NPS Pharma to host conference call today at 5:30 PM EDT
PDUFA date for Natpara BLA is October 24, 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 unanimously 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.
NPS Pharmaceuticals, Inc.Media:Scott Santiamo, +1
908-432-6962SSantiamo@npsp.comorInvestors:Susan Mesco, +1
908-391-8283SMesco@npsp.com
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