NeuroSearch is restructuring operations and developing the Huntexil® Phase III program. The company plans to reduce headcount and focus resources on developing Huntexil® for Huntington's disease. Huntexil® showed significant effects on motor function in Phase II trials. The Phase III program will include additional studies and confirm efficacy in a global trial. Completing the development program is estimated to cost $200 million. NeuroSearch expects operating losses to increase in 2011 and 2012 as it conducts the Phase III program and restructures operations, with the goal of securing funding to enroll the first patient in 2012.
Keynote Presentation "Big Data, Value Analysis and Population Health Science at Mayo Clinic"
Ryan Uitti, M.D.
Professor of Neurology
Deputy Director
Center for the Science of Health Care Delivery
Mayo Clinic
Keynote Presentation "Big Data, Value Analysis and Population Health Science at Mayo Clinic"
Ryan Uitti, M.D.
Professor of Neurology
Deputy Director
Center for the Science of Health Care Delivery
Mayo Clinic
Allon Therapeutics Inc. is a clinical-stage biotechnology company focused on bringing to market innovative central nervous system therapies. Allon’s lead drug, davunetide, is proceeding in a pivotal Phase 2/3 clinical trial in an orphan indication, progressive supranuclear palsy (PSP), under a Special Protocol Assessment (SPA) with the Food and Drug Administration (FDA). This pivotal trial is based upon statistically significant human efficacy demonstrated in amnestic mild cognitive impairment, cognitive impairment associated with schizophrenia, and positive biomarker data.
The Company is listed on the Toronto Stock Exchange (TSX:NPC) and based in Vancouver.
Pharma-Nutrition: a pharma perspective. View how the pharmaceutical drug development model can and should be combined with the nutrition field to optimally implement personalized healthcare.
PAREXEL Early Phase Clinical Research Services experts discuss developing trends in drug development including adaptive trials design, real-world data and biomarkers.
Allon Therapeutics Inc. is a clinical-stage biotechnology company focused on bringing to market innovative central nervous system therapies. Allon’s lead drug, davunetide, is proceeding in a pivotal Phase 2/3 clinical trial in an orphan indication, progressive supranuclear palsy (PSP), under a Special Protocol Assessment (SPA) with the Food and Drug Administration (FDA). This pivotal trial is based upon statistically significant human efficacy demonstrated in amnestic mild cognitive impairment, cognitive impairment associated with schizophrenia, and positive biomarker data.
The Company is listed on the Toronto Stock Exchange (TSX:NPC) and based in Vancouver.
Pharma-Nutrition: a pharma perspective. View how the pharmaceutical drug development model can and should be combined with the nutrition field to optimally implement personalized healthcare.
PAREXEL Early Phase Clinical Research Services experts discuss developing trends in drug development including adaptive trials design, real-world data and biomarkers.
BYD SWOT Analysis and In-Depth Insights 2024.pptxmikemetalprod
Indepth analysis of the BYD 2024
BYD (Build Your Dreams) is a Chinese automaker and battery manufacturer that has snowballed over the past two decades to become a significant player in electric vehicles and global clean energy technology.
This SWOT analysis examines BYD's strengths, weaknesses, opportunities, and threats as it competes in the fast-changing automotive and energy storage industries.
Founded in 1995 and headquartered in Shenzhen, BYD started as a battery company before expanding into automobiles in the early 2000s.
Initially manufacturing gasoline-powered vehicles, BYD focused on plug-in hybrid and fully electric vehicles, leveraging its expertise in battery technology.
Today, BYD is the world’s largest electric vehicle manufacturer, delivering over 1.2 million electric cars globally. The company also produces electric buses, trucks, forklifts, and rail transit.
On the energy side, BYD is a major supplier of rechargeable batteries for cell phones, laptops, electric vehicles, and energy storage systems.
how can i use my minded pi coins I need some funds.DOT TECH
If you are interested in selling your pi coins, i have a verified pi merchant, who buys pi coins and resell them to exchanges looking forward to hold till mainnet launch.
Because the core team has announced that pi network will not be doing any pre-sale. The only way exchanges like huobi, bitmart and hotbit can get pi is by buying from miners.
Now a merchant stands in between these exchanges and the miners. As a link to make transactions smooth. Because right now in the enclosed mainnet you can't sell pi coins your self. You need the help of a merchant,
i will leave the telegram contact of my personal pi merchant below. 👇 I and my friends has traded more than 3000pi coins with him successfully.
@Pi_vendor_247
how to sell pi coins in South Korea profitably.DOT TECH
Yes. You can sell your pi network coins in South Korea or any other country, by finding a verified pi merchant
What is a verified pi merchant?
Since pi network is not launched yet on any exchange, the only way you can sell pi coins is by selling to a verified pi merchant, and this is because pi network is not launched yet on any exchange and no pre-sale or ico offerings Is done on pi.
Since there is no pre-sale, the only way exchanges can get pi is by buying from miners. So a pi merchant facilitates these transactions by acting as a bridge for both transactions.
How can i find a pi vendor/merchant?
Well for those who haven't traded with a pi merchant or who don't already have one. I will leave the telegram id of my personal pi merchant who i trade pi with.
Tele gram: @Pi_vendor_247
#pi #sell #nigeria #pinetwork #picoins #sellpi #Nigerian #tradepi #pinetworkcoins #sellmypi
how to sell pi coins in all Africa Countries.DOT TECH
Yes. You can sell your pi network for other cryptocurrencies like Bitcoin, usdt , Ethereum and other currencies And this is done easily with the help from a pi merchant.
What is a pi merchant ?
Since pi is not launched yet in any exchange. The only way you can sell right now is through merchants.
A verified Pi merchant is someone who buys pi network coins from miners and resell them to investors looking forward to hold massive quantities of pi coins before mainnet launch in 2026.
I will leave the telegram contact of my personal pi merchant to trade with.
@Pi_vendor_247
What price will pi network be listed on exchangesDOT TECH
The rate at which pi will be listed is practically unknown. But due to speculations surrounding it the predicted rate is tends to be from 30$ — 50$.
So if you are interested in selling your pi network coins at a high rate tho. Or you can't wait till the mainnet launch in 2026. You can easily trade your pi coins with a merchant.
A merchant is someone who buys pi coins from miners and resell them to Investors looking forward to hold massive quantities till mainnet launch.
I will leave the telegram contact of my personal pi vendor to trade with.
@Pi_vendor_247
Abhay Bhutada Leads Poonawalla Fincorp To Record Low NPA And Unprecedented Gr...Vighnesh Shashtri
Under the leadership of Abhay Bhutada, Poonawalla Fincorp has achieved record-low Non-Performing Assets (NPA) and witnessed unprecedented growth. Bhutada's strategic vision and effective management have significantly enhanced the company's financial health, showcasing a robust performance in the financial sector. This achievement underscores the company's resilience and ability to thrive in a competitive market, setting a new benchmark for operational excellence in the industry.
how to sell pi coins on Bitmart crypto exchangeDOT TECH
Yes. Pi network coins can be exchanged but not on bitmart exchange. Because pi network is still in the enclosed mainnet. The only way pioneers are able to trade pi coins is by reselling the pi coins to pi verified merchants.
A verified merchant is someone who buys pi network coins and resell it to exchanges looking forward to hold till mainnet launch.
I will leave the telegram contact of my personal pi merchant to trade with.
@Pi_vendor_247
what is the future of Pi Network currency.DOT TECH
The future of the Pi cryptocurrency is uncertain, and its success will depend on several factors. Pi is a relatively new cryptocurrency that aims to be user-friendly and accessible to a wide audience. Here are a few key considerations for its future:
Message: @Pi_vendor_247 on telegram if u want to sell PI COINS.
1. Mainnet Launch: As of my last knowledge update in January 2022, Pi was still in the testnet phase. Its success will depend on a successful transition to a mainnet, where actual transactions can take place.
2. User Adoption: Pi's success will be closely tied to user adoption. The more users who join the network and actively participate, the stronger the ecosystem can become.
3. Utility and Use Cases: For a cryptocurrency to thrive, it must offer utility and practical use cases. The Pi team has talked about various applications, including peer-to-peer transactions, smart contracts, and more. The development and implementation of these features will be essential.
4. Regulatory Environment: The regulatory environment for cryptocurrencies is evolving globally. How Pi navigates and complies with regulations in various jurisdictions will significantly impact its future.
5. Technology Development: The Pi network must continue to develop and improve its technology, security, and scalability to compete with established cryptocurrencies.
6. Community Engagement: The Pi community plays a critical role in its future. Engaged users can help build trust and grow the network.
7. Monetization and Sustainability: The Pi team's monetization strategy, such as fees, partnerships, or other revenue sources, will affect its long-term sustainability.
It's essential to approach Pi or any new cryptocurrency with caution and conduct due diligence. Cryptocurrency investments involve risks, and potential rewards can be uncertain. The success and future of Pi will depend on the collective efforts of its team, community, and the broader cryptocurrency market dynamics. It's advisable to stay updated on Pi's development and follow any updates from the official Pi Network website or announcements from the team.
Seminar: Gender Board Diversity through Ownership NetworksGRAPE
Seminar on gender diversity spillovers through ownership networks at FAME|GRAPE. Presenting novel research. Studies in economics and management using econometrics methods.
where can I find a legit pi merchant onlineDOT TECH
Yes. This is very easy what you need is a recommendation from someone who has successfully traded pi coins before with a merchant.
Who is a pi merchant?
A pi merchant is someone who buys pi network coins and resell them to Investors looking forward to hold thousands of pi coins before the open mainnet.
I will leave the telegram contact of my personal pi merchant to trade with
@Pi_vendor_247
US Economic Outlook - Being Decided - M Capital Group August 2021.pdfpchutichetpong
The U.S. economy is continuing its impressive recovery from the COVID-19 pandemic and not slowing down despite re-occurring bumps. The U.S. savings rate reached its highest ever recorded level at 34% in April 2020 and Americans seem ready to spend. The sectors that had been hurt the most by the pandemic specifically reduced consumer spending, like retail, leisure, hospitality, and travel, are now experiencing massive growth in revenue and job openings.
Could this growth lead to a “Roaring Twenties”? As quickly as the U.S. economy contracted, experiencing a 9.1% drop in economic output relative to the business cycle in Q2 2020, the largest in recorded history, it has rebounded beyond expectations. This surprising growth seems to be fueled by the U.S. government’s aggressive fiscal and monetary policies, and an increase in consumer spending as mobility restrictions are lifted. Unemployment rates between June 2020 and June 2021 decreased by 5.2%, while the demand for labor is increasing, coupled with increasing wages to incentivize Americans to rejoin the labor force. Schools and businesses are expected to fully reopen soon. In parallel, vaccination rates across the country and the world continue to rise, with full vaccination rates of 50% and 14.8% respectively.
However, it is not completely smooth sailing from here. According to M Capital Group, the main risks that threaten the continued growth of the U.S. economy are inflation, unsettled trade relations, and another wave of Covid-19 mutations that could shut down the world again. Have we learned from the past year of COVID-19 and adapted our economy accordingly?
“In order for the U.S. economy to continue growing, whether there is another wave or not, the U.S. needs to focus on diversifying supply chains, supporting business investment, and maintaining consumer spending,” says Grace Feeley, a research analyst at M Capital Group.
While the economic indicators are positive, the risks are coming closer to manifesting and threatening such growth. The new variants spreading throughout the world, Delta, Lambda, and Gamma, are vaccine-resistant and muddy the predictions made about the economy and health of the country. These variants bring back the feeling of uncertainty that has wreaked havoc not only on the stock market but the mindset of people around the world. MCG provides unique insight on how to mitigate these risks to possibly ensure a bright economic future.
Even tho Pi network is not listed on any exchange yet.
Buying/Selling or investing in pi network coins is highly possible through the help of vendors. You can buy from vendors[ buy directly from the pi network miners and resell it]. I will leave the telegram contact of my personal vendor.
@Pi_vendor_247
1. Huntexil® Phase III programme and restructuring of operations
ProInvestor Life Science Seminar
IT-universitetet, 5. oktober 2011
2. Forward looking disclaimer
This presentation includes forward-looking statements and opinions, including statements on future
results and cash resources, and other forecasts about the company’s expectations. Forward-
looking statements involve risk, uncertainties and other factors, many of which are beyond
NeuroSearch’s control. This could cause actual results and other factors to differ, even materially,
from the results and factors discussed in the forward-looking statements. Forward-looking
statements include statements concerning our plans, objectives, goals, future events, performance
and/or other information that is not a statement of historical fact. We undertake no obligation to
publicly update or revise forward-looking statements to reflect subsequent events or circumstances,
except as required by law or similar binding rules.
Proinvestor- Life Science Seminar 2 5. oktober 2011
3. Contents
Introduction
Restructuring of operations
Design of the Huntexil® Phase III programme
Financial guidance for 2011 and outlook for 2012
Proinvestor- Life Science Seminar 3 5. oktober 2011
4. NeuroSearch focus resources on Huntexil®
The aim for NeuroSearch is to create a profitable, specialty
pharmaceutical company building on the platform that the
company would achieve from a successful development of
Huntexil®
Huntexil® for Huntington’s disease is the company’s lead
asset
Huntexil® belongs to the new class of ’dopidines’ together
with ordopidine and seridopidine
We have an obligation towards patients and shareholders to
realise the full potential of Huntexil®
With an optimised use of resources, NeuroSearch will gain
significant financial flexibility
Proinvestor- Life Science Seminar 4 5. oktober 2011
5. Restructuring of operations
NeuroSearch plans to carry out a comprehensive restructuring of the
company’s operations
The employee headcount will be reduced to a size necessary to primarily continue the
development of Huntexil®
The headcount at NeuroSearch is expected to be reduced
– to about 100 employees during Q2 2012
– to about 50 employees at the end of Q3 2012
– to about 35 employees when the restructuring is fully implemented in mid-2013
This is expected to reduce fixed and employee-related costs from about DKK 200
million per year to about DKK 50 million per year
The obligations towards Lilly and Janssen will be met
NeuroSearch will seek buyers for all drug candidates with the exception of Huntexil®,
ordopidine and seridopidine
In the months ahead, NeuroSearch will explore the possibilities for the company’s
research activities to continue under new ownership
Proinvestor- Life Science Seminar 5 5. oktober 2011
6. Huntexil® investment highlights
Huntexil® represents a unique opportunity to add significantly to the
treatment options for Huntington's disease
There is no cure or effective treatment of Huntington’s disease and Huntexil® is the
first compound to address the overall motor symptoms
Large clinical studies have shown significant improvement of patients’ overall motor
function and a strong tendency towards a positive treatment effect on voluntary
movement function
Safe and well-tolerated in the doses tested and no treatment-related decline
detected in other disease symptoms
Designated orphan drug status with both the FDA and the EMA granting 7 and 10
years market exclusivity, respectively
NeuroSearch believes there is a large unmet medical need with an estimated
approximately 110,000 patients in main markets
All rights for Huntexil® are retained
Patent protection until 2024 / 2025 in the USA and 2025 in the EU, both including
extensions
Proinvestor- Life Science Seminar 6 5. oktober 2011
7. Huntexil® Phase IIb/III trials
MermaiHD
Randomised, double-blind and placebo-controlled phase III study
Conducted in HD centres in Austria, Belgium, France, Germany, Italy, Portugal, Spain
and United Kingdom
Objective: Evaluate efficacy and safety of Huntexil® (45 mg once or twice daily) after 26
weeks with mMS as primary endpoint and TMS among other endpoints
437 patients were enrolled
HART
Randomised, double-blind and placebo-controlled phase IIb study
Conducted in HD centres in Canada and United States
Objective: Evaluate efficacy and safety of Huntexil® (10 mg, 22.5 mg or 45 mg – all twice
daily) after 12 weeks + establish dose-response relationship with mMS as primary
endpoint and TMS among other endpoints
227 patients were enrolled
Proinvestor- Life Science Seminar 7 5. oktober 2011
8. The Total Motor Score, TMS
TMS, part of the Unified HD Rating scale (UHDRS)
- Measures 15 items related
to motor symptoms
- Disease progression: ~4–5
points increase p.a.
- TMS is the most commonly
used scale to assess
movement disorders related
to Huntington’s disease
Proinvestor- Life Science Seminar 8 5. oktober 2011
9. Huntexil® effect on TMS
The MermaiHD study The HART study
The MermaiHD study The HART study
• Phase III study with 437 patients in eight European • Phase IIb study with 237 patients in the United States
countries and Canada
• Significant effects on TMS after 26 weeks • Significant effect on TMS after 12 weeks
• The primary endpoint (mMS) was not met • The primary endpoint (mMS) was not met
Proinvestor- Life Science Seminar 9 5. oktober 2011
10. Huntexil®
Effect on hand movements, gait and balance
Hand movements Gait and balance
The MermaiHD study The MermaiHD study
The HART study The HART study
Proinvestor- Life Science Seminar 10 5. oktober 2011
11. Huntexil®
The HART study – TMS dose response
Proinvestor- Life Science Seminar 11 5. oktober 2011
12. Huntexil® clinical data
The clinical results for Huntexil® can be summarised as
Two independent trials with a total of 664 HD patients demonstrate that 45 mg twice
daily improves overall motor function (TMS)
Strong tendency towards effect on the modified motor score though this primary
endpoint was not met
Effect on TMS corresponds to approximately 6-8 months disease progression
Dose response relationship established in HART
Adverse event profile similar to placebo and no worsening of other symptoms such as
cognition and behaviour
Favourable safety profile as demonstrated by 621 HD patients (822 subjects in total)
having received Huntexil®
HART MermaiHD
Variable
(12 weeks) (26 weeks)
N= 227 437
mMS (PE) -1.2 points (p = 0.078) -1.0 points (p = 0.042)
TMS (SE) -2.8 points* (p = 0.039) -3.0 points* (p = 0.004)
* Significant improvement from baseline versus placebo
Proinvestor- Life Science Seminar 12 5. oktober 2011
13. Huntexil® - regulatory status
NeuroSearch has, in the course of H1 2011, had an End of Phase II meeting with
the FDA and a scientific advice meeting with the EMA to discuss the results from
the HART and MermaiHD studies
Both agencies require additional Phase III data to confirm efficacy measured
on the TMS
Additional endpoint to support clinical relevance is required
The FDA also recommended exploring higher doses than 45 mg twice daily
Proinvestor- Life Science Seminar 13 5. oktober 2011
14. Huntexil® - NeuroSearch development programme
NeuroSearch has now designed the development programme for
Huntexil® based on the recommendations from EMA and the FDA, the
results of the HART and MermaiHD studies and discussions with
leading experts in the field
Huntexil® is being developed as a drug for the treatment of impaired
motor function associated with Huntington’s disease
The Phase III protocol will be submitted for an informal protocol review
at the FDA during Q4 2011 and the feedback will determine the final
details of the efficacy study
Results from the development programme will form the basis for
marketing application in Europe and the USA
Proinvestor- Life Science Seminar 14 5. oktober 2011
15. Huntexil® Phase III programme overview
MAD, TQT and bioEQ are performed in healthy volunteers
Abuse liability is performed in recreational drug abusers
Proinvestor- Life Science Seminar 15 5. oktober 2011
16. Prime-HD for Huntexil®
Confirmatory Phase III efficacy study design
Confirmatory Phase III efficacy study
• Global study with 630 patients in three treatment arms
• Primary endpoint is TMS. The primary objective is to show efficacy of Huntexil® 45 mg twice daily
on TMS
• Other endpoints include Clinical Global Impression (CGI), activities on daily living (ADCS-ADL) and
non-motor scales from UHDRS
Proinvestor- Life Science Seminar 16 5. oktober 2011
17. Prime-HD for Huntexil®
Other programme information
Patients will be recruited in Europe and the United States and possibly
also in South America and Australia
Patient enrolment criteria will be similar to those in the HART and
MermaiHD studies
Patient enrolment is expected to take 12 months
First patient is expected to be dosed during H1 2012 provided
NeuroSearch has secured financing to complete Prime-HD
The efficacy of the two Prime-HD doses measured on the TMS and CGI
scales will be tested within a closed testing procedure to ensure an
overall significance level of 5%
Proinvestor- Life Science Seminar 17 5. oktober 2011
18. Complementary studies
Multiple Ascending Dose (MAD) study
– Increasing doses to test the safety and tolerability of Huntexil®
– Select a supra-therapeutical dose for the TQT heart study
– Enrolling up to 36 healthy volunteers – first patient recently dosed
– Interim analyses of the data will be used in the other studies
TQT heart study
– Mandatory study of Huntexil®’s effect on the heart’s conductive properties
(electrocardiogram)
– The study will be conducted in healthy volunteers
Abuse potential study
– Mandatory abuse liability study for CNS-active compounds
– The study will be conducted in subjects classified as recreational drug
abusers
Bioequivalence study
– Study to confirm the bio-equivalence between Huntexil® capsules and
Huntexil® tablets that will be developed for commercial use
– Study will be performed in healthy volunteers
Proinvestor- Life Science Seminar 18 5. oktober 2011
19. Next steps in development of Huntexil®
Results from MAD are expected during Q1 2012
The Prime-HD protocol will be submitted for an informal protocol review by
the FDA during Q4 2011
Interaction with KOLs and CROs for planning of TQT and abuse liability
studies will be initiated during Q4 2011
Publications of the results from the MermaiHD and the HART studies
Operational preparations for Prime-HD will be initiated Q4 2011
Tablet formulation is planned to be available Q4 2012
Continuation of the Open-HART study (98 patients enrolled) and
compassionate use programme (129 patients participating)
Key results from Prime-HD are expected H1 2014
Proinvestor- Life Science Seminar 19 5. oktober 2011
20. External cost of Huntexil® development programme
Total external costs for completion of the Huntexil® development
programme, consisting of Prime-HD and four additional studies, are
estimated to be about DKK 200 million of which the majority relates to
Prime-HD
Most of the external costs are expected to be incurred in 2012 and
2013 provided that the study is initiated in the first half of 2012
Proinvestor- Life Science Seminar 20 5. oktober 2011
21. Revised financial guidance for 2011
Previous guidance for 2011 Adjusted guidance for 2011
DKK million DKK million
Continuing operations 130
Restructuring costs (related to 240
continuing operations) (no cash effect)
Operating loss (EBIT) 300 Operating loss (EBIT) 370
Loss on discontinuing activities 345
(140 in cash effect)
The value of cash and cash equivalents and securities
is expected to be approximately DKK 230 million at the
end of 2011
Basis for guidance and reporting
The financial guidance and reporting will, going forward, distinguish between loss from
continuing operations, being primarily Huntexil® related activities, and loss from
discontinuing activities
Proinvestor- Life Science Seminar 21 5. oktober 2011
22. Outlook for 2012
Outlook for 2012
DKK million
Continuing operations 150 -175
Restructuring 0
Operating loss (EBIT) 150 - 175
Loss on discontinuing activities 0
(~70 in cash effect)
The costs relate primarily to the Phase III programme for Huntexil®, provided it
progresses according to plan, but also include costs for continuing the Open
HART study, the compassionate use programme, development of a tablet
formulation for commercial use, preparation of product registration and
marketing, further development of seridopidine and ordopidine and costs of a
significantly reduced organisation
Proinvestor- Life Science Seminar 22 5. oktober 2011
23. Conclusions on financials
With an optimised use of resources, NeuroSearch will gain significant
financial flexibility
NeuroSearch will be a going concern until beginning of 2013, should
the Prime-HD study not be initiated
Our ambition is to secure funding to be able to enrol the first patient in
Prime-HD in H1 2012
We are actively assessing different funding options, including a
partnership agreement for Huntexil® and a rights issue
Proinvestor- Life Science Seminar 23 5. oktober 2011
24. For more information, please visit; www.neurosearch.com
or write to; investor@neurosearch.com
26. Portfolio of assets
Product Indication Mechanism of action Partner Phase PC I II III Reg.
Tesofensine Obesity MRI Ready for Phase III
ABT-894 ADHD NNR modulator Abbott Phase II
ABT-560 CNS diseases NNR modulator Abbott Phase I
NSD-788 Anxiety / depression MRI Phase I
NSD-721 Social anxiety disorder Ion channel modulator Phase I
NSD-726 Inflammatory CNS diseases Ion channel modulator Preclinical
NSD-801 Ataxias Ion channel modulator Preclinical
Proinvestor- Life Science Seminar 26 5. oktober 2011