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 demonstrated a statistically significant improvement 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 inhibitor affecting mechanisms for tumour growth and progression - angiogenesis, oncogenesis and the tumour microenvironment.ⁱⁱ

"New treatment options offer hope for patients living with advanced disease and highlight 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 the Colorectal Cancer Association of Canada. "Stivarga represents another new option for Canadian patients and it is important that this innovative treatment be made accessible to all Canadians living with metastatic colorectal cancer 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 to me, and also to them."

The CORRECT clinical trial achieved all of its primary and secondary endpoints.  Pivotal Phase III data showed regorafenib plus best supportive care (BSC) significantly improved overall survival (OS) (HR=0.77, two-sided p-value=0.010356) and progression-free survival (PFS) (HR=0.49, two-sided p-value<0.000001) compared to placebo plus BSC.

Median OS was 6.4 months with regorafenib versus 5.0 months with placebo; median PFS was 1.9 months with regorafenib versus 1.7 months with placebo.  The data also showed 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 randomized to receive regorafenib plus BSC or placebo plus BSC, as BSC is the standard of care in this setting. Treatment cycles consisted of 160 mg of regorafenib 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 is an oral multi-kinase inhibitor affecting mechanisms for tumour growth and progression - angiogenesis, oncogenesis and the tumour microenvironment. In preclinical studies, regorafenib inhibits several angiogenic VEGF receptor tyrosine kinases that play a role in tumour angiogenesis and lymphangiogenesis (the growth of new blood vessels and lymphatic vessels). It also inhibits various oncogenic and tumour microenvironment kinases including VEGFR 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.

Regorafenib is also under investigation in metastatic and/or unresectable gastrointestinal stromal tumours (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 ASCO 2013 Meeting. 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. Meropolⁱ, 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

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_24748.mp4&posterurl=http://photos.newswire.ca/images/20130325_C7800_PHOTO_EN_24748.jpg&clientName=Bayer%20Inc%2E&caption=Video%3A%20First%20New%20Colon%20Cancer%20Treatment%20Since%202006%20Received%20Priority%20Review%20From%20Health%20Canada%20And%20Is%20Now%20Approved%20For%20Canadian%20Patients%20With%20Metastatic%20Colorectal%20Cancer&title=&headline=First%20New%20Colon%20Cancer%20Treatment%20Since%202006%20Received%20Priority%20Review%20From%20Health%20Canada%20And%20Is%20Now%20Approved%20For%20Canadian%20Patients%20With%20Metastatic%20Colorectal%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_24747.mp4&posterurl=http://photos.newswire.ca/images/20130325_C7800_PHOTO_EN_24747.jpg&clientName=Bayer%20Inc%2E&caption=Video%3A%20First%20New%20Colon%20Cancer%20Treatment%20Since%202006%20Received%20Priority%20Review%20From%20Health%20Canada%20And%20Is%20Now%20Approved%20For%20Canadian%20Patients%20With%20Metastatic%20Colorectal%20Cancer&title=&headline=First%20New%20Colon%20Cancer%20Treatment%20Since%202006%20Received%20Priority%20Review%20From%20Health%20Canada%20And%20Is%20Now%20Approved%20For%20Canadian%20Patients%20With%20Metastatic%20Colorectal%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_24749.mp4&posterurl=http://photos.newswire.ca/images/20130325_C7800_PHOTO_EN_24749.jpg&clientName=Bayer%20Inc%2E&caption=Video%3A%20First%20New%20Colon%20Cancer%20Treatment%20Since%202006%20Received%20Priority%20Review%20From%20Health%20Canada%20And%20Is%20Now%20Approved%20For%20Canadian%20Patients%20With%20Metastatic%20Colorectal%20Cancer&title=&headline=First%20New%20Colon%20Cancer%20Treatment%20Since%202006%20Received%20Priority%20Review%20From%20Health%20Canada%20And%20Is%20Now%20Approved%20For%20Canadian%20Patients%20With%20Metastatic%20Colorectal%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_24746.mp4&posterurl=http://photos.newswire.ca/images/20130325_C7800_PHOTO_EN_24746.jpg&clientName=Bayer%20Inc%2E&caption=Video%3A%20First%20New%20Colon%20Cancer%20Treatment%20Since%202006%20Received%20Priority%20Review%20From%20Health%20Canada%20And%20Is%20Now%20Approved%20For%20Canadian%20Patients%20With%20Metastatic%20Colorectal%20Cancer&title=&headline=First%20New%20Colon%20Cancer%20Treatment%20Since%202006%20Received%20Priority%20Review%20From%20Health%20Canada%20And%20Is%20Now%20Approved%20For%20Canadian%20Patients%20With%20Metastatic%20Colorectal%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.

Emily Hanft, Bayer
[email protected]
416-240-5466

Ethan Pigott, beSPEAK Communications
[email protected]
416-558-2783