May 28, 2015
Not intended for U.S. and UK Media

Bayer Extends Clinical Investigation of Xarelto® for the Prevention and Treatment of Life-Threatening Blood Clots in Patients with Cancer

Cancer increases a person's risk of venous thromboembolism (VTE) four- to seven-fold, with chemotherapy increasing the risk further by up to 6.5 times / Outside the cancer itself, blood clots are the leading cause of death in patients with cancer / Current Clinical Guidelines lack recommendations for routine VTE prevention in most ambulatory patients with cancer / Bayer and Janssen initiating CALLISTO, a multi-trial prospective clinical research initiative in the management of cancer-associated thrombosis
Berlin, May 28, 2015 - Bayer HealthCare and its development partner Janssen
Pharmaceuticals, Inc. announced today the initiation of the CALLISTO Clinical
Research Programme to explore the potential benefits of the oral Factor Xa
inhibitor Xarelto® (rivaroxaban) for the prevention and treatment of pulmonary
embolism and deep vein thrombosis in patients with various types of cancer.

In patients with active cancer, the risk of VTE is four to seven times higher
than in people of the same age without cancer. And importantly, chemotherapy
significantly increases the risk further by up to 6.5 times. Despite this, none
of the current Clinical Guidelines recommend the routine use of VTE prevention
in most ambulatory cancer patients. Regarding the use of anticoagulation
therapy for the treatment and secondary prevention of VTE, current Clinical
Guideline recommendations are based on few and small clinical trials.

"Today, there is limited evidence and guidance on the routine use of
anticoagulants for the long-term treatment and prevention of pulmonary embolism
and deep vein thrombosis in patients with cancer, despite blood clots being the
leading cause of death in patients with cancer outside the cancer itself," said
Professor Guy Meyer, Université Paris Descartes, European Hospital Georges
Pompidou, Paris, France and one of the Principal Investigators within the
CALLISTO Programme. "I am optimistic that results from the CALLISTO Programme
will provide important clinical insights to help reduce the risk of pulmonary
embolism and deep vein thrombosis, conditions that can be treated and

The CALLISTO Programme is a multi-trial prospective clinical research
initiative aimed at generating new evidence to help manage cancer-associated
thrombosis (CAT). The Programme will consist of nine initiatives in total,
comprising both clinical studies and Registries, and will involve more than
4,000 patients worldwide. CALLISTO addresses three key areas of
cancer-associated thrombosis:

- Prevention of VTE
Evaluation of rivaroxaban in comparison to placebo for the prevention of
pulmonary embolism and deep vein thrombosis in patients at high risk of blood
clots undergoing chemotherapy for different forms of cancer

- Treatment and Secondary Prevention of VTE
A series of five initiatives (three clinical studies and two Registries) will
assess rivaroxaban for the treatment and secondary prevention of pulmonary
embolism and deep vein thrombosis in patients with active cancer

- Important Clinical Aspects
Three additional studies will focus on important clinical aspects such as
enhancing the clinical knowledge on rivaroxaban treatment in patients with
cancer receiving standard cancer therapies, e.g. chemotherapy, and the
assessment of a bridging strategy between rivaroxaban and low-molecular-weight
heparin in instances where chemotherapy-induced vomiting makes oral therapy

"The CALLISTO Programme is an important milestone for Bayer in our ongoing work
to address unmet medical needs through our experience in both oncology as well
as thrombosis management," said Dr Michael Devoy, Member of the Bayer
HealthCare Executive Committee and Chief Medical Officer of Bayer HealthCare.
"CALLISTO will build on the existing clinical evidence for rivaroxaban in the
prevention and treatment of potentially deadly blood clots across a broad range
of indications and patients."

The CALLISTO Clinical Research Programme will add to the overall investigation
of rivaroxaban, which - by the time of its completion - is expected to include
more than 275,000 patients in both clinical trials and real world settings.

About Xarelto® (Rivaroxaban)

Rivaroxaban is the most broadly indicated novel oral anticoagulant and is
marketed under the brand name Xarelto®. Xarelto is approved for seven
indications, protecting patients across more venous and arterial thromboembolic
(VAT) conditions than any other novel oral anticoagulant:

- The prevention of stroke and systemic embolism in adult patients with
non-valvular atrial fibrillation (AF) with one or more risk factors

- The treatment of deep vein thrombosis (DVT) in adults

- The treatment of pulmonary embolism (PE) in adults

- The prevention of recurrent DVT and PE in adults

- The prevention of venous thromboembolism (VTE) in adult patients undergoing
elective hip replacement surgery

- The prevention of VTE in adult patients undergoing elective knee replacement

- The prevention of atherothrombotic events (cardiovascular death, myocardial
infarction or stroke) after an Acute Coronary Syndrome in adult patients with
elevated cardiac biomarkers and no prior stroke or transient ischaemic attack
(TIA) when co-administered with acetylsalicylic acid (ASA) alone or with ASA
plus clopidogrel or ticlopidine

Whilst licences may differ from country to country, across all indications
Xarelto is approved in more than 125 countries.

Rivaroxaban was discovered by Bayer HealthCare, and is being jointly developed
with Janssen Research & Development, LLC. Xarelto is marketed outside the U.S.
by Bayer HealthCare and in the U.S. by Janssen Pharmaceuticals, Inc. (a Johnson
& Johnson Company).

Anticoagulant medicines are potent therapies used to prevent or treat serious
illnesses and potentially life-threatening conditions. Before initiating
therapy with anticoagulant medicines, physicians should carefully assess the
benefit and risk for the individual patient.

Responsible use of Xarelto is a very high priority for Bayer, and the company
has developed a Prescribers Guide for physicians and a Xarelto Patient Card for
patients to support best practice.

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To learn more about Xarelto, please visit

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

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