NPS Pharmaceuticals and Takeda Revise Agreements and NPS Re-Gains Full
Worldwide Rights to Teduglutide and Recombinant Human Parathyroid Hormone
Takeda to receive NPS common stock of $50 million and a potential future
sales-based milestone payment
Provides NPS with opportunity to establish global orphan specialty franchise
NPS to host conference call today at 8:30 AM ET
BEDMINSTER, N.J. & OSAKA, Japan -- March 19, 2013
NPS Pharmaceuticals, Inc. (NASDAQ: NPSP) and Takeda Pharmaceutical Company
Limited (TSE: 4502, “Takeda”) announced today that NPS has re-gained the full
worldwide rights to teduglutide (trade name in Europe: Revestive^®) and
recombinant human parathyroid hormone 1-84 (PTH 1-84) (trade name in Europe:
Preotact^®). NPS licensed the commercial rights to Preotact and Revestive in
2004 and 2007, respectively, for territories outside of North America to
Nycomed, which was acquired by Takeda in 2011.
Under the terms of the agreement, NPS will have worldwide rights to develop
and commercialize teduglutide and PTH 1-84. Takeda will also assign to NPS its
assets related to the two products, including all of its active pharmaceutical
ingredient inventory and information related to the products’ continued
development, manufacture, and commercialization, including life cycle
management assets. Takeda will receive NPS common stock valued at $50 million.
Takeda will also earn a milestone payment in the first calendar year that
combined worldwide net sales of both products exceed $750 million. NPS has the
option of making this milestone payment in the amount of $30 million, in cash
or NPS common stock.
“This transaction establishes NPS as a global commercial rare disease
company,” said Francois Nader, M.D., president and chief executive officer of
NPS Pharmaceuticals. “Our primary focus is to secure reimbursement for
Revestive in Europe and to finalize our commercial strategy for both drugs to
maximize their worldwide success. However, our 2013 priorities remain the
successful U.S. launch of Gattex and the submission of our U.S. marketing
application for Natpara.”
“Orphan drugs like teduglutide, serve high unmet medical needs. We are
confident that as an orphan and specialty company, NPS is best suited to
maximize the value of teduglutide and PTH 1-84 and ensure that as many
patients as possible benefit from treatment. The structure of this transaction
allows us to participate in NPS’ future success with these products,” said Dr.
Frank Morich, chief commercial officer of Takeda.
Teduglutide, marketed in the U.S. under the trade name Gattex^®, and approved
in Europe under the trade name Revestive is indicated for the treatment of
adult short bowel syndrome. Teduglutide was approved in the European Union and
the U.S. in August and December 2012, respectively. PTH 1-84 is approved for
post-menopausal osteoporosis in the European Union since April 2006, where it
is known under the trade name Preotact®. NPS is developing PTH 1-84 under the
brand name Natpara^® in the U.S. for the treatment of hypoparathyroidism.
NPS will host a conference call Tuesday, March 19, 2013 at 8:30 a.m. Eastern
Time. To participate in the conference call, dial (800) 237-9752 and use pass
code 73884017. International callers may dial (617) 847-8706, using the same
pass code. In addition, a live audio of the conference call will be available
over the Internet. Interested parties can access the event through the NPS
For those unable to participate in the live call, a replay will be available
at (888) 286-8010, with pass code 51837309, until midnight Eastern Time, April
2, 2013. International callers may access the replay by dialing (617)
801-6888, using the same pass code. The webcast will also be available through
the NPS website for the same period.
About NPS Pharmaceuticals
NPS Pharmaceuticals is a biopharmaceutical company pioneering and delivering
therapies that transform the lives of patients with rare diseases worldwide.
The company’s lead product, Gattex^® 0.05 mg/kg/d (teduglutide [rDNA origin])
for injection is FDA-approved for the treatment of adult patients with short
bowel syndrome (SBS) who are dependent on parenteral support. NPS is also
developing Natpara^® (rhPTH[1-84]) for the treatment of adult
hypoparathyroidism and expects to submit its Biologic License Application
(BLA) to the FDA in 2013.
NPS's 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, and Kyowa
Hakko Kirin. Additional information about NPS is available through its
corporate website, http://www.npsp.com.
“NPS,” “NPS Pharmaceuticals,” “Gattex,” “Natpara”, “Preotact”, and “Revestive”
are the company's trademarks.
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 patients worldwide through leading innovation in
medicine. Additional information about Takeda is available through its
corporate website, http://www.takeda.com.
Statements made in this press release, which are not historical in nature,
constitute forward-looking statements for purposes of the safe harbor provided
by the Private Securities Litigation Reform Act of 1995. These statements are
based on NPS Pharmaceuticals’ current expectations and beliefs and are subject
to a number of factors and uncertainties that could cause actual results to
differ materially from those described in the forward-looking statements.
Forward looking statements include, but are not limited to, statements
concerning our future commercial performance. Risks associated to the
company's business include, but are not limited to, the risks associated with
any failure by the company to successfully commercialize Gattex, including the
risk that physicians and patients may not see the advantages of Gattex and may
therefore be reluctant to utilize the product, the risk that private and
public payers may be reluctant to cover or provide reimbursement for Gattex,
as well as other risk factors described in the company's periodic filings with
the U.S. Securities and Exchange Commission, including its Annual Report on
Form 10-K and Form 10-Qs. All information in this press release is as of the
date of this release and NPS undertakes no duty to update this information,
whether as a result of new information, future events or otherwise.
Photos/Multimedia Gallery Available:
NPS Pharmaceuticals, Inc.
Susan Mesco, 908-450-5516
Takeda Pharmaceutical Company Limited
Corporate Communications Dept.
Takeda Pharmaceuticals International GmbH
Tobias Cottmann, +41445551501
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