-----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, CuXsP2VJ0idi7rcNjuZRVD1w5WVPHN75KQzWwUCBv63z1Qeiy7lqu8MfC0oEI7lU aUrBaOnDHwWDT3m8AeBQGg== 0000950134-05-022578.txt : 20051205 0000950134-05-022578.hdr.sgml : 20051205 20051205081625 ACCESSION NUMBER: 0000950134-05-022578 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20051202 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20051205 DATE AS OF CHANGE: 20051205 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: 051242736 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 a15097e8vk.htm FORM 8-K DATED DECEMBER 2, 2005 Haloyzyme 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
December 2, 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))
 
 

 


TABLE OF CONTENTS

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


Table of Contents

Item 8.01 Other Events.
     On December 5, 2005, Halozyme Therapeutics, Inc. announced the U.S. Food and Drug Administration's approval of its new drug application (“NDA”) for Hylenex recombinant (hyaluronidase human injection) for use as an adjuvant agent to increase the absorption and dispersion of other injected drugs. The press release announcing the approval 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 December 5, 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.
 
 
December 5, 2005  By:   /s/ David A. Ramsay    
    David A. Ramsay   
    Secretary and Chief Financial Officer   
 

 

EX-99.1 2 a15097exv99w1.htm EXHIBIT 99.1 exv99w1
 

Exhibit 99.1
     
(Halozyme Logo)
  (Baxter Logo)
     
Halozyme Contacts
  Baxter Contacts
Investors:
  Investors:
David A. Ramsay
  Mary Kay Ladone
Chief Financial Officer
  (847) 948-3371
(858) 794-8889
  or
dramsay@halozyme.com
  Clare Sullivan
or
  (847) 948-3085
Don Markley
  Media:
Lippert/Heilshorn & Associates
  Erin Gardiner
(310) 691-7100
  (847) 948-4210
dmarkley@lhai.com
  or
Media:
  Cindy Resman
Kathy W. Sweeney
  (847) 948-2815
Mentus
   
(858) 455-5500, x230
   
kwitz@mentus.com
FOR IMMEDIATE RELEASE
HALOZYME THERAPEUTICS AND BAXTER HEALTHCARE CORPORATION ANNOUNCE FDA APPROVAL OF HYLENEX
Approval Marks the First Recombinant Human Hyaluronidase Approved for Use
As an Adjuvant Drug to Increase the Absorption and Dispersion of Other Injected Drugs
SAN DIEGO, Calif. and DEERFIELD, Ill., December 5, 2005 – Halozyme Therapeutics, Inc. (AMEX: HTI), a biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, and Baxter Healthcare Corporation announced today that the U.S. Food and Drug Administration (FDA) has approved Halozyme’s Hylenex recombinant (hyaluronidase human injection) for use as an adjuvant agent to increase the absorption and dispersion of other injected drugs. Baxter will market and sell Hylenex, a proprietary recombinant human hyaluronidase, in the United States.
“We are thrilled that the FDA has approved our first NDA filing,” said Jonathan Lim, MD, Halozyme’s Chairman and CEO. “This is a landmark achievement for Halozyme. We believe Hylenex will help enhance the practice of medicine by offering healthcare providers and their patients a human recombinant product as an adjuvant to increase the absorption of other injected drugs.”
“We look forward to using our expertise and strong channels to successfully launch Hylenex, allowing patients in many clinical settings to benefit from the product manufactured with this promising technology,” said Daniel Tasse, general manager of Baxter’s Anesthesia, Critical Care and Oncology business. “We will continue to work with Halozyme to help clinicians fully realize the drug delivery and administration benefits this product offers.”

 


 

Results from a clinical trial conducted to support the Hylenex NDA demonstrated no allergic reactions to Hylenex and significantly reduced injection site discomfort. The double-blinded clinical study compared Hylenex to a saline control in 100 human volunteers. These volunteers were injected intradermally with Hylenex in one forearm and saline control in the other forearm, and evaluated for allergic responses and injection site side effects. The data showed injection site discomfort (e.g., stinging, burning, other discomfort) of 28% in the saline arm and 3% in the Hylenex arm.
About Hylenex
Hylenex recombinant (hyaluronidase human injection) is indicated for use as an adjuvant agent to increase the absorption and dispersion of other injected drugs, for hypodermoclysis, and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents. Hylenex recombinant is contraindicated in patients with hypersensitivity to hyaluronidase enzyme or any other ingredients in the formulation. The contraindications and warnings regarding the use of Hylenex should be recognized and adhered to prior to prescription or administration. For full prescribing information, visit www.halozyme.com or www.baxter.com.
About Baxter Healthcare Corporation
Baxter Healthcare Corporation is the principal U.S. operating subsidiary of Baxter International Inc. (NYSE:BAX). Baxter International Inc., through its subsidiaries, assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients’ lives.
About Halozyme Therapeutics, Inc.
Halozyme is a 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, statements set forth in this news release include forward-looking statements including, without limitation, statements concerning: anticipated timing of regulatory filings and the potential success in gaining regulatory approval for developmental products; the potential effectiveness of products under development; the potential benefits from collaborative relationships; the ability to effectively exploit drug-delivery platform opportunities in other markets; demand for and market acceptance for new and existing products; the impact of competitive products and pricing, including generic competition, drug reimportation and disruptive technologies; internal and external factors that could impact commercialization; and other factors discussed in each company’s filings with the Securities and Exchange Commission 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,” “expect,” “enable,” “may,” “will,” “could,” “intends,” “estimate,” “anticipate,” “plan,” “predict,” “probable,” “potential,” “possible,” “should,” “continue,” and other words of similar meaning, which are predictions of or indicate future events and trends and which do not relate to historical matters. The companies do not undertake any obligation to update any forward-looking statements as a result of new information, future events, changes assumptions or otherwise, and all forward-looking statements speak only as of the time when made. Actual results or experience could differ materially from the expectations contained in the forward-looking statements.
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