) recently announced that the European Commission has approved
Jetrea intravitreal injection (ocriplasmin) for the treatment of
vitreomacular traction (VMT) and macular hole.
Affecting 250,000 to 300,000 people in Europe, VMT causes
sight-threatening symptoms, which might result in irreversible
vision loss. So far, people suffering from VMT had only surgery
as a treatment option for this eye disease.
The approval does not come as a surprise since in Jan 2013 the
Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) had recommended the approval of
Jetrea for the indication.
The approval was based on results from pivotal studies, which
demonstrated that patients treated with Jetrea successfully
achieved resolution of VMT and closure of macular holes compared
to placebo on the 28th day of treatment.
We note that Novartis caters to the eye care market through its
division Alcon. Novartis acquired rights to commercialize Jetrea
outside the US from Belgian biopharmaceutical company
ThromboGenics. However, ThromboGenics retains the right to market
the drug in the US.
We remind investors that Jetrea was approved by the US Food and
Drug Administration (FDA) in Oct 2012 subsequent to which
ThromboGenics launched Jetrea in the US in Jan 2013.
Earlier this month, the EC also approved Novartis' drug llaris
(canakinumab, ACZ885) for an additional indication - treatment of
adults suffering from gouty arthritis (gout).
Ilaris is already approved for treating children and adults
suffering from cryopyrin associated periodic syndrome (CAPS) in
the EU, US, Switzerland and Japan.
We are encouraged by the recent bout of regulatory approvals at
Novartis. Right now, Novartis carries a Zacks Rank #3 (Hold).
Pharma stocks, which currently look more attractive include
Furiex Pharmaceuticals Inc.
), all with a Zacks Rank #2 (Buy).
FURIEX PHARMACT (FURX): Free Stock Analysis
NOVO-NORDISK AS (NVO): Free Stock Analysis
NOVARTIS AG-ADR (NVS): Free Stock Analysis
SHIRE PLC-ADR (SHPG): Free Stock Analysis
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