Halozyme Therapeutics, Inc.
) announced that
) 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
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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
) 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.
), carrying a Zacks Rank #1 (Strong Buy).