Isis Pharmaceuticals, Inc
) recently announced that it has received a $7.5 million
milestone payment from
) as per its amended agreement with the latter.
The payment primarily relates to initiation of a phase II/III
clinical study for ISIS-TTRRx. The study will span 15 months
enrolling 200 patients. Isis is developing ISIS-TTRRx in
collaboration with GlaxoSmithKline for the treatment of
transthyretin (TTR) amyloidosis.
Amyloidosis is a genetic disease, which is typically
characterized by progressive dysfunction of peripheral nerve
and/or heart tissues.
We remind investors that Isis entered into a strategic
alliance with GlaxoSmithKline in Mar 2010. The alliance, covering
up to six programs, will primarily develop new drugs for rare and
serious diseases, including infectious diseases and some
conditions causing blindness.
In 2011, Iris initiated a phase 1 clinical study on ISIS-TTRRx
as part of its collaboration with GlaxoSmithKline. In Oct 2012,
Isis and GlaxoSmithKline amended the original agreement to
accelerate the clinical development for ISIS-TTRRx.
Under the amended agreement, Isis has received an upfront
payment of $2.5 million and $7.5 million as milestone payment
following the initiation of the phase II/III study on ISIS-TTR
Rx. Isis will also be entitled to receive an additional $50
million in pre-licensing milestone payments associated with the
phase II/III clinical study.
We note that the candidate received fast track designation
from the US Food and Drug Administration (FDA) and orphan drug
status for the treatment of FAP, a type of TTR amyloidosis.
Isis already received approval for Kynamro (mipomersen sodium)
injection in Jan 2013. Kynamro, Isis' lead pipeline candidate, is
a second generation compound being developed for the treatment of
familial hypercholesterolemia (FH) with
Isis Pharma currently carries a Zacks Rank #3 (Hold).
) looks more attractive in the pharma sector with a Zacks Rank #2
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