8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): September 20, 2010

CHELSEA THERAPEUTICS INTERNATIONAL, LTD.

(Exact name of registrant as specified in its charter)

Delaware	000-51462	20-3174202
(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)

Registrant’s 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 the following 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))

Item 8.01. Other Events.

On September 20, 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, September 20, 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.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.	Description
99.1	Slide 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 its behalf by the undersigned hereunto duly authorized.

	CHELSEA THERAPEUTICS INTERNATIONAL, LTD.
Date: September 20, 2010	/s/ J. Nick Riehle
	J. Nick Riehle, Chief Financial Officer

3

EX-99.1

©

2004-2010 Chelsea Therapeutics, Inc.

Northera™

(droxidopa)

Preliminary Findings From Study 301 in

Symptomatic Neurogenic Orthostatic

Hypotension

September 2010

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Forward-Looking Statement

Forward-Looking Statement

This presentation is being provided for informational and discussion purposes.  This

presentation

is

not

intended

to

provide

and

should

not

be

relied

upon

as

investment

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 offer to

buy, any securities.

This

presentation contains forward-looking statements regarding future events.  These

statements are just predictions and are subject to risks and uncertainties that could cause

the actual events or results to differ materially.  These risks and uncertainties

include

failure 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 additional products.  The

reader

is

referred

to

the

documents

that

Chelsea

Therapeutics

International,

Ltd.

files

from time to time with the Securities and Exchange Commission.

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Northera  Phase III Program: NOH

Northera  Phase III Program: NOH

Study

302:

Pivotal

Proof

of

Efficacy

–

Withdrawal

Design

Study

303:

Long-Term

Safety

Extension

to

Study

302

–

includes

long-term 

efficacy

assessment

after

3

months

Study

301:

Pivotal

Proof

of

Efficacy

–

Induction

Design

Study 304: Long-Term Safety Extension to Study 301

Study

305:

24

HR

Blood

Pressure

Monitoring

Study

–

subgroup

of

301

patients

Study

306:

Pivotal

Proof

of

Efficacy

–

Induction

Design

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Key Symptomatic Efficacy Outcome Measures

Key Symptomatic Efficacy Outcome Measures

Orthostatic Hypotension Questionnaire: OHQ

•

Orthostatic Hypotension Symptom Assessment: OHSA

Please 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

every

symptom.

If

you

do

not

experience

the

symptom,

circle

zero

(0).

PLEASE

RATE

THE

SYMPTOMS THAT ARE DUE ONLY TO YOUR LOW BLOOD PRESSURE PROBLEM.

1.Dizziness, lightheadedness, feeling faint, or feeling like you might blackout

2.Problems with vision (blurring, seeing spots, tunnel vision, etc.)

3.Weakness

4.Fatigue

5.Trouble concentrating

6.Head/neck discomfort

•

Orthostatic Hypotension Daily Activities Scale: OHDAS

We 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 blood pressure

symptoms you experienced.

1.

Standing short time

2.

Standing long time

3.

Walking short time

4.

Walking long time

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Study 301: Baseline Diagnoses

Study 301: Baseline Diagnoses

Symptomatic, 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

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Study 301: Demographic Data

Study 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

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Study 301: Trial Design

Study 301: Trial Design

Titration Stopping Rules:

1.Asymptomatic

and

>10

mmHG

in

Standing

SBP

2.Sustained SBP

180 mmHg or DBP

110 mmHg

3.Intolerable AEs

4.Maximum Dose of 600mg TID reached

Responder Criteria:

1.

1

unit

improvement

on

OHSA

item

#1

(dizziness);

AND

2.

10

mmHg

in

Standing

SBP

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Study 301: Optimal Dose Post-Titration

Study 301: Optimal Dose Post-Titration

100

200

300

400

500

600

0

10

20

30

40

50

Dose of Northera (mg TID)

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Study 301: Broad Symptomatic Benefits

Study 301: Broad Symptomatic Benefits

Favors

Northera

Favors

Placebo

0.0

0.2

0.4

0.6

0.8

1.0

1.2

1.4

OHSA

OHDAS

***

*

p

0.05

**

p

0.01

***

p

0.001

**

*

*

**

***

**

**

**

**

**

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Study 301: Change in OHSA Scores

Study 301: Change in OHSA Scores

0

1

2

3

Placebo

*

p

0.05

**

p

0.01

***

p

0.001

***

**

*

*

Northera

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Study 301: Change in OHDAS Scores

Study 301: Change in OHDAS Scores

0

1

2

3

Placebo

***

**

**

**

Northera

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Study 301: Change in Composite Scores

Study 301: Change in Composite Scores

OHQ

OHSA

OHDAS

0.0

0.5

1.0

1.5

2.0

2.5

Placebo

*

p

0.05

**

p

0.01

***

p

0.001

**

**

**

Northera

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Study 301: Effect of Northera on Standing SBP

Study 301: Effect of Northera on Standing SBP

Washout

R

Placebo

70

80

90

100

110

120

Northera

No Drug

Placebo

*

p

0.05

**

p

0.01

***

p

0.001

***

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Study 301: Effect of Northera on Supine SBP

Study 301: Effect of Northera on Supine SBP

Washout

R

Placebo

70

80

90

100

110

120

130

140

Northera

No Drug

Placebo

*

p

0.05

**

p

0.01

***

p

0.001

***

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Study 301: Effect of Northera

Study 301: Effect of Northera

on Standing SBP

on Standing SBP

SBP from randomization

Supine

Standing

0

2

4

6

8

10

12

Placebo

Northera

***

p

0.001

***

***

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Study 301: No Serious Adverse Events

Study 301: No Serious Adverse Events

•

Most common adverse events reported:

•

Headache:

0.0 % placebo,   7.4 % Northera

•

Falls:

4.3 % placebo,   0.0 % Northera

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Study 301: Response in Parkinson’s  Disease

Study 301: Response in Parkinson’s  Disease

0.00

0.25

0.50

0.75

1.00

1.25

1.50

1.75

2.00

2.25

Placebo

Northera

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0

2

4

6

8

10

12

0

1

2

3

4

5

6

7

8

9

302

301

303

Weeks of Treatment

Study 302: Parkinson’s Response Over Time

Study 302: Parkinson’s Response Over Time

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Study 306: NOH in Parkinson’s Disease

Study 306: NOH in Parkinson’s Disease

Randomization

Visit 2

Up to 2 weeks

8 weeks

Visit 1

Visit 3a, 3b, 3c….

Visit 7

2 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 2011

Double-Blind Titration

Double-Blind Treatment

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Next Steps: NOH Registration Program

Next Steps: NOH Registration Program

Complete Study 301 Data Analysis

Present full data set: American Autonomic Society Annual Meeting, Nov. 2010

Continue

Preparations

for

Rolling

NDA

Submission

to

be

initiated

first

half

2011

Request Pre-NDA Meeting

Complete Study 306

Estimated Completion of Enrollment: Year End 2010

Top-line Data: Q2 11

Complete Data Analysis for NDA

Complete NDA Submission: Q3 11

Anticipating Robust Filing Package

Supportive Data from Study 302

Highly Significant Outcome in Study 301

Confirmatory Data from Study 306

Strong Safety Data from Studies 303, 304 & 305

Meaningful Data from Japanese registration program

Fast-Track status should expedite NDA review process

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Study 301: Broad Symptomatic Benefits

Study 301: Broad Symptomatic Benefits

-0.50

-0.25

0.00

0.25

0.50

0.75

1.00

1.25

1.50

OHSA

OHDAS

302

301

*

p

0.05

**

p

0.01

***

p

0.001

*

**

***

**

**

*

**

**

***

**

**

*

*

*

*

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Positioning Northera

Positioning Northera

Target Profile: Northera™

is 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.

Pharmacoeconomic

Rationale: Reduction of Falls

•

Of the estimated 1.7 million nursing home residents in the US, approximately half fall annually,

twice the rate for persons dwelling in the community; 11% sustain a serious fall-related injury.

•

The mean incidence of falls in nursing homes is 1.5 falls per bed per year.  The most common

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 hypertension…22% 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)

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Current Therapeutic Landscape

Current 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

•

Medical

Science

Liaison

outreach

to

KOLs

and

Patient

Support

Groups

•

Accounts for ~80 %  of effort and spending

•

Non-Personal Promotion: ~45,000 MDs

•

Journal advertising

•

Direct mail educational and promotional programs

•

Sampling

programs

via

mail

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Northera: US Commercial Opportunity

Northera: US Commercial Opportunity

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Study 301: Summary Findings

Study 301: Summary Findings

•

Broad Symptomatic & Functional Benefits

•

Statistically

Significant

Improvement

in

Composite

OHQ

Score

vs.

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. Placebo (p<0.001)

•

Mean improvement of 11.2 mmHg in standing SBP

•

Preferential Effect on Standing SBP vs. Supine SBP

•

Safe and Well Tolerated

•

No Serious or Severe Adverse Events

•

Headache (7.4%): all cases reported mild

•

Treatment associated with fewer falls

•

No patients on Northera reported falling vs. 3 patients on Placebo

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Looking Ahead….

Looking Ahead….

Top-line Results Northera: Study 303

Q2 10

Initiate Northera PIII: NOH Study 306

Q2 10

Interim Analysis Droxidopa PII: Fibromyalgia

H2 10

Top-line Results Northera PIII: NOH Study 301

Q3 10

Initiate CH-4051 PII: RA

Q4 10

Top-line Results Droxidopa Investigator PII: ADHD

Q1 11

Top-line Results Northera PIII: NOH Study 306

Q2 11

Un-blinded Interim Data CH-4051: RA

Q3 11

Top-line Results Droxidopa PII: Fibromyalgia

YE 11

•

Operational Focus

•

Drive Northera Registration Program/NDA

•

Advance CH-4051 in RA and Droxidopa in additional indications

•

Execute strategic, cash generating licensing/partnership opportunities

•

Upcoming Milestones