into one industry leader that can meet the evolving identity security needs of all of the audiences both companies serve – from consumers and partners to businesses of all sizes. Both EZShield’s and IdentityForce’s best-in-class products will continue to evolve with up-to-the-minute capabilities for a world that is increasingly connected and vulnerable to fraud.

The new parent company name, Sontiq, is derived from the Latin word “sonticus” meaning serious or critical. Sontiq’s Intelligent Identity Security solutions focus on protecting every aspect of an identity in today’s fast-paced digital world where security incidents, cyber threats, and data breaches are the norm. Protecting what matters most – identity – through award-winning customer service and ironclad protection is at the core of what Sontiq will deliver to its customers.

“Sontiq is a natural evolution for our two companies, EZShield and IdentityForce,” said Dale Dabbs, President and CEO of Sontiq. “Today, we are excited to launch as Sontiq and we are committed to defending consumers and businesses against cyber threats and identity thieves by providing the latest in product innovation and service excellence. Our smarter, stronger, and more integrated approach is built for the speed and volume of modern information sharing an approach we call Sontiq’s Intelligent Identity Security.”

Learn more about Sontiq’s story:

  • Sontiq.com| Learn more about the audiences and markets Sontiq serves, and how its brands, EZShield and IdentityForce, will continue to deliver best-in-class products and world-class services. Visit Sontiq.com.
  • Two-Minute Explainer Video | Understand more of Sontiq’s disruptive brand story and the strength in partnership between EZShield and IdentityForce. View now.
  • About Sontiq Datasheet | Get a snapshot of the new company and how EZShield and IdentityForce will continue to deliver innovation across multiple markets. Read now.
  • General FAQ | Additional answers to frequent questions around Sontiq, EZShield, and IdentityForce. Read now.

“Uniting our brands under Sontiq speaks to the evolution of the company and the breadth of the markets we are able to serve,” said Daniel L. Black, Managing Partner at Wicks, majority owner of Sontiq. “We have successfully introduced a number of new products and services during the past two years to outpace the rapidly changing ID theft environment. The Sontiq name acknowledges the transformation in the business that we envisioned when we initially invested in EZShield, and then expanded further with the IdentityForce acquisition. Sontiq preserves two great and trusted brands that are highly recognized and respected by millions of consumers, financial institutions, small and large enterprises and federal, state and local governments. We are excited to continue on the path of growing our business, innovating ahead of the market, and serving our clients with passion.”

Sontiq’s Brand Identity

The Sontiq brand icon is indicative of a thumbprint — the ultimate symbolism of a physical and digital identity. The icon represents the coming together of EZShield and IdentityForce through the two lines that form the “S” — showing the unification of two identity security powerhouses.

Learn more in Sontiq’s Press Room.

Intelligent Identity Security

Sontiq’s Intelligent Identity Security solutions focus on protecting every component of an identity in today’s highly volatile digital world where security incidents, cyber threats, and data breaches are the norm. This is at the core of what Sontiq delivers. Owning an identity is a serious responsibility, and through Sontiq’s intelligent and proactive identity protection and mobile cybersecurity product offering, we’re all less vulnerable.

Learn more about Sontiq’s products and solutions.

About Sontiq

Sontiq, headquartered in Nottingham, Maryland, is a high-tech security and identity protection company arming businesses and consumers with award-winning products built to protect what matters most. Sontiq’s brands, EZShield and IdentityForce, provide a full range of identity monitoring, restoration, and response products and services that empower customers to be less vulnerable to the financial and emotional consequences of identity theft and cybercrimes. Learn more at www.sontiq.com or engage with us on Twitter, Facebook, LinkedIn, or YouTube.

About EZShield and IdentityForce

In August 2018, EZShield, a portfolio company of The Wicks Group (“Wicks”), merged with IdentityForce, and became known as EZShield + IdentityForce. For a combined 60 years, EZShield and IdentityForce have helped individuals, enterprises of all sizes, and trusted partners protect what matters most — through secure, digital identity protection and resolution services that enhance customer relationships, while adding value to existing products. Together, they have trailblazed the identity theft protection space, receiving consistent recognition by Javelin Strategy & Research as a leader in Identity Protection, most recently as the 2018 Identity Protection Service Provider Best-in-Class award winner. Today, thousands of financial institutions rely on EZShield and IdentityForce’s award-winning solutions, all delivered on a secure, flexible platform backed by best-in-class customer support. Additionally, EZShield and IdentityForce provide identity theft, privacy, and credit protection solutions to consumers, businesses, and government agencies. With EZShield and IdentityForce, individuals and companies benefit from the most robust and award-winning identity protection to keep personal and business information safe. In June 2019, EZShield and IdentityForce unified as two distinct brands that sit under their parent company, Sontiq.

Follow EZShield on Twitter, become a fan on Facebook, and engage with us on LinkedIn. Learn more at www.ezshield.com. Follow IdentityForce on Twitter, become a fan on Facebook, and engage with us on LinkedIn. Learn more at www.identityforce.com.

About Wicks

The Wicks Group is a private investment firm based in New York City that invests in lower middle market information businesses that create and deliver niche content and services to the business, consumer and education markets. Since its founding in 1989, Wicks has invested over $1 billion of capital in more than 30 platform companies and approximately 100 add-on acquisitions. The firm has applied a consistent investment strategy since its founding, partnering with high-quality, experienced management teams to build businesses organically and through acquisitions. Learn more at www.wicksgroup.com.

©2019 Sontiq, Inc. All other trademarks or trade names are properties of their respective owners. All rights reserved.

Contacts

Maria Miller or Justine Schneider

sontiq@moxiemettle.com

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Business Wire

dxFeed Launches the First White Label Ready Market Screener for Options

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dxFeed, a leading provider of market data analytics and services for the global financial industry, extends dxFeed Radar, a white-label ready market screener for B2B clients, with options analytics.

NEW YORK–(BUSINESS WIRE)–dxFeed Radar is an advanced market screener empowered with fundamentals, technical analysis, analytical data points and a library of advanced custom functions that scans on-demand the whole universe of US stocks, indices, ETFs and now options.

This solution is an opportunity for brokerages and investment companies to have their own branded market screener to offer their clients as a value-added service.

dxFeed Radar’s key advantage is its embeddability, configurability and zero-footprint. The platform is available as an out-of-the-box solution ready to be branded and integrated into an existing IT infrastructure or as a service with REST and Java APIs. It is suitable for:

– Brokerages, looking to offer their clients an exceptional market analysis tool

– Wealth Managers, who want to save time on analysis and generate more profits

– Algorithmic Trading firms looking for an extra edge

– Traders and Analysts who need more accuracy and precision in their analysis

– Financial News Websites who need to be alerted quickly to sudden market changes or embed the screener component for their users

Oleg Solodukhin, CEO of dxFeed commented: “With the launch of dxFeed Radar we address the market’s demand for an advanced tool for reliable and timely analysis of market data on the fly. This extends the portfolio of our services which provide powerful analytics to our clients while not putting any stress on their infrastructure.”

dxFeed Radar innovative features include advanced filtering, charting, and alerts. It also supports dxScript, an intuitive functional programing language. dxScript saves huge amounts of time and increases the accuracy of financial market data analysis.

For more information please visit https://www.dxfeed.com/dxfeed-radar/

About dxFeed

dxFeed is a subsidiary of Devexperts, with the primary focus of delivering financial markets information and services to buy-side and sell-side institutions of the global financial industry, specifically to traders, data analysts, quants and portfolio managers.

dxFeed today serves over 6 million end-users globally through direct and B2B2C relationships, streaming financial information for more than 1.7 million instruments (equities, futures, options, indices, FX, derivatives and cryptocurrencies), from a variety of exchanges in North America, Europe and around the world.

Contacts

Alexander Kariagin, CMO at Devexperts

akariagin@devexperts.com

+1(773)5708155

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Celltrion Adopts Veeva Vault eTMF for Greater Visibility into Trial Activities

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Leading South Korean biopharmaceutical modernizes trial operations to maintain inspection readiness and have a comprehensive view of study status

PLEASANTON, Calif.–(BUSINESS WIRE)–#activeTMFVeeva Systems (NYSE:VEEV) today announced that Celltrion, one of the top South Korean biopharmaceutical companies, implemented Veeva Vault eTMF to improve oversight across its trial master file (TMF) processes and achieve greater compliance.

Vault eTMF enables an active TMF operating model where all processes and documents are managed in one system, in real time, as they are executed. With this model, TMF management is automated and the TMF stays in a constant state of inspection readiness.

“Veeva Vault eTMF will help us streamline our clinical operations and give us a complete view of study documents at every stage of drug development,” said Sueun Song, head of clinical operations at Celltrion. “As clinical trials become more complex, we need advanced insights into study processes and the ability to stay compliant with regulatory authorities around the world.”

Recent ICH E6(R2) amended guidelines require sponsors to maintain oversight throughout the clinical trial lifecycle. With Vault eTMF, Celltrion has a single source of truth for trial documentation that provides simplified access for auditors and inspectors. Moving to Vault eTMF, Celltrion also improves operational performance and strengthens collaboration with study partners and sites.

“Life sciences organizations are choosing Veeva Vault eTMF for active TMF management to improve study quality in today’s highly regulated environment,” said Chris Shim, country manager for Veeva Korea. “We’re excited about the opportunity to work with companies such as Celltrion in Asia Pacific to modernize their trial processes.”

Veeva Vault eTMF is part of the Veeva Vault Clinical Suite, the industry’s first cloud platform that includes CDMS, CTMS, eTMF, and study start-up to unify clinical data management and clinical operations. Veeva’s suite of unified applications provides global visibility into trial activities and streamlines end-to-end clinical processes. For more information, visit veeva.com/Clinical.

Additional Information

For more on Veeva Vault eTMF, visit: veeva.com/eTMF

Connect with Veeva on LinkedIn: linkedin.com/company/veeva-systems

Follow @veevasystems on Twitter: twitter.com/veevasystems

Like Veeva on Facebook: facebook.com/veevasystems

About Celltrion Inc.

Headquartered in Incheon, Korea, Celltrion is a leading biopharmaceutical company specializing in research, development, and manufacturing of biosimilar and innovative drugs. Celltrion strives to provide more affordable biosimilar mAbs to patients who previously had limited access to advanced therapeutics. Celltrion received FDA and EMA approval for Inflectra and Remsima, respectively, which is the world’s first mAb biosimilar to receive approval from a regulatory agency in a developed country. For more information, visit celltrion.com.

About Veeva Systems

Veeva Systems Inc. is the leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves more than 750 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices throughout North America, Europe, Asia, and Latin America. For more information, visit veeva.com.

Forward-looking Statements

This release contains forward-looking statements, including the market demand for and acceptance of Veeva’s products and services, the results from use of Veeva’s products and services, and general business conditions, particularly in the life sciences industry. Any forward-looking statements contained in this press release are based upon Veeva’s historical performance and its current plans, estimates, and expectations, and are not a representation that such plans, estimates, or expectations will be achieved. These forward-looking statements represent Veeva’s expectations as of the date of this press announcement. Subsequent events may cause these expectations to change, and Veeva disclaims any obligation to update the forward-looking statements in the future. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially. Additional risks and uncertainties that could affect Veeva’s financial results are included under the captions, “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in the company’s filing on Form 10-Q for the period ended April 30, 2019. This is available on the company’s website at veeva.com under the Investors section and on the SEC’s website at sec.gov. Further information on potential risks that could affect actual results will be included in other filings Veeva makes with the SEC from time to time.

Contacts

Roger Villareal

Veeva Systems

925-264-8885

roger.villareal@veeva.com

Lisa Barbadora

Veeva Systems

610-420-3413

pr@veeva.com

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