-----BEGIN PRIVACY-ENHANCED MESSAGE-----Proc-Type: 2001,MIC-CLEAROriginator-Name: webmaster@www.sec.govOriginator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQABMIC-Info: RSA-MD5,RSA, UE8ED1iv7l2fUqEG3qwDOoSVpbnh7MNOVxy1rBCyt9Nu3y0u+zN5PyBKMbjnXgo4 X3QLXKXLz5KQC3QIsY/HNA==

0001193125-10-212817.txt : 201009200001193125-10-212817.hdr.sgml : 2010092020100920112303ACCESSION NUMBER:0001193125-10-212817CONFORMED SUBMISSION TYPE:8-KPUBLIC DOCUMENT COUNT:29CONFORMED PERIOD OF REPORT:20100920ITEM INFORMATION:Other EventsITEM INFORMATION:Financial Statements and ExhibitsFILED AS OF DATE:20100920DATE AS OF CHANGE:20100920

FILER:

COMPANY DATA:COMPANY CONFORMED NAME:Chelsea Therapeutics International, Ltd.CENTRAL INDEX KEY:0001333763STANDARD INDUSTRIAL CLASSIFICATION:BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]IRS NUMBER:203174202STATE OF INCORPORATION:DEFISCAL YEAR END:1231

FILING VALUES:FORM TYPE:8-KSEC ACT:1934 ActSEC FILE NUMBER:000-51462FILM NUMBER:101079814

BUSINESS ADDRESS:STREET 1:3530 TORINGDON WAYSTREET 2:SUITE 200CITY:CHARLOTTESTATE:NCZIP:28277BUSINESS PHONE:704-341-1516

MAIL ADDRESS:STREET 1:3530 TORINGDON WAYSTREET 2:SUITE 200CITY:CHARLOTTESTATE:NCZIP:28277

8-K1d8k.htmFORM 8-K

Form 8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section13 or 15(d) of

the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): September20, 2010

CHELSEA THERAPEUTICS INTERNATIONAL, LTD.

(Exact name of registrant as specified in its charter)

Delaware000-5146220-3174202

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(IRS Employer

ID Number)

3530 Toringdon Way, Suite 200, Charlotte, North Carolina 28277

(Address of principal executive offices) (Zip Code)

Registrants telephone number, including area code (704) 341-1516

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of thefollowing provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item8.01.Other Events.

OnSeptember20, 2010, Chelsea Therapeutics International, Ltd. is hosting a conference call to discuss the trial results of its Phase III trial of Northera for neurogenic orthostatic hypotension at 8:30 a.m. on Monday, September20,2010. A copy of the slide presentation being presented at the conference call is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Item9.01.Financial Statements and Exhibits.

(d)Exhibits

ExhibitNo.

Description

99.1Slide presentation for conference call on September 20, 2010.

2

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on itsbehalf by the undersigned hereunto duly authorized.

CHELSEA THERAPEUTICS INTERNATIONAL, LTD.

Date: September20, 2010

/s/ J. Nick Riehle

J. Nick Riehle, Chief Financial Officer

3

EX-99.12dex991.htmSLIDE PRESENTATION

Slide presentation

2004-2010 Chelsea Therapeutics, Inc.Northera(droxidopa)Preliminary Findings From Study 301 in Symptomatic Neurogenic Orthostatic HypotensionSeptember 2010

NASDAQ:CHTP 2Forward-Looking StatementForward-Looking StatementThis presentation is being provided for informational and discussion purposes. This presentationisnotintendedtoprovideandshouldnotberelieduponasinvestment advice or an opinion regarding the appropriateness or suitability of any investment. Nothing herein should be construed to be an offer to sell, or a solicitation of an offerto buy, any securities.Thispresentation contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that couldcause the actual events or results to differ materially. These risks anduncertainties includefailure to get regulatory approval for our product candidates, market acceptance for approved products, management of rapid growth, risks of regulatory review and clinical trials, intellectual property risks, and the need to acquire additionalproducts. The readerisreferredtothedocumentsthatChelseaTherapeuticsInternational,Ltd.filesfrom time to time with the Securities and Exchange Commission.

NASDAQ:CHTP 3Northera Phase III Program: NOHNorthera Phase III Program: NOHStudy302:PivotalProofofEfficacy

WithdrawalDesignStudy303:Long-TermSafetyExtensiontoStudy302

includeslong-term efficacyassessmentafter3monthsStudy301:PivotalProofofEfficacy

InductionDesignStudy 304: Long-Term Safety Extension to Study 301Study305:24HRBloodPressureMonitoringStudy

subgroupof301patientsStudy306:PivotalProofofEfficacy

InductionDesign

NASDAQ:CHTP 4Key Symptomatic Efficacy Outcome Measures Key Symptomatic Efficacy Outcome Measures Orthostatic Hypotension Questionnaire: OHQ

Orthostatic Hypotension Symptom Assessment: OHSAPlease circle the number on the scale (0-10) that best rates how severe your symptoms from low blood pressure have been on average over the past week Please respond to everysymptom.Ifyoudonotexperiencethesymptom,circlezero(0).PLEASERATETHE SYMPTOMS THAT ARE DUE ONLY TO YOUR LOW BLOOD PRESSURE PROBLEM.1.Dizziness, lightheadedness, feeling faint, or feeling like youmight blackout 2.Problems withvision (blurring, seeing spots, tunnel vision, etc.)3.Weakness4.Fatigue5.Trouble concentrating6.Head/neck discomfort

Orthostatic Hypotension Daily Activities Scale: OHDASWe are interested in how the low blood pressure symptoms you experience affect your daily life. Please rate each item by circling the number that best represents how much the activity has been interfered with on average over the past week by the low bloodpressure symptoms you experienced.1.Standing short time2.Standing long time3.Walking short time4.Walking long time

NASDAQ:CHTP 5Study 301: Baseline DiagnosesStudy 301: Baseline DiagnosesSymptomatic, Neurogenic Orthostatic Hypotension Associated with Primary Autonomic Failure, Dopamine -hydroxylase Deficiency & Non-diabetic Autonomic Neuropathies

Diverse patient population with varied & distinct primary diseases

Common feature: 20 mm Hg drop in SBP upon Standing

NASDAQ:CHTP 6Study 301: Demographic DataStudy 301: Demographic Data Double Blind Phase Placebo Northera (N=80) (N=82) Gender [N(%)] Male 42 ( 52.5) 42 ( 51.2) Female 38 ( 47.5) 40 ( 48.8) Ethnicity White 75 ( 93.8) 82 (100.0) Black/African-American 1 ( 1.3) 0 Asian 1 ( 1.3) 0 Hispanic/Latino 3 ( 3.8) 0 Age (years) at Screening n 80 82 Mean (SD) 55.7 (20) 57.4 (17) Median 61.5 60.0

NASDAQ:CHTP 7Study 301: Trial DesignStudy 301: Trial DesignTitration Stopping Rules:1.Asymptomaticand>10mmHGinStandingSBP2.Sustained SBP 180 mmHg or DBP 110 mmHg3.Intolerable AEs4.Maximum Dose of 600mg TID reachedResponder Criteria:1.1unitimprovementonOHSAitem#1(dizziness);AND2.10mmHginStandingSBP

NASDAQ:CHTP 8Study 301: Optimal Dose Post-TitrationStudy 301: Optimal Dose Post-Titration10020030040050060001020304050Dose of Northera (mg TID)

NASDAQ:CHTP Study 301: Broad Symptomatic BenefitsStudy 301: Broad Symptomatic BenefitsFavorsNortheraFavorsPlacebo0.00.20.40.60.81.01.21.4OHSAOHDAS****p0.05**p0.01***p0.001*******************

NASDAQ: CHTP10Study 301: Change in OHSA ScoresStudy 301: Change in OHSA Scores0123Placebo*p0.05**p0.01***p0.001*******Northera

NASDAQ:CHTP 11Study 301: Change in OHDAS ScoresStudy 301: Change in OHDAS Scores0123Placebo*********Northera

NASDAQ:CHTP 12Study 301: Change in Composite ScoresStudy 301: Change in Composite ScoresOHQOHSAOHDAS0.00.51.01.52.02.5Placebo*p0.05**p0.01***p0.001******Northera

NASDAQ:CHTP 13Study 301: Effect of Northera on Standing SBPStudy 301: Effect of Northera on Standing SBPWashoutRPlacebo708090100110120NortheraNo DrugPlacebo*p0.05**p0.01***p0.001***

NASDAQ:CHTP 14Study 301: Effect of Northera on Supine SBPStudy 301: Effect of Northera on Supine SBPWashoutRPlacebo708090100110120130140NortheraNo DrugPlacebo*p0.05**p0.01***p0.001***

NASDAQ:CHTP 15Study 301: Effect of NortheraStudy 301: Effect of Northeraon Standing SBPon Standing SBPSBP from randomizationSupineStanding024681012PlaceboNorthera***p0.001******

NASDAQ:CHTP 16Study 301: No Serious Adverse EventsStudy 301: No Serious Adverse Events

Most common adverse events reported:

Headache: 0.0 % placebo, 7.4 % Northera

Falls: 4.3 % placebo, 0.0 % Northera

NASDAQ: CHTPStudy 301: Response in Parkinsons DiseaseStudy 301: Response in Parkinsons Disease0.000.250.500.751.001.251.501.752.002.25PlaceboNorthera

NASDAQ:CHTP 180246810120123456789302301303Weeks of TreatmentStudy 302: Parkinsons Response Over TimeStudy 302: Parkinsons Response Over Time

NASDAQ:CHTP 19Study 306: NOH in Parkinsons Disease Study 306: NOH in Parkinsons Disease RandomizationVisit 2Up to 2 weeks8 weeksVisit 1Visit 3a, 3b, 3c.Visit 72 weeks

Enriched Homogeneous population: 84 PD Patients with NOH

Longer Treatment duration allows active arm to improve and placebo to fail

Primary efficacy measure: OHQ composite

Top-line data Q2 2011Double-Blind TitrationDouble-Blind Treatment

NASDAQ:CHTP 20Next Steps: NOH Registration ProgramNext Steps: NOH Registration ProgramComplete Study 301 Data AnalysisPresent full data set: American Autonomic Society Annual Meeting, Nov. 2010ContinuePreparationsforRollingNDASubmissiontobeinitiatedfirsthalf2011Request Pre-NDA Meeting Complete Study 306Estimated Completion of Enrollment: Year End 2010Top-line Data: Q2 11Complete Data Analysis for NDAComplete NDA Submission: Q3 11Anticipating Robust Filing PackageSupportive Data from Study 302Highly Significant Outcome in Study 301Confirmatory Data from Study 306Strong Safety Data from Studies 303, 304 & 305Meaningful Data from Japanese registration programFast-Track status should expedite NDA review process

NASDAQ:CHTP Study 301: Broad Symptomatic BenefitsStudy 301: Broad Symptomatic Benefits-0.50-0.250.000.250.500.751.001.251.50OHSAOHDAS302301*p0.05**p0.01***p0.001**************************

NASDAQ:CHTP 22Positioning NortheraPositioning NortheraTarget Profile: Northerais used as first line chronic oral therapy in NOH because it is the only drug proven to reduce the physical symptoms of dizziness, lightheadedness, and falling sensations associated with neurogenic orthostatic hypotension by safely replenishing low levels of the natural neurotransmitter, norepinephrine.PharmacoeconomicRationale: Reduction of Falls

Of the estimated 1.7 million nursing home residents in the US, approximately half fallannually, twice the rate for persons dwelling in the community; 11% sustain a seriousfall-related injury. The mean incidence of falls in nursing homes is 1.5 falls per bed per year. The mostcommon precipitating causes include gait and balance disorders, weakness, dizziness,environmental hazards, confusion, visual impairment, and postural hypotension.

$10B for hip fractures (1996)*

Does not include cost for head trauma, soft tissue injury, dislocations, etc.

$20B for all fall related costs (1998)**

Poor Surrogate at Best: Midodrine (ProAmatine)alpha agonist: 52,000 patients*

Not approved for symptomatic benefit

Provides constant/undifferentiated pressor effect: equal effect supine vs. standing

Black box warning for supine hypertension22% at 10 mg. dose

Alpha agonist side effects

piloerection (goose bumps, hair standing on end)

paresthesia (tingling, pricking or numbness of skin (scalp)

Poor patient persistence and compliance

Poor penetration of PD Market

$55-60M sales (priced at $30/day would generate $315 million annually)NASDAQ: CHTP23Current Therapeutic LandscapeCurrent Therapeutic Landscape*Verispan

Attractive US Pricing Model: US sales of $300-$375 million within 3-5 years of launch assuming:

Price: $30/day

Compliance: 70%

Limited Sales Force Requirements ~ 85 Sales Reps

10% of Midodrine Sales Generated by Only 232 Physicians

~4,000 physicians responsible for 50% of midodrine sales

No Competing Sales Force

Personal Promotion: Top 5 Deciles: ~20,000 MDs

Direct Sales force promotion to high prescribers

Promotional support & spending at Medical Meetings

Sampling program for new patients

MedicalScienceLiaisonoutreachtoKOLsandPatientSupportGroups

Accounts for ~80 % of effort and spending

Non-Personal Promotion: ~45,000 MDs

Journal advertising

Direct mail educational and promotional programs

SamplingprogramsviamailNASDAQ: CHTP24Northera: US Commercial OpportunityNorthera: US Commercial Opportunity

NASDAQ:CHTP 25Study 301: Summary FindingsStudy 301: Summary Findings

Broad Symptomatic & Functional Benefits

StatisticallySignificantImprovementinCompositeOHQScorevs.Placebo (p=0.003)

Mean decrease of 1.83 units in composite OHQ score

Statistically Significant Improvement in composite OHSA(p=0.01) and composite OHDAS(p=0.003)

Statistically Significant Improvement in 8 out of 10 Individual OHQ Items

Clear Mechanistic Rational for Symptomatic & Functional Improvements

Statistically Significant Improvement in Standing SBP vs. 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