FDA Grants Vical Orphan Drug Designation for VL-23
Post# of 94141
Posted On: 01/06/2016 6:46:21 AM
FDA Grants Vical Orphan Drug Designation for VL-2397 for the Treatment of Invasive Aspergillosis
Source: GlobeNewswire Inc.
Vical Incorporated (Nasdaq:VICL), a biotechnology company developing vaccines and therapeutics for prevention and treatment of infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Vical orphan drug designation for its investigational antifungal product candidate, VL-2397 for the treatment of invasive aspergillosis. VL-2397 is also known as ASP2397 and Cyclo{-Asn-Leu-d-Phe-Al[(N5-acetyl-N5-hydroxy-Orn)-(N5-acetyl-N5-hydroxy-Orn)-(N5-hydroxy-Orn)]-} . Al(III). Orphan drug designation provides several benefits to Vical, including a seven-year period of market exclusivity in the United States.
“We are pleased that the FDA has granted Vical orphan drug designation to develop VL-2397 for the treatment of invasive aspergillosis,” said Mammen P. Mammen, Jr., M.D., Vical’s Vice President of Clinical Vaccines. “This is in addition to the qualified infectious disease product (QIDP) designation that FDA granted Vical for VL-2397 for the treatment of invasive aspergillosis in August 2015. We are excited by the potential for VL-2397 to save lives of patients with systemic fungal infections such as aspergillosis. We plan to initiate a Phase 1 clinical trial in the first half of 2016.”
VL-2397 is part of a potential new class of antifungal compounds for the treatment of systemic fungal infections. Systemic fungal infections are major causes of morbidity and mortality in immunocompromised patients, such as transplant recipients, in patients undergoing chemotherapy and in patients in intensive care units. In preclinical studies to date, VL-2397 has demonstrated both faster fungicidal activity than marketed drugs and activity against azole-resistant fungal pathogens. VL-2397 was initially developed by Astellas Pharma Inc. (TOKYO: 4503). In March 2015, Astellas granted Vical an exclusive worldwide license to develop and commercialize VL-2397.
About Vical
Vical develops biopharmaceutical products for the prevention and treatment of chronic or life-threatening infectious diseases, based on its patented DNA delivery technologies and other therapeutic approaches. Additional information on Vical is available at www.vical.com.
Forward-Looking Statements
This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include the potential benefits of VL-2397 and orphan drug designation, Vical's capabilities to develop VL-2397 and Vical's development plans and timelines for VL-2397. Risks and uncertainties include whether Vical or others will continue development of VL-2397; whether planned clinical development of VL-2397 will begin when expected, or at all; whether the results of future preclinical or clinical studies will be consistent with prior preclinical studies or will otherwise merit further development; whether Vical or its collaborative partners will seek or gain approval to market any product candidates, including VL-2397; whether Vical will be able to realize any of the potential benefits of orphan drug designation for VL-2397; and additional risks set forth in the company's filings with the Securities and Exchange Commission. These forward-looking statements represent the company's judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.
Contact: Andrew Hopkins (858) 646-1127 Website: www.vical.com

Source: GlobeNewswire Inc.
Vical Incorporated (Nasdaq:VICL), a biotechnology company developing vaccines and therapeutics for prevention and treatment of infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Vical orphan drug designation for its investigational antifungal product candidate, VL-2397 for the treatment of invasive aspergillosis. VL-2397 is also known as ASP2397 and Cyclo{-Asn-Leu-d-Phe-Al[(N5-acetyl-N5-hydroxy-Orn)-(N5-acetyl-N5-hydroxy-Orn)-(N5-hydroxy-Orn)]-} . Al(III). Orphan drug designation provides several benefits to Vical, including a seven-year period of market exclusivity in the United States.
“We are pleased that the FDA has granted Vical orphan drug designation to develop VL-2397 for the treatment of invasive aspergillosis,” said Mammen P. Mammen, Jr., M.D., Vical’s Vice President of Clinical Vaccines. “This is in addition to the qualified infectious disease product (QIDP) designation that FDA granted Vical for VL-2397 for the treatment of invasive aspergillosis in August 2015. We are excited by the potential for VL-2397 to save lives of patients with systemic fungal infections such as aspergillosis. We plan to initiate a Phase 1 clinical trial in the first half of 2016.”
VL-2397 is part of a potential new class of antifungal compounds for the treatment of systemic fungal infections. Systemic fungal infections are major causes of morbidity and mortality in immunocompromised patients, such as transplant recipients, in patients undergoing chemotherapy and in patients in intensive care units. In preclinical studies to date, VL-2397 has demonstrated both faster fungicidal activity than marketed drugs and activity against azole-resistant fungal pathogens. VL-2397 was initially developed by Astellas Pharma Inc. (TOKYO: 4503). In March 2015, Astellas granted Vical an exclusive worldwide license to develop and commercialize VL-2397.
About Vical
Vical develops biopharmaceutical products for the prevention and treatment of chronic or life-threatening infectious diseases, based on its patented DNA delivery technologies and other therapeutic approaches. Additional information on Vical is available at www.vical.com.
Forward-Looking Statements
This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include the potential benefits of VL-2397 and orphan drug designation, Vical's capabilities to develop VL-2397 and Vical's development plans and timelines for VL-2397. Risks and uncertainties include whether Vical or others will continue development of VL-2397; whether planned clinical development of VL-2397 will begin when expected, or at all; whether the results of future preclinical or clinical studies will be consistent with prior preclinical studies or will otherwise merit further development; whether Vical or its collaborative partners will seek or gain approval to market any product candidates, including VL-2397; whether Vical will be able to realize any of the potential benefits of orphan drug designation for VL-2397; and additional risks set forth in the company's filings with the Securities and Exchange Commission. These forward-looking statements represent the company's judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.
Contact: Andrew Hopkins (858) 646-1127 Website: www.vical.com

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