Saturday, April 12, 2014 8:53:54 PM
Halozyme Therapeutics Inc.
SC MabThera Receives EU Approval
What’s New? Roche and Halozyme just announced that the subcutaneous (SC)
formulation of MabThera for the treatment of non-Hodgkin Lymphoma has been
approved in Europe. This is a positive for HALO and was largely expected following the
positive opinion and recommendation by the EU Committee for Medicinal Products for
Human Use (CHMP) in January.
SC MabThera significantly reduces administration time: This approval was based on
Phase III data from the SABRINA trial, which demonstrated equivalent efficacy and
safety between the previously-approved IV formulation of MabThera versus SC
MabThera. There were no issues with antibody titers. This SC formulation reduces the
administration time from approximately 2.5 hours with the IV formulation to only 5
minutes.
Royalties expected in a couple quarters: Roche will start launching SC MabThera in
different countries in Europe throughout 2014. We expect pricing for SC MabThera to
be comparable to MabThera (IV formulation) and estimate that HALO will receive a 5%
royalty from Roche. We believe meaningful royalties will take a couple quarters to kick
in as Roche works through pricing and reimbursement negotiations. We are currently
modeling $2.1mn in 2014 and $2.7mn in 2015.
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