-----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, MEjoxAPx2BUoDCprxQmdFU6y0Ke7MlYjPo21/ar9+GKzh3VdDRqRHvrMYyXrvd/o rHIKPOvu8jZkg9cVsFNOhA== 0000950137-05-006571.txt : 20050611 0000950137-05-006571.hdr.sgml : 20050611 20050526160703 ACCESSION NUMBER: 0000950137-05-006571 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20050526 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050526 DATE AS OF CHANGE: 20050526 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: 05860305 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 a09560e8vk.htm FORM 8-K e8vk
 

 
 

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

May 26, 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))

 
 

 


 

Item 8.01 Other Events.

On May 26, 2005, Halozyme Therapeutics, Inc. announced that the U.S. Food and Drug Administration accepted for filing its new drug application (“NDA”) for HylenexÔ. The press release announcing the acceptance of the NDA 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 May 26, 2005.

 


 

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.
 
 
May 26, 2005  By:   /s/ David A. Ramsay    
    David A. Ramsay   
    Secretary and Chief Financial Officer   
 

 

EX-99.1 2 a09560exv99w1.txt EXHIBIT 99.1 EXHIBIT 99.1 (HALOZYME THERAPEUTICS 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 FDA ACCEPTANCE OF HYLENEX NDA SAN DIEGO, MAY 26, 2005 - Halozyme Therapeutics, Inc. (AMEX: HTI), a development stage biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review Halozyme's New Drug Application (NDA) for Hylenex(TM) (formerly referred to as Enhanze SC(TM)). Halozyme submitted the Hylenex NDA on March 23, 2005, seeking approval for use as a spreading agent to facilitate the dispersion and absorption of other drugs. The Company previously announced in April 2005 that the FDA granted Priority Review status to the Hylenex NDA, which sets the target date for initial FDA action within six months from the NDA submission date. "We are excited that the FDA has accepted our NDA filing," said Jonathan Lim, MD, Halozyme's Chairman and CEO. "This is a significant step in the FDA's review of Hylenex for use as a spreading agent. If approved by the FDA, we believe Hylenex could offer physicians an attractive alternative to animal-derived hyaluronidases." Halozyme's hyaluronidase (rHuPH20) is a highly purified, recombinant form of the naturally occurring human enzyme and is being investigated for its ability to break down hyaluronic acid (HA), the space-filling "gel"-like substance that is a major component of tissues throughout the body. Hyaluronidase that is injected in the skin or in the muscle can temporarily digest the HA gel to enhance the penetration and diffusion of other injected drugs or fluids. 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 Company's products under development, the timing of expected regulatory filings, and the regulatory approval of products under development) 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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