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.
LGM Pharma unveils enhanced analytical testing services and expands CDMO portfolio with additional suppository manufacturing capabilities