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): February 9, 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 7.01. Regulation FD Disclosure.

At 1:30 p.m. on February 9, 2010, our President and Chief Executive Officer, Simon Pedder, will give a presentation to the 12^th Annual BIO CEO & Investor Conference in New York City. A copy of Dr. Pedder’s presentation is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

The information in this Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.	Description of Document
99.1	Presentation of Dr. Simon Pedder to be given on February 9, 2010 at the 12th Annual BIO CEO & Investor Conference.

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: February 9, 2010	/S/    J. NICK RIEHLE
	J. Nick Riehle, Chief Financial Officer

EX-99.1

February 2010

Exhibit 99.1

©

2004-2010 Chelsea Therapeutics, Inc.     

2

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.

3

Chelsea Overview

Chelsea Overview

Developing Two Major Assets With Multiple, High-Potential Indications

•

Droxidopa:

•

Neurogenic

Orthostatic Hypotension*(Northera™)

•

Intradialytic

Hypotension*

•

Fibromyalgia

•

Adult Attention Deficit and Hyperactivity Disorder

•

Freezing of Gait*

•

Chronic Fatigue

•

Other

norepinephrine

related

indications

•

Non-Metabolized Antifolates

(CH-1504/CH-4051/CH-4446/Others):

•

Rheumatoid Arthritis

•

Psoriasis

•

Crohn’s

Disease

•

Ankylosing

Spondylitis

•

Uveitus

•

Oncology

•

Other Inflammatory Diseases

*Approved indication in Japan

Preclinical

Phase I

Phase II

Phase III

Droxidopa:

NOH (Northera)

Study 302:

PD, MSA, PAF

Study 301:

PD, MSA, PAF

Study 306:

PD

Fibromyalgia

Intradialytic

Hypotension

Metabolically Inert

Antifolates:

Rheumatoid Arthritis

CH-4051

CH-1504

Other  Autoimmune:

CH-4051

Investigator

Studies:

AdultADHD:

Droxidopa

Chronic

Fatigue

Droxidopa

4

Strong and Balanced Pipeline

Strong and Balanced Pipeline

Data: Q3 09

Data: Q3 10

Data: Q2 11

Data: Q4 10/Q1 11

Data: Q1 09

Data: Q1 09

Data: Q2 11

Data: Q2 09

Data: 2011

Data: 2011

5

Neurogenic

Neurogenic

Orthostatic Hypotension

Orthostatic Hypotension

•

Neurogenic

Orthostatic Hypotension (NOH)

•

Sudden fall in BP when standing from a sitting/lying position

•

Symptoms include lightheadedness, dizziness, falling, syncope

•

Caused by diminished synthesis and/or release of the NE used by autonomic nerves to

regulate blood vessels and heart

•

80%

of

all

incidence

of

orthostatic

hypotension

is

neurogenic

in

nature

•

Generates

significant

health

care

costs

and

impact

on

quality

of

life

•

Associated with 3 Primary Patient Groups

6

Northera

Northera

Overview

Overview

•

“Prodrug”

of Norepinephrine: Allows Autonomic Nervous System to Naturally

Resume Normal Function

•

Enviable

Safety

and

Efficacy

Profile:

Million+

years

of

Japanese

Post-Approval

Patient

Data

•

SAEs

never statistically significantly exceeded placebo in any clinical trial to date

•

Therapeutic

use

of

peripheral

dopa-decarboxylase

inhibitors

(DDI)

in

PD

patients

does

not

blunt

effect of Northera

•

Sinemet®

–

a synthetic metabolic precursor

to Dopamine

•

Effectively treats movement disorders

caused by Dopamine deficits

•

Northera™

–

a synthetic metabolic precursor

to Norepinephrine

•

Effectively treats signs and symptoms of

dysautonomia

caused by norepinephrine

deficits

Sinemet

®

Northera™

7

Original Northera

Original Northera

Phase III Program: NOH

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

8

Study 302: Design

Study 302: Design

•

Withdrawal design study in 101 NOH patients with primary autonomic failure

•

Primary Efficacy Measure: OHSA item 1 (dizziness)

100mg

200mg

300mg

400mg

500mg

600mg

Up to 2 weeks (open-label)

1 week (open-

label)

Northera™

2 weeks (blinded)

Randomization

Northera™

Visit

9

Study 302: Demographics

Study 302: Demographics

All Patients

PD Patients Only

Placebo

Northera

Placebo

Northera

Number of

Patients

51

50

23

21

Age

(Years)

66.6

63.1

69.5

72.4

Gender

(% Male)

62.8

60.0

73.9

71.4

Mean

Northera

at

Titration (tid)

361 mg

412 mg

387 mg

352 mg

DDI Use

29 (57%)

28 (56%)

23 (100%)

21 (100%)

10

No Significant Adverse Events

No Significant Adverse Events

•

Midodrine

label: supine hypertension (>200mmHg) =13.4%

•

Most common adverse events reported:

•

Falls: 2% Northera, 12% placebo

•

Headache: 2% Northera, 8% placebo

•

Supine Hypertension:

BP (mm HG)

Number of

Placebo

Patients

Number of

Northera

Patients

180-200

3 (6%)

6 (12%)

?

200

0

1 (2%)

11

Key Symptomatic Efficacy Outcome Measures

Key Symptomatic Efficacy Outcome Measures

•

Orthostatic Hypotension Questionnaire: OHQ

•

Orthostatic Hypotension Symptom Assessment: OHSA

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

1.

Standing short time

2.

Standing long time

3.

Walking short time

4.

Walking long time

Broad Symptomatic and Functional Benefits

Broad Symptomatic and Functional Benefits

*  

p<0.05

**

p<0.01

Favors

Northera

Favors

Placebo

Study 302: Benefit on OHQ Composite Scores

Study 302: Benefit on OHQ Composite Scores

Composite Score Best Capture Full Therapeutic Benefit of Northera

13

14

Study 302: Results Summary

Study 302: Results Summary

•

Northera™

treatment associated with positive trends in 13 of 14 prospectively

identified individual outcome variables

•

16 of 17 including composite scores

•

5 prospectively defined endpoints achieved statistical significance

•

Symptomatic/functional benefit Scorecard

Droxidopa

5

Midodrine

0

•

Greatest improvement in activities of daily living

•

Most robust treatment effect in PD subgroup

•

Post Hoc analysis of OHQ composite significant  (p<0.05)

•

Significant improvement for both the clinician-recorded (p<o.o5) and patient-

recorded (p<o.o1) CGI-severity scale

•

Reduction in self-reported falls

•

6 placebo patients reported falls

•

1 Northera

patient reported falls

•

Safe and very well tolerated

Incorporating Key Findings from 302

Incorporating Key Findings from 302

•

Met

with

FDA

to

Discuss

Results

and

Key

Learnings

from

Study

302

•

Provided all data and sensitivity testing on outcome scales

•

Indicate benefit of using OHQ composite score

•

Open Label Response Criteria Not Optimal Enrichment Technique

•

BP responders didn’t correlate with efficacy outcome parameter

•

Item #1 (Dizziness) Does Not Fully Capture Treatment Effect

•

Item 1 scores don’t correlate to Global Impressions of Disease Severity (CGI-S)

•

Behavior modification occurs

•

Patients doing poorly don’t challenge themselves therefore don’t get dizzy

•

Adjusted Clinical Program in Response to New Data

15

History of Successful FDA Interactions

History of Successful FDA Interactions

•

Granted Orphan Status

•

Granted SPA for Study 301

•

Granted Fast Track Status

•

Met with FDA in November 2009

•

Granted Increase in Study 301 patient enrollment to 150

•

Increases power/robustness of outcome and viability of overall NDA submission

•

Improves likelihood of positive outcome

•

Granted Request to Change Primary Outcome in Ongoing Study 301

•

Confirmed SPA for Study 301 following change in endpoint

16

17

Current Northera

Current Northera

Phase III Program: NOH

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

Change in Primary Endpoint to OHQ composite

Increasing Enrollment to 150 patients

•

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

NOH

in

Parkinson’s

Patients

Only

–

targeting

most

robust

effect

Primary Endpoint: OHQ composite

18

Study 301: Revised Design

Study 301: Revised Design

•

Induction

design

study

in150

NOH

patients

with

primary

autonomic

failure

•

Primary efficacy measure: OHQ composite

•

Special Protocol Assessment

100mg

200mg

300mg

400mg

500mg

600mg

Washout

Randomization

Placebo

Up to 2 weeks (open-label)

1 week (open-

label)

1 weeks (blinded)

Visit

19

Study 306: NOH in Parkinson’s Disease

Study 306: NOH in Parkinson’s Disease

Randomization

Visit 2

Up to 2 weeks

8 weeks

N= 42

N= 42

Visit 1

Placebo, TID

100mg

200mg

300mg

400mg

500mg

600mg

100mg

200mg

300mg

400mg

500mg

600mg

Northera™, TID

Visit 3a, 3b, 3c….

Visit 7

2 weeks

•

Enriched Heterogeneous population: 84 PD Patients with NOH

•

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

•

Primary efficacy measure: OHQ composite

•

Starting Q2 2010, top-line data Q2 2011

OR

Double-Blind Treatment

Double-Blind Titration

•

Differentiated Profile

•

Treats underlying cause of NOH

•

Ideal candidate for first line therapy

•

Benign safety profile a significant benefit for patients taking multiple medications

•

Significant Upside Potential:

20

Northera

Northera

NOH Value Proposition

NOH Value Proposition

US TID Sales*

$300-375

million

+ QD Formulation

+ Better PD Efficacy

+  Midodrine

Withdrawn

+ ROW

*Assumptions:

Price: $30/day,Compliance: 70%

Droxidopa: Label Expansion Opportunities

Droxidopa: Label Expansion Opportunities

21

Fibromyalgia

Chronic

Fatigue

Syndrome

Adult

Attention Deficit

Disorder

Intradialytic

Hypotension

CHTP:

Phase II

CHTP:

Phase II

Investigator:

Phase II

Investigator:

Phase II

Norepinephrine

Related Disorders

15-25% of all

hemodialysis

patients suffer

from IDH

Chronic Pain

Disorder that

Affects 5.8 million

Americans

Second Most

Common

Neuropsychiatric

Disorder Affecting

4.4% of US adults

Debilitating

Fatigue Disorder

Affecting 1 -

4

million Americans

Droxidopa

Droxidopa

+ Carbidopa

Droxidopa

+ Carbidopa

Droxidopa

+ Carbidopa

Future Growth Opportunities

22

Novel Antifolates

Novel Antifolates

with Blockbuster Potential

with Blockbuster Potential

•

First non-metabolized oral antifolates

•

Engineered for improved safety and increased tolerability vs. methotrexate

•

Potential first line and

combination treatment for rheumatoid arthritis

•

Not competing with Biologics

•

Methotrexate

(MTX) remains most widely prescribed RA treatment:

•

Limitations

are

AEs

and

long-term

safety

concerns

•

Undergoes significant metabolism

Hydroxylated

Polyglutamylated

•

An estimated 1/3 of patients who continue treatment with MTX only achieve  a partial

efficacy response

•

Additional high potential global markets

•

Psoriasis, other immunological disorders and Cancer

23

CH-1504: Phase II Proof-of-Concept

CH-1504: Phase II Proof-of-Concept

•

12-week trial comparing CH-1504 to MTX in 200 MTX naive RA patients

•

0.25, 0.5 or 1.0 mg daily dose of CH-1504 vs. 20 mg weekly dose of MTX

•

Achieved Primary Objective by Demonstrating Comparable ACR 20 Response

Rates To MTX and Improved Safety Profile

•

No Drop outs Resulting From GI Tolerability Issues in Any CH-1504 Arm

24

CH-4051: Greater Efficacy/Safety

CH-4051: Greater Efficacy/Safety

•

Key preclinical findings suggests:

•

Superior preclinical efficacy to both CH-1504  MTX

•

Enzymatic activity (DHFR inhibition)

•

Uptake by Reduced Folate

Carrier

•

Increases activity in CIA model over both CH-1504 and MTX

•

Improved safety/toxicity

•

Phase I SAD study & MAD study:

•

Significantly higher doses tolerated than CH-1504

•

No serious adverse events

•

GI and reversible LFT elevations at highest doses

•

Improved bioavailability vs. CH-1504

•

Plasma concentrations suggest superior efficacy over MTX based on animal models

25

CH-4051 Phase II: MTX Partial Responders RA

CH-4051 Phase II: MTX Partial Responders RA

2 weeks

12 weeks

N= 50

Up to 2 weeks

20 mg/wk MTX + FOLATE

3.0 mg CH-4051/daily + FOLATE

3.0 mg CH-4051/daily

1.0 mg CH-4051/daily

0.3 mg CH-4051/daily

N= 50

N= 50

N= 50

N= 50

+

4 weeks

•

12-week, 5-arm trial comparing CH-4051 to MTX in 250 RA patients

•

MTX Partial Responders

•

Primary efficacy measure: ACR Hybrid Score

•

Starting Q2 2010, top-line data Q2 2011

Double-Blind Treatment

MTX Washout

Efficacy Analysis Using Hybrid ACR

Efficacy Analysis Using Hybrid ACR

•

Hybrid ACR Score (hACR).

•

Endorsed by ACR, FDA and key opinion leaders

•

More sensitive to treatment effects than traditional ACR 20/50/70

•

Starts with ACR 20/50/70 as a basis--permits greater precision than discrete ACR scores

Example:

If a patient meets traditional criteria for ACR20 (minimum 20% improvement),

but really has 35% improvement in all signs and symptoms--that patient is hACR35

•

If the study shows statistically significant benefits in hACR

for CH4051:

•

Second part of primary analysis tests ACR 20/50/70

•

"step-down" procedure used--no statistical penalty

26

27

Financial Summary

Financial Summary

Capitalization as of January 31, 2009

Common Stock 33,500,406

Warrants

4,060,758

Options

4,606,430

Fully Diluted42,167,594

Cash as of September 30, 2009

$30 million

Expected Q4 09 Cash$22 million

28

Looking Ahead….

Looking Ahead….

Finalize Protocol Northera

PIII: NOH Study 306

Q1 10

Top-line Results Northera: Study 305

Q1 10

Initiate Northera

PIII: NOH Study 306

Q2 10

Top-line Results Northera: Study 303

Q2 10

Initiate CH-4051 PII: RA

Q2 10

Top-line

Results

Northera

PIII:

NOH

Study

301

Q3 10

Interim

Results

Droxidopa

PII:

Fibromyalgia

H2 10

Top-line

Results

Northera

PIII:

NOH

Study

306

Q2 11

Northera

NDA: NOH

Q2 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