Halozyme Therapeutics has identified a corrective action plan to get its Hylenex pediatric-rehydration product back on the market. It completed a manufacturing root cause investigation and is prepping with partner Baxter for an FDA meeting to get the go-ahead.
Halozyme voluntarily withdrew from distribution lots of Hylenex, a preparation of the enzyme recombinant human hyaluronidase, after finding particle contamination during a stability inspection in May, according to the company's second quarter financial report. The contamination culprit is delamination, stemming from an incompatibility of product formulation with the glass vial. Halozyme licensed Hylenex to Baxter in 2005 and Baxter launched the product last October.
The partners have had their issues. Baxter maintains its innocence in a response to Halozyme's Tuesday announcement of the corrective plan, making clear that the contamination was unrelated to the contract manufacturer's fill/finish work. Halozyme filed a notice of breach against Baxter in Ma, but says it has now lifted the notice in light of Baxter's cooperation for the upcoming FDA meeting.
The product is intended to alter intravenous drugs so they can be delivered by injection rather than IV drip, says Bloomberg. The company announced in mid-August that it had received a patent for the proprietary enzyme platform.
- see the Halozyme release
- read the Baxter response
- here's the Bloomberg report