EDISON EQUITY RESEARCH - GLG LIFE TECH
26 August 2014 - 6:47AM
InvestorsHub NewsWire
Edison Investment Research:
Halozyme
Therapeutics - HyQvia got a favourable
vote
The positive vote (15 to one) by the FDA’s Blood Products Advisory
Committee (BPAC) for HyQvia should pave the way for its US approval
(Q3) and its launch by Baxter, the drug’s commercial partner.
Potential risk factors raised and extensively discussed by the FDA
at the panel meeting could result in some label restrictions, which
will be in line with the drug’s restricted approval in the EU. An
FDA approval would remove one near-term risk for Halozyme. The
panel vote, though positive, has only a small impact on Halozyme’s
valuation, which is now $1,448m, or $11.7 per basic share, vs
previously $1,445m, or $11.6 per basic share.
Halozyme Therapeutics focuses on development of
extracellular matrix-based drugs. Its rHuPH20-based delivery
platform has been used by partners, including Roche, Baxter and
Pfizer, to develop SC injection of IV drugs such as Herceptin,
Rituxan (Roche) and GAMMAGARD (Baxter). Its pipeline consists of
Hylenex, approved for hydration, PEGPH20 in Phase II trials for
pancreatic cancer, and HTI-501 in Phase II trials for
cellulite.
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