First New Colon Cancer Treatment Since 2006 Received Priority Review From Health Canada And Is Now Approved For Canadian

First New Colon Cancer Treatment Since 2006 Received Priority Review From 
Health Canada And Is Now Approved For Canadian Patients With Metastatic 
Colorectal Cancer 
Stivarga(®) (Regorafenib tablets) demonstrated extended overall survival in 
patients with Metastatic Colorectal Cancer whose disease progressed after 
previous treatments 
TORONTO, March 25, 2013 /CNW/ - Bayer Inc. announced today the Health Canada 
approval of Stivarga (regorafenib tablets), indicated for the treatment of 
patients with metastatic colorectal cancer (mCRC) who have been previously 
treated with fluoropyrimidine-based chemotherapy, oxaliplatin, irinotecan, an 
anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy.(i) 
"The approval of Stivarga marks the first proven option that increases both 
overall and progression-free survival in patients with mCRC whose disease has 
progressed after approved standard therapies," says Dr. Scot Dowden, medical 
oncologist at the Tom Baker Cancer Centre in Calgary. "It is a new reality 
for mCRC patients who are managing their cancer and living longer - until now 
there was nothing to offer stage IV patients, they had run out of options." 
The Canadian approval of Stivarga(regorafenib) is based on results from a 
pivotal Phase III study (CORRECT) that demonstrateda statistically 
significantimprovement in overall survival (OS) and progression-free 
survival (PFS) compared to placebo in patients with mCRC whose disease had 
progressed after treatment with approved standard therapies. 
Stivarga(regorafenib)is an oral multi-kinase inhibitoraffecting 
mechanisms fortumour growth and progression - angiogenesis, oncogenesis and 
thetumourmicroenvironment.(ii) 
"Newtreatment options offer hope for patients living with advanced disease 
andhighlight the oncology community's ongoing commitment to patients 
offering not only the opportunity to improve their quality of life, but in 
some cases even prolong their lives," says Barry D. Stein, President of 
theColorectal Cancer Association of Canada."Stivarga represents another 
new option for Canadian patientsand itis important that this innovative 
treatment bemade accessible to all Canadians living with metastatic 
colorectalcancer to ensure they have every reasonable opportunity to combat 
this disease." 
"I want to make the most out of every moment," says Stephen Dunn, stage IV 
colorectal cancer patient. "Treatment options that give patients more time are 
one more step on an important journey - celebrating another day with my family 
means everything tome, and also to them." 
The CORRECT clinical trial achieved all of its primary and secondary 
endpoints. Pivotal Phase III data showed regorafenibplus best supportive 
care (BSC) significantly improved overall survival (OS) 
(HR=0.77,two-sidedp-value=0.010356) and progression-free survival (PFS) 
(HR=0.49,two-sidedp-value<0.000001) compared to placebo plus BSC. 
Median OS was 6.4 months withregorafenibversus 5.0 months with 
placebo;median PFS was1.9 months withregorafenib versus 1.7 months with 
placebo. The data alsoshowed a survival benefit (OS and PFS) in the 
regorafenib arm across nearly all subgroups analyzed. The most serious 
adverse reactions are hepatotoxicity, hemorrhage and gastrointestinal 
perforation. The most common treatment related adverse reactions (≥30%) 
are fatigue, hand-foot-skin reaction (HFSR), diarrhea and anorexia.(iii) 
"A metastatic colorectal cancer diagnosis can be overwhelming for the patient 
as well as for their family and loved ones," says Bunnie Schwartz, Co-founder 
and President of Colon Cancer Canada. "New and available treatment options 
that can prolong a patient's life are critical - the additional time allows 
the patient to continue to build memories that will be cherished by their 
families." 
"Stivarga's approval in Canada further establishes Bayer as a company 
committed to improving the lives of patients," says Christian Lauterbach, 
President & CEO of Bayer Inc. in Canada. "Stivarga is an important step for 
Bayer in enhancing our oncology portfolio and providing physicians and 
patients with new and effective tools to fight cancer and prolong life." 
About Colorectal Cancer
Colorectal Cancer(CRC)is the third most common cancer worldwide, with over 
1.2 million cases occurring every year.(iv) It is the second leading cause of 
cancer death in Canada.(v) An estimated 23,300 Canadians were diagnosed with 
colorectal cancer in 2012 and 9,200 died of it.(vi) 
Metastatic cancer is cancer that has spread from the place where it first 
started to another place in the body. A tumour formed by metastatic cancer 
cells is called a metastatic tumour or a metastasis. The process by which 
cancer cells spread to other parts of the body is also called 
metastasis.(vii) Of the patients with colorectal cancer, approximately 
20,600 have metastatic colorectal cancer.(viii) mCRC is one of the most 
aggressive forms of cancer; however, ongoing research and new treatment 
options have extended median overall survival to more than 20 months, an 
increase that has changed the view of advanced colorectal cancer from an acute 
to a chronic condition.(ix) 
About the CORRECT Study(x)
CORRECT was an international, multicenter, randomized, double-blind, 
placebo-controlled Phase III study that enrolled 760 patients with mCRC whose 
disease had progressed during or within three months following last 
administration of approved standard therapies. Patients were randomizedto 
receiveregorafenibplus BSC or placebo plus BSC, as BSC is the standard of 
care in this setting. Treatment cycles consisted of 160 mg ofregorafenib 
plus BSC(or matching placebo) taken orally once daily for three weeks on 
followed by one week off plus BSC. 
The CORRECT study recruitment saw rapid enrollment, it opened and closed in 
less than 11 months. It was unblinded in late 2011 and ended early following a 
pre-planned interim analysis for efficacy. Data determined the regorafenib 
arm showed significant improvement in overall survival achieving the primary 
endpoint of the study. 
About Stivarga(®)(Regorafenib tablets)
Regorafenib isan oral multi-kinase inhibitoraffecting mechanisms 
fortumour growth and progression - angiogenesis, oncogenesis and the tumour 
microenvironment. In preclinical studies,regorafenibinhibits several 
angiogenic VEGF receptor tyrosine kinases that play a role in 
tumourangiogenesis and lymphangiogenesis (the growth of new blood vessels 
and lymphatic vessels). It also inhibits various oncogenic 
andtumourmicroenvironment kinases includingVEGFR 1-3,KIT, RET, PDGFR, 
and FGFR, which individually and collectively impact upon tumour growth, 
formation of a stromal microenvironment and disease progression. 
Safety and adverse events were similar to those observed with other tyrosine 
kinase inhibitors (TKIS).(xi) The most frequently observed adverse drug 
reactions (≥30%) in patients receiving regorafenib were asthenia/fatigue, 
decreased appetite and food intake, hand-foot-skin reaction, diarrhea, 
mucositis, weight loss, infection, hypertension and dysphonia. The most 
serious adverse drug reactions in patients receiving regorafenib were 
hepatotoxicity, hemorrhage and gastrointestinal perforation. 
Regorafenibis also under investigation in metastatic and/or unresectable 
gastrointestinal stromaltumours (GIST) for patients whose disease has 
progressed despite prior treatment with imatinib and sunitinib. Positive Phase 
III data showing a significant increase in progression-free survival (PFS) was 
published in The Lancet Oncology and presented at the ASCO2013Meeting. 
Market authorization for this indication in Canada has not yet been obtained, 
and the safety and efficacy are still being reviewed for GIST, although it has 
been approved for this indication in the US (February 25(th), 2013). 
About Bayer Inc.
Bayer Inc. is a Canadian subsidiary of Bayer AG and the headquarters for the 
Canadian operations. Celebrating its 150 anniversary, 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 its CropScience business from Calgary, AB. 
With more than 1,300 employees across the country, in 2012, Bayer had sales of 
$1.6 billion CDN and invested $55.9 million CDN in research and development in 
Canada. Globally, Bayer AG had sales of $39.8 billion Euro and invested $3 
billion Euro in research and development. For more information about Bayer 
Inc., please visit www.bayer.ca. 
REFERENCES 
(i) Canadian Stivarga Product Monograph, March 2013
(ii) Grothey, et al. The Lancet 21 January 2013 doi: 
10.1016/S0140-6736(12)61900-X
(iii) Grothey, et al. The Lancet 21 January 2013 doi: 
10.1016/S0140-6736(12)61900-X
(iv) http://www.wcrf.org/cancer_statistics/world_cancer_statistics.php
(v) 
http://www.cancer.ca/Canada-wide/About%20cancer/Cancer%20statistics/Stats%20at%
20a%20glance/Colorectal%20cancer.aspx?sc_lang=en
(vi) 
http://www.cancer.ca/Canada-wide/About%20cancer/Cancer%20statistics/Stats%20at%
20a%20glance/Colorectal%20cancer.aspx?sc_lang=en
(vii) http://www.cancer.gov/cancertopics/factsheet/Sites-Types/metastatic
(viii) SEER Data - 2008 (2005 dataset)
(ix) The Continuum of Care: A Paradigm for the Management of Metastatic 
Colorectal Cancer Richard M. Goldberg(a), Mace L. Rothenberg(b), Eric Van 
Cutsem(c), Al B. Benson III(d), Charles D. Blanke(e), Robert B. Diasio(f), 
Axel Grothey(g), Heinz-Josef Lenz(h), Neal J. Meropol(i), Ramesh K. 
Ramanathan(j), Carlos H. Roberto Becerra(k), Rita Wickham(l), Delma 
Armstrong(m) and Carol Viele(n)
(x) Grothey, et al. The Lancet 21 January 2013 doi: 
10.1016/S0140-6736(12)61900-X
(xi) Grothey, et al. The Lancet 21 Nov 2012 doi: 10.1016/S0140-6736(12)61900-X 
Page 8 
To view a colon cancer infographic, please click here: 
http://files.newswire.ca/1217/ColonCancerInfoEng.pdf 
Emily Hanft, Bayer Emily.hanft@bayer.ca 416-240-5466 
Ethan Pigott, beSPEAK Communications ethan@bespeakcommunications.com 
416-558-2783 
Video with caption: "Video: First New Colon Cancer Treatment Since 2006 
Received Priority Review From Health Canada And Is Now Approved For Canadian 
Patients With Metastatic Colorectal Cancer". Video available at:  
http://stream1.newswire.ca/cgi-bin/playback.cgi?file=20130325_C7800_VIDEO_EN_24
748.mp4&posterurl=http://photos.newswire.ca/images/20130325_C7800_PHOTO_EN_2474
8.jpg&clientName=Bayer%20Inc%2E&caption=Video%3A%20First%20New%20Colon%20Cancer
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c%20Colorectal%20Cancer&title=&headline=First%20New%20Colon%20Cancer%20Treatmen
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tal%20Cancer 
Video with caption: "Video: First New Colon Cancer Treatment Since 2006 
Received Priority Review From Health Canada And Is Now Approved For Canadian 
Patients With Metastatic Colorectal Cancer". Video available at:  
http://stream1.newswire.ca/cgi-bin/playback.cgi?file=20130325_C7800_VIDEO_EN_24
747.mp4&posterurl=http://photos.newswire.ca/images/20130325_C7800_PHOTO_EN_2474
7.jpg&clientName=Bayer%20Inc%2E&caption=Video%3A%20First%20New%20Colon%20Cancer
%20Treatment%20Since%202006%20Received%20Priority%20Review%20From%20Health%20Ca
nada%20And%20Is%20Now%20Approved%20For%20Canadian%20Patients%20With%20Metastati
c%20Colorectal%20Cancer&title=&headline=First%20New%20Colon%20Cancer%20Treatmen
t%20Since%202006%20Received%20Priority%20Review%20From%20Health%20Canada%20And%
20Is%20Now%20Approved%20For%20Canadian%20Patients%20With%20Metastatic%20Colorec
tal%20Cancer 
Video with caption: "Video: First New Colon Cancer Treatment Since 2006 
Received Priority Review From Health Canada And Is Now Approved For Canadian 
Patients With Metastatic Colorectal Cancer". Video available at:  
http://stream1.newswire.ca/cgi-bin/playback.cgi?file=20130325_C7800_VIDEO_EN_24
749.mp4&posterurl=http://photos.newswire.ca/images/20130325_C7800_PHOTO_EN_2474
9.jpg&clientName=Bayer%20Inc%2E&caption=Video%3A%20First%20New%20Colon%20Cancer
%20Treatment%20Since%202006%20Received%20Priority%20Review%20From%20Health%20Ca
nada%20And%20Is%20Now%20Approved%20For%20Canadian%20Patients%20With%20Metastati
c%20Colorectal%20Cancer&title=&headline=First%20New%20Colon%20Cancer%20Treatmen
t%20Since%202006%20Received%20Priority%20Review%20From%20Health%20Canada%20And%
20Is%20Now%20Approved%20For%20Canadian%20Patients%20With%20Metastatic%20Colorec
tal%20Cancer 
Video with caption: "Video: First New Colon Cancer Treatment Since 2006 
Received Priority Review From Health Canada And Is Now Approved For Canadian 
Patients With Metastatic Colorectal Cancer". Video available at:  
http://stream1.newswire.ca/cgi-bin/playback.cgi?file=20130325_C7800_VIDEO_EN_24
746.mp4&posterurl=http://photos.newswire.ca/images/20130325_C7800_PHOTO_EN_2474
6.jpg&clientName=Bayer%20Inc%2E&caption=Video%3A%20First%20New%20Colon%20Cancer
%20Treatment%20Since%202006%20Received%20Priority%20Review%20From%20Health%20Ca
nada%20And%20Is%20Now%20Approved%20For%20Canadian%20Patients%20With%20Metastati
c%20Colorectal%20Cancer&title=&headline=First%20New%20Colon%20Cancer%20Treatmen
t%20Since%202006%20Received%20Priority%20Review%20From%20Health%20Canada%20And%
20Is%20Now%20Approved%20For%20Canadian%20Patients%20With%20Metastatic%20Colorec
tal%20Cancer 
Audio with caption: "First New Colon Cancer Treatment Since 2006 Received 
Priority Review From Health Canada And Is Now Approved For Canadian Patients 
With Metastatic Colorectal Cancer". Audio available at:  
http://stream1.newswire.ca/media/2013/03/25/20130325_C7800_AUDIO_EN_24753.mp3 
PDF available at:  
http://stream1.newswire.ca/media/2013/03/25/20130325_C7800_DOC_EN_24755.pdf 
SOURCE: Bayer Inc. 
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-0- Mar/25/2013 12:00 GMT
 
 
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