Navigation Links
Halozyme Provides HYLENEX® Product Reintroduction Update
Date:8/31/2010

SAN DIEGO, Aug. 31 /PRNewswire/ -- 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.

(Logo:  http://photos.prnewswire.com/prnh/20100302/LA63139LOGO)

(Logo:  http://www.newscom.com/cgi-bin/prnh/20100302/LA63139LOGO)

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 HYLENEXHYLENEX, 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™ 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.Halozyme Contact  Robert H. UhlSenior Director, Investor Relations(858) 704-8264ruhl@halozyme.com
'/>"/>

SOURCE Halozyme Therapeutics, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Halozyme Therapeutics Completes Enrollment in Chemophase Phase I/IIa Clinical Trial for Superficial Bladder Cancer
2. Halozyme Therapeutics Announces Peer-Reviewed Publications of the INFUSE-LR Clinical Trial Results and Clinical Practice Experience With Hylenex
3. Halozyme Therapeutics Presents Pre-Clinical Studies of Systemic Delivery of Pegylated rHuPH20 Enyzme in Prostate Cancer Models at American Association for Cancer Research Conference
4. Halozyme Therapeutics Presents Findings on Combinations of rHuPH20 Enzyme With Bisphosphonates at the American Association for Cancer Research Conference
5. Halozyme Therapeutics Announces Phase I Clinical Trial Results Demonstrating that the Combination of Recombinant Human Hyaluronidase (rHuPH20) With Humulin R(R) and with Humalog(R) Yields Faster, More Physiologic Insulin Kinetics and Better Predictability
6. Halozyme Therapeutics Announces That Chemophase Meets Primary Endpoint in Phase I/IIa Clinical Trial
7. Halozyme Therapeutics Announces Positive Findings With Pegylated Enzyme in Prostate Cancer Models
8. Halozyme Therapeutics Announces Roche Begins Phase 1 Clinical Trial and Selects Fourth Exclusive Biologic Target
9. Halozyme Therapeutics Begins Phase 1 Clinical Trial of Bisphosphonate Administered With rHuPH20 Enzyme
10. CuraGen Provides Update on Velafermin, Belinostat and CR011-vcMMAE Clinical Development Programs
11. Access Pharmaceuticals Provides Update on Clinical Development Plan of ProLindac
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/12/2016)... Holdings, Inc. (NASDAQ: IPHS ), a leading international producer ... will host a live conference call on Tuesday, February 23, ... and full year 2015 results. --> ... and full year results will be issued on Monday, February ... --> The conference call can be accessed ...
(Date:2/12/2016)... Inc., a medical device company that pioneered the use of the ... device indicated for fusion for certain disorders of the sacroiliac (SI) ... Contractor (MAC) covering the states of Connecticut , ... Massachusetts , Minnesota , ... Rhode Island , Vermont and ...
(Date:2/12/2016)... Feb. 12, 2016 On Thursday, Feb. 11, ... at St. David,s North Austin Medical Center successfully completed ... Xi ® Surgical System with Trumpf Medical,s ... Thiru Lakshman , M.D., colorectal surgeon at the ... utilizing Integrated Table Motion technology, which seamlessly combines the ...
Breaking Medicine Technology:
(Date:2/14/2016)... ... February 14, 2016 , ... In ... Heart Failure Nurses (AAHFN) is promoting healthier living with heart failure by providing ... Life! Healthy Living with Heart Failure will kick-off February 14 and includes tips ...
(Date:2/13/2016)... (PRWEB) , ... February 13, 2016 , ... Many individuals ... of protein for a multitude of reasons. IsoPasta by Isolator Fitness has delved ... it once more, but without the high-carb repercussions. IsoPasta has 30 grams of ...
(Date:2/13/2016)... ... ... an Au Pair comes all the way around the world to provide child ... are often worried things won’t go well. More often than not, however, they find out ... the Year winner’s all commented how their Au Pairs have become a part of the ...
(Date:2/12/2016)... ... February 12, 2016 , ... The law firm of Morrow, Morrow, Ryan & ... purpose of these scholarships is to encourage applicants to pursue a degree in their ... these two parishes. , “We have available jobs in St. Landry and Evangeline ...
(Date:2/12/2016)... ... February 12, 2016 , ... Each year, the American Physical Therapy ... Anaheim, CA at the Anaheim Convention Center. Almost 10,000 physical therapists across the country ... in action, learn more about their chosen field and network with their colleagues. ...
Breaking Medicine News(10 mins):