Roche Begins Phase I with Halozyme Formulation

Roche has dosed the first patient in a Phase I pharmacokinetic trial with a subcutaneous formulation using Halozyme Therapeutics’ Enhanze Technology of a biologic directed to a Roche exclusive target. This has triggered a milestone payment under the collaboration agreement between the two companies.

Roche has also selected an additional exclusive target under the existing license and collaboration agreement. Roche will pay Halozyme for exclusive, global rights for the application of its hyaluronidase enzyme, rHuPH20, to a fourth biologic target selected by Roche.

“Roche and Halozyme have successfully completed the necessary drug product formulation and preclinical studies required to initiate a clinical trial. Entering the clinic is a significant achievement and demonstrates Roche’s strong commitment to a successful partnership,” said Jonathan Lim, M.D., Halozyme’s president and chief executive officer. “We are very pleased with the progress that is being made through our collaboration. Roche is a global leader in the development of biologics and we are excited that they have selected a fourth exclusive target, in addition to the three already under development, further validating Halozyme’s core technology.”

Roche has also maintained its rights to other targets covered in the license and collaboration agreement. An aggregate payment of $10.25 million will be made to Halozyme for commencing a Phase I clinical trial, exercising exclusive global rights to a fourth biologic target and for annual maintenance fees.

In addition, Halozyme has entered into a supply agreement with Roche to provide rHuPH20 for use in formulations with biologics directed against Roche targets covered under the licensing and collaboration agreement. Halozyme is continuing scale-up of its manufacturing processes to enhance yields and efficiencies in order to produce multi-kilogram quantities of enzyme. Halozyme will supply rHuPH20 to Roche to fulfill all of its clinical development and commercialization requirements.