|FDA Grants Soligenix Orphan Drug Designation for SGX94; Quidel Wins FDA Clearance for Two Molecular Diagnostic Tests|
|By Staff and Wire Reports|
|Monday, 16 September 2013 19:07|
Soligenix, Inc. (NASDAQ: SNGX), a clinical stage biopharmaceutical company focused on developing products to treat inflammatory diseases and biodefense countermeasures where there remains an unmet medical need, announced the Office of Orphan Products Development of the US Food and Drug Administration (FDA) has granted orphan drug designation to the active ingredient SGX94 for the treatment of acute radiation syndrome (ARS). SGX94 is an innate defense regulator (IDR), a new class of short, synthetic peptides that accelerates resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma, radiation and/or chemotherapy.
The US Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders. In addition to providing a seven year term of market exclusivity upon final FDA approval, orphan drug designation also positions Soligenix to be able to leverage a wide range of financial and regulatory benefits, including government grants for conducting clinical trials, waiver of expensive FDA user fees for the potential submission of a New Drug Application, and certain tax credits.
"The FDA's decision to grant SGX94 orphan drug designation signifies an important step for Soligenix as we continue to expand our biodefense pipeline and the many potential applications of our novel IDR technology," stated Christopher J. Schaber, PhD, President & Chief Executive Officer of Soligenix. "SGX94's activity in preclinical models has demonstrated the potential to mitigate damage to the skin and gastrointestinal tract, as well as enabling clearance of infection as a result of damage to the hematopoietic system, all of which occur with varying severity in ARS. The marketing exclusivity that orphan drug designation imparts adds significantly to the existing patent estate surrounding SGX94."
Quidel Corporation (NASDAQ: QDEL) and Life Technologies Corporation (NASDAQ: LIFE) announced the U.S. FDA has granted 510(k) clearances to the Quidel Molecular Influenza A+B assay and the Quidel Molecular RSV + hMPV assay, both for use on the QuantStudio™ Dx Real-Time PCR Instrument by Life Technologies. The QuantStudio™ Dx is Life Technologies' flagship instrument for the diagnostics market, offering the advanced capabilities in flexible sample batching needed by higher-volume hospital and reference laboratories. The two 510(k) clearances add to the infectious disease menu available on the QuantStudio Dx instrument with assays for the diagnosis of some of the more common respiratory tract infections that often share similar influenza-like symptoms (ILI) and that can be difficult to distinguish, based on clinical signs and symptoms alone.
The Quidel Molecular Influenza A+B assay reports the presence or absence of influenza A and/or B virus; it does not differentiate influenza A subtypes. However, importantly, this molecular assay does demonstrate the analytical detection of subtype H7N9. The H7N9 subtype has caused more than one hundred infections to date in China, with a mortality rate of approximately 30 percent.^1 Transmission of H7N9 infections to date have been as a result of human exposure to infected poultry, but a possible case of human-to-human transmission was recently reported in the British Medical Journal.^2
The assay was also cleared to include the analytical detection of H3N2v, a variant influenza virus that has caused infection in patients exposed to infected swine at agricultural fairs in the United States.
The Quidel Molecular RSV + hMPV assay detects the presence of respiratory syncytial virus (RSV) and/or human metapneumovirus (hMPV). RSV is a respiratory virus that infects the lungs and breathing passages, and although most RSV infections are generally mild, some infections can be severe, especially among young children, the immunocompromised and the elderly. According to the Centers for Disease Control and Prevention (CDC), between 25% to 40% of infants and children exposed to RSV for the first time show signs or symptoms of bronchiolitis or pneumonia, and up to 2% may require hospitalization.^3 hMPV was recently identified in 2001, and accounts for approximately 7.1% of respiratory tract infections.^4 The virus appears to be distributed worldwide and by the age of five, virtually all children have been exposed to hMPV.^5 Like RSV, hMPV generally causes mild respiratory tract infection, but can be severe, especially among young children, the immunocompromised and the elderly.
The Quidel Molecular Influenza A+B and RSV + hMPV assays are part of Quidel's expanding line of molecular diagnostics products. Quidel's product line offers PCR reagent kits that are designed to be used with a molecular laboratory's existing thermocycling infrastructure, effectively requiring no additional capital commitment on the part of the customer. These molecular kits provide attractive features that include refrigerated storage instead of freezing, ready-to-use reagents, a short time to result, and other benefits that favorably affect diagnostic test outcomes. Because most Quidel Molecular assays share a common extraction protocol, the RSV and hMPV Assay can be performed using the same extracted RNA as the Quidel Molecular Influenza A+B Assay.
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