Nexavar® (sorafenib tablets) now Approved in Canada for the Treatment of Differentiated Thyroid Cancer

July 7, 2014
        --  Nexavar is the only approved treatment for patients with
            RAI-refractory differentiated thyroid cancer
        --  Nexavar significantly extended progression-free survival in
            patients with RAI-refractory differentiated thyroid cancer
            compared to placebo in the Phase III DECISION trial

TORONTO, July 7, 2014 /CNW/ – Bayer Inc. is pleased to announce the
Health Canada approval of Nexavar for the treatment of patients with
locally advanced or metastatic, progressive, differentiated thyroid
carcinoma (DTC), refractory to radioactive iodine (RAI).

The approval is based on data from the Phase III DECISION (stuDy of sorafEnib in loCally advanced or metastatIc patientS with radioactive Iodine refractory thyrOid caNcer) trial. In the trial, sorafenib significantly extended
progression-free survival (PFS), the primary endpoint of the study,
compared to placebo (HR=0.59 [95% CI, 0.45-0.76]; p<0.0001), which
represents a 41 percent reduction in the risk of disease progression or
death for patients who received sorafenib compared to placebo-treated
patients. The median PFS was 10.8 months in patients treated with
sorafenib, compared to 5.8 months in patients receiving placebo.

The safety and tolerability profile of sorafenib in patients in the
trial was generally consistent with the known profile of sorafenib. The
most common treatment-emergent adverse events in the sorafenib arm were
hand-foot skin reaction, diarrhea, alopecia, weight loss, fatigue,
hypertension and rash. Results from the trial were presented at the
Annual Meeting of the American Society of Clinical Oncology (ASCO) in
June 2013 and published in The Lancet in April 2014.

About Thyroid Cancer

Thyroid cancer is the most common endocrine malignancy(1). There are more than 298,000 new cases of thyroid cancer annually and
nearly 40,000 people die from thyroid cancer worldwide each year.(2) In 2014, it is estimated that 6,000 Canadians will be diagnosed with
thyroid cancer.(3)

Papillary, follicular (including Hürthle cell) and poorly differentiated
types of thyroid cancer are classified as “differentiated thyroid
cancer” and account for approximately 94 percent of all thyroid
cancers.(4) While the majority of differentiated thyroid cancers are treatable,
RAI-refractory locally advanced or metastatic disease is more difficult
to treat and is associated with a lower patient survival rate.

About Nexavar(®) (sorafenib tablets)

Nexavar® (sorafenib tablets), an oral anti-cancer therapy, is currently
approved in more than 100 countries worldwide. In Canada, it is
approved for the treatment of hepatocellular carcinoma (HCC) and for
the treatment of patients with advanced renal cell carcinoma (RCC) who
have failed or are intolerant to prior systemic therapy(5). Nexavar is also now approved in Canada for the treatment of patients
with locally advanced or metastatic, progressive differentiated
(papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory
to radioactive iodine (RAI).

In preclinical studies, Nexavar has been shown to inhibit multiple
kinases thought to be involved in both cell proliferation (growth) and
angiogenesis (blood supply) – two important processes that enable
cancer growth. These kinases include Raf kinase (C-CRAF, BRAF, mutant

Nexavar is also being evaluated by Bayer and Onyx, international study
groups, government agencies and individual investigators in a range of
other cancers.

Nexavar is co-developed by Onyx Pharmaceuticals, Inc., an Amgen
subsidiary, and Bayer, except in Japan where Bayer manages all
development. The companies co-promote Nexavar in the U.S. Outside of
the U.S. Bayer has exclusive marketing rights, and Bayer and Onyx share
profits globally, excluding Japan.

About Oncology at Bayer

Bayer is committed to delivering Science for a Better Life by advancing a portfolio of innovative treatments. The oncology
franchise at Bayer now includes three oncology products and several
other compounds in various stages of clinical development. Together,
these products reflect the company’s approach to research, which
prioritizes targets and pathways with the potential to impact the way
that cancer is treated.

About Bayer Inc.

Bayer Inc. is a Canadian subsidiary of Bayer AG and the corporate
headquarters for the Canadian operations. Founded in 1863, Bayer AG is
an international research-based group with core businesses in
healthcare, crop science and innovative materials committed to creating
a better life for all through science.

In Canada, Bayer operates its healthcare business – Pharmaceuticals,
Consumer Care, Diabetes Care, Animal Health and Radiology &
Interventional – from its headquarters in Toronto, ON, and Bayer
CropScience Inc. operates out of its head office in Calgary, AB.
Together with its material science business, Bayer improves the quality
of life for Canadians through products that fight disease, protect
crops and animals, and provide high-performance materials for numerous
daily life uses.

With more than 1,300 employees across the country, in 2013, Bayer had
sales of $1.6 billion and invested $61 million in research and
development in Canada. Globally, Bayer AG had sales of EUR40.2 billion
and invested EUR3.2 billion in research and development.

For more information about Bayer, please visit www.bayer.ca.

Forward-Looking Statements

This release may contain forward-looking statements based on current
assumptions and forecasts made by Bayer Group or subgroup management.
Various known and unknown risks, uncertainties and other factors could
lead to material differences between the actual future results,
financial situation, development or performance of the company and the
estimates given here. These factors include those discussed in Bayer’s
public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these
forward-looking statements or to conform them to future events or developments.


    1 National Cancer Institute. "General Information about Thyroid Cancer."


    2 World Health Organization: GLOBOCAN 2012. Cancer Incidence and Mortality Worldwide in 2012.


    3 Canadian Cancer Society


    4 Naifa Lamki Busaidy and Maria E. Cabanillas, "Differentiated Thyroid Cancer: Management of Patients with Radioiodine Nonresponsive Disease," Journal of Thyroid Research, vol. 2012

    5 Nexavar Product Monograph, June 30, 2014

SOURCE Bayer Inc.

Source: PR Newswire

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