-----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, OzIhVpy86BZsVUMoon4fe0pGZnImJVY/EvB8Esem+mNoBlVnQF6lR6yevLLY4dg7 J8KXfiUxF1gWrvMutkYKAQ== 0001203944-08-000033.txt : 20081021 0001203944-08-000033.hdr.sgml : 20081021 20081021135648 ACCESSION NUMBER: 0001203944-08-000033 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20081020 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20081021 DATE AS OF CHANGE: 20081021 FILER: COMPANY DATA: COMPANY CONFORMED NAME: RAPTOR PHARMACEUTICALS CORP. CENTRAL INDEX KEY: 0001203944 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 980379351 FISCAL YEAR END: 0831 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-50720 FILM NUMBER: 081133092 BUSINESS ADDRESS: STREET 1: 9 COMMERCIAL BLVD, SUITE 200 CITY: NOVATO STATE: CA ZIP: 94949 BUSINESS PHONE: 415-382-1390 MAIL ADDRESS: STREET 1: 9 COMMERCIAL BLVD, SUITE 200 CITY: NOVATO STATE: CA ZIP: 94949 FORMER COMPANY: FORMER CONFORMED NAME: HIGHLAND CLAN CREATIONS CORP. DATE OF NAME CHANGE: 20060531 FORMER COMPANY: FORMER CONFORMED NAME: HIGHLAND CLAN CREATIONS CORP DATE OF NAME CHANGE: 20021106 8-K 1 raptor8k102108.htm RAPTOR FORM 8-K 102108

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): October 20, 2008

 

RAPTOR PHARMACEUTICALS CORP.

(Exact name of registrant as specified in its charter)

 

Delaware

000-50720

98-0379351

(State or other jurisdiction of incorporation)

(Commission File Number)

(IRS Employer Identification No.)

 

9 Commercial Blvd., Suite 200, Novato, California 94949

(Address of principal executive offices and Zip Code)

 

Registrant’s telephone number, including area code: (415) 382-8111

 

Not applicable

(Former name or former address, if changed since last report)

 

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):

 

o 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 October 20, 2008, Raptor Pharmaceuticals Corp. (the “Company”) issued a press release announcing the initiation of patient dosing in a Phase 2a clinical trial, in collaboration with the University of California, San Diego (“UCSD”), to evaluate cysteamine bitartrate (“cysteamine”) in adolescents diagnosed with Non-alcoholic Steatohepatitis (“NASH”). NASH, a progressive form of liver disease that accounts for approximately 10% of newly diagnosed cases of chronic liver disease, is one of the leading causes of cirrhosis in the U.S. UCSD is performing the Phase 2a open-label clinical study at UCSD’s General Clinical Research Center while Raptor is providing funding and clinical supplies of cysteamine.

 

The press release, in the form attached to this Current Report on Form 8-K as Exhibit 99.1, is incorporated by reference into this Item 8.01 in its entirety.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

 

99.1

  

Press Release of the Company dated October 20, 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.

 


 

 

 

RAPTOR PHARMACEUTICALS CORP.

 

 


By: /s/ Kim R. Tsuchimoto

 

 

 

Kim R. Tsuchimoto
Chief Financial Officer, Treasurer and Secretary
Date: October 21, 2008

 

 

 

 

 

Exhibit Index

 

 

Exhibit No.

 

Description

99.1

  

Press Release of the Company dated October 20, 2008.

 

 

 

                                                                                                                                                                                                               

 

 

 

 

EX-99 2 raptorpressrelease102008.htm RAPTOR PRESS RELEASE 102008 NASH TRIAL INITIATION


 

 

Exhibit 99.1

Raptor Pharmaceuticals Announces

Phase 2a Clinical Trial Initiation in

Non-Alcoholic Steatohepatitis (NASH)

 

Commences Patient Dosing of Delayed-Release

Cysteamine in Collaboration with UC, San Diego

Novato, California, October 20, 2008 – Raptor Pharmaceuticals Corp. (“Raptor” or the “Company”) (OTC Bulletin Board: RPTP), today announced the initiation of patient dosing in a Phase 2a clinical trial, in collaboration with the University of California, San Diego (“UCSD”), to evaluate cysteamine bitartrate (“cysteamine”) in adolescents diagnosed with Non-alcoholic Steatohepatitis (“NASH”). NASH, a progressive form of liver disease that accounts for approximately 10% of newly diagnosed cases of chronic liver disease, is one of the leading causes of cirrhosis in the U.S.

Under a previously announced collaboration agreement between Raptor and UCSD to evaluate the safety and potential efficacy of cysteamine in NASH patients, UCSD is performing the Phase 2a open-label clinical study at UCSD’s General Clinical Research Center while Raptor is providing funding and clinical supplies of cysteamine. The trial is expected to enroll 12 adolescent NASH patients who have been managing the disease through diet and exercise. Positive data could provide the rationale for later stage clinical studies of cysteamine in NASH patients.

Cysteamine is currently cleared for market by the U.S. Food and Drug Administration (“FDA”) and European Medicines Agency (“EMEA”) to treat nephropathic cystinosis (“cystinosis”), a rare and genetic lysosomal storage disease. Raptor is developing cysteamine and a delayed release form of cysteamine (“DR Cysteamine”) for a number of new potential therapeutic indications, including NASH, under licenses acquired from UCSD. Cysteamine has demonstrated potential efficacy in preclinical and clinical studies in NASH, Huntington’s Disease, Batten Disease and other indications.

Ted Daley, President of Raptor’s clinical division stated, “We are pleased that dosing is now underway in the Phase 2a clinical trial in NASH, a disease that may have a severe impact on the long-term health of a large number of people. Cysteamine represents an exciting potential treatment for NASH patients currently limited to diet and exercise for disease management. The NASH program is part of our strategy to leverage cysteamine’s known safety profile and potential efficacy in several indications where it has already shown promise in clinical and preclinical studies.”

Joel Lavine, M.D., Ph.D., pediatric gastroenterologist at UCSD and principal investigator for the NASH study, commented, “The initiation of patient dosing in the NASH trial offers the opportunity to evaluate a potential new treatment for this disorder. We’re pleased to collaborate with Raptor for this study as we work to find a treatment for NASH.”

 

 

 

 

NASH is believed to affect 2% to 5% of the U.S. population. While commonly diagnosed in insulin-resistant obese adults with diabetes and abnormal serum lipid profiles, NASH can also occur in children, elderly and non-diabetic persons of average weight. Though most people with NASH feel healthy and show no outward signs of liver disease, NASH causes decreased liver function and potentially leads to cirrhosis, liver failure and end-stage liver disease. In more severe cases, the progressive nature of NASH may require liver transplantation in affected patients.

 

About Cysteamine and DR Cysteamine

Cysteamine is cleared for market by the FDA and EMEA to treat cystinosis, a rare and genetic lysosomal storage disease. The drug’s potential to accumulate in the liver may create a targeted treatment effect for patients with NASH. DR Cysteamine is designed as an enterically coated, oral formulation of cysteamine.

Raptor obtained an exclusive, worldwide license to DR Cysteamine, as well as orphan drug designation from the FDA for DR Cysteamine for the treatment of nephropathic cystinosis, through its December 2007 acquisition of Encode Pharmaceuticals. In March 2008, Raptor acquired an exclusive worldwide license to intellectual property from UCSD for the use of cysteamine and DR Cysteamine for the treatment of NASH.

 

About Raptor Pharmaceuticals Corp.

 

Raptor Pharmaceuticals Corp. (“Raptor”) is a publicly traded biotechnology company dedicated to speeding the delivery of new treatment options to patients by enhancing existing therapeutics through the application of highly specialized drug targeting platforms and formulation expertise. Raptor focuses on underserved patient populations where it can have the greatest impact. Raptor is involved in clinical development of its proprietary Delayed-Release Cysteamine (“DR Cysteamine”) product candidate in nephropathic cystinosis, non-alcoholic steatohepatitis (“NASH”), Huntington’s Disease and Batten Disease, and its Convivia™ product candidate in aldehyde dehydrogenase (“ALDH2”) deficiency. In its preclinical programs Raptor bioengineers novel drug candidates and drug-targeting platforms derived from the human receptor-associated protein (“RAP”) and related proteins to target cancer, neurodegenerative disorders and infectious diseases. Raptor’s preclinical programs include HepTide™, WntTide™ and NeuroTrans™.

 

For additional information, please visit www.raptorpharma.com.

 

 

FORWARD LOOKING STATEMENTS

 

This document contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements relate to future events or our future results of operation or future financial performance, including, but not limited to the following statements: Raptor’s ability to develop DR Cysteamine for the treatment of NASH, cystinosis and other indications; Raptor’s ability to formulate and manufacture DR Cysteamine in clinical quantities to support clinical trials; and cysteamine’s ability to benefit NASH patients. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, which may cause our actual results to be materially different from these forward-looking statements. Factors which may significantly change or prevent our forward looking statements from fruition include that we may be unsuccessful in developing any products or acquiring products; that our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; that we are unable to retain or attract key employees whose knowledge is essential to the development of our products; that unforeseen scientific difficulties develop with our process; that our patents are not sufficient to protect essential aspects of our technology; that competitors may invent better technology; that our products may not work as well as hoped or worse, that our products may harm recipients; and that we may not be able to raise sufficient funds for development or working capital when we require it. As well, our products may

 

 

never develop into useful products and even if they do, they may not be approved for sale to the public. We caution readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they were made. Certain of these risks, uncertainties, and other factors are described in greater detail in our filings from time to time with the Securities and Exchange Commission (the “SEC”), which we strongly urge you to read and consider, including our Registration Statement on Form S-1that was declared effective on August 7, 2008; our annual report on Form 10-KSB filed with the SEC on November 14, 2007; and our Form 10-QSB filed with the SEC on July 9, 2008, all of which are available free of charge on the SEC’s web site at http://www.sec.gov. Subsequent written and oral forward-looking statements attributable to us or to persons acting on our behalf are expressly qualified in their entirety by the cautionary statements set forth in our reports filed with the SEC. We expressly disclaim any intent or obligation to update any forward-looking statements.

 

# # #

For more information, please contact:

The Ruth Group

Sara Ephraim (investors)

Janine McCargo (media)

 

(646) 536-7002

(646) 536-7033

 

sephraim@theruthgroup.com

jmccargo@theruthgroup.com

 

 

 

 

 

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