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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

Africa Solar Energy Market Size and Outlook 2014-2019 & Forecast to 2029 by Installed Capacity, Demand, Project Capacity – ResearchAndMarkets.com

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DUBLIN–(BUSINESS WIRE)–The “Africa Solar Energy Market Size and Outlook Report by Installed Capacity, by Demand, by Project Capacity (2019-2029)” report has been added to ResearchAndMarkets.com’s offering.

The African solar energy market has enormous potential due to its abundant solar resource. Africa is also called a ‘Sun Continent’. Over half of the population in Africa do not have access to electricity. Solar energy if properly deployed, can help the region to reduce its dependence on traditional power types such as coal and oil. It is also an efficient way of power generation in remote areas.

Indeed, there is a vast potential for solar energy to expand renewable energy share in the total energy mix. Governments across the region are devising ways to support the solar energy market. Many global solar energy giants are also taking keen interest and increasing their focus on the region. The enormous untapped potential has yet to be explored in countries such as Algeria, Angola, Egypt, Ethiopia, Ghana, Morocco, Namibia, Nigeria and Tanzania.

In South Africa, the Renewable Energy Independent Power producer Programme (REIPPPP) has been playing a pivotal role in supporting the solar energy market. We expect that the country will continue to support the renewable market, particularly solar energy and will remain the dominant player in the region.

Kenya is also keen to produce more electricity from solar power parks. The government is providing various incentives such as feed-in-tariff for using solar panels. Kenya has set a target to achieve 200 MW of solar panels electricity by 2022.

The solar energy market in Africa is far behind than other regions due to poor economic conditions and lack of infrastructure, among other reasons. Moreover, the political and economic turmoil in the past had pushed most countries far behind in the developing energy infrastructure. The lack of funding and technical know-how is some major factors which keep the solar energy industry underdeveloped.

We expect that in most countries, the existing power infrastructure needs to be upgraded while new capacities need to be installed. Solar energy can be in the best position to help the region in the energy sector through faster and efficient ways.

Key Topics Covered:

  • Solar energy generation by country 2014-2029 (TWh)
  • Solar power capacity by country 2014-2029 (GW)
  • Solar power project capacity by plants 2019 (MW)

    • Project/plant type
    • Project/plant name
    • Location
    • Capacity
    • Ownership
    • Year of operating
    • Status of the project
  • Macroeconomics indicators by country 2014-2029
  • ROTS Analysis (Risks, Opportunities, Trends and Strategies) in the Africa solar energy market

Forecast Segmentation

  • Solar power capacity by country in Africa 2014-2029
  • Solar demand by country in Africa 2014-2029
  • Macroeconomic forecasts by country in Africa 2014-2029

For more information about this report visit https://www.researchandmarkets.com/r/m4ul8c

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470

For U.S./CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

Continue Reading

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North East Asia Solar Energy Market and Outlook 2019-2029 by Installed Capacity, Demand, Project Capacity – ResearchAndMarkets.com

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DUBLIN–(BUSINESS WIRE)–The “North East Asia Solar Energy Market Size and Outlook Report by Installed Capacity, by Demand, by Project Capacity (2019-2029)” report has been added to ResearchAndMarkets.com’s offering.

The solar energy market in North East Asia has shown remarkable growth, mainly driven by China. Over the past few years, China has taken over all other countries in clean and eco-friendly energy in terms of installed capacity, including solar projects.

China is currently considered the leader in the solar market with many major companies expanding their business globally. The Chinese government is continuously trying to support the sector further by providing various incentives. Some new laws are passed in China to control carbon emissions and to reduce dependency on petroleum-based products. By toughening regulations around electricity produced from fossil fuel, renewable sources like solar energy will likely to gain more market share.

Japan, South Korea and Taiwan are also active in promoting solar energy. Japan plans to increase the electricity generation mix mostly from solar PV, but it is still facing some several challenges in promoting its domestic solar PV industry. The cost of solar system installation and generation are still high. In addition, the grid and land availability are the other two factors responsible for slow growth in the PV market.

The Japanese government is investing heavily in solar energy with the introduction of feed-in-tariff and subsidies. It has been a global player working across the entire value chain including polysilicon, ingot, wafer, cells and module producers. Japan is mainly focusing on the export of solar panels as the domestic installation level is lower than annual production.

South Korea is trying to increase its renewable power share. It has a strong solar PV manufacturing industry base. It plans to cut its dependence on nuclear power, which would help solar PV adoption. The Korean government introduced a feed-in tariff system, making it compulsory for power generation companies to purchase electricity produced from solar panels. South Korea is also encouraging power generation companies to invest in building large scale solar power plants.

Key Topics Covered:

  • Solar energy generation by country 2014-2029 (TWh)
  • Solar power capacity by country 2014-2029 (GW)
  • Solar power project capacity by plants 2019 (MW)

    • Project/plant type
    • Project/plant name
    • Location
    • Capacity
    • Ownership
    • Year of operating
    • Status of the project
  • Macroeconomics indicators by country 2014-2029
  • ROTS Analysis (Risks, Opportunities, Trends and Strategies) in the North East Asia solar energy market

Forecast Segmentation

  • Solar power capacity by country in North East Asia 2014-2029
  • Solar demand by country in North East Asia 2014-2029
  • Macroeconomic forecasts by country in North East Asia 2014-2029

For more information about this report visit https://www.researchandmarkets.com/r/1zjzwa

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470

For U.S./CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

Continue Reading

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North America Solar Energy Market Size and Outlook to 2029 by Installed Capacity, Demand, Project Capacity – ResearchAndMarkets.com

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DUBLIN–(BUSINESS WIRE)–The “North America Solar Energy Market Size and Outlook Report by Installed Capacity, by Demand, by Project Capacity (2019-2029)” report has been added to ResearchAndMarkets.com’s offering.

The US solar market is expected to face some issues as the Trump administration priorities are different from the previous governments. The US imposed 30% import tariff on crystalline silicon solar cells and modules from China in 2018, which is scheduled to decrease by 5% yearly, ultimately reaching 15% in 2021. We expect that the tariffs impacted some solar projects due to increased solar panel prices, but local manufacturers are benefiting from tariffs.

Solar Energy Market in North America is mainly dominated by the US. Canada, Mexico and the US have set various regulatory frameworks and policies to develop their renewable energy from various sources such as solar and wind power. Feed-in Tariffs (FIT) and Renewable Portfolio Standard (RPS) systems are also adopted the US, Canada and Mexico to endorse the renewable energies.

The solar energy market in the US is on the rise due to the increasing demand for electricity. Furthermore, the falling costs of solar power modules coupled with the government initiatives to increase renewable shares in the total energy mix, are driving the solar power market in the country. In addition, environmental policies in favour of renewable energy, the expanding investor interest in the sector and the advanced technologies have also underpinned the solar energy market.

Some other key factors behind the solar power market growth are the declining cost of solar generation, the advancement in battery storage technology, and grid operators growing expertise is helping to compete with other conventional technologies.

The US states also set their capacity targets, which has further fuelled the solar market. The solar power sector becomes one of the largest and fastest-growing markets for electricity generation. The solar electricity is now economically competitive with conventional energy sources in various states of the country, including California, Hawaii, Texas and Minnesota as they aim to switch to renewable energy resources. Some states are even targeting for 100% renewable such as Hawaii set a target to have 100% renewable energy by 2045.

Canada and Mexico also set some goals for solar energy as both countries have the potential to generate a substantial amount of solar energy. Both countries are working to encourage the use of solar energy in residential, commercial and industrial sectors. The solar market is getting traction as the Canadian government planned to achieve the target of 6,300 MW of solar electricity by 2020, although it would account for just 1% of total electricity generated in Canada.

Key Topics Covered:

  • Solar energy generation by country 2014-2029 (TWh)
  • Solar power capacity by country 2014-2029 (GW)
  • Solar power project capacity by plants 2019 (MW)

    • Project/plant type
    • Project/plant name
    • Location
    • Capacity
    • Ownership
    • Year of operating
    • Status of the project
  • Macroeconomics indicators by country 2014-2029
  • ROTS Analysis (Risks, Opportunities, Trends and Strategies) in the North America solar energy market

Forecast Segmentation

  • Solar power capacity by country in North America 2014-2029
  • Solar demand by country in North America 2014-2029
  • Macroeconomic forecasts by country in North America 2014-2029

For more information about this report visit https://www.researchandmarkets.com/r/e7m03

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470

For U.S./CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

Continue Reading

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