Data Published in the New England Journal of Medicine for Vedolizumab, an Investigational New Drug from Takeda for Moderately to

Data Published in the New England Journal of Medicine for Vedolizumab, an 
Investigational New Drug from Takeda for Moderately to Severely Active 
Ulcerative Colitis and Crohn's Disease 
OAKVILLE, ON, Aug. 21, 2013 /CNW/ - Takeda Pharmaceutical Company Limited 
("Takeda") today announced that results from two Phase 3 studies evaluating 
vedolizumab, an investigational humanized monoclonal antibody, for the 
treatment of adults with moderately to severely active ulcerative colitis (UC) 
and Crohn's disease (CD), were published in the August 22, 2013 issue of the 
New England Journal of Medicine.(1,2) Chronic and debilitating diseases, CD 
and UC are the two most common types of inflammatory bowel disease (IBD)(3,4) 
and affect more than four million people worldwide,(5,6,7,8,9,1 )including 
approximately 233,000 Canadians(11), 1.4 million Americans, and 2.2 million 
Europeans.(12,13 )Vedolizumab is designed to specifically antagonize the 
alpha4beta7 (α4β7) integrin, which is expressed on a subset of circulating 
white blood cells that have been shown to play a role in mediating the 
inflammatory process in CD and UC.(14,15 ) 
"The publication of these study findings is important since the results 
support the potential for vedolizumab, if approved, to help manage symptoms in 
some patients for whom certain previous treatments have failed," said Brian 
Feagan, M.D., professor of medicine, epidemiology, and biostatistics at the 
University of Western Ontario, Canada and GEMINI lead investigator. "The data 
from the GEMINI program suggest that vedolizumab may provide people living 
with CD and UC an additional option for inducing and maintaining clinical 
remission." 
In the publication, study results from GEMINI I, a placebo-controlled 
induction and maintenance study in patients with UC, showed that vedolizumab 
met primary endpoints of improvement in clinical response (reduction in the 
Mayo Clinic score of ≥3 points and ≥30 percent from baseline, along with a 
decrease of at least 1 point on the rectal bleeding subscale or an absolute 
rectal bleeding score of 0 or 1) at six weeks and clinical remission (Mayo 
score of 2 or lower and no subscore higher than 1) at 52 weeks. In addition, a 
significantly greater proportion of patients receiving vedolizumab achieved 
mucosal healing (Mayo endoscopic subscore of 0 or 1) at six and 52 weeks, and 
glucocorticoid-free remission at 52 weeks, compared with placebo.(16) 
Discussed in a separate publication, results from GEMINI II, a 
placebo-controlled induction and maintenance study in patients with CD, showed 
that vedolizumab demonstrated statistically significant improvement in the 
primary endpoint of clinical remission (Crohn's disease activity index [CDAI] 
score ≤150 points) at six weeks and at 52 weeks compared to placebo. At six 
weeks, no significant difference was observed in the co-primary endpoint of 
CDAI-100 response (≥100-point decrease in the CDAI score) between the 
vedolizumab and placebo groups. A significantly greater proportion of patients 
showed CDAI-100 response and glucocorticoid-free remission at 52 weeks.(17) 
GEMINI I and GEMINI II are part of the four-study GEMINI Studies™, studying 
vedolizumab in 2,700 patients in nearly 40 countries, making it the largest 
Phase 3 clinical trial program conducted to date simultaneously evaluating 
both CD and UC.(18,19,2) Enrolled patients had failed at least one 
conventional therapy, including glucocorticoids, immunomodulators and/or a 
tumor necrosis factor-alpha (TNF-α) antagonist. TNF-α antagonist failure 
patients included those with inadequate response (primary non-responders), 
loss of response (secondary non-responders) or those who were 
intolerant.(21,22,23 ) 
"These clinical studies suggest that vedolizumab may have the potential to 
maintain clinical remission in the appropriate patients," said Asit Parikh, 
M.D., Ph.D., vice president, general medicine, Takeda. "Takeda has a strong 
legacy of researching and treating GI disorders globally, and vedolizumab 
represents our focus on and commitment to patient communities." 
Takeda submitted a Biologics License Application (BLA) to the U.S. Food and 
Drug Administration (FDA) in June, 2013, as well as a Marketing Authorisation 
Application (MAA) to the European Medicines Agency (EMA) in March, 2013, 
seeking approval for vedolizumab for the treatment of adults with moderately 
to severely active CD and UC. The safety and efficacy of vedolizumab has not 
been evaluated by Health Canada and is currently not approved for sale in 
Canada. 
CD and UC are chronic diseases of the digestive tract.(24) CD can involve all 
areas of the digestive tract, while UC typically affects the colon and 
rectum.(25,26 )CD and UC can be both painful and debilitating and patients may 
have bleeding, diarrhea, fatigue, weight loss and anemia, among other 
symptoms.(27,28,29) Both diseases involve excess inflammation in the gut 
tissue that occurs when white blood cells infiltrate the gastrointestinal 
tract and may lead to serious complications.(3,31) 
"Vedolizumab as Induction and Maintenance Therapy for Ulcerative Colitis"
The publication, titled "Vedolizumab as Induction and Maintenance Therapy for 
Ulcerative Colitis", discusses findings from GEMINI I, a Phase 3, randomized, 
double-blind, placebo-controlled induction and maintenance study designed to 
assess the efficacy and safety of vedolizumab on clinical response and 
remission in patients with moderately to severely active UC, in whom one prior 
therapy had failed.(32) In the induction phase, the primary endpoint was 
improvement in clinical response at six weeks. Secondary endpoints were to 
determine the effect of vedolizumab induction treatment on clinical remission 
and mucosal healing at six weeks. The intent-to-treat (ITT) population 
comprised 374 patients, with an additional 521 patients receiving open-label 
vedolizumab. Of the 374 225 received vedolizumab 300 mg IV and 149 received 
placebo on days 1 and 15. Approximately 40 percent of the ITT population had 
prior anti-TNF failure. At week six, 47.1 percent of patients receiving 
vedolizumab achieved clinical response compared to 25.5 percent of patients 
receiving placebo (p <0.001), 16.9 percent achieved clinical remission versus 
5.4 percent receiving placebo (p = 0.001), and 40.9 percent of 
vedolizumab-treated patients experienced mucosal healing compared to 24.8 
percent of patients receiving placebo (p=0.001).(33) 
The maintenance arm of GEMINI I assessed the efficacy and safety of 
vedolizumab for maintaining clinical response and remission for 52 weeks in 
patients with moderately to severely active UC with evidence of clinical 
response and decrease of rectal bleeding after two 300 mg IV induction doses 
of vedolizumab. The primary endpoint was clinical remission at week 52, while 
the secondary endpoints were durable clinical response (response at both week 
six and 52) and durable clinical remission (remission at both week six and 
52), mucosal healing at week 52, and glucocorticoid-free remission at week 52 
in patients receiving glucocorticoids at week six. Of 895 patients enrolled, 
373 met response criteria at six weeks (ITT population) and were randomized to 
receive vedolizumab 300 mg IV every four weeks (n=125) or eight weeks (n=122), 
or placebo (n=126) for up to 52 weeks. 41.8 percent and 44.8 percent of 
patients receiving vedolizumab every eight and four weeks, respectively, were 
in clinical remission at week 52, compared to 15.9 percent of patients who 
received placebo (p <0.001). 56.6 percent and 52.0 percent of patients treated 
with vedolizumab every eight and four weeks, respectively, achieved durable 
clinical response (defined by a response at both week six and week 52), 
compared to 23.8 percent of patients receiving placebo (p<0.001). 51.6 percent 
and 56.0 percent of patients treated with vedolizumab every eight and four 
weeks, respectively, achieved mucosal healing at week 52, compared to 19.8 
percent of patients receiving placebo (p<0.001). 20.5 percent and 24.0 percent 
of patients treated with vedolizumab every eight and four weeks, respectively, 
achieved durable clinical remission at week 52, compared to 8.7 percent of 
patients receiving placebo (p=0.008, p=0.001, respectively). 31.4 percent and 
45.2 percent of patients on oral glucocorticoids at baseline treated with 
vedolizumab every eight and four weeks, respectively, achieved 
glucocorticoid-free remission at week 52, compared to 13.9 percent of patients 
receiving placebo (p=0.01, p<0.001, respectively).(34) 
The safety population in GEMINI I comprised 895 patients for weeks 0-52. The 
most common adverse events reported in the 620-patient vedolizumab arm (≥9.0 
percent) were ulcerative colitis, headache, nasopharyngitis and arthralgia. 
The most common adverse events reported in the 275-patient placebo arm (˃9.0 
percent) were ulcerative colitis, headache, nasopharyngitis and arthralgia. No 
increase in rates of serious, opportunistic or enteric infections was observed 
with vedolizumab. One death occurred in a 66-yr-old man who received one 
induction dose of vedolizumab and died 14 days later from acute coronary 
syndrome.(35) 
"Vedolizumab as Induction and Maintenance Therapy for Crohn's Disease"
The publication, titled "Vedolizumab as Induction and Maintenance Therapy for 
Crohn's Disease", discusses findings from GEMINI II, a Phase 3, randomized, 
parallel-group, double-blind, placebo-controlled induction and maintenance 
study designed to assess the efficacy and safety of vedolizumab as a therapy 
for adults with moderately to severely active Crohn's disease (CD), in whom 
one prior therapy had failed.(36) In the induction phase, the co-primary 
endpoints were clinical remission and CDAI-100 response at week six, while the 
secondary endpoint was mean change in serum C-reactive protein (CRP) levels 
from baseline to week six. The ITT population comprised 368 patients, with an 
additional 747 patients receiving open-label vedolizumab. Of the 368, 220 
received vedolizumab 300 mg IV and 148 received placebo. Approximately 50 
percent of the ITT population had prior anti-TNFα failure; 26 percent were 
primary failures. In addition, approximately 30 percent had failed at least 
two TNF antagonists. At week six, clinical remission was seen in 14.5 percent 
of patients randomized to vedolizumab versus 6.8 percent who received placebo 
(p=0.02). At six weeks, no significant difference was observed in CDAI-100 
response between the vedolizumab and placebo groups (31.4 percent versus 25.7 
percent, respectively [p=0.23]).(37) 
The maintenance arm of GEMINI II assessed the efficacy and safety of 
vedolizumab for maintaining response and remission in patients with moderately 
to severely active CD with evidence of clinical response after two 300 mg IV 
induction doses of vedolizumab. Patients responding (≥70-point decrease in 
CDAI from baseline) at week six to induction treatment with vedolizumab were 
randomized to vedolizumab 300 mg IV every four weeks, every eight weeks, or 
placebo for up to 52 weeks. The primary endpoint was clinical remission at 
week 52, while the secondary endpoints were CDAI-100 response, 
glucocorticoid-free remission at week 52, and durable clinical remission 
(clinical remission at ≥80 percent of visits including the final visit) at 
week 52. Of the 1,115 patients who received induction treatment, 461 met 
response criteria at six weeks (ITT population) and were randomized to receive 
vedolizumab every four weeks (n=154) or eight weeks (n=154), or placebo 
(n=153). At week 52, remission was seen in 39.0 percent and 36.4 percent of 
patients randomized, respectively, to vedolizumab every eight weeks or every 
four weeks versus 21.6 percent of the patients receiving placebo (p<0.001, 
p=0.004, respectively). CDAI-100 response was seen in 43.5 percent and 45.5 
percent of patients randomized, respectively, to vedolizumab every eight weeks 
or every four weeks versus 30.1 percent of patients receiving placebo at week 
52 (p=0.01, p=0.005 respectively). Glucocorticoid-free remission was seen in 
31.7 percent and 28.8 percent of patients taking oral glucocorticoids at 
baseline randomized, respectively, to vedolizumab every eight weeks or every 
four weeks versus 15.9 percent of patients receiving placebo at week 52 
(p=0.02, p=0.04, respectively).(38) 
The safety population in GEMINI II comprised 1,115 patients for weeks 0-52.( 
)The most common adverse events reported in the 814-patient vedolizumab arm 
(˃8.0 percent) were Crohn's disease exacerbation, arthralgia, pyrexia, 
nasopharyngitis, headache, nausea and abdominal pain. The most common adverse 
events reported in the 301-patient placebo arm (≥8.0 percent) were Crohn's 
disease exacerbation, headache, arthralgia, pyrexia, abdominal pain, nausea, 
and nasopharyngitis. Five deaths occurred during the study period, four among 
patients receiving vedolizumab (one death each from Crohn's disease with 
sepsis, intentional overdose of prescription medication, myocarditis, and 
septic shock) and one in the placebo group (from bronchopneumonia).(39) 
About the GEMINI™ Studies
Announced in early 2009, the GEMINI Studies™ is a Phase 3 program evaluating 
the effect of vedolizumab on clinical response and remission (along with 
effect on mucosal healing in UC), and long-term safety in moderately to 
severely active CD and UC patients who had failed at least one conventional 
therapy or a TNFα antagonist.(4,41,42,43,44) The GEMINI program consists of 
four separate studies - a placebo-controlled induction and maintenance study 
in patients with UC (GEMINI I),(45) a placebo-controlled induction and 
maintenance study in patients with CD (GEMINI II),(46) a placebo-controlled 
induction study in patients with CD (GEMINI III)(47) and an open-label 
long-term safety study in patients with either CD or UC (GEMINI LTS).(48) 
About Crohn's disease and ulcerative colitis
Crohn's disease (CD) and ulcerative colitis (UC) are the two most common forms 
of inflammatory bowel disease (IBD), which is marked by inflammation in the GI 
tract.(49) CD and UC can, in many patients, present in mild form, which can be 
well managed. CD can impact any part of the digestive tract and common 
symptoms may include abdominal pain, diarrhea, rectal bleeding, weight loss, 
and fever.(5) UC impacts the large intestine only, which includes the colon 
and the rectum.(51) The most common symptoms of UC include abdominal 
discomfort and blood or pus in diarrhea.(52) There is no known cause for CD or 
UC, although many researchers believe that the interaction between genes, the 
body's immune system, and environmental factors may play a role.(53) The aim 
of CD and UC treatments is to induce and maintain remission, or achieve 
extended periods of time when patients do not experience symptoms.(54,55) 
About vedolizumab
Vedolizumab, under development for the treatment of CD and UC, is a humanized 
monoclonal antibody that specifically antagonizes the alpha4beta7 (α4β7) 
integrin, inhibiting the binding of α4β7 integrin to intestinal mucosal cell 
adhesion molecule (MAdCAM-1).(56 )MAdCAM-1 is preferentially expressed on 
blood vessels and lymph nodes of the gastrointestinal tract.(57 )The α4β7 
integrin is expressed on a subset of circulating white blood cells.(58) These 
cells have been shown to play a role in mediating the inflammatory process in 
CD and UC.(59,6 ) 
About Takeda Pharmaceutical Company Limited 
Located in Osaka, Japan, Takeda is a research-based global company with its 
main focus on pharmaceuticals. As the largest pharmaceutical company in Japan 
and one of the global leaders of the industry, Takeda is committed to strive 
towards better health for people worldwide through leading innovation in 
medicine. Additional information about Takeda is available through its 
corporate website, www.takeda.com. 
(___________________________________)
(1) Feagan B, Rutgeerts P, Sands B, et al. Vedolizumab as Induction and 
Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2013;369;8:699-710.
(2) Sandborn W, Feagan B, Rutgeerts P, et al. Vedolizumab as Induction and 
Maintenance Therapy for Crohn's Disease. N Engl J Med. 2013;369;8:711-721.
(3) Crohn's and Colitis Foundation of America. The facts about inflammatory 
bowel diseases. http://www.ccfa.org/assets/pdfs/ibdfactbook.pdf. Published 
June, 2011. Accessed January 4, 2013.
(4) Knigge KL. Inflammatory bowel disease. Clin Cornerstone. 2002;4(4):49-60.
(5) Centers for Disease Control. Inflammatory bowel disease. 
http://www.cdc.gov/ibd/. Updated July 15, 2011. Accessed February 11, 2013.
(6) The Crohn's and Colitis Foundation of Canada. The impact of inflammatory 
bowel disease in Canada. 
http://www.isupportibd.ca/pdf/ccfc-ibd-impact-report-2012.pdf. Published 
November, 2012. Accessed February 11, 2013.
(7) Loftus EV Jr. Clinical epidemiology of inflammatory bowel disease: 
incidence, prevalence, and environmental influences. Gastroenterology. 
2004;126(6):1504-1517. 
http://download.journals.elsevierhealth.com/pdfs/journals/0016-5085/PIIS0016508
504004627.pdf. Accessed March 1, 2013.
(8) Wilson J, Hair C, Knight R et al. High incidence of inflammatory bowel 
disease in Australia: a prospective population -based Australian incidence 
study. Inflamm Bowel Dis. 2010;16(9):1550-1556.
(9) Asakura K, Nishiwaki Y, Inoue N, Hibi T, Watanabe M, Takebayashi T. 
Prevalence of ulcerative colitis and Crohn's disease in Japan. J. 
Gastroenterol. 2009;44:659-665.
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of ulcerative colitis in Punjab, North India. Gut. 2003;52:1587-1590.
(11) The Impact of Inflammatory Bowel Disease in Canada: 2012 Final Report 
and Recommendations. Crohn's and Colitis Foundation of Canada. [Online] 
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(12) Centers for Disease Control. Inflammatory bowel disease. 
http://www.cdc.gov/ibd/. Updated July 15, 2011. Accessed February 11, 2013.
(13) Loftus EV Jr. Clinical epidemiology of inflammatory bowel disease: 
incidence, prevalence, and environmental influences. Gastroenterology. 
2004;126(6):1504-1517. 
http://download.journals.elsevierhealth.com/pdfs/journals/0016-5085/PIIS0016508
504004627.pdf. Accessed March 1, 2013.
(14) Soler D, Chapman T, Yang L, et al. The binding specificity and selective 
antagonism of vedolizumab, an anti-α4β7 integrin therapeutic antibody in 
development for inflammatory bowel diseases. J Pharmacol Exp Ther. 
2009;330(3):864-875. 
http://jpet.aspetjournals.org/content/330/3/864.full.pdf+html. Published June 
9, 2009. Accessed March 1, 2013.
(15) Gledhill T, Bodger K. New and emerging treatments for ulcerative colitis: 
a focus on vedolizumab. Biologics: targets and therapy. 2013;7:123-130.
(16) Feagan B, Rutgeerts P, Sands B, et al. Vedolizumab as Induction and 
Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2013;369;8:699-710.
(17) Sandborn W, Feagan B, Rutgeerts P, et al. Vedolizumab as Induction and 
Maintenance Therapy for Crohn's Disease. N Engl J Med. 2013;369;8:711-721.
(18) Data on File: Vedolizumab Integrated Summary of Safety.
(19) REMICADE Prescribing Information. Horsham, PA: Janssen Biotech, Inc.; 
March 2013.
(20) HUMIRA Prescribing Information. North Chicago, IL: AbbVie Inc.; April 
2013.
(21) Data on File: Final Clinical Study Report C13006. 2012.
(22) Data on File: Final Clinical Study Report C13007. 2012.
(23) Data on File: Final Clinical Study Report C13011. 2012.
(24) Knigge KL. Inflammatory bowel disease. Clin Cornerstone. 2002;4(4):49-60.
(25) National Institutes of Health, National Institute of Diabetes and 
Digestive and Kidney Diseases, National Digestive Diseases Information 
Clearinghouse. Crohn's disease. 
http://digestive.niddk.nih.gov/ddiseases/pubs/crohns/index.aspx. Published 
December 2011. Accessed March 1, 2013.
(26) National Institutes of Health, National Institute of Diabetes and 
Digestive and Kidney Diseases, National Digestive Diseases Information 
Clearinghouse. Ulcerative colitis. 
http://digestive.niddk.nih.gov/ddiseases/pubs/colitis/index.aspx. Published 
October 2011. Accessed March 1, 2013.
(27) National Institutes of Health, National Institute of Diabetes and 
Digestive and Kidney Diseases, National Digestive Diseases Information 
Clearinghouse. Crohn's disease. 
http://digestive.niddk.nih.gov/ddiseases/pubs/crohns/index.aspx. Accessed 
March 1, 2013.
(28) National Institutes of Health, National Institute of Diabetes and 
Digestive and Kidney Diseases, National Digestive Diseases Information 
Clearinghouse. Ulcerative colitis. 
http://digestive.niddk.nih.gov/ddiseases/pubs/colitis/index.aspx. Published 
October 2011. Accessed March 1, 2013.
(29) Crohn's and Colitis Foundation of America. The facts about inflammatory 
bowel diseases. http://www.ccfa.org/assets/pdfs/ibdfactbook.pdf. Published 
June, 2011. Accessed January 4, 2013.
(30) Crohn's and Colitis Foundation of America. The facts about inflammatory 
bowel diseases. http://www.ccfa.org/assets/pdfs/ibdfactbook.pdf. Published 
June, 2011. Accessed January 4, 2013.
(31) Centers for Disease Control. Inflammatory bowel disease. 
http://www.cdc.gov/ibd/. Updated July 15, 2011. Accessed February 11, 2013.
(32) ClinicalTrials.gov. Study of vedolizumab (MLN0002) in patients with 
moderate to severe ulcerative colitis (GEMINI I). 
http://www.clinicaltrials.gov/ct2/show/NCT00783718?term=vedolizumab&rank=5. 
Updated March 18, 2013. Accessed May 7, 2013.
(33) Feagan B, Rutgeerts P, Sands B, et al. Vedolizumab as Induction and 
Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2013;369;8:699-710.
(34) Feagan B, Rutgeerts P, Sands B, et al. Vedolizumab as Induction and 
Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2013;369;8:699-710.
(35) Feagan B, Rutgeerts P, Sands B, et al. Vedolizumab as Induction and 
Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2013;369;8:699-710.
(36) ClinicalTrials.gov. Study of vedolizumab (MLN0002) in patients with 
moderate to severe Crohn's disease (GEMINI II). 
http://www.clinicaltrials.gov/ct2/show/NCT00783692?term=vedolizumab&rank=2. 
Updated April 8, 2013. Accessed May 7, 2013.
(37) Sandborn W, Feagan B, Rutgeerts P, et al. Vedolizumab as Induction and 
Maintenance Therapy for Crohn's Disease. N Engl J Med. 2013;369;8:711-721.
(38) Sandborn W, Feagan B, Rutgeerts P, et al. Vedolizumab as Induction and 
Maintenance Therapy for Crohn's Disease. N Engl J Med. 2013;369;8:711-721.
(39) Sandborn W, Feagan B, Rutgeerts P, et al. Vedolizumab as Induction and 
Maintenance Therapy for Crohn's Disease. N Engl J Med. 2013;369;8:711-721.
(40) ClinicalTrials.gov. Study of vedolizumab (MLN0002) in patients with 
moderate to severe ulcerative colitis (GEMINI I). 
http://www.clinicaltrials.gov/ct2/show/NCT00783718?term=vedolizumab&rank=5. 
Updated March 18, 2013. Accessed May 7, 2013.
(41) ClinicalTrials.gov. Study of vedolizumab (MLN0002) in patients with 
moderate to severe Crohn's disease (GEMINI II). 
http://www.clinicaltrials.gov/ct2/show/NCT00783692?term=vedolizumab&rank=2. 
Updated April 8, 2013. Accessed May 7, 2013.
(42) ClinicalTrials.gov. Study of vedolizumab in patients with moderate to 
severe Crohn's disease (GEMINI III). 
http://www.clinicaltrials.gov/ct2/show/NCT01224171?term=vedolizumab&rank=4. 
Updated March 7, 2013. Accessed May 7, 2013.
(43) ClinicalTrials.gov. An open-label study of vedolizumab (MLN0002) in 
patients with ulcerative colitis and Crohn's disease (GEMINI LTS). 
http://www.clinicaltrials.gov/ct2/show/NCT00790933?term=vedolizumab&rank=3. 
Updated January 23, 2013. Accessed May 7, 2013.
(44) Feagan B, Rutgeerts P, Sands B, et al. Vedolizumab as Induction and 
Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2013;369;8:699-710.
(45) ClinicalTrials.gov. Study of vedolizumab (MLN0002) in patients with 
moderate to severe ulcerative colitis (GEMINI I). 
http://www.clinicaltrials.gov/ct2/show/NCT00783718?term=vedolizumab&rank=5. 
Updated March 18, 2013. Accessed May 7, 2013.
(46) ClinicalTrials.gov. Study of vedolizumab (MLN0002) in patients with 
moderate to severe Crohn's disease (GEMINI II). 
http://www.clinicaltrials.gov/ct2/show/NCT00783692?term=vedolizumab&rank=2. 
Updated April 8, 2013. Accessed May 7, 2013.
(47) ClinicalTrials.gov. Study of vedolizumab in patients with moderate to 
severe Crohn's disease (GEMINI III). 
http://www.clinicaltrials.gov/ct2/show/NCT01224171?term=vedolizumab&rank=4. 
Updated March 7, 2013. Accessed May 7, 2013.
(48) ClinicalTrials.gov. An open-label study of vedolizumab (MLN0002) in 
patients with ulcerative colitis and Crohn's disease (GEMINI LTS). 
http://www.clinicaltrials.gov/ct2/show/NCT00790933?term=vedolizumab&rank=3. 
Updated January 23, 2013. Accessed May 7, 2013.
(49) Knigge KL. Inflammatory bowel disease. Clin Cornerstone. 2002;4(4):49-60.
(50) National Institutes of Health, National Institute of Diabetes and 
Digestive and Kidney Diseases, National Digestive Diseases Information 
Clearinghouse. Crohn's disease. 
http://digestive.niddk.nih.gov/ddiseases/pubs/crohns/index.aspx. Published 
December 2011. Accessed March 1, 2013.
(51) National Institutes of Health, National Institute of Diabetes and 
Digestive and Kidney Diseases, National Digestive Diseases Information 
Clearinghouse. Ulcerative colitis. 
http://digestive.niddk.nih.gov/ddiseases/pubs/colitis/index.aspx. Published 
October 2011. Accessed March 1, 2013
(52) National Institutes of Health, National Institute of Diabetes and 
Digestive and Kidney Diseases, National Digestive Diseases Information 
Clearinghouse. Ulcerative colitis. 
http://digestive.niddk.nih.gov/ddiseases/pubs/colitis/index.aspx. Published 
October 2011. Accessed March 1, 2013
(53) Crohn's and Colitis Foundation of America. The facts about inflammatory 
bowel diseases. http://www.ccfa.org/assets/pdfs/ibdfactbook.pdf. Published 
June, 2011. Accessed January 4, 2013.
(54) National Institutes of Health, National Institute of Diabetes and 
Digestive and Kidney Diseases, National Digestive Diseases Information 
Clearinghouse. Crohn's disease. 
http://digestive.niddk.nih.gov/ddiseases/pubs/crohns/index.aspx. Published 
December 2011. Accessed March 1, 2013.
(55) National Institutes of Health, National Institute of Diabetes and 
Digestive and Kidney Diseases, National Digestive Diseases Information 
Clearinghouse. Ulcerative colitis. 
http://digestive.niddk.nih.gov/ddiseases/pubs/colitis/index.aspx. Published 
October 2011. Accessed March 1, 2013
(56) Soler D, Chapman T, Yang L, et al. The binding specificity and selective 
antagonism of vedolizumab, an anti-α4β7 integrin therapeutic antibody in 
development for inflammatory bowel diseases. J Pharmacol Exp Ther. 
2009;330(3):864-875. 
http://jpet.aspetjournals.org/content/330/3/864.full.pdf+html. Published June 
9, 2009. Accessed March 1, 2013.
(57) Briskin M, Winsor-Hines D, Syjan A, et al. Human mucosal addressin cell 
adhesion molecule-1 is preferentially expressed in intestinal tract and 
associated lymphoid tissue. American Journal of Pathology. 1997;51(1):97.
(58) Soler D, Chapman T, Yang L, et al. The binding specificity and selective 
antagonism of vedolizumab, an anti-α4β7 integrin therapeutic antibody in 
development for inflammatory bowel diseases. J Pharmacol Exp Ther. 
2009;330(3):864-875. 
http://jpet.aspetjournals.org/content/330/3/864.full.pdf+html. Published June 
9, 2009. Accessed March 1, 2013.
(59) Soler D, Chapman T, Yang L, et al. The binding specificity and selective 
antagonism of vedolizumab, an anti-α4β7 integrin therapeutic antibody in 
development for inflammatory bowel diseases. J Pharmacol Exp Ther. 
2009;330(3):864-875. 
http://jpet.aspetjournals.org/content/330/3/864.full.pdf+html. Published June 
9, 2009. Accessed March 1, 2013.
(60) Gledhill T, Bodger K. New and emerging treatments for ulcerative colitis: 
a focus on vedolizumab. Biologics: targets and therapy. 2013;7:123-130.  
 

SOURCE  Takeda Canada, Inc. 
Laurene Redding Takeda Canada Inc. Laurene.Redding@takeda.com Phone: 
905.465.4170 Cellular: 416.303.2682 
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