RESEARCH TRIANGLE PARK, NC, November 30, 2021 (GLOBE NEWSWIRE) – Fennec Pharmaceuticals Inc., a specialty pharmaceutical company, today announced that it received a Complete Response Letter (CRL) on November 29, 2021 from the US Food and Drug Administration (FDA), after PDUFA’s target action date of November 27, 2021, regarding its New Drug Application (NDA) for PEDMARK ™ (a unique formulation of sodium thiosulfate), for intravenous administration for prevention of ototoxicity associated with cisplatin chemotherapy in pediatric patients ≥ 1 month to 18 years of age with localized, non-metastatic solid tumors.
The CRL was issued as a result of identified manufacturing defects that must be satisfactorily resolved before the NDA Pedmark can be approved. Fennec plans to request a Type A meeting with the FDA to discuss these and other issues outlined in the CRL, as well as the steps required for the resubmission of the NDA for PEDMARK ™.
“We remain true to our commitment to reducing the risk of lifelong hearing loss for children and young adults receiving cisplatin chemotherapy who currently have no approved treatment for this devastating disease,” said Rosty Raykov, CEO of Fennec Pharmaceuticals. “We will work closely with our current manufacturer as well as the FDA to fully resolve the issues raised in the letter. In addition, we continue to advance our second pharmaceutical manufacturing facility. “
As of September 30, 2021, Fennec had existing cash and cash equivalents, which totaled approximately $ 24 million.
About PEDMARK ™ (A unique formulation of sodium thiosulfate (STS))
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 pediatric cancer survivors.
In the United States and Europe, it is estimated that more than 10,000 children each year can receive platinum-based chemotherapy. The incidence of ototoxicity depends on the dose and duration of chemotherapy, and many of these children need hearing aids for life. There is currently no established preventative agent for this type of hearing loss and only expensive, technically difficult and suboptimal cochlear (inner ear) implants have been shown to provide some benefit. Infants and young children who suffer from ototoxicity at critical stages of development lack language development and literacy, and older children and adolescents lack socio-emotional development and academic achievement.
PEDMARK has been studied by cooperative groups in two phase 3 clinical studies on survival and reduction of ototoxicity, the clinical oncology group protocol ACCL0431 and SIOPEL 6. Both studies have been completed. The COG ACCL0431 protocol included one of five childhood cancers typically treated with intensive treatment with cisplatin for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, and medulloblastoma. SIOPEL 6 only recruited hepatoblastoma patients with localized tumors.
The Marketing Authorization Application (MAA) for sodium thiosulfate (trade name PEDMARQSI) is currently being assessed by the European Medicines Agency (EMA). PEDMARK received Breakthrough and Fast Track Therapy designation by the FDA in March 2018.
About Fennec Pharmaceuticals
Fennec Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the development of PEDMARK™ for the prevention of platinum-induced ototoxicity in pediatric patients. In addition, PEDMARK has received orphan drug designation in the United States for this parameter. Fennec has a licensing agreement with Oregon Health and Science University for the exclusive worldwide license rights to intellectual property relating to STS and its use for chemoprotection, including the prevention of ototoxicity induced by platinum chemotherapy, in humans. For more information, please visit www.fennecpharma.com
With the exception of historical information described in this press release, all other statements are forward-looking. These forward-looking statements include the Company’s expectations regarding its interactions and communications with the FDA, including its expectation to discuss with the FDA the issues raised in the CRL and the Company’s plans to resolve them. Forward-looking statements are subject to certain risks and uncertainties inherent in the Company’s business which could cause actual results to vary, including risks and uncertainties that regulatory developments and guidelines may change, scientific data and / or manufacturing capabilities. may not be sufficient to meet regulatory standards or receipt of required regulatory authorizations or approvals, clinical results may not be reproduced in actual patient settings, Fennec’s reliance on third party manufacturing, unanticipated global instability, including political instability, or instability due to an outbreak of a pandemic or contagious disease, such as the novel coronavirus (COVID-19), or surrounding the duration and severity of an outbreak, the protection afforded by the Company’s patents and patent applications may be challenged, invalidated or circumvented by its competitors, the market available for the Company’s products will not be as large as expected, the Company’s products will not be able to penetrate one or more targeted markets, the revenues will not be sufficient to finance further development and clinical studies, the Company may not meet its future capital needs in different countries and municipalities, and other risks detailed from time to time in documents filed by the Company with the Securities and Exchange Commission, including its annual report on Form 10-K for the fiscal year ended December 31, 2020 and its quarterly report on Form 10-Q for the quarter ended September 30, 2021. Fennec disclaims any obligation to update these statements, except where the law requires it.
For a more detailed discussion of related risk factors, please refer to our public documents available at www.sec.gov and www.sedar.com.
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