-----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, KUIxyZRtcIszi4F3b7V2+wNWnhwgKDBrXJ/8APi87hFrQQVc5ogUlk3TV0pCqTHn JxObgfENUs6i5FKi/TFHTg== 0000936392-05-000070.txt : 20050328 0000936392-05-000070.hdr.sgml : 20050328 20050328110019 ACCESSION NUMBER: 0000936392-05-000070 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20050328 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050328 DATE AS OF CHANGE: 20050328 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: 05705593 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 a07301e8vk.htm FORM 8-K e8vk
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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

March 28, 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 March 28, 2005, Halozyme Therapeutics, Inc. announced that it filed a new drug application (“NDA”) with the U.S. Food and Drug Administration for Enhanze SC. The press release announcing the filing 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 March 28, 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.


 
March 28, 2005  By:   /s/ David A. Ramsay  
    David A. Ramsay  
    Secretary and Chief Financial Officer  
 

 

EX-99.1 2 a07301exv99w1.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 FILES NDA FOR ENHANZE SC SAN DIEGO, MARCH 28, 2005 - Halozyme Therapeutics, Inc. (AMEX: HTI), a development stage biopharmaceutical company developing and commercializing recombinant human enzymes, today announced it has filed a New Drug Application (NDA) for Enhanze SC(TM), the first product in Halozyme's Enhanze(TM) Technology portfolio. Enhanze SC is a local formulation of recombinant human hyaluronidase being developed as a "spreading agent" to enhance the drug delivery of local anesthesia, contrast agents, and for subcutaneous fluid replacement (also called hypodermoclysis). On March 3, 2005, Halozyme received confirmation from the Food and Drug Administration (FDA) that Enhanze SC will be designated a New Chemical Entity. "We at Halozyme are proud to have met our stated goal of filing an NDA in the first quarter of 2005 for Enhanze SC, an important product in our pipeline," said Jonathan Lim, MD, Halozyme's Chairman and CEO. "Filing a first NDA is a major milestone for any company, but filing one merely 21 months after vector construction, as Halozyme has achieved, is quite rare. It is a testament to the efficiency of our development strategy and extraordinary efforts of our team." Halozyme's hyaluronidase (rHuPH20) is a 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. In August 2004, Halozyme signed an exclusive agreement with Baxter Healthcare Corporation for Baxter to market, distribute, and sell Enhanze SC for certain indications in the United States and Puerto Rico upon approval of the therapeutic by the FDA. Upon approval, Baxter and Halozyme will be equal partners in the commercialization of the product. In February 2005, Halozyme signed a commercial manufacturing supply agreement with Avid Bioservices to manufacture the recombinant human enzyme under current good manufacturing practice (cGMP). 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, the regulatory approval of products under development and product launch dates) 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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