CARLSBAD, Calif., March 2, 2015 /PRNewswire/ -- Isis
Pharmaceuticals, Inc. (NASDAQ: ISIS) announced today that it has
earned a $15 million milestone
payment from GSK related to advancing the Phase 2/3 study of
ISIS-TTRRx in patients with familial amyloid
polyneuropathy (FAP).
"We are very pleased with the progress we are making with
ISIS-TTRRx, and plan to report data from the Phase 2/3
study in 2017. We have many patients who have completed
the fifteen months of dosing and are now receiving
ISIS-TTRRx in an open-label extension study," said
B. Lynne Parshall, chief operating
officer at Isis Pharmaceuticals.
ISIS-TTRRx is an antisense drug Isis is developing
with GSK for the treatment of transthyretin amyloidosis, a severe
and rare genetic disease characterized by progressive dysfunction
of peripheral nerve and/or heart tissues. Including this
milestone payment, Isis has generated $60
million in upfront and milestone payments for advancing
ISIS-TTRRx. In addition, if GSK elects to exercise
its option to exclusively license ISIS-TTRRx, Isis is
eligible to receive a license fee, regulatory and sales milestone
payments and double-digit royalties on sales of
ISIS-TTRRx.
The Phase 2/3 study of ISIS-TTRRx is a randomized,
double-blind, placebo-controlled, international study designed to
support an application for marketing approval of
ISIS-TTRRx in patients with FAP. The fifteen month
study will measure the effects of ISIS-TTRRx on
neurological dysfunction and on
quality-of-life. ISIS-TTRRx is a drug that is
designed to inhibit the production of all forms of TTR, and to
treat all types of transthyretin-related amyloidosis. For
further study information, please visit www.clinicaltrials.gov and
search for the identifier number NCT01737398.
ABOUT ISIS PHARMACEUTICALS, INC.
Isis is exploiting
its leadership position in RNA-targeted technology to discover and
develop novel drugs for its product pipeline and for its partners.
Isis' broad pipeline consists of 38 drugs to treat a wide variety
of diseases with an emphasis on cardiovascular, metabolic, severe
and rare diseases, including neurological disorders, and
cancer. Isis' partner, Genzyme, is commercializing Isis' lead
product, KYNAMRO®, in the
United States and other countries for the treatment of
patients with homozygous FH. Isis has numerous drugs in Phase
3 development in severe/rare diseases and cardiovascular
diseases. These include ISIS-APOCIIIRx, a drug Isis
is developing through its wholly owned subsidiary, Akcea
Therapeutics, to treat patients with severely high triglycerides,
such as patients with familial chylomicronemia syndrome;
ISIS-TTRRx, a drug Isis is developing with GSK to treat
patients with the polyneuropathy form of TTR amyloidosis; and,
ISIS-SMNRx, a drug Isis is developing with Biogen Idec
to treat infants and children with spinal muscular atrophy, a
severe and rare neuromuscular disease. Isis' patents provide
strong and extensive protection for its drugs and
technology. Additional information about Isis is available at
www.isispharm.com.
ISIS PHARMACEUTICALS' FORWARD-LOOKING STATEMENT
This
press release includes forward-looking statements regarding Isis'
strategic alliance with GSK, and the development, activity,
therapeutic and commercial potential and safety of
ISIS-TTRRx. Any statement describing Isis' goals,
expectations, financial or other projections, intentions or beliefs
is a forward-looking statement and should be considered an at-risk
statement. Such statements are subject to certain risks and
uncertainties, particularly those inherent in the process of
discovering, developing and commercializing drugs that are safe and
effective for use as human therapeutics, and in the endeavor of
building a business around such drugs. Isis' forward-looking
statements also involve assumptions that, if they never materialize
or prove correct, could cause its results to differ materially from
those expressed or implied by such forward-looking
statements. Although Isis' forward-looking statements reflect
the good faith judgment of its management, these statements are
based only on facts and factors currently known by Isis. As a
result, you are cautioned not to rely on these forward-looking
statements. These and other risks concerning Isis' programs
are described in additional detail in Isis' annual report on Form
10-K for the year ended December 31,
2014, which is on file with the SEC. Copies of this and
other documents are available from the Company.
In this press release, unless the context requires otherwise,
"Isis," "Company," "we," "our," and "us" refers to Isis
Pharmaceuticals and its subsidiaries.
Isis Pharmaceuticals® is a registered trademark of
Isis Pharmaceuticals, Inc. Akcea Therapeutics™ is a trademark
of Isis Pharmaceuticals, Inc. KYNAMRO® is a
registered trademark of Genzyme Corporation.
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SOURCE Isis Pharmaceuticals, Inc.