Halozyme Therapeutics says that it has identified a corrective action plan and regulatory strategy to reintroduce Hylenex to the market. It is finalizing materials for a meeting with the FDA to seek concurrence with the re-introduction strategy. Additionally, Halozyme lifted its notice of breach on Baxter Healthcare, its manufacturing partner.
Hylenex, approved by the FDA for subcutaneous fluid administration, works by temporarily making the tissue beneath the skin more permeable, allowing fluids to be more readily absorbed into the blood vessels.
On May 17, Halozyme reported the voluntary withdrawal of affected lots of 150 U Hylenex product from distribution after it confirmed the presence of small flake-like glass particles in a limited number of vials at the Baxter Healthcare’s manufacturing facility. At the time Baxter said that the recall would affect approximately 3,500 vials in the distribution chain.
To date no adverse medical events have been reported in connection with noncompliant Hylenex product, the companies point out. Halozyme's assessment is that the health risk posed by the noncompliant Hylenex product is low. Neither the rHuPH20 bulk enzyme nor any other products containing the enzyme are believed to be affected.
When Halozyme decided to pull Hylenex from the market, it also delivered a notice of breach to Baxter due to its failure to provide Hylenex in accordance with the terms of the parties' development and supply contracts. Baxter had also said that if it was unable to remedy all material breaches within 120 days, it would terminate its relationship with Hylenex.
During meetings held between the companies since May, Halozyme says that Baxter's senior management has reiterated its commitment to the successful commercialization of Hylenex. Halozyme has thus lifted the notice of breach that it delivered to Baxter.
Halozyme is 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.
The company’s Enhanze™ technology is a drug-delivery platform designed to increase the absorption and dispersion of biologics. The company has a partnership with Roche to apply Enhanze to Roche's biologicals including Herceptin and MabThera for up to 13 targets. It also has an arrangement with Baxter BioScience to use Enhanze with 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.