CARLSBAD, Calif., May 4, 2015 /PRNewswire/ -- Isis
Pharmaceuticals, Inc. (NASDAQ: ISIS) has entered into an exclusive
license agreement with Bayer HealthCare (Bayer) to develop and
commercialize ISIS-FXIRx for the prevention of
thrombosis. Under the terms of the agreement, Isis is eligible to
receive up to $155 million in
near-term payments, including an immediate $100 million up-front payment and a $55 million payment upon advancement of the
program following a Phase 2 study in patients with compromised
kidney function. Isis is also eligible to receive milestone
payments as the drug advances toward the market. 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.
As part of the clinical development program, Bayer plans to
evaluate the therapeutic profile of ISIS-FXIRx in
patients for whom currently available anticoagulants may not be
used, such as in patients with a high risk of bleeding due to
multiple co-morbidities.
"We believe Bayer, a leading pharmaceutical company in the
treatment of thrombotic disease, is the ideal partner for
ISIS-FXIRx. This transaction further demonstrates
Bayer's commitment to the field. Bayer has the expertise,
commitment and resources to develop ISIS-FXIRx in areas
where unmet medical needs exist. We are pleased with the value of
this partnership, which supports a robust development program to
maximize the value of ISIS-FXIRx globally and which
allows us to participate significantly in future commercial
success," said Stanley Crooke, Ph.D,
M.D., chief executive officer at Isis Pharmaceuticals. "We
believe that this transaction represents the right deal, with the
right partner and the right development plan."
"This first-in-class FXI inhibitor perfectly complements our
in-house thrombosis pipeline and is an innovative development
candidate for a variety of anti-coagulation needs," said Dr.
Joerg Moeller, Member of the Bayer
HealthCare Executive Committee and Head of Global Development. "We
believe the novel mechanism of Factor XI inhibition may offer an
additional pathway for treating patients for whom there are
currently no suitable therapeutic options available. We share a
common vision with Isis in developing ISIS-FXIRx to its
full potential."
This transaction is subject to clearances under the Hart-Scott
Rodino Antitrust Improvements Act.
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, 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.