UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
September
12, 2014
Date
of Report (Date of earliest event reported)
NPS
PHARMACEUTICALS, INC.
|
(Exact name of registrant as specified in its charter)
|
Delaware
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0-23272
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87-0439579
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(State or other jurisdiction of incorporation)
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(Commission File Number)
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(I.R.S. Employer Identification Number)
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550 Hills Drive, 3rd Floor
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Bedminster, NJ 07921
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(Address of principal executive offices)
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(908) 450-5300
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(Registrant’s
telephone number, including area code)
|
Check the
appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any
of the following provisions:
⃞
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
⃞
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
⃞
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
⃞
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
Item 8.01. Other Events.
On September 12, 2014, NPS Pharmaceuticals, Inc. (the “Company”) issued
a press release announcing the results of the U.S. Food and Drug
Administration’s Endocrinologic and Metabolic Drugs Advisory Committee
vote regarding Natpara® (rhPTH [1-84]). The text of the press release
is furnished as Exhibit 99.1 to this Form 8-K.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
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Exhibit No.
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Description
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99.1
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Press Release of NPS Pharmaceuticals, Inc. dated September 12, 2014
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SIGNATURES
Pursuant to
the requirements of the Securities Exchange Act of 1934, the Registrant
has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
Date:
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September 12, 2014
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NPS PHARMACEUTICALS, INC.
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|
|
|
|
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By:
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/s/ CHRISTINE MIKAIL
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Christine Mikail
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Senior Vice President, Legal Affairs, General Counsel
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and Corporate Secretary
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Exhibit 99.1
FDA
Advisory Committee Recommends Approval of Natpara® for Long-Term
Treatment of Hypoparathyroidism
NPS
Pharma to host conference call today at 5:30 PM EDT
PDUFA
date for Natpara BLA is October 24, 2014
BEDMINSTER, N.J.--(BUSINESS WIRE)--September 12, 2014--NPS
Pharmaceuticals, Inc. (NASDAQ:NPSP), a global biopharmaceutical company
pioneering and delivering therapies that transform the lives of patients
with rare diseases, today announced that the U.S. Food and Drug
Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory
Committee voted 8 to 5 that the available data support the approval of
Natpara® (rhPTH [1-84]) for the long-term treatment of
Hypoparathyroidism, a rare endocrine disorder characterized by
insufficient levels of parathyroid hormone, or PTH. The Committee’s
recommendation will be considered by the FDA in its review of the
company’s Biologics License Application (BLA) for Natpara, which has a
Prescription Drug User Fee Act (PDUFA) date of October 24, 2014.
“We are very pleased with the Committee’s vote. Their recommendation
reinforces our belief in the favorable benefit-risk profile of Natpara
and its potential as a long-term treatment option for
Hypoparathyroidism,” said Francois Nader, MD, president and chief
executive officer of NPS Pharma. “As a bioengineered replacement therapy
targeting the underlying cause of the disorder, Natpara has been shown
in clinical studies to maintain serum calcium while demonstrating
similar physiologic effects to the native parathyroid hormone. We look
forward to working with the FDA to complete the final stages of review
of our BLA for Natpara.”
The Committee reviewed data from the Natpara clinical development
program for Hypoparathyroidism, consisting of one pharmacology study and
four efficacy and safety studies. The pivotal Phase 3 study, known as
REPLACE, was a randomized, double-blind, placebo controlled study and
the largest clinical trial conducted to date in Hypoparathyroidism.
Natpara is a bioengineered replacement therapy for endogenous PTH that
NPS Pharma has developed for the treatment of Hypoparathyroidism. The
FDA has granted orphan drug status for Natpara for the treatment of
Hypoparathyroidism. The European Medicines Agency has also granted
orphan drug status for the drug under the trade name Natpar™.
Conference Call Information
NPS Pharma will host a conference call beginning today, Friday,
September 12, at 5:30 p.m. Eastern Daylight Time. To participate in the
conference call, dial (800) 295-4740 and use pass code 30397283.
International callers may dial +1 (617) 614-3925, 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 Pharma website, www.npsp.com.
For those unable to participate in the live call, a replay will be
available at (888) 286-8010, with pass code 61768634, until midnight
EDT, September 26, 2014. International callers may access the replay by
dialing +1 (617) 801-6888, using the same pass code. The webcast will
also be available through the NPS Pharma website for the same period.
About Hypoparathyroidism
Hypoparathyroidism is a rare condition in which the parathyroid glands
fail to produce sufficient amounts of parathyroid hormone (PTH) or where
PTH lacks biologic activity. PTH plays a central role in a variety of
critical physiological functions in the body. In patients with
Hypoparathyroidism, insufficient levels of PTH lead to many
physiological abnormalities, including low serum calcium and an
inability to convert native vitamin D into its active state to properly
absorb dietary calcium.
Acute symptoms of Hypoparathyroidism are largely due to low serum
calcium and range from muscle pain and tingling, to lack of focus or
ability to concentrate, and anxiety and depression. In extreme cases,
life-threatening events, such as arrhythmias and seizures, may occur. In
the absence of an approved parathyroid replacement therapy, the standard
approach focuses on using large doses of calcium and active vitamin D to
increase calcium levels in the blood and reduce the severity of
symptoms. However, balancing the administration of large doses of
calcium and vitamin D is challenging due to calcium fluctuations and the
long-term use of this regimen may lead to serious complications. In
addition, calcium and vitamin D do not correct the abnormal bone
metabolism due to PTH deficiency or enable the activation of vitamin D.
About NPS Pharma
NPS Pharma is a global biopharmaceutical company pioneering and
delivering therapies that transform the lives of patients with rare
diseases. The company’s current therapeutic areas of focus are
gastrointestinal disease and endocrine disorders. These include Short
Bowel Syndrome, a potentially fatal gastrointestinal disorder in which
patients may have to rely on parenteral nutrition for their survival;
Hypoparathyroidism, a complex endocrine disorder in which the
parathyroid glands are either absent or damaged, and the body produces
insufficient or no parathyroid hormone; and Autosomal Dominant
Hypocalcemia, an ultra-rare, genetic disorder of calcium homeostasis
caused by mutations of the calcium-sensing receptor gene. NPS Pharma
continues to seek in-licensing opportunities to develop new therapies
for a broad range of rare diseases, and 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. NPS Pharma has operations in the
U.S., Canada, Europe, Latin America and Japan. Learn more at: www.npsp.com
“NPS Pharma” and “NPS Pharmaceuticals” are the company's trademarks.
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 the company's 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 the company’s future financial
performance and plans for the commercialization of its products, beliefs
or expectations regarding our products in development, statements
concerning the company’s plans for international expansion, beliefs or
expectations regarding potential revenue and earnings from product
sales, including beliefs regarding our ability to grow sales,
expectations regarding the market size for our products, including those
in development, and beliefs or expectations regarding our operating
expenses. 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/Revestive (teduglutide [rDNA origin])
for injection, including the risk that physicians and patients may not
see the advantages of Gattex/Revestive 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, risks related to
regulatory approvals for recombinant human parathyroid hormone 1-84
(rhPTH [1-84]), the risks associated with the company's strategy, global
macroeconomic conditions, the impact of changes in management or staff
levels, the effect of legislation effecting healthcare reform in the
United States, 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 press release and NPS
undertakes no duty to update this information, whether as a result of
new information, future events or otherwise.
CONTACT:
NPS Pharmaceuticals, Inc.
Media:
Scott Santiamo, +1
908-432-6962
SSantiamo@npsp.com
or
Investors:
Susan
Mesco, +1 908-391-8283
SMesco@npsp.com
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