Isis Pharmaceuticals Inc.
) recently announced that it has received a milestone payment of
$3.5 million from its partner,
Biogen Idec Inc.
). The milestone payment was triggered by dosing of the first
patient in a phase II study evaluating ISIS-SMNin infants
suffering from spinal muscular atrophy (SMA).
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The open-label, multiple-dose, dose-escalation pilot phase II
study will be conducted in eight infants (between three weeks and
seven months) for the treatment of SMA. ISIS-SMN enjoys orphan
drug as well as fast track status with the US Food and Drug
We remind investors that in Mar 2013, data from an open-label
phase I study evaluating ISIS-SMN in children with SMA was
presented. Results showed that ISIS-SMN was well tolerated at all
the evaluated dose levels. Additionally, improvements in
Hammersmith scores were also observed.
Isis Pharma is also evaluating ISIS-SMN in a multiple-dose phase
Ib/2a study. The company expects to report data from this study
by late 2013 or early 2014. Isis Pharma intends to initiate phase
II/III studies on ISIS-SMN in infants in 2013 and children in the
first half of 2014.
We note that as per the terms of the Isis Pharma-Biogen
agreement, inked in Jan 2012, Isis Pharma is responsible for the
global development of ISIS-SMN through the completion of phase
II/III registrational studies, with input from Biogen. The latter
will take over global development, regulatory and
commercialization responsibilities if it decides to exercise its
option. Biogen has the option to license ISIS-SMN until
completion of the first successful phase II/III trial.
Isis Pharma currently carries a Zacks Rank #2 (Buy). Stocks such
Lannett Company, Inc.
) look equally attractive with a Zacks Rank #2.