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): July 9, 2013

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 (see General Instruction A.2. below):

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

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

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

o 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 July 9, 2013, Chelsea Therapeutics International, Ltd. issued a press release related to the resubmission of the Northera™ (droxidopa) New Drug Application with the U.S. Food and Drug Administration. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Chelsea Therapeutics International, Ltd. has accordingly updated its investor slide presentation. A copy of this updated slide presentation is attached hereto as Exhibit 99.2 and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.	Description
99.1	Press release dated July 9, 2013
99.2	PowerPoint Presentation updated as of July 9, 2013

Signature

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.
		By:	/s/ J. Nick Riehle
			J. Nick Riehle
			Chief Financial Officer
Dated:	July 9,  2013

EX-99.1

 

July 9, 2013

Chelsea Therapeutics Resubmits New Drug Application for NORTHERA™ (droxidopa) for the Treatment of Symptomatic NOH

• Submission Includes Successful 300 mg Bioequivalence Study

• Six Month Review Decision Expected Under PDUFA

CHARLOTTE, N.C., July 9, 2013 -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today announced that it resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market NORTHERA™ (droxidopa), an orally active synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure (Parkinson’s disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy. The NDA resubmission includes data from Study 306B, a large phase 3 study which confirms findings from Study 301 demonstrating improvement in dizziness/lightheadedness, the cardinal symptom of NOH. Under the Prescription Drug User Fee Act, or PDUFA, the FDA is expected to review and act on the NDA six months from the date of resubmission.

"The resubmission of our Northera NDA marks a critical step in our effort to bring an important new therapeutic option to patients living with this debilitating condition," said Joseph G. Oliveto, Interim Chief Executive Officer of Chelsea. "We now have two large randomized placebo-controlled clinical studies which show that treatment with Northera results in consistent and statistically significant improvements in the symptoms of NOH, and a greatly expanded database supporting the safety of Northera. We look forward to working closely with the FDA as they review our application and, in parallel, planning for commercialization.”

In addition to Study 306B, the filing also includes three smaller supportive randomized controlled trials, two long-term open-label extension studies, a dedicated thorough QTc study, a 24-hour ambulatory blood pressure monitoring study and a bioequivalence study for the 300 mg dose form of droxidopa. The bioequivalence study showed comparable pharmacokinetics between the 300 mg dose form of droxidopa and the 100 mg and 200 mg combination dose form.

As previously disclosed, FDA has indicated that the revised Northera NDA may be reviewed by the Cardiovascular and Renal Drug Advisory Committee, or CRDAC. The FDA has also raised the possibility of accelerated approval for Northera, where it has indicated that endpoints measuring short-term clinical benefits can be used as valid surrogates reasonably likely to predict long-term clinical benefits under accelerated approval. FDA also noted that the Company may be required to verify the durability of effect of Northera in a post-marketing study. Chelsea continues to work with the FDA on the design of such a study, which it intends to initiate in the fourth quarter of 2013. The study is expected to include short-term clinical endpoints should the Agency require an additional clinical trial for the approval of Northera.

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Northera was previously granted Orphan Drug Designation and received Fast Track designation from the FDA. Fast Track designation is designed to facilitate the review of products that address serious or potentially life-threatening conditions for which there is an unmet medical need.

About Symptomatic NOH

NOH is a chronic neurogenic disorder resulting from deficient release of norepinephrine that predominantly affects patients with primary autonomic failure, a group of diseases which includes Parkinson's disease (PD), multiple system atrophy (MSA) and pure autonomic failure (PAF). Symptoms of NOH include: dizziness, lightheadedness, blurred vision, fatigue, poor concentration, and fainting episodes when a person assumes a standing position, often severely limiting a person's ability to perform routine daily activities that require standing or walking for both short and long periods of time.

About Northera

NORTHERA™ (droxidopa), the lead investigational agent in Chelsea Therapeutics' pipeline, is currently in Phase III development for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure — an indication that includes a significant number of patients with Parkinson's disease, multiple system atrophy (MSA) and pure autonomic failure (PAF).  Droxidopa is a synthetic catecholamine that is directly converted to norepinephrine (NE) via decarboxylation, resulting in increased levels of NE in the nervous system, both centrally and peripherally.

Droxidopa, developed by and licensed from Dainippon Sumitomo Pharma Co., Ltd. (DSP), initially received Japanese approval in 1989 for the treatment of frozen gait and dizziness on standing associated with Parkinson's Disease and for the treatment of orthostatic hypotension, syncope or dizziness on standing associated with Shy-Drager syndrome and Familial Amyloidotic Polyneuropathy. In 2000, Droxidopa received expanded marketing approval to include prevention of vertigo, dizziness and weakness associated with orthostatic hypotension in hemodialysis patients.

About Chelsea Therapeutics

Chelsea Therapeutics (Nasdaq:CHTP) is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases, including central nervous system disorders.  Chelsea is currently pursuing FDA approval in the U.S. for Northera™ (droxidopa), a novel, late-stage, orally-active therapeutic agent for the treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure.  For more information about the Company, visit www.chelseatherapeutics.com.

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This press release contains forward-looking statements regarding future events including our intention to pursue the development of Northera. These statements are subject to risks and uncertainties that could cause the actual events or results to differ materially. These include reliance on key personnel and our ability to attract and/or retain key personnel; the risk that FDA will not agree that our clinical trial results demonstrate the safety and effectiveness of droxidopa; the risk that the FDA will not accept our proposal regarding any trial or other data to support a new drug application; the risk that the FDA does not accept the resubmitted NDA for Northera for filing and that the FDA will not approve the resubmitted NDA; the risk that our resources will not be sufficient to conduct any study of Northera that will be acceptable to the FDA; the risk that we cannot complete any additional study for Northera without the need for additional capital; the risks and costs of drug development and that such development may take longer or be more expensive than anticipated; our need to raise additional operating capital in the future; our reliance on our lead drug candidate droxidopa; risk that we will not be able to obtain regulatory approvals of droxidopa or our other drug candidates for additional indications; risk of volatility in our stock price, related litigation, and analyst coverage of our stock; reliance on collaborations and licenses; intellectual property risks; our history of losses; competition; market acceptance for our products if any are approved for marketing.

CONTACT:

Investors:

Fara Berkowitz / Susan Kim

Argot Partners

212-600-1902

fara@argotpartners.com

susan@argotpartners.com

Media:

David Pitts

Argot Partners

212-600-1902

david@argotpartners.com

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EX-99.2

Chelsea Therapeutics Corporate Overview July 2013 © 2004 - 2013 Chelsea Therapeutics, Inc.

Forward - Looking Statements 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 including our intention to pursue the development of Northera . These statements are subject to risks and uncertainties that could cause the actual events or results to differ materially . These include reliance on key personnel and our ability to attract and/or retain key personnel ; the risk that FDA will not agree that our clinical trial results demonstrate the safety and effectiveness of droxidopa ; the risk that the FDA will not accept our proposal regarding any trial or other data to support a new drug application ; the risk that the FDA does not accept the resubmitted NDA for Northera for filing and that the FDA will not approve the resubmitted NDA ; the risk that our resources will not be sufficient to conduct any study of Northera that will be acceptable to the FDA ; the risk that we cannot complete any additional study for Northera without the need for additional capital ; the risks and costs of drug development and that such development may take longer or be more expensive than anticipated ; our need to raise additional operating capital in the future ; our reliance on our lead drug candidate droxidopa ; risk that we will not be able to obtain regulatory approvals of droxidopa or our other drug candidates for additional indications ; risk of volatility in our stock price, related litigation, and analyst coverage of our stock ; reliance on collaborations and licenses ; intellectual property risks ; our history of losses ; competition ; market acceptance for our products if any are approved for marketing . NASDAQ: CHTP 2

Lead Drug C andidate is Northera (droxidopa) Oral “pro - drug ” of norepinephrine; directly metabolized to form norepinephrine • Replenishes diminished level of natural neurotransmitter, norepinephrine, within the autonomic nervous system • Unique mechanism of action limits side effects seen with other drugs • Only chronic oral therapy treating root cause of NOH Well documented safety and efficacy; marketed in Japan since 1989 • Orthostatic hypotension associated with Parkinson’s Disease • Freezing of gait in Parkinson's Disease • Hypotension associated with dialysis Targeting Symptomatic Neurogenic Orthostatic Hypotension (NOH ) • Significant unmet medical need Northera ™ (droxidopa) NASDAQ: CHTP 3

Neurogenic Orthostatic Hypotension Neurogenic Orthostatic Hypotension (Neurogenic OH or NOH): Sudden, potentially dangerous, fall in blood pressure when standing from a sitting or lying position • Caused by diminished synthesis and/or release of the norepinephrine used by autonomic nerves to regulate vasoconstriction • 500 – 1000 mL of blood shifts to the lower body upon standing • Reduced ability to push blood back to the heart and brain from the lower body • Poor perfusion of the brain leads to dizziness, lightheadedness & syncope • Some patients cannot stand unaided for more than a few minutes a day NASDAQ: CHTP 4

The Neurogenic OH Patient Parkinson’s Disease • Prevalence of disease: 120 cases per 100,000 population • Prevalence of symptomatic Neurogenic OH: approx. 18% Multiple System Atrophy • Prevalence of disease: 1 - 9 cases per 100,000 population • Prevalence of symptomatic Neurogenic OH: approx. 81% Pure Autonomic Failure • Prevalence of disease: 1 - 9 per 100,000 population • Prevalence of symptomatic Neurogenic OH: 100% Symptomatic Neurogenic OH is an orphan disease Affects patients with primary autonomic failure, a group of diseases that includes… NASDAQ: CHTP 5

NOH: Current Therapeutic Landscape NASDAQ: CHTP 6 Midodrine (ProAmatine ®) … available in generic form • Alpha agonist - undifferentiated pressor effect with troublesome side effects • Black box warning for supine hypertension…22% at 10 mg dose • Paresthesia (tingling, pricking or numbness of skin (scalp)… 18% • Piloerection (goose bumps, hair standing on end )… 13% • Poor patient persistence and compliance • Poor penetration of PD market • Never satisfied FDA’s requirement to demonstrate symptomatic improvement • FDA agreement - As of Dec 2011 Shire is required to conduct two milestone - driven efficacy trials to demonstrate symptomatic benefit with a submission deadline of Sept 2014. Fludrocortisone ( Florinef ®) … available in generic form • Synthetic corticosteroid indicated for treatment of Addison's disease • Water and Salt retention is one of the side effects • Extensively utilized off - label for Orthostatic Hypotension

Existing Symptomatic NOH Market Market size: • Approximately 145K patients taking midodrine and/or fludrocortisone for NOH (2010 data) • Growing market with aging US population NO existing promotion or Pharma sponsored awareness programs Concentrated prescriber base: • Small identified group of Neurology + Cardiology + PCP prescribers NASDAQ: CHTP 0 100,000 200,000 300,000 400,000 500,000 600,000 2006 2007 2008 2009 2010 2011 2012 Midodrine Annual Total Rx* 232 MDs = 10% 3700 MDs 50% Midodrine Prescribers 7

Northera: US Commercial Opportunity in NOH Projected US sales potential of $300 - $375 million within 3 - 5 years of launch Assumptions: • Differentiated product label would allow for an attractive US Pricing Model • Majority of payers will cover but with high co - pays and/or as second line to generic midodrine • Relatively limited Sales Force and Promotional Requirements • Peak sales projections equate to capturing 15 - 20% of market (of existing treated patients) • Midodrine remains on the market with no form of restriction NASDAQ: CHTP 8

Regulatory Landscape Complete Response Letter (CRL) • Requirement for an additional clinical study showing efficacy to support Study 301 • Inconsistencies in the overall findings (failure of Study 302, 303) • Disproportionate contribution of specific clinical sites to the overall results of Study 301 • Cited need for evidence of durability of effect FDA Feedback Post - CRL • Study 306B could serve as confirmatory study • Short term endpoint acceptable for approval review • Durability could potentially be verified post - approval NASDAQ: CHTP 9

NDA Resubmission: Basis for Approval Accelerated Approval; allows durability to be proven post - approval • Proposed two complementary post - market trials • Study 1 – Long term (12 week) study, n~450. Planned initiation in Q4, 2013 • Study 2 – Design to be discussed with FDA during review and initiated post - approval Two adequate, well controlled, positive Phase III studies demonstrating short - term effectiveness • Study 301 and 306B provide independent substantiation for each other • Alleviates potential concerns with individual study results or design • Reduces the importance of smaller studies (Study 302, 303) for the development program overall • Study 306B results consistent with the overall Study 306 (A+B) • Highly consistent data across multiple endpoints NASDAQ: CHTP 10

Two Independent Studies: Highly Consistent Efficacy Mean +SEM Improvement OHSA Item #1 from Baseline to Week 1 NASDAQ: CHTP 11

Two Independent Studies: Highly Consistent Efficacy Proportion of Patients with ≥50% Improvement in OHSA Item 1 at Week 1 NASDAQ: CHTP 12

Two Independent Studies: Highly Consistent Efficacy Change in Standing SBP at Week 1 NASDAQ: CHTP 13

Study 306B: Striking Reduction in Falls Droxidopa also associated with a reduction in fall related injuries • 25.6% of placebo patients injured • 16.9% of droxidopa patients injured Includes debilitating injuries in Placebo patients • Traumatic Brain Injury • Fibula Fracture • Facial Bones Fracture • Not observed in droxidopa patients Neither falls nor fall related injuries were statistically significant Cumulative Patient Falls 232 391 498 586 716 46 76 101 140 229 0 100 200 300 400 500 600 700 800 By End of Titration By Week 1 By Week 2 By Week 4 By Week 8 32. 1 60.9 62. 3 52.6 Droxidopa n = 69 Placebo, n = 78 NASDAQ: CHTP 14 Placebo D roxidopa

Potential Review or Advisory Committee Issues Potential Issue Chelsea Strategy Disproportionate contribution of two Ukrainian clinical sites to Study 301 results • Audits at sites have identified no major issues with study conduct or good clinical practices • Sensitivity analyses excluding these sites (US - Only sites) remains statistically significant • Chelsea acknowledges disproportionate results and that study 301 does not meet guidelines for single study approval • Study 306B provides independent substantiation of the results seen in Study 301 Interim Analysis in Study 306, concern of un - blinding and impact on conclusions • Extensive documentation on blinding procedures submitted • Sensitivity analyses show Study 306 is consistent across patient subsets • Expect and prepare for FDA audits NASDAQ: CHTP 15

Potential Review or Advisory Committee Issues Potential Issue Chelsea Strategy Use of a modified Intent To Treat analysis in Study 306B; More dropouts in droxidopa group during titration • The mITT analysis is an appropriate population, similar to real world use • Multiple sensitivity analyses on dropouts supports the overall 306B conclusions • Based on modeling, a larger study would likely be successful regardless of how dropout data is handled Durability of effect not adequately addressed for a chronic disease • Study 306B suggests durable effect on several endpoints • Proposing Accelerated Approval, durability to be verified post - approval NASDAQ: CHTP 16

Durability: Suggestion of Durable Clinical Benefit • Study 306 was designed to capture durable (8 week) clinical benefit • Meta - analyses of Study 306 (A+B) show suggestion of durable benefit • Trends favoring droxidopa on most endpoints • Statistical significance in certain analyses • Appears 306AB (n=197 in Full Analysis Set) was underpowered to show treatment benefits at Week 8 • Chelsea proposes to verify durable clinical benefits post - approval NASDAQ: CHTP 17

Durability: OHSA Item 1 (Dizziness) Mean Changes (Study 306AB) -3 -2.5 -2 -1.5 -1 -0.5 0 BL 1 2 3 4 5 6 7 8 Weeks of Stable Dose 5.1 3.4 3.6 3.1 3.6 p =0.077 Placebo Droxidopa Mean Change in OHSA Item 1 Baseline to Week 8 ** *p<0.05 **p<0.01 NASDAQ: CHTP 18

Durability: OHSA Item 1 (Dizziness) Responders , Week 8 (Study 306AB) 0.0 10.0 20.0 30.0 40.0 50.0 60.0 70.0 80.0 90.0 100.0 ≥ 1 Unit ≥ 2 Unit ≥ 3 Unit ≥ 4 Unit ≥ 25% ≥ 50% Placebo (N=92) Droxidopa (N=84) Percentage of Patients Improvement From Baseline * * *p<0.05 NASDAQ: CHTP 19

Durability: Standing Systolic BP Mean Changes (Study 306AB) -4 -2 0 2 4 6 8 10 12 BL 1 2 3 4 5 6 7 8 Weeks of Stable Dose 5.1 3.4 3.6 3.1 3.6 Placebo Droxidopa Mean Change in Lowest Standing SBP Baseline to Week 8 ** *p<0.05 **p<0.01 NASDAQ: CHTP 20

Consistent Results Across Studies -4 -3 -2 -1 0 1 2 3 4 Change in Dizziness/Lightheadedness Study 301 Study 306 Study 360A Study 302 Study 302 Study 360B Induction Designs Withdrawal Designs Favors Placebo Favors Droxidopa p<0.001 n=162 p=0.008 n=197 p=ns n=50 p<0.018 n=147 p=ns n=101 p=ns n=75 NASDAQ: CHTP 21

Strong Safety Profile Across Multiple Studies Study 301/302 1 - 2 wk double - blind Study 306AB 8 - 10 wk double - blind Study 303/304 ~1 year open label NORTHERA (N=131) PLACEBO (N=132) NORTHERA (N=114) PLACEBO (N=108) NORTHERA (N=422) % % % % % Patients with AEs 22.9 23.5 79.8 80.6 76.1 Patients with SAEs 0 0.8 4.4 3.7 24.9 Patients with AEs Leading to Discontinuation 0 1.5 10.5 4.6 14.9 NASDAQ: CHTP 22

Strong Safety Profile Across Multiple Studies AEs ≥5% in either group of Study 301/302 or 306 Study 301/302 1 - 2 wk double - blind Study 306AB 8 - 10 wk double - blind Study 303/304 ~1 year open label NORTHERA (N=131) PLACEBO (N=132) NORTHERA (N=114) PLACEBO (N=108) NORTHERA (N=422) % % % % % Headache 6.1 3.0 13.2 7.4 13.3 Dizziness 3.8 1.5 9.6 4.6 10.0 Nausea 1.5 1.5 8.8 4.6 6.4 Fatigue 1.5 2.3 7.0 5.6 7.1 Hypertension 1.5 0 7.0 0.9 4.5 Excoriation 0 0.8 5.3 7.4 2.6 Contusion 0 0 5.3 11.1 4.5 Skin Laceration 0.8 0 4.4 9.3 4.7 Edema 0 1.5 4.4 5.6 3.3 Fall 0.8 6.8 N/A N/A 23.5 Diarrhea 0.8 0.8 3.5 7.4 3.6 BP Increased 0 0 3.5 6.5 1.7 Back Pain 0 0 5.6 2.6 7.3 NASDAQ: CHTP 23

Study 306AB: Incidence of Supine Hypertension NORTHERA (N=114) PLACEBO (N=108) N (%) N (%) SBP > 200 mmHg 4 (3.5%) 1 (0.9%) SBP > 180 mmHg 9 (7.9%) 5 (4.6%) SBP > 160 mmHg 33 (28.9%) 26 (24.1%) Note: Incidence of supine hypertension defined by 3 consecutive blood pressure measurements during Orthostatic Standing Test at any study visit NASDAQ: CHTP 24

Clinical & Regulatory Milestones • July 3, 2013: Resubmitted Northera NDA: • Data from new supportive Phase III studies (306A/B ) • Final open - label safety extension study data (304) • Expanded 650 patient safety database • New bioequivalence study to support the 300 mg dose • 4Q2013: Begin New Clinical Study of Northera: • Address guidance regarding potential need to verify durability of effect in post - marketing setting • Include short - term clinical endpoints should the Agency require an additional trial for approval • Potential for Cardiovascular and Renal Drug Advisory Committee • Expected 1Q2014 PDUFA Date: • NDA subject to 6 - month review period from date of submission NASDAQ: CHTP 25

Key Financial Information Cash and Cash Equivalents at 3/31/13 $25.1 million • We anticipate this will cover our operating expenses into Q3 - 2014 • Cash usage includes costs for NDA filing and starting a new study in Q4 - 2013 • Costs related to NDA approval and commercialization are not included Capitalization at 4/25/13: Shares Outstanding 67,085,154 Stock options issued & outstanding 7,772,959 Warrants outstanding 250,000 Fully diluted shares 75,108,113 NASDAQ: CHTP 26

Chelsea Therapeutics Corporate Overview July 2013 © 2004 - 2013 Chelsea Therapeutics, Inc.