Nastech Pharmaceutical Company Inc. said it received word from the Food and Drug Administration that its abbreviated new drug application (ANDA) for a nasal spray to treat osteoporosis is "not approvable at this time."
Shares in Bothell-based Nastech (NASDAQ: NSTK - News) plummeted more than 20 percent in early trading Thursday on the news.
According to Nastech, the FDA expressed a concern relating to the potential for "immunogenicity that might result from a possible interaction between calcitonin-salmon and chlorobutanol, the preservative in the formulation." Immunogenicity refers to inducing an immune response.
Officials at Nastech were hoping its generic product would compete with branded formulations of calcitonin-salmon spray, which had 2005 U.S. sales of approximately $225 million.
They added that they intend to keep talking to the FDA to "determine which, if any, additional data Nastech can submit to the FDA in order for the FDA to approve the ANDA."
Shares of Epix Pharmaceuticals (EPIX) , a maker of drugs used in medical imaging, fell 7.4% to $4.49 after the company said Schering (SHR) won't exercise its option on the development of a drug intended to help doctors find blood clots using an MRI.
Schering is merging with another German drug company, Bayer (BAY) . Epix says it intends to seek another collaborator for the development of the drug, dubbed EP-2104R.
Johnson & Johnson's (JNJ) shares dipped 8 cents to $60.54 after the company's Cordis medical-device division acquired the privately held wound-closure firm Ensure Medical. Terms of the deal weren't disclosed, but J&J expects to take a charge of $52 million after taxes, or 2 cents a share, for acquired research and development.
Following the close of trading Wednesday, J&J announced positive efficacy results from a trial of its schizophrenia drug Paliperidone ER, saying it significantly delayed the recurrence of symptoms.
Diagnostics-device maker Biosite (BSTE) said the FDA cleared its Triage TOX drug screen as a way to identify patients on methadone, a drug that's known to interact with a number of other medications. Shares fell 0.7% to $45.60.
Biopharmaceutical company Corautus Genetics (VEGF) was up 3.6% to 87 cents after the company said the FDA lifted the clinical hold imposed in March on trials of its drug Genasis. The drug is intended to increase the length of time patients with severe angina can exercise.
Tapestry Pharmaceuticals (TPPH) , down 8% to $3, Cephalon (CEPH) , whose shares fell 2.6% to $62.16, Genetic Technologies (GENE) , down 6.5% to $8.32, and Novavax (NVAX) , whose shares were 1.8% lower at $4.34.
Among those rising were Omrix Biopharmaceuticals (OMRI) , up 2 cents to $11.85, and GenVec (GNVC) , up 2.3% to $1.31.
Shares in Bothell-based Nastech (NASDAQ: NSTK - News) plummeted more than 20 percent in early trading Thursday on the news.
According to Nastech, the FDA expressed a concern relating to the potential for "immunogenicity that might result from a possible interaction between calcitonin-salmon and chlorobutanol, the preservative in the formulation." Immunogenicity refers to inducing an immune response.
Officials at Nastech were hoping its generic product would compete with branded formulations of calcitonin-salmon spray, which had 2005 U.S. sales of approximately $225 million.
They added that they intend to keep talking to the FDA to "determine which, if any, additional data Nastech can submit to the FDA in order for the FDA to approve the ANDA."
Shares of Epix Pharmaceuticals (EPIX) , a maker of drugs used in medical imaging, fell 7.4% to $4.49 after the company said Schering (SHR) won't exercise its option on the development of a drug intended to help doctors find blood clots using an MRI.
Schering is merging with another German drug company, Bayer (BAY) . Epix says it intends to seek another collaborator for the development of the drug, dubbed EP-2104R.
Johnson & Johnson's (JNJ) shares dipped 8 cents to $60.54 after the company's Cordis medical-device division acquired the privately held wound-closure firm Ensure Medical. Terms of the deal weren't disclosed, but J&J expects to take a charge of $52 million after taxes, or 2 cents a share, for acquired research and development.
Following the close of trading Wednesday, J&J announced positive efficacy results from a trial of its schizophrenia drug Paliperidone ER, saying it significantly delayed the recurrence of symptoms.
Diagnostics-device maker Biosite (BSTE) said the FDA cleared its Triage TOX drug screen as a way to identify patients on methadone, a drug that's known to interact with a number of other medications. Shares fell 0.7% to $45.60.
Biopharmaceutical company Corautus Genetics (VEGF) was up 3.6% to 87 cents after the company said the FDA lifted the clinical hold imposed in March on trials of its drug Genasis. The drug is intended to increase the length of time patients with severe angina can exercise.
Tapestry Pharmaceuticals (TPPH) , down 8% to $3, Cephalon (CEPH) , whose shares fell 2.6% to $62.16, Genetic Technologies (GENE) , down 6.5% to $8.32, and Novavax (NVAX) , whose shares were 1.8% lower at $4.34.
Among those rising were Omrix Biopharmaceuticals (OMRI) , up 2 cents to $11.85, and GenVec (GNVC) , up 2.3% to $1.31.
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1:22 PM
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