By Toni Clarke
WASHINGTON Wed Sep 10, 2014 11:50am EDT
A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012.
Credit: Reuters/Jason Reed
<span id="articleText"><span id="midArticle_start"/> WASHINGTON (Reuters) - NPS Pharmaceuticals Inc's hormone replacement therapy Natpara appears effective, though data from one clinical trial site was excluded due to manufacturing violations, according to a preliminary report by the U.S. Food and Drug Administration.
<span id="midArticle_1"/> NPS shares rose 18 percent to $30.48 in late-morning trading, returning to levels they were trading at on Sept. 4 before investors grew concerned that the FDA report would disclose contain negative information about the treatment.
<span id="midArticle_2"/> The report, posted on Wednesday on the FDA's website, comes 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.
<span id="midArticle_3"/> "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."
<span id="midArticle_4"/> 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.
<span id="midArticle_5"/> 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.
<span id="midArticle_6"/> 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.
<span id="midArticle_7"/> 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.
<span id="midArticle_8"/> That uncontrolled population is what NPS initially plans to target and it consists of about 20,000 patients in the United States.
<span id="midArticle_9"/> 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.
<span id="midArticle_10"/> 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.
<span id="midArticle_11"/> 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."
<span id="midArticle_12"/> 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.
<span id="midArticle_13"/> A heightened risk of osteosarcoma is associated with a similar drug, Forteo, which is made by Eli Lilly & Co and approved to treat osteoporosis. Forteo carries a black box warning on the potential risk of osteosarcoma.
<span id="midArticle_14"/> In a two-year rat study, high doses of Natpara were also associated with an increased risk of osteosarcoma. The risk all but disappeared when the drug was given in low doses.
<span id="midArticle_15"/> Even so, the FDA reviewer said, the data "does not suggest a negligible risk for developing bone tumors in humans at clinical exposure levels."
<span id="midArticle_0"/> 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.
<span id="midArticle_1"/> 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.
<span id="midArticle_2"/> "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.
<span id="midArticle_3"/> The FDA is scheduled to make its decision on whether to approve the drug by October 24th.
<span id="midArticle_4"/><span id="midArticle_5"/> (Reporting by Toni Clarke; additional reporting by Bill Berkrot in New York; Editing by Susan Heavey, Chizu Nomiyama and Tom Brown)
<span id="midArticle_6"/>
WASHINGTON Wed Sep 10, 2014 11:50am EDT
Credit: Reuters/Jason Reed
<span id="articleText"><span id="midArticle_start"/> WASHINGTON (Reuters) - NPS Pharmaceuticals Inc's hormone replacement therapy Natpara appears effective, though data from one clinical trial site was excluded due to manufacturing violations, according to a preliminary report by the U.S. Food and Drug Administration.
<span id="midArticle_1"/> NPS shares rose 18 percent to $30.48 in late-morning trading, returning to levels they were trading at on Sept. 4 before investors grew concerned that the FDA report would disclose contain negative information about the treatment.
<span id="midArticle_2"/> The report, posted on Wednesday on the FDA's website, comes 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.
<span id="midArticle_3"/> "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."
<span id="midArticle_4"/> 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.
<span id="midArticle_5"/> 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.
<span id="midArticle_6"/> 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.
<span id="midArticle_7"/> 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.
<span id="midArticle_8"/> That uncontrolled population is what NPS initially plans to target and it consists of about 20,000 patients in the United States.
<span id="midArticle_9"/> 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.
<span id="midArticle_10"/> 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.
<span id="midArticle_11"/> 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."
<span id="midArticle_12"/> 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.
<span id="midArticle_13"/> A heightened risk of osteosarcoma is associated with a similar drug, Forteo, which is made by Eli Lilly & Co and approved to treat osteoporosis. Forteo carries a black box warning on the potential risk of osteosarcoma.
<span id="midArticle_14"/> In a two-year rat study, high doses of Natpara were also associated with an increased risk of osteosarcoma. The risk all but disappeared when the drug was given in low doses.
<span id="midArticle_15"/> Even so, the FDA reviewer said, the data "does not suggest a negligible risk for developing bone tumors in humans at clinical exposure levels."
<span id="midArticle_0"/> 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.
<span id="midArticle_1"/> 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.
<span id="midArticle_2"/> "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.
<span id="midArticle_3"/> The FDA is scheduled to make its decision on whether to approve the drug by October 24th.
<span id="midArticle_4"/><span id="midArticle_5"/> (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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