8-K

 

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): August 13, 2010

HALOZYME THERAPEUTICS, INC.
__________________________________________
(Exact name of registrant as specified in its charter)

Delaware	001-32335	88-0488686
_____________________ (State or other jurisdiction	_____________ (Commission	______________ (I.R.S. Employer
of incorporation)	File Number)	Identification No.)
11388 Sorrento Valley Road, 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:

[  ]  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[  ]  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[  ]  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[  ]  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 8.01 Other Events.

Update on HYLENEX® Reintroduction

On August 31, 2010, Halozyme Therapeutics, Inc. ("Halozyme") issued a press release to report on its plans for the reintroduction of HYLENEX. In addition, Halozyme announced the lifting of the notice of breach previously delivered to Baxter Healthcare International. The press release is attached as Exhibit 99.1 to this Form 8-K.

Update on United States and European Patents

On August 12, 2010, Halozyme announced the issuance of United States Patent No. 7,767,429 (the "’429 Patent") claiming its proprietary recombinant human hyaluronidase enzyme platform (rHuPH20). Claims to the human PH20 glycoprotein, PEGylated variants, the glycoprotein produced by recombinant methods, and pharmaceutical compositions with other agents, including antibodies, insulins, cytokines, anti-infectives and additional therapeutic classes were awarded in this patent and additional claims are in prosecution. This patent will not expire until September 23, 2027.
A European counterpart patent, EP1603541, was also granted to Halozyme on November 11, 2009. On August 13, 2010, Halozyme learned that an opposition to this patent was filed with the European Patent Office. Halozyme plans on contesting the opposition with written submissions to the European Patent Office. Halozyme expects to obtain European patent protection that is equal or superior to the claims recently issued in the ’429 patent. The European patent provides protection until March 5, 2024.

Item 9.01 Financial Statements and Exhibits.

Exhibit No. Description
99.1 Press release, dated August 31, 2010

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.
August 31, 2010	By:	James E. Cartoni
		Name: James E. Cartoni
		Title: Secretary and Vice President, Legal

Exhibit Index

Exhibit No.	Description
99.1	Press release, dated August 31, 2010

EX-99.1

Exhibit 99.1

Halozyme Contact
Robert H. Uhl
Senior Director, Investor Relations
(858) 704-8264
ruhl@halozyme.com

Halozyme Provides HYLENEX^® Product Reintroduction Update

- Affirms commitment to expeditious product reintroduction strategy -

- Lifts notice of breach to Baxter Healthcare regarding HYLENEX^® -

SAN DIEGO, August 31, 2010 – Halozyme Therapeutics, Inc. (Nasdaq: HALO) today announced the completion of its root cause investigation regarding HYLENEX manufacturing and has identified a corrective action plan and regulatory strategy to reintroduce HYLENEX to the market. Halozyme and Baxter are finalizing the materials for a meeting with the U.S. Food and Drug Administration to seek concurrence with the reintroduction strategy. During several meetings and discussions held between the two companies, Baxter’s senior management has reiterated its commitment to the successful commercialization of HYLENEX. As a result of this progress, Halozyme has lifted the notice of breach that was delivered to Baxter Healthcare Corporation on May 16, 2010.

On May 17, 2010, Halozyme announced the voluntary withdrawal of affected lots of 150U HYLENEX product from distribution after Halozyme and Baxter confirmed the presence of particles in a limited number of vials of HYLENEX. This action was taken as a precautionary measure to ensure patient safety. Since then, the voluntary withdrawal has been proceeding as planned. To date, no adverse medical events have been reported in connection with noncompliant HYLENEX product.

About HYLENEX
HYLENEX, approved by the FDA for subcutaneous fluid administration, works by temporarily making the tissue beneath the skin more permeable (capable of being passed through) and able to absorb fluid, allowing fluids to be more readily absorbed into the blood vessels. HYLENEX, when administered for pediatric rehydration, can be given in a site that is convenient for both the child and caregiver, such as in the child’s upper back, while the child is held by a parent. Once HYLENEX has been injected, fluids can be administered subcutaneously.

 About Halozyme

Halozyme Therapeutics is a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the endocrinology, oncology, dermatology and drug delivery markets. The company’s product portfolio is based primarily on intellectual property covering the family of human enzymes known as hyaluronidases and additional enzymes that affect the extracellular matrix. Halozyme’s Enhanze^Ô technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. The company has key partnerships with Roche to apply Enhanze technology to Roche’s biological therapeutics, including Herceptin® and MabThera®, for up to 13 targets, and with Baxter BioScience to apply Enhanze technology to GAMMAGARD Liquid^®. Halozyme’s Ultrafast Insulin program combines its rHuPH20 enzyme with mealtime insulins, which may produce more rapid absorption, faster action, and improved glycemic control. The product candidates in Halozyme’s pipeline target multiple areas of significant unmet medical need. For more information visit www.halozyme.com.

Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning the commercialization of HYLENEX) 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-K, 10-Q, and other filings with the Securities and Exchange Commission.

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