milestones and up to $105 million for regulatory milestones. We will earn the next $3.3 million milestone
payment if AstraZeneca selects a development candidate under this collaboration. In addition, we are eligible to
receive royalties up to the low teens on sales from any product that AstraZeneca successfully commercializes
under this collaboration program.
Our agreement withAstraZeneca will continue until the expiration of all payment obligations under the
agreement. In addition, the agreement, or any program under the agreement, may terminate early under the
following situations:
•
AstraZeneca may terminate the agreement or any program at any time by providing written notice to
us;
•
AstraZeneca may terminate the agreement or any program by providing written notice if we undergo a
change of control with a third party; and
•
Either we or AstraZeneca may terminate the agreement or any program by providing written notice to
the other party upon the other party’s uncured failure to perform a material obligation under the
agreement, or the entire agreement if the other party becomes insolvent.
During 2014, 2013 and 2012 we earned revenue of $27.7 million, $29.1 million and $9.3 million,
respectively, from our relationship withAstraZeneca, which represented 13 percent, 20 percent and nine percent,
respectively, of our total revenue for those periods.
Biogen Idec
We have established four strategic collaborations with Biogen Idec that broaden and expand our severe and
rare disease franchise for neurological disorders.
ISIS-SMN
Rx
In January 2012, we entered into a collaboration agreement with Biogen Idec to develop and commercialize
ISIS-SMN
Rx
for the treatment of SMA. We are currently conducting a Phase 3 study evaluating ISIS-SMN
Rx
in
infants with SMAand a Phase 3 study evaluating ISIS-SMN
Rx
in children with SMA. In addition, we are
evaluating ISIS-SMN
Rx
in a Phase 2 open-label, multiple-dose, dose-escalation study in children with SMAand a
Phase 2 open-label, multiple-dose, dose-escalation study in infants with SMA. Patients from both of the Phase 2
studies continue to have access to ISIS-SMN
Rx
through open-label extension dosing. We are responsible for
completing the Phase 2 and Phase 3 trials we are currently conducting. If Biogen Idec exercises its option, it will
pay us a license fee and will assume all other global development, regulatory and commercialization
responsibilities. Biogen Idec has the option to license ISIS-SMN
Rx
. Biogen Idec may exercise this option upon
completion of and data review of the first successful Phase 2/3 trial or completion of both Phase 2/3 trials. An
amendment in December 2014 provided for additional opt-in scenarios, based on the filing or the acceptance of a
new drug application or marketing authorization application with the FDAor EMA.
We received an upfront payment of $29 million, which we are amortizing through February 2017. We are
also eligible to receive a license fee, milestone payments and royalties up to the mid-teens on any product sales
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 milestone and other payments associated with the clinical development of ISIS-SMN
Rx
prior to licensing and
$150 million in 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
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