{"id":499621,"date":"2021-05-28T06:03:08","date_gmt":"2021-05-28T10:03:08","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/fennec-pharmaceuticals-resubmits-new-drug-application-to-u-s-food-and-drug-administration-for-pedmark\/"},"modified":"2021-05-28T06:03:08","modified_gmt":"2021-05-28T10:03:08","slug":"fennec-pharmaceuticals-resubmits-new-drug-application-to-u-s-food-and-drug-administration-for-pedmark","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/fennec-pharmaceuticals-resubmits-new-drug-application-to-u-s-food-and-drug-administration-for-pedmark\/","title":{"rendered":"Fennec Pharmaceuticals Resubmits New Drug Application to U.S. Food and Drug Administration for PEDMARK\u2122"},"content":{"rendered":"

\n~ If Approved by the FDA, PEDMARK Stands to Be the First Therapy for the Prevention of Cisplatin-Induced Hearing Loss in Children ~
\n<\/h2>\n
\n

RESEARCH TRIANGLE PARK, N.C., May 28, 2021 (GLOBE NEWSWIRE) — Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a specialty pharmaceutical company, today announced the resubmission of its New Drug Application (NDA) to the\u00a0U.S. Food and Drug Administration (FDA) for PEDMARK\u2122\u00a0(a unique formulation of sodium thiosulfate) for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to < 18 years of age with localized, non-metastatic, solid tumors.<\/p>\n

The resubmission for PEDMARK follows receipt of final minutes from a Type A meeting with the FDA. Importantly, the Complete Response Letter (CRL) received on August 10, 2020 referred to deficiencies with the facility of the drug product manufacturer; no clinical safety or efficacy issues were identified and there was no requirement for further clinical data.<\/p>\n

\u201cWe are pleased to have resubmitted the NDA for PEDMARK\u2122\u00a0and look forward to working with the FDA through the review process,\u201d said\u00a0Rosty Raykov, Chief Executive Officer of\u00a0Fennec Pharmaceuticals, Inc. \u201cWe remain committed to reducing the risk of life-long hearing loss for children receiving cisplatin chemotherapy. If approved, PEDMARK stands to be the first FDA approved therapy to reduce the risk of cisplatin induced ototoxicity in pediatric patients.\u201d<\/p>\n

\n About PEDMARK\u2122\u00a0<\/strong>\n <\/p>\n

Cisplatin and other platinum compounds are essential chemotherapeutic agents for many pediatric malignancies. Unfortunately, platinum-based therapies cause ototoxicity, or hearing loss, which is permanent, irreversible, and particularly harmful to the survivors of pediatric cancer.<\/p>\n

In the U.S. and\u00a0Europe,\u00a0it is estimated that, annually, over 10,000 children may receive platinum-based chemotherapy.\u00a0 The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids. There is currently no established preventive agent for this hearing loss and only expensive, technically difficult, and sub-optimal cochlear (inner ear) implants have been shown to provide some benefit. Infants and young children that suffer ototoxicity at critical stages of development lack speech language development and literacy, and older children and adolescents lack social-emotional development and educational achievement.<\/p>\n

PEDMARK has been studied by co-operative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, The Clinical Oncology Group Protocol ACCL0431 and SIOPEL 6. Both studies have been completed. The COG ACCL0431 protocol enrolled childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, medulloblastoma, and other solid tumors. \u00a0SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.<\/p>\n

The Marketing Authorization Application (MAA) for sodium thiosulfate (tradename PEDMARQSI) is currently under evaluation by the\u00a0European Medicines Agency\u00a0(EMA).\u00a0 PEDMARK\u00a0received Breakthrough Therapy and Fast Track Designation from the FDA in\u00a0March 2018.\u00a0<\/p>\n

\n About Fennec Pharmaceuticals<\/strong>\n <\/p>\n

Fennec Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the development of PEDMARK\u2122<\/strong> for the prevention of platinum-induced ototoxicity in pediatric patients. \u00a0 Further, PEDMARK has received Orphan Drug Designation in the U.S. for this potential use. Fennec has a license agreement with\u00a0Oregon Health and Science University\u00a0(OHSU) for exclusive worldwide license rights to intellectual property directed to sodium thiosulfate and its use for chemoprotection, including the prevention of ototoxicity induced by platinum chemotherapy, in humans.\u00a0 For more information, please visit www.fennecpharma.com<\/a><\/u><\/p>\n

\n Forward Looking Statements<\/strong>\n <\/p>\n

\n Except for historical information described in this press release, all other statements are forward-looking. Words such as \u201cbelieve,\u201d \u201canticipate,\u201d \u201cplan,\u201d \u201cexpect,\u201d \u201cestimate,\u201d \u201cintend,\u201d \u201cmay,\u201d \u201cwill,\u201d or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include the Company\u2019s expectations regarding its interactions and communications with the FDA, including the Company\u2019s expectations and goals respecting the resolution the issues raised in the CRL and the Company\u2019s plans to address them, and the anticipated timing of the Company\u2019s finalization and filing of an NDA resubmission for PEDMARK.\u00a0 Forward-looking statements are subject to certain risks and uncertainties inherent in the Company\u2019s business that could cause actual results to vary, including such risks and uncertainties relating to the Company\u2019s reliance on third party manufacturing, the risk that unforeseen factors may delay the resubmission of the NDA, the risks of delays in or failure to obtain FDA approval of PEDMARK, the risks relating to the Company\u2019s and its manufacturer\u2019s ability to adequately address the concerns identified in the CRL, the risk that the resubmission of the NDA to the FDA will not be satisfactory, that regulatory and guideline developments may change, scientific data and\/or manufacturing capabilities may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, unforeseen global instability, including political instability, or instability from an outbreak of pandemic or contagious disease, such as the novel coronavirus (COVID-19), or surrounding the duration and severity of an outbreak, protection offered by the Company\u2019s patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the Company\u2019s products will not be as large as expected, the Company\u2019s products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to fund further development and clinical studies, the Company may not meet its future capital requirements in different countries and municipalities, and other risks detailed from time to time in the Company\u2019s filings with the\u00a0Securities and Exchange Commission\u00a0including its Annual Report on Form 10-K for the year ended\u00a0December 31, 2020.\u00a0 Fennec disclaims any obligation to update these forward-looking statements except as required by law.<\/em>\n <\/p>\n

For a more detailed discussion of related risk factors, please refer to our public filings available at\u00a0www.sec.gov<\/a>\u00a0and\u00a0www.sedar.com<\/a>.<\/p>\n

\n For further information, please contact:<\/strong>\n <\/p>\n

\n Investors:<\/strong>
\n
Robert Andrade
Chief Financial Officer
Fennec Pharmaceuticals Inc.
(919) 246-5299<\/p>\n

\n Media:<\/strong>
\n
Elixir Health Public Relations
Lindsay Rocco
(862) 596-1304
lrocco@elixirhealthpr.com<\/a><\/p>\n

\n
\n
\n \n <\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

~ If Approved by the FDA, PEDMARK Stands to Be the First Therapy for the Prevention of Cisplatin-Induced Hearing Loss in Children ~ RESEARCH TRIANGLE PARK, N.C., May 28, 2021 (GLOBE NEWSWIRE) — Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a specialty pharmaceutical company, today announced the resubmission of its New Drug Application (NDA) to the\u00a0U.S. Food and Drug Administration (FDA) for PEDMARK\u2122\u00a0(a unique formulation of sodium thiosulfate) for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to < 18 years of age with localized, non-metastatic, solid tumors. The resubmission for PEDMARK follows receipt of final minutes from a Type A meeting with the FDA. Importantly, the Complete Response Letter (CRL) received on August 10, 2020 … <\/p>\n

Continue reading “Fennec Pharmaceuticals Resubmits New Drug Application to U.S. Food and Drug Administration for PEDMARK\u2122”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-499621","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nFennec Pharmaceuticals Resubmits New Drug Application to U.S. Food and Drug Administration for PEDMARK\u2122 - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/fennec-pharmaceuticals-resubmits-new-drug-application-to-u-s-food-and-drug-administration-for-pedmark\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Fennec Pharmaceuticals Resubmits New Drug Application to U.S. Food and Drug Administration for PEDMARK\u2122 - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"~ If Approved by the FDA, PEDMARK Stands to Be the First Therapy for the Prevention of Cisplatin-Induced Hearing Loss in Children ~ RESEARCH TRIANGLE PARK, N.C., May 28, 2021 (GLOBE NEWSWIRE) — Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a specialty pharmaceutical company, today announced the resubmission of its New Drug Application (NDA) to the\u00a0U.S. Food and Drug Administration (FDA) for PEDMARK\u2122\u00a0(a unique formulation of sodium thiosulfate) for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to < 18 years of age with localized, non-metastatic, solid tumors. The resubmission for PEDMARK follows receipt of final minutes from a Type A meeting with the FDA. 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(NASDAQ: FENC; TSX: FRX), a specialty pharmaceutical company, today announced the resubmission of its New Drug Application (NDA) to the\u00a0U.S. Food and Drug Administration (FDA) for PEDMARK\u2122\u00a0(a unique formulation of sodium thiosulfate) for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to < 18 years of age with localized, non-metastatic, solid tumors. The resubmission for PEDMARK follows receipt of final minutes from a Type A meeting with the FDA. 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