May 04, 2015
Bayer Licenses ISIS-FXI Rx from Isis Pharmaceuticals to Develop and Commercialize for the Prevention of Thrombosis
exclusive license agreement with Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) on
ISIS-FXI, an antisense drug in
clinical development for the prevention of thrombosis. Under the agreement
Bayer will further develop and commercialize ISIS-FXI in areas of high unmet medical need. As
part of the clinical development program, Bayer plans to evaluate the
therapeutic profile of ISIS-FXI 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.
"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-FXI."
"We believe Bayer, a leading pharmaceutical company in the treatment of
thrombotic disease, is the ideal partner for ISIS-FXI. This transaction further demonstrates
Bayer's commitment to the field. Bayer has the expertise, commitment and
resources to develop ISIS-FXI 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-FXI 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."
Under the terms of the agreement, Isis is eligible to receive up to USD155
million in near-term payments, including an immediate USD100 million up-front
payment and a USD55 million payment upon advancement of the program following a
Phase II 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-FXI. After completion of ongoing activities at
Isis, Bayer will assume all global clinical development as well as worldwide
regulatory and commercialization responsibilities for ISIS-FXI.
This transaction is subject to clearances under the Hart-Scott Rodino Antitrust
ISIS-FXIis an antisense drug in
development for the prevention of clotting disorders. Antisense drugs are
single-stranded RNA molecules that are complementary to a messenger RNA (mRNA)
strand which was transcribed from the DNA strand as part of the protein
expression machinery within a cell. Antisense drugs bind to the target mRNA
molecules in the cell and inhibit the production of disease-causing proteins.
ISIS-FXI 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 II
comparator-controlled study evaluating the incidence of venous thromboembolism,
or VTE, in patients treated with ISIS-FXI undergoing total knee replacement surgery, patients treated with 300 mg
of ISIS-FXI 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-FXI 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
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 drug candidates to treat a wide variety of
diseases with an emphasis on cardiovascular, metabolic, severe and rare
diseases, including neurological disorders, and cancer. Isis has numerous drug
candidates in Phase III development in severe/rare diseases and cardiovascular
diseases. Isis' patents provide strong and extensive protection for its drugs
and technology. Additional information about Isis is available at
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.
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