In addition to ISIS-TTR
Rx
, we have four drugs in development. We are developing ISIS-HBV
Rx
,
an
antisense drug designed to reduce the production of viral proteins associated with HBV infection. We are also
developing ISIS-GSK4-L
Rx
and ISIS-RHO-2.5
Rx
,
formerly ISIS-GSK5
Rx
, which are antisense drugs we designed
to treat ocular diseases. In addition, we recently advanced a drug to treat an undisclosed target, ISIS-GSK6-L
Rx
,
into development.
Under our agreement, if GSK successfully develops all five drugs for one or more indications and achieves
pre-agreed sales targets, we could receive license fees and milestone payments of more than $1.2 billion,
including up to $146.5 million for the achievement of development milestones, up to $483.5 million for the
achievement of regulatory milestones and up to $428 million for the achievement of commercialization
milestones. We will earn the next $15 million milestone payment if we further advance ISIS-TTR
Rx
. In addition,
we are eligible to receive royalties up to the mid-teens on sales from any product that GSK successfully
commercializes under this alliance.
Our alliance with GSKwill continue until the earlier of the date that all of GSK’s options to obtain the
exclusive licenses under the agreement expire unexercised or, if GSK exercises its option, 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:
•
GSKmay terminate any program, other than the ISIS-TTR
Rx
program, at any time by providing written
notice to us;
•
GSKmay terminate the ISIS-TTR
Rx
program by providing written notice to us after reviewing specific
data from the Phase 3 study for the program; and
•
Either we or GSKmay terminate 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 with respect to the
affected program, or the entire agreement if the other party becomes insolvent.
During 2014, 2013 and 2012, we earned revenue of $37.3 million, $35.3 million and $8.2 million,
respectively, from our relationship with GSK, which represented 17 percent, 24 percent and eight percent,
respectively, of our total revenue for those years.
Janssen Biotech, Inc., a pharmaceutical company of Johnson & Johnson
In December 2014, we entered into a collaboration agreement with Janssen Biotech, Inc. to discover and
develop antisense drugs that can be locally administered, including oral delivery, to treat autoimmune disorders
of the GI tract. Janssen has the option to license drugs from us through the designation of a development
candidate for up to three programs. Prior to option exercise we are responsible for the discovery activities to
identify a development candidate. If Janssen exercises an option for one of the programs, it will be responsible
for the global development, regulatory and commercial activities under that program. Under the terms of the
agreement, we received $35 million in payments, made up of a $30 million payment we received in December
2014 and a $5 million payment we received in February 2015. We are amortizing these payments through
December 2018. We are eligible to receive nearly $800 million in milestone payments and license fees for these
programs, including up to $175 million for the achievement of development milestones, up to $420 million for
the achievement of regulatory milestones and up to $180 million for the achievement of commercialization
milestones. In addition, we are eligible to receive tiered royalties up to the near teens on any product sales of
drugs resulting from this collaboration. We will earn the next milestone payment of $5 million if Janssen chooses
another target to advance under this collaboration.
Our agreement with Janssen will continue until the earlier of the date that all of Janssen’s options to obtain
the exclusive licenses under the agreement expire unexercised or, if Janssen exercises its option, 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:
•
Janssen may terminate the agreement or any program at any time by providing written notice to
us; and
•
Either we or Janssen may terminate 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.
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