Revestive(R) (Teduglutide) Receives European Marketing Authorization for the Treatment of Adults With Short Bowel Syndrome (SBS)

Osaka, Japan And Bedminster, New Jersey (ots/PRNewswire) -

- SBS is a rare and highly disabling condition that impacts patients'
quality of life and can lead to serious life-threatening complications.
- Teduglutide has received orphan drug designation for the treatment of SBS from
the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA).

Takeda Pharmaceutical Company Limited and NPS Pharmaceuticals,
Inc. jointly announced today that the European Commission (EC) has
granted European market authorization for the medicinal product
teduglutide (trade name in Europe: Revestive(R)) as a once-daily
treatment for adult patients with short bowel syndrome. The marketing
authorization follows a positive opinion issued on June 21, 2012, by
the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA). Following the authorization, Takeda
intends to provide patient access to Revestive(R) within Europe
initially through a Named Patient Program (NPP)[1].

"Short Bowel Syndrome patients suffer from malnutrition and
diarrhoea, and often parenteral nutrition is necessary to maintain
life," said Professor Palle Bekker Jeppesen, M.D., Ph.D, Department
of Medical Gastroenterology, Rigshospitalet, University Hospital of
Copenhagen, Denmark. "Revestive is a new, unique and important
treatment option for our patients and is adding important value to
the limited treatment armamentarium."

"Teduglutide is the first approved treatment in Europe for this
debilitating disease and offers an important new treatment option to
patients who are reliant on parenteral nutrition," said Trevor Smith,
Head of Commercial Operations, Europe & Canada, of Takeda.

"The granting of European marketing authorisation for teduglutide
is welcome news for patients who suffer from short bowel syndrome,"
said Francois Nader, MD, President and Chief Executive Officer of NPS
Pharmaceuticals. "We look forward to supporting our partner Takeda as
it works to launch this important therapy for patients in Europe."

The marketing authorization will be held by Nycomed Danmark
ApS[2] and is valid in the current EU Member States. National
approvals are expected in Iceland and Norway within 30 days. It is
based on data obtained from the STEPS pivotal Phase 3 safety and
efficacy trial, a double-blind, placebo-controlled study in patients
with SBS, who required parenteral nutrition. During the study, 43
patients were randomized to a subcutaneous 0.05 mg/kg/day dose of
teduglutide and 43 patients to placebo for up to 24 weeks.[3]

The proportion of patients treated with teduglutide who achieved
a 20% to 100% reduction of parenteral nutrition at Week 20 and 24 was
significantly higher compared with those receiving placebo, (63%
versus 30%, p=0.002). Treatment with teduglutide resulted in a 4.4
litre/week reduction in parenteral nutrition requirements versus 2.3
litre/week for placebo at 24 weeks (p<0.001). 21 patients treated
with teduglutide (54%) versus nine on placebo (23%) achieved at least
a one-day reduction in parenteral nutrition administration (p=0.005).
Teduglutide was well-tolerated in the doses, frequency, and duration
of treatment used in this study.[3]

About Short Bowel Syndrome

Short bowel syndrome (SBS) is a highly disabling condition that
can impair a patient's quality of life and lead to serious
life-threatening complications. SBS typically arises after extensive
resection of the bowel due to Crohn's disease, ischemia or other
conditions. SBS patients often suffer from malnutrition, severe
diarrhoea, dehydration, fatigue, osteopenia, and weight loss due to
the reduced intestinal capacity to absorb nutrients, water, and
electrolytes. The usual treatment for short bowel syndrome is
nutritional support, including parenteral nutrition (PN) and/or
intravenous (IV) fluids to supplement and stabilize nutritional
needs.

Although PN can provide nutritional support for short bowel
syndrome patients, it does not improve the body's own ability to
absorb nutrients. PN is also associated with serious complications,
such as infections, blood clots or liver damage, and the risks
increase the longer patients are on PN. Patients on PN often
experience a poor quality of life with difficulty sleeping, frequent
urination and loss of independence.

About Teduglutide (Revestive(R))

Teduglutide is a novel, recombinant analogue of human
glucagon-like peptide 2 (GLP-2), a naturally occurring protein
involved in the rehabilitation of the intestinal lining. It has been
developed to reduce dependence on parenteral nutrition (PN) in adult
patients with short bowel syndrome (SBS). Two Phase 3 studies of
teduglutide demonstrated a favorable safety profile and significant
reductions in mean PN volume from baseline to end of treatment. In
addition some patients were able to be weaned off PN and continue
their life without parenteral support.[3, 4]

Teduglutide has received orphan drug designation for the
treatment of SBS from the European Medicines Agency (EMA) and U.S.
Food and Drug Administration (FDA).

In 2007, NPS Pharmaceuticals, Inc. , a specialty pharmaceutical
company developing innovative therapeutics for rare gastrointestinal
and endocrine disorders, granted Nycomed the rights to develop and
commercialize teduglutide outside the United States, Canada and
Mexico and Israel. NPS retains all rights to teduglutide in North
America. NPS submitted a new drug application for teduglutide to the
U.S. Food and Drug Administration (FDA) in November 2011. Teduglutide
is known as Gattex(R) in the U.S.

About Takeda Pharmaceuticals 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
patients worldwide through leading innovation in medicine. Additional
information about Takeda is available through its corporate website,
http://www.takeda.com.

About NPS Pharmaceuticals

NPS Pharmaceuticals is a biopharmaceutical company focused on
bringing orphan products to patients with rare disorders and few, if
any, therapeutic options. NPS is advancing two late-stage
registration programs. A New Drug Application is undergoing FDA
review for Gattex(R) (teduglutide) as a treatment for adult short
bowel syndrome (SBS) and a Phase 3 registration study has been
completed for Natpara(TM) (recombinant human parathyroid hormone
(rhPTH [1-84]) in adult hypoparathyroidism. NPS' earlier stage
pipeline includes two calcilytic compounds, NPSP790 and NPSP795, with
potential application in rare disorders involving increased calcium
receptor activity, such as autosomal dominant hypocalcemia with
hypercalciuria (ADHH). NPS complements its proprietary programs with
a royalty-based portfolio of products and product candidates that
includes agreements with Amgen, GlaxoSmithKline, Janssen
Pharmaceuticals, Kyowa Hakko Kirin, and Nycomed (acquired by Takeda
Pharmaceutical Company Limited). Additional information about NPS is
available through its corporate website, http://www.npsp.com.

Forward-looking statements

This press release contains forward-looking statements.
Forward-looking statements include statements regarding Takeda's and
NPS' 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,"
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"guidance," "outlook" or "intend" or other similar words or
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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 and NPS' 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 and NPS
undertake 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 and NPS do
update or correct one or more of these statements, investors and
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or corrections.

References

1) A Named Patient Program is a facility that enables the distribution or
supply of a medicine for the treatment of an individual patient, at the specific
request of his/her healthcare provider, in cases where the medicine is currently not
licensed or reimbursed. Each country has its own regulations that provide a legal and
ethical way to allow access to patients who need these particular medicines.
2) Valid name until 30 November 2012. After this date MA holder will be Takeda
Pharma A/S.
3) Publication of STEPS is in preparation. First results were reported at the
AGA 2011 in an abstract: Jeppesen PB, Pertkiewicz M, Seidner DL, O'Keefe S, Heinze H,
Joelsson B: Teduglutide, a novel analogue of Glucagon-like Peptide 2 (GLP-2), is
effective and safe in reducing parenteral support volume in short bowel
syndrome-intestinal failure subjects: Results from a 24-week, placebo-controlled phase
3 trial (STEPS), Gastroenterology 2011; 140 (5), Supplement 1, S146.
4) Jeppesen PB, Gilroy R, Pertkiewicz M, Allard JP, Messing B, O'Keefe SJ.
Randomised placebo-controlled trial of teduglutide in reducing parenteral nutrition
and/or intravenous fluid requirements in patients with short bowel syndrome. Gut. 2011
Jul;60(7):902-14. ePub 2011 Feb 11.

ots Originaltext: Takeda Pharmaceutical Company Limited
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Takeda Pharmaceutical Company Limited, Public Relations and
Investor Relations, +81-3-3278-2037; European media: Tobias Cottmann,
+41445551510, tobias.cottmann@takeda.com; NPS Pharmaceuticals, Inc.,
Susan
Mesco, +1-908-450-5516, smesco@npsp.com