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 NPS shares rose 25 percent to close at $32.24. They had fallen as
low as $25.77 in the lead-up to the report by the U.S. Food and Drug
Administration, amid speculation it would bode poorly for approval.
The report, posted on Wednesday on the FDA's website, came two days
ahead of a meeting of outside advisers to the agency who will
discuss the drug and recommend whether it should be approved.
The FDA reviewer said serious adverse events were similar between
the treatment group and the placebo group. Data from one clinical
trial was excluded due to manufacturing violations.
"Overall, we believe that the language in the documents suggests
that the FDA is not opposed to approving Natpara," Joseph Schwartz,
an analyst at Leerink, said in a research note. "Our take is that
the documents and questions are much less negative than many on the
Street have been fearing."
Natpara is designed to treat hypoparathyroidism, a condition in
which the body's parathyroid gland does not secrete enough
parathyroid hormone (PTH). The hormone works with vitamin D to
regulate body calcium.
Low levels of PTH can cause tingling in the fingers and toes, muscle
spasms, fatigue, muscle aches, hair loss, dry skin, headaches, mood
swings and memory problems.
The condition can be caused by congenital disorders or surgery and
is currently treated with high doses of calcium and vitamin D.
Natpara is a bioengineered version of the hormone.
About 180,000 people globally suffer from hypoparathyroidism,
according to NPS. In about 40 percent of cases, the condition cannot
be controlled with calcium and vitamin D.
That uncontrolled population is what NPS initially plans to target
and it consists of about 20,000 patients in the United States.
Data from a late-stage clinical trial showed 53 percent of patients
treated with Natpara were able to reduce their calcium and vitamin D
supplements by 50 percent or more, compared with 2 percent of
placebo-treated patients.
By week 24, 43 percent of patients treated with Natpara were able to
stop vitamin D therapy and required 500 mg a day or less of calcium,
compared with only 5 percent of patients treated with placebo.
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Alan Carr, an analyst at Needham, said in a research note on Monday
that he expected a favorable advisory committee vote given the need
for new treatments, positive clinical trial results and the
"straightforward hormone replacement strategy."
The FDA plans to ask its advisers how concerned they are with the
risk of hypercalcemia, a condition in which calcium levels rise too
much, or hypocalcemia in which levels drop too low. The agency is
also seeking input on the potential risk of osteosarcoma, or bone
cancer, with long-term use of the drug.
The drug was approved in Europe in 2006 to treat osteoporosis in
post-menopausal women at high risk for fractures under the trade
name Preotact. Regulators noted the osteosarcoma risk and said that
until further clinical data became available treatment should not be
continued beyond 24 months.
Preotact was recently withdrawn. NPS said the drug was not
commercially viable for osteoporosis. The company plans to file for
approval of Natpara in Europe later this year.
"It remains to be seen whether the FDA would put a black box for
osteosarcoma," Eun Yang, an analyst at Jefferies, said in a research
note on Monday. A black box or treatment duration limitations "could
have potential impact on commercial uptake, if approved," Yang
added.
The FDA is scheduled to make its decision on whether to approve the
drug by October 24th.
(Reporting by Toni Clarke; additional reporting by Bill Berkrot in
New York; Editing by Susan Heavey, Chizu Nomiyama and Tom Brown)
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