AstraZeneca
In December 2012, we entered into a collaboration agreement withAstraZeneca to discover and develop
antisense drugs against five cancer targets. As part of the agreement, we grantedAstraZeneca an exclusive
license to develop and commercialize ISIS-STAT3-2.5
Rx
and ISIS-AR-2.5
Rx
for the treatment of cancer and an
option to license up to three anti-cancer drugs under a separate research program. Together withAstraZeneca, we
are evaluating ISIS-STAT3-2.5
Rx
in patients with advanced cancer. AstraZeneca is conducting a clinical study of
ISIS-STAT3-2.5
Rx
in patients with advanced metastatic HCC. We are conducting a clinical study evaluating
ISIS-STAT3-2.5
Rx
in patients with advanced lymphomas, including patients with diffuse large b-cell lymphoma.
We are responsible for completing our clinical study in patients with advanced lymphomas andAstraZeneca is
responsible for all other global development, regulatory and commercialization activities for ISIS-STAT3-2.5
Rx
.
In June 2013, we andAstraZeneca added a second development candidate, ISIS-AR-2.5
Rx
, to our collaboration.
ISIS-AR-2.5
Rx
is an antisense drug we designed to treat patients with prostate cancer by inhibiting the production
of AR. AstraZeneca is currently evaluating ISIS-AR-2.5
Rx
in a Phase 1/2 study in patients withAR-related
cancers. AstraZeneca is responsible for all other global development, regulatory and commercialization activities
for ISIS-AR-2.5
Rx
. In addition, we are responsible for identifying a development candidate for each of the three
anti-cancer research programs. AstraZeneca has the option to license drugs resulting from each of the three
anti-cancer research programs, and if AstraZeneca exercises its option for a drug, it will be responsible for all
further global development, regulatory and commercialization activities for such drug.
Under the terms of the agreement, we received $31 million comprised of a $25 million upfront payment we
received in December 2012 and a $6 million payment we received in June 2013. We recorded revenue of
$11.5 million upon receipt of these payments. We are recognizing the remaining $19.5 million into revenue as
follows:
•
$11.2 million related to the ISIS-AR-2.5
Rx
program, which we amortized throughMarch 2014;
•
$7.6 million related to the option to license three drugs under a separate research program, which we
are amortizing through December 2016; and
•
$0.7 million related to the ISIS-STAT3-2.5
Rx
program, which we amortized through February 2015.
In June 2014, we earned a $15 million milestone payment whenAstraZeneca initiated a Phase 1 study of
ISIS-AR-2.5
Rx
. From inception through February 2015, we have earned $25 million in milestone payments
related to the development of ISIS-AR-2.5
Rx
.
In October 2014, we andAstraZeneca amended our agreement for ISIS-STAT3-2.5
Rx
. Under the amended
terms of the agreement, we received a $7.5 million milestone payment in November 2014 fromAstraZeneca for
advancing ISIS-STAT3-2.5
Rx
in patients with advanced cancers. We recognized into revenue $7.1 million of the
$7.5 million milestone payment when we received the payment in November 2014 and we amortized the
remaining balance through February 2015. UponAstraZeneca’s initiation of a Phase 2 study, we will earn a
$17.5 million milestone payment.
We are eligible to receive milestone payments and license fees fromAstraZeneca as programs advance in
development. In addition, we are eligible to receive royalties up to the low to mid-teens on any product sales of
drugs resulting from this collaboration. If AstraZeneca successfully develops ISIS-STAT3-2.5
Rx
, ISIS-AR-2.5
Rx
,
and the three drugs under the research program, we could receive milestone payments of more than $858 million,
including up to $238 million for the achievement of development milestones and up to $620 million for the
achievement of regulatory milestones. We will earn the next milestone payment of $10 million if we designate a
development candidate for a cancer drug under our research programwithAstraZeneca.
InAugust 2013, we added another collaboration programwithAstraZeneca to discover and develop an
antisense drug against an undisclosed target. AstraZeneca has the option to license a drug resulting from this
research collaboration. If AstraZeneca exercises its option, it will be responsible for all further global
development, regulatory and commercialization activities for such drug. We received a $0.8 million upfront
payment, which we are amortizing through December 2016. We are eligible to receive license fees and milestone
payments of $163.2 million, including up to $45.3 million for the achievement of research and development
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