-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, KX3+9jnPKTXa4X9XUhSuCGINI4FvYk9+mFKlqQg1pL/8xqrYWo9/mwuX3g+m3SzC PyyPkIZug3Xv24ZWhhs9fA== 0001193125-08-144764.txt : 20080701 0001193125-08-144764.hdr.sgml : 20080701 20080701105755 ACCESSION NUMBER: 0001193125-08-144764 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20080626 ITEM INFORMATION: Departure of Directors or Principal Officers; Election of Directors; Appointment of Principal Officers ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080701 DATE AS OF CHANGE: 20080701 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Chelsea Therapeutics International, Ltd. CENTRAL INDEX KEY: 0001333763 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 203174202 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-51462 FILM NUMBER: 08928228 BUSINESS ADDRESS: STREET 1: 13950 BALLANTYNE CORPORATE PLACE STREET 2: UNIT 325 CITY: CHARLOTTE STATE: NC ZIP: 28277 BUSINESS PHONE: 704-341-1516 MAIL ADDRESS: STREET 1: 13950 BALLANTYNE CORPORATE PLACE STREET 2: UNIT 325 CITY: CHARLOTTE STATE: NC ZIP: 28277 8-K 1 d8k.htm FORM 8-K Form 8-K

 

 

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): June 26, 2008

 

 

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 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers

(d) On June 26, 2008, the Board of Directors of Chelsea Therapeutics International, Ltd. appointed William Schwieterman, M.D. as a member of the Board. Dr. Schwieterman will hold office until the Company’s 2009 Annual Meeting of Stockholders or until his successor is elected and qualified.

The Nominating and Corporate Governance Committee of the Board (the “Committee”) conducted the search for director candidates. Although the Committee has not formulated any specific minimum qualifications for director candidates, it has determined that desirable characteristics include strength of character, mature judgment, career specialization, relevant technical skills, diversity and independence. It also focused this search on candidates with significant experience in drug development and related regulatory matters. After reviewing several director candidates, the Committee recommended Dr. Schwieterman for appointment to the Board.

There were no arrangements or understandings between Dr. Schwieterman and any other person pursuant to which Dr. Schwieterman was appointed as director and there are no related party transactions between Dr. Schwieterman and the Company. The Board committee that Dr. Schwieterman will serve on is the Compensation.

Dr. Schwieterman is a board-certified internist and a rheumatologist, currently serving as an independent consultant to biotechnology and pharmaceutical companies, focusing on clinical drug development and regulatory matters. Dr. Schwieterman was formerly Chief of the Medicine Branch and Chief of the Immunology and Infectious Disease Branch in the Division of Clinical Trials at the Food and Drug Administration (FDA). In these and other capacities, Dr. Schwieterman served 10 years at the FDA in the Center for Biologics overseeing a wide range of clinical development programs for a large number of therapeutic candidates.

A press release dated June 30, 2008 announcing Dr. Schwieterman’s appointment is attached as Exhibit 99.1

 

Item 9.01. Financial Statements and Exhibits.

 

  (c) Exhibits

 

Exhibit No.

 

Description

99.1   Press release dated June 30, 2008.


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: June 30, 2008    

/s/ J. Nick Riehle

    J. Nick Riehle, Chief Financial Officer
EX-99.1 2 dex991.htm PRESS RELEASE Press release

Exhibit 99.1

William D. Schwieterman, M.D. Joins Chelsea Therapeutics’ Board of Directors

Charlotte, NC, June 30, 2008 – Chelsea Therapeutics International, Ltd. (NASDAQ: CHTP) announced that William D. Schwieterman, M.D. has been appointed to the Company’s Board of Directors.

Dr. Schwieterman, a board-certified internist and a rheumatologist, was formerly Chief of the Medicine Branch and Chief of the Immunology and Infectious Disease Branch in the Division of Clinical Trials at the Food and Drug Administration (FDA). In these and other capacities, Dr. Schwieterman served 10 years at the FDA in the Center for Biologics overseeing a wide range of clinical development programs for a large number of therapeutic candidates. He worked closely with industrial sponsors developing new drugs in a variety of therapeutic areas, including pulmonary medicine, neurology, sepsis, hepatitis, rheumatology, infectious disease, solid organ transplantation and wound healing, and also with FDA reviewers of vaccines, devices (CDRH) and oncology products. Dr. Schwieterman helped author the FDA’s “Good Review Practices” for investigational products, and was instrumental in developing several guidance documents for industry. He currently serves as an independent consultant to biotechnology and pharmaceutical companies, focusing on clinical drug development and regulatory matters.

“As a member of our scientific advisory board, Bill has been an active and invaluable advisor to our important antifolate development program since the Company’s inception,” commented Dr. Kevan Clemens, Chairman of the Board. “As we now approach the filing of our first NDA, we look forward to leveraging the full breadth of Bill’s expertise in his new position as Director to assist us in navigating the final regulatory steps toward approval of Droxidopa.”

About Chelsea Therapeutics

Chelsea Therapeutics is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases. The Company is currently developing a library of metabolically inert antifolate compounds engineered to have potent anti-inflammatory and anti-tumor activity to treat a range of immunological disorders. Early clinical data suggests that Chelsea’s lead antifolate compound, CH-1504, is a safe and effective treatment alternative to methotrexate for RA and may have further applications for psoriasis, IBD and certain cancers. Chelsea’s antifolate program is complemented by the development of the I-3D portfolio of therapeutics targeting immune-mediated inflammatory disorders and transplantation. In addition to its autoimmune pipeline, Chelsea is developing Droxidopa, an orally active synthetic precursor of norepinephrine, for the treatment of neurogenic orthostatic hypotension. Currently approved and marketed in Japan, Droxidopa has accumulated over 15 years of proven safety and efficacy, historically generating annual revenues of approximately $50 million in Japan.

This press release 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 reliance on collaborations and licenses, risks and costs of drug development, regulatory approvals,


intellectual property risks, our reliance on our lead drug candidate, our history of losses and need to raise more money, competition, market acceptance for our products if any are approved for marketing, reliance on key personnel including specifically Dr. Pedder, management of rapid growth, and the need to acquire or develop additional products.

***

 

Chelsea Therapeutics:         
Nick Riehle       Kathryn McNeil   
Chief Financial Officer       Investor/Media Relations   
704-341-1516 x101       718-788-2856   
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