of ISIS-SMN
Rx
. In 2014, we and Biogen Idec amended our original agreement to reflect changes made to the
clinical development plan for ISIS-SMN
Rx
. As a result, we and Biogen Idec agreed to increase the payments that
we are eligible to receive under this collaboration by approximately $57 million. Under the terms of the amended
agreement, we are eligible to receive up to $327 million in a license fee and payments, including $102.2 million
in substantive milestone and other payments associated with the clinical development of ISIS-SMN
Rx
prior to
licensing and $150 million in substantive milestone payments if Biogen Idec achieves pre-specified regulatory
milestones. We will earn the next milestone payment of $9 million if we further advance the Phase 3 study in
infants with SMA.
In 2014, we earned an $18 million milestone payment when we initiated the Phase 3 study evaluating
ISIS-SMN
Rx
in infants with SMAand we earned a $27 million milestone payment when we initiated the Phase 3
study evaluating ISIS-SMN
Rx
in children with SMA. From inception through February 2015, we have earned
$71.3 million in payments for advancing ISIS-SMN
Rx
. We are amortizing a portion of those payments as
follows:
•
$3.8 million related to the Phase 2 studies in children and infants with SMA, which we amortized
through July 2014; and
•
$7.5 million related to an open-label extension study in children with SMA, which we are amortizing
throughMarch 2015.
ISIS-DMPK-2.5
Rx
In June 2012, we and Biogen Idec entered into a second and separate collaboration agreement to develop
and commercialize a novel antisense drug, ISIS-DMPK-2.5
Rx
, formerly ISIS-DMPK-2
Rx
, targeting DMPK for the
treatment of myotonic dystrophy type 1, or DM1. We are responsible for global development of the drug through
the completion of the first Phase 2 clinical trial. Biogen Idec has the option to license the drug through the
completion of the first Phase 2 trial. If Biogen Idec exercises its option, it will assume all other global
development, regulatory and commercialization responsibilities. Under the terms of the agreement, we received
an upfront payment of $12 million, which we are amortizing through June 2017. Over the term of the
collaboration, we are eligible to receive up to $259 million in a license fee and substantive milestone payments,
including up to $59 million in development milestone payments and $130 million in milestone payments if
Biogen Idec achieves pre-specified regulatory milestones. In addition, we are eligible to receive royalties up to
the mid-teens on any product sales of the drug. From inception through February 2015, we have earned
$24 million in milestone payments associated with the clinical development of ISIS-DMPK-2.5
Rx
. We will earn
the next milestone payment of $35 million if we initiate a Phase 2 study for ISIS-DMPK-2.5
Rx
.
Neurology
In December 2012, we and Biogen Idec entered into a third and separate collaboration agreement to develop
and commercialize novel antisense drugs to three targets to treat neurological or neuromuscular diseases. We are
responsible for the development of each of the drugs through the completion of the initial Phase 2 clinical study
for such drug. Biogen Idec has the option to license a drug from each of the three programs through the
completion of the first Phase 2 study for each program. If Biogen Idec exercises its option for a drug, it will
assume all further global development, regulatory and commercialization responsibilities for that drug. Under the
terms of the agreement, we received an upfront payment of $30 million, which we are amortizing through
December 2020. Over the term of the collaboration, we are eligible to receive up to $259 million in a license fee
and substantive milestone payments per program. We are eligible to receive up to $59 million in development
milestone payments to support research and development of each program, including amounts related to the cost
of clinical trials. We are also eligible to receive up to $130 million in milestone payments per program if Biogen
Idec achieves pre-specified regulatory milestones. In addition, we are eligible to receive royalties up to the
mid-teens on any product sales of drugs resulting from each of the three programs. In February 2015, we earned
a $10 million milestone payment when we initiated an IND-enabling toxicology study of ISIS-BIIB4
Rx
, a drug
for an undisclosed target designed to treat a neurodegenerative disease. We will earn the next milestone payment
of up to $14 million if we initiate a Phase 1 study for ISIS-BIIB4
Rx
.
Strategic Neurology
In September 2013, we and Biogen Idec entered into a fourth and separate collaboration agreement, which
is a long-term strategic relationship focused on applying antisense technology to advance the treatment of
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