CARLSBAD, Calif., June 5, 2015 /PRNewswire/ -- Isis
Pharmaceuticals, Inc. (NASDAQ: ISIS) today announced that its
license agreement with Bayer HealthCare (Bayer) to develop and
commercialize ISIS-FXIRx has received clearance under
the Hart-Scott-Rodino Antitrust Improvements Act. Based on this
approval, Bayer will pay Isis an immediate $100 million up-front payment. In total, Isis is
eligible to receive up to $375
million in payments, including the upfront payment and a
$55 million near-term milestone
payment upon advancement of the program following the Phase 2 study
in patients with compromised kidney function. In addition, Isis is
eligible to receive tiered royalties in the low to high twenty
percent range on gross margins of ISIS-FXIRx. After
completion of ongoing activities at Isis, Bayer will assume all
global clinical development as well as worldwide regulatory and
commercialization responsibilities for ISIS-FXIRx.
ABOUT ISIS-FXIRx
ISIS-FXIRx is an antisense drug in development for
the prevention of clotting disorders. It targets Factor XI, a
clotting factor produced in the liver that is an important
component of the coagulation pathway. High levels of Factor XI
increase the risk of thrombosis, a process involving aberrant blood
clot formation that can be responsible for heart attacks and
strokes, while Factor XI deficiency results in a lower incidence of
thromboembolic events with minimal increase in bleeding risk. In a
Phase 2 comparator-controlled study evaluating the incidence of
venous thromboembolic events, or VTEs, in patients treated with
ISIS-FXIRx undergoing total knee replacement surgery,
patients treated with 300 mg of ISIS-FXIRx experienced a
seven-fold lower rate of VTE as compared with those treated with
enoxaparin (4.2% and 30.4%, respectively; p<0.001). In this
study, ISIS-FXIRx was generally well tolerated with no
observed differences in safety outcomes compared with enoxaparin.
The data from this study was published in the New England Journal
of Medicine in December 2014.
ABOUT BAYER HEALTHCARE
The Bayer Group is a global enterprise with core competencies in
the fields of health care, agriculture and high-tech materials.
Bayer HealthCare, a subgroup of Bayer AG with annual sales of
around EUR 20.0 billion (2014), is
one of the world's leading, innovative companies in the healthcare
and medical products industry and is based in Leverkusen,
Germany. The company combines the
global activities of the Animal Health, Consumer Care, Medical Care
and Pharmaceuticals divisions. Bayer HealthCare's aim is to
discover, develop, manufacture and market products that will
improve human and animal health worldwide. Bayer HealthCare has a
global workforce of 60,700 employees (Dec 31, 2014) and is
represented in more than 100 countries. More information is
available at www.healthcare.bayer.com.
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 and plans to
commercialize through its wholly owned subsidiary, Akcea
Therapeutics, to treat patients with familial chylomicronemia
syndrome and partial lipodystrophy; ISIS-TTRRx, a drug
Isis is developing with GSK to treat patients with the
polyneuropathy and cardiomyopathy forms of TTR amyloidosis; and
ISIS-SMNRx, a drug Isis is developing with Biogen 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' alliance with Bayer, the development, activity, therapeutic
potential, commercial potential and safety of
ISIS-FXIRx. 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, and its most recent quarterly report on Form 10-Q,
which are on file with the SEC. Copies of these 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.
Logo -
http://photos.prnewswire.com/prnh/20130807/LA60006LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/isis-pharmaceuticals-license-agreement-with-bayer-for-isis-fxi-rx-receives-hart-scott-rodino-approval-300094602.html
SOURCE Isis Pharmaceuticals, Inc.