EC Approves Roche/Halozyme's MabThera SC

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Halozyme Therapeutics, Inc. (HALO) announced that Roche's (RHHBY) subcutaneous (SC) formulation of MabThera (rituximab) was approved by the European Commission (EC) for the treatment of patients suffering from follicular lymphoma and diffuse large B-cell lymphoma.

We note that an intravenous version of MabThera is already marketed by Roche in the EU, the U.S. (known as Rituxan in the U.S.) and other countries for various indications including non-Hodgkin lymphoma (:NHL).

However, the subcutaneous formulation of MabThera offers a faster administration time than the intravenous injection which requires an infusion time of approximately 2.5 hours.

The EU approval of MabThera SC was expected given the Committee for Medicinal Products for Human Use’s (CHMP) positive opinion on the drug earlier this year.

The subcutaneous formulation has been made using Halozyme's patented Enhanze (recombinant human hyaluronidase or rHuPH20) technology. The company’s collaboration agreement with Roche covers the use of rHuPH20 for the development of up to five exclusive targets and three additional targets (optional). Halozyme is entitled to receive license fees and milestone payments from Roche.

Apart from Roche, we note that Halozyme has partnered programs with companies like Pfizer (PFE) among others. Halozyme’s agreement with Pfizer covers the development and commercialization of products combining Halozyme’s rHuPH20 with Pfizer’s biologics.

Meanwhile, Halozyme is working towards label expansion of Hylenex recombinant as an adjunct in the treatment of type I diabetes patients using insulin pumps. Top-line results from the study (CONSISTENT-1) should be out shortly.

Halozyme carries a Zacks Rank#3 (Hold). A better-ranked stock in the biotech sector is Alexion Pharmaceuticals, Inc. (ALXN), carrying a Zacks Rank #1 (Strong Buy).

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