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.
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(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 bo
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