Isis Pharmaceuticals, Inc. Form 10K - page 33

$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
, 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 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 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
neurological diseases. As part of the collaboration, Biogen Idec gained exclusive rights to the use of our
antisense technology to develop therapies for neurological diseases and has the option to license drugs resulting
from this collaboration. The exclusivity for neurological diseases will last through September 2019, and may be
extended for any drug development programs being pursued under the collaboration. We will usually be
responsible for drug discovery and early development of antisense drugs and Biogen Idec will have the option to
license antisense drugs after Phase 2 proof of concept. If Biogen Idec exercises its option for a drug, it will
assume all further global development, regulatory and commercialization responsibilities for that drug. Biogen
Idec will be responsible for all of the drug discovery and development activities for drugs using other modalities.
Under the terms of the agreement, we received an upfront payment of $100 million and are eligible to
receive milestone payments, license fees and royalty payments for all drugs developed through this collaboration,
with the specific amounts dependent upon the modality of the molecule advanced by Biogen Idec. If we have a
change of control during the first six years of the collaboration, we may be required to refund Biogen Idec a
portion of the $100 million upfront payment, with the amount of the potential refund decreasing ratably as we
progress through the initial six year term of the collaboration. We are amortizing the $100 million upfront
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