-----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, CQuRp5eb7GYLyEoM1fIuieago57UFBulNS6nxtxfWSrSDzUGBbVVsOfzpYfgh8ca s/ZJwzHTWCMDLfpuM2foXQ== 0000950134-05-012780.txt : 20050701 0000950134-05-012780.hdr.sgml : 20050701 20050701060231 ACCESSION NUMBER: 0000950134-05-012780 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20050701 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050701 DATE AS OF CHANGE: 20050701 FILER: COMPANY DATA: COMPANY CONFORMED NAME: HALOZYME THERAPEUTICS INC CENTRAL INDEX KEY: 0001159036 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 880488686 STATE OF INCORPORATION: NV FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-32335 FILM NUMBER: 05930162 BUSINESS ADDRESS: STREET 1: 11588 SORRENTO VALLEY ROAD STREET 2: SUITE 17 CITY: SAN DIEGO STATE: CA ZIP: 92121 BUSINESS PHONE: (858) 794-8889 FORMER COMPANY: FORMER CONFORMED NAME: GLOBAL YACHT SERVICES INC DATE OF NAME CHANGE: 20010912 8-K 1 a10366e8vk.htm FORM 8-K Halozyme Therapeutics, Inc.
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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

July 1, 2005

HALOZYME THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)
         
Nevada   000-49616   88-0488686
 
(State or other jurisdiction
of incorporation)
  (Commission
File Number)
  (IRS Employer
Identification No.)
     
11588 Sorrento Valley Road, Suite 17, San Diego, California   92121
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (858) 794-8889

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))

 
 

 


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Item 8.01 Other Events.
Item 9.01 Financial Statements and Exhibits.
SIGNATURES
EXHIBIT 99.1


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Item 8.01 Other Events.

     On June 30, 2005, Halozyme Therapeutics, Inc. announced the submission of its investigational new drug application (“IND”) for ChemophaseÔ to the U.S. Food and Drug Administration. The press release announcing the submission of the IND is attached hereto as Exhibit 99.1 and is incorporated by reference.

Item 9.01 Financial Statements and Exhibits.

     (c) Exhibits.

         
Exhibit No.   Description
  99.1    
Press Release dated June 30, 2005.

 


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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.
         
  Halozyme Therapeutics, Inc.
 
 
July 1, 2005  By:   /s/ David A. Ramsay    
    David A. Ramsay   
    Secretary and Chief Financial Officer   
 

 

EX-99.1 2 a10366exv99w1.txt EXHIBIT 99.1 EXHIBIT 99.1 [HALOZYME LOGO] HALOZYME CONTACT INVESTOR RELATIONS CONTACTS David A. Ramsay Ina McGuinness/Bruce Voss Chief Financial Officer Lippert/Heilshorn & Associates (858) 794-8889 (310) 691-7100 dramsay@halozyme.com imcguinness@lhai.com MEDIA CONTACTS Kathy Sweeney/Joleen Schultz Mentus (858) 455-5500, x230/x215 kwitz@mentus.com jschultz@mentus.com HALOZYME THERAPEUTICS ANNOUNCES SUBMISSION OF INVESTIGATIONAL NEW DRUG APPLICATION FOR CHEMOPHASE SAN DIEGO, JUNE 30, 2005 - Halozyme Therapeutics, Inc. (AMEX: HTI), a biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, today announced it has submitted its Investigational New Drug (IND) application for Chemophase(TM) to the U.S. Food and Drug Administration (FDA). Chemophase is a formulation of recombinant human hyaluronidase being developed as a chemoadjuvant for the treatment of cancer. This IND was submitted to enable the initiation of the first clinical trial with Chemophase, administered intravesically with the chemotherapeutic agent mitomycin to patients with bladder cancer. "We are thrilled to file our first IND for Chemophase," said Jonathan Lim, MD, Halozyme's Chairman and CEO. "This novel therapeutic biologic is being developed to enhance the delivery of chemotherapy. Based on the promising pre-clinical data gathered to date, and the previous clinical work done with bovine hyaluronidase in bladder cancer, adjunctive delivery of Chemophase may increase the penetration of the drug throughout the tumor. We are excited about this clinical program and look forward to evaluating Chemophase for potential treatment of superficial bladder cancer." Patient enrollment may not begin until the FDA IND review period has passed and the clinical protocol has received Institutional Review Board approval. If accepted, the Phase 1 study will enroll up to ten patients with superficial bladder cancer. The objectives of the Chemophase clinical trial are to determine the safety, tolerability and pharmacokinetics of Chemophase administered intravesically with mitomycin. ABOUT HALOZYME THERAPEUTICS, INC. Halozyme is a development stage biopharmaceutical company dedicated to developing and commercializing recombinant human enzymes for the infertility, ophthalmology, and oncology communities. The company's portfolio of products under development is based on intellectual property covering the family of human enzymes known as hyaluronidases. Halozyme's recombinant human enzymes may replace current animal slaughterhouse-derived enzymes that carry potential risks of animal pathogen transmission and immunogenicity. The versatility of the first enzyme, rHuPH20, enables Halozyme to develop the product as a medical device, drug enhancement agent, and therapeutic biologic. SAFE HARBOR STATEMENT In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning the timing and nature of the Chemophase clinical trial) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are also identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including regulatory approval requirements and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the company's reports on Forms 10-KSB, 10-QSB and other filings with the Securities and Exchange Commission. ###
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