ENTYVIO™ (vedolizumab) Now Available in the United States for the Treatment of Adults with Moderately to Severely Active Ulce

ENTYVIO™ (vedolizumab) Now Available in the United States for the Treatment of
   Adults with Moderately to Severely Active Ulcerative Colitis and Crohn's
                                   Disease

PR Newswire

DEERFIELD, Ill., and OSAKA, Japan, June 16, 2014

DEERFIELD, Ill.,and OSAKA, Japan, June 16, 2014 /PRNewswire/ --Takeda
Pharmaceutical Company Limited ("Takeda") and its wholly-owned subsidiary,
Takeda Pharmaceuticals U.S.A., Inc., today announced the United States (U.S.)
commercial availability of a new biologic therapy, ENTYVIO^™ (vedolizumab),
for the treatment of adults with moderately to severely active ulcerative
colitis (UC) or Crohn's disease (CD).

"We understand how a great need still exists for additional treatment options
for ulcerative colitis and Crohn's disease patients," said Nicole
Mowad-Nassar, vice president, marketing, Takeda Pharmaceuticals, U.S.A., Inc.
"We're pleased that we were able to make Entyvio available for appropriate
patients so quickly after receiving FDA approval."

In May, the U.S. Food and Drug Administration (FDA) simultaneously approved
Entyvio for the treatment of adults with moderately to severely active UC and
CD. That same month, Entyvio was also granted Marketing Authorisation in the
European Union from the European Commission (EC) for the treatment of adults
with moderately to severely active UC and CD.

Entyvio is now available to U.S. healthcare providers for inducing and
maintaining clinical response and remission, improving endoscopic appearance
of the mucosa, and achieving corticosteroid-free remission in adult patients
with moderately to severely active UC who have had an inadequate response
with, lost response to, or were intolerant to a TNF blocker or
immunomodulator; or had an inadequate response with, were intolerant to, or
demonstrated dependence on corticosteroids. Entyvio is also indicated for
achieving clinical response and remission, and achieving corticosteroid-free
remission in adult patients with moderately to severely active CD who have had
an inadequate response with, lost response to, or were intolerant to a TNF
blocker or immunomodulator; or had an inadequate response with, were
intolerant to, or demonstrated dependence on corticosteroids.

In order to connect patients in need with access and services for Entyvio,
Takeda has launched EntyvioConnect, with dedicated case managers available to
answer questions. For more information, visit www.ENTYVIO.com/hub/.

About ENTYVIO^™ (vedolizumab)
Entyvio, an integrin receptor antagonist, is a humanized monoclonal antibody
that specifically binds to the alpha4beta7 integrin and blocks the interaction
of alpha4beta7 integrin with mucosal addressin cell adhesion molecule-1
(MAdCAM-1) and inhibits the migration of memory T-lymphocytes across the
endothelium into inflamed gastrointestinal parenchymal tissue. Entyvio does
not bind to or inhibit function of the alpha4beta1 and alpha E beta 7
integrins and does not antagonize the interaction of alpha4 integrins with
vascular cell adhesion molecule-1 (VCAM-1). The alpha4beta7 integrin is
expressed on the surface of a discrete subset of memory T-lymphocytes that
preferentially migrate into the gastrointestinal tract. MAdCAM-1 is mainly
expressed on gut endothelial cells and plays a critical role in the homing of
T-lymphocytes to gut lymph tissue. The interaction of the alpha4beta7 integrin
with MAdCAM-1 has been implicated as an important contributor to the chronic
inflammation that is a hallmark of ulcerative colitis and Crohn's disease.

INDICATIONS: ENTYVIO^™(vedolizumab)

Adult Ulcerative Colitis (UC)
Adult patients with moderately to severely active UC who have had an
inadequate response with, lost response to, or were intolerant to a tumor
necrosis factor (TNF) blocker or immunomodulator; or had an inadequate
response with, were intolerant to, or demonstrated dependence on
corticosteroids:

  oinducing and maintaining clinical response
  oinducing and maintaining clinical remission
  oimproving endoscopic appearance of the mucosa
  oachieving corticosteroid-free remission

Adult Crohn's Disease (CD)
Adult patients with moderately to severely active CD who have had an
inadequate response with, lost response to, or were intolerant to a TNF
blocker or immunomodulator; or had an inadequate response with, were
intolerant to, or demonstrated dependence on corticosteroids:

  oachieving clinical response
  oachieving clinical remission
  oachieving corticosteroid-free remission

IMPORTANT SAFETY INFORMATION

  oENTYVIO (vedolizumab) is contraindicated in patients who have had a known
    serious or severe hypersensitivity reaction to ENTYVIO or any of its
    excipients.
  oInfusion-related reactions and hypersensitivity reactions including
    anaphylaxis have occurred. If anaphylaxis or other serious allergic
    reactions occur, discontinue administration of ENTYVIO immediately and
    initiate appropriate treatment.
  oPatients treated with ENTYVIO are at increased risk for developing
    infections. Serious infections have been reported in patients treated with
    ENTYVIO. ENTYVIO is not recommended in patients with active, severe
    infections until the infections are controlled. Consider withholding
    ENTYVIO in patients who develop a severe infection while on treatment with
    ENTYVIO. Exercise caution in patients with a history of recurring severe
    infections.
  oAlthough no cases of PML have been observed in ENTYVIO clinical trials, JC
    virus infection resulting in progressive multifocal leukoencephalopathy
    (PML) and death has occurred in patients treated with another integrin
    receptor antagonist. A risk of PML cannot be ruled out. Monitor patients
    for any new or worsening neurological signs or symptoms. If PML is
    suspected, withhold dosing with ENTYVIO and refer to a neurologist; if
    confirmed, discontinue ENTYVIO dosing permanently.
  oThere have been reports of elevations of transaminase and/or bilirubin in
    patients receiving ENTYVIO. ENTYVIO should be discontinued in patients
    with jaundice or other evidence of significant liver injury.
  oPrior to initiating treatment with ENTYVIO, all patients should be brought
    up to date with all immunizations according to current immunization
    guidelines. Patients receiving ENTYVIO may receive non-live vaccines and
    may receive live vaccines if the benefits outweigh the risks.
  oMost common adverse reactions (incidence greater than or equal to 3% and
    greater than or equal to 1% higher than placebo): nasopharyngitis,
    headache, arthralgia, nausea, pyrexia, upper respiratory tract infection,
    fatigue, cough, bronchitis, influenza, back pain, rash, pruritus,
    sinusitis, oropharyngeal pain, and pain in extremities.

Please see the accompanying full Prescribing Information including Medication
Guide for ENTYVIO.

More information is also available at www.ENTYVIO.com and www.ENTYVIOHCP.com.

About Ulcerative Colitis and Crohn's Disease
Ulcerative colitis (UC) and Crohn's disease (CD) are marked by inflammation in
the lining of the gastrointestinal tract. UC impacts the large intestine only,
which includes the colon and the rectum, while CD can impact any part of the
digestive tract, and predominantly affects the ileum. There is no known cause
for UC and CD, although many researchers believe that the interaction between
genes, the body's immune system, and environmental factors may play a role.

About Takeda Pharmaceuticals U.S.A., Inc.
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.

The company has a commercial presence covering around 70 countries, with
particular strength in Asia, North America, Europe and fast-growing emerging
markets including Latin America, Russia-CIS and China. Takeda is ranked 15th
globally. Areas of focus include cardiovascular and metabolic, oncology,
respiratory and immunology, central nervous system, general medicine, and
vaccines.

Through the integration of Millennium Pharmaceuticals and Nycomed, Takeda has
been transforming itself, broadening its therapeutic expertise and geographic
outreach.

Takeda Pharmaceuticals U.S.A., Inc. is located in Deerfield, Ill., and is the
U.S. marketing and sales organization of Takeda Pharmaceutical Company
Limited.

Additional information about Takeda is available through its corporate
website, www.takeda.com, and additional information about Takeda
Pharmaceuticals U.S.A., Inc. is available through its website, www.takeda.us.

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.

This press release contains forward-looking statements. Forward-looking
statements include statements regarding Takeda's plans, outlook, strategies,
results for the future, and other statements that are not descriptions of
historical facts. Forward-looking statements may be identified by the use of
forward-looking words such as "may," "believe," "will," "expect," "project,"
"estimate," "should," "anticipate," "plan," "assume," "continue," "seek," "pro
forma," "potential," "target," "forecast," "guidance," "outlook" or "intend"
or other similar words or expressions of the negative thereof. Forward-looking
statements are based on estimates and assumptions made by management that are
believed to be reasonable, though they are inherently uncertain and difficult
to predict. Investors are cautioned not to unduly rely on such forward-looking
statements.

Forward-looking statements involve risks and uncertainties that could cause
actual results or experience to differ materially from that expressed or
implied by the forward-looking statements. Some of these risks and
uncertainties include, but are not limited to, (1) the economic circumstances
surrounding Takeda's business, including general economic conditions in Japan,
the United States and worldwide; (2) competitive pressures and developments;
(3) applicable laws and regulations; (4) the success or failure of product
development programs; (5) actions of regulatory authorities and the timing
thereof; (6) changes in exchange rates; (7) claims or concerns regarding the
safety or efficacy of marketed products or product candidates in development;
and (8) integration activities with acquired companies.

The forward-looking statements contained in this press release speak only as
of the date of this press release, and Takeda undertakes no obligation to
revise or update any forward-looking statements to reflect new information,
future events or circumstances after the date of the forward-looking
statement. If Takeda does update or correct one or more of these statements,
investors and others should not conclude that Takeda will make additional
updates or corrections.

SOURCE Takeda Pharmaceutical Company Limited

Website: http://www.takeda.com
Contact: Roseanne Durril, Takeda Pharmaceuticals U.S.A., Inc., (224) 554-1474,
roseanne.durril@takeda.com; or Takeda Pharmaceutical Company, Corporate
Communications Dept., PR/IR, +81-3-3278-2037
 
Press spacebar to pause and continue. Press esc to stop.