|
| [March 19, 2013] |
 |
NPS Pharmaceuticals and Takeda Revise Agreements and NPS Re-Gains Full Worldwide Rights to Teduglutide and Recombinant Human Parathyroid Hormone 1-84
BEDMINSTER, N.J. & OSAKA, Japan --(Business Wire)--
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 trae
name Preotact®. NPS is developing PTH 1-84 under the brand name Natpara®
in the U.S. for the treatment of hypoparathyroidism.
Conference call
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 website, http://www.npsp.com.
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.
Disclosure notice
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: http://www.businesswire.com/multimedia/home/20130318006722/en/
[ Back To Technology News's Homepage ]
|