Halozyme (HALO) announced that the EU Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion on the approval of Roche's (RHHBY) subcutaneous (SC) formulation of MabThera (rituximab) using Halozyme's recombinant human hyaluronidase (rHuPH20) for the treatment of patients suffering from non-Hodgkin lymphoma (:NHL).
A final decision from the EU regulatory authority on the approval of MabThera using rHuPH20 is expected in the coming months. The positive opinion from the CHMP was based on favorable results from Roche’s phase III SABRINA study.
The study evaluated the efficacy and safety of the SC formulation of MabThera in comparison to the IV formulation. Results showed a comparatively non-inferior MabThera serum concentration after SC injection compared to the IV infusion. We note that the news failed to impress investors.
In 2006, Halozyme entered into an agreement with Roche, which enabled the latter to use Halozyme's proprietary Enhanze technology or its biological therapeutic compounds. To date, five exclusive targets of Roche have used Halozyme’s rHuPH20 and it has the option to use the technology for three more compounds by paying annual license and maintenance fees.
Apart from Roche, Halozyme also has an agreement with Baxter International Inc. (BAX). As per the deal inked in 2007, Baxter obtained a worldwide, exclusive license to develop and commercialize a product consisting of rHuPH20 in combination with Baxter’s Gammagard liquid.
Halozyme is awaiting a response on Baxter’s Biologic License Application (:BLA) from the U.S. Food and Drugs Administration for HyQvia (primary immunodeficiency) in mid-2014. HyQvia is a combination of Gammagard liquid and rHuPH20.
Moreover, Halozyme is expecting several study results on its pipeline. We expect 2014 to be a catalyst rich year for Halozyme.
Halozyme, a biopharmaceutical company, carries a Zacks Rank #3 (Hold). A better-ranked stock in the same sector is Actelion Ltd. (ALIOF), which carries a Zacks Rank #1 (Strong Buy).