Full Press Release Details
Pharmaceuticals Announces Commercial Availability of PEDMARK (sodium thiosulfate injection) in the
~ PEDMARK is the First and Only FDA-Approved
Therapy Indicated to Reduce the Risk of Cisplatin-Induced Hearing Loss in Pediatric Patients ~
~ Fennec HEARS Program Offers Comprehensive
Patient Services, Including Access to Care Coordinators, Financial and Prescription Drug Support ~
TRIANGLE PARK, N.C., October 17, 2022 - Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a commercial stage specialty
pharmaceutical company, today announced the U.S. commercial launch and availability of PEDMARK (sodium thiosulfate
injection) to reduce the risk of ototoxicity associated with cisplatin in pediatric patients one
month of age and older with localized, non-metastatic solid tumors.
"We are proud to announce that PEDMARK
is now available to pediatric patients and their physicians who are in need of options to help reduce the risk of cisplatin-induced hearing
loss," said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals. "Children who get platinum-based chemotherapy,
such as cisplatin, are at risk for permanent hearing loss, a condition that previously could only be managed with cochlear implants and
hearing aids. PEDMARK provides the first and only FDA-approved treatment specifically designed to help protect hearing in children and
young adults after receiving cisplatin. We look forward to engaging with healthcare providers and supporting patient access to this breakthrough
therapy with our assistance program, Fennec HEARS ."
has established Fennec HEARS , a comprehensive single source program designed to connect PEDMARK patients to both patient financial
and product access support. The program offers assistance and resources, regardless of insurance type, that can address co-pays or lack
of coverage when certain eligibility requirements are met. Fennec HEARS also provides access to care coordinators that can answer insurance
questions about coverage for PEDMARK and provide tips and resources for managing treatment. For more information about product availability
and patient support, please contact the Fennec HEARS program at 1-833-7PEDMARK (1-833-773-3627).
PEDMARK was approved by the U.S. Food and Drug
Administration (FDA) in September 2022 based upon safety and efficacy data from two pivotal open-label, randomized Phase 3 trials (Clinical
Oncology Group [COG] Protocol ACCL0431 and SIOPEL 6), which compared PEDMARK plus cisplatin-based regimen to cisplatin-based regimens
alone for the reduction of cisplatin-induced hearing loss in pediatric patients.
Advances in chemotherapy-based treatment approaches
for pediatric patients with localized, solid tumors have improved, resulting in an 85 percent or higher five-year survival rate for these
patients.i However, use of platinum-based chemotherapy, still the treatment of choice in many cases, can be toxic to the ears
and cisplatin treatment frequently causes permanent and irreversible bilateral (affecting both ears) hearing loss. Permanent hearing
loss can be seen in approximately 60 percent of children treated with cisplatin and can be as high as 90 percent.1,ii Until
now, interventions with management strategies such as cochlear implants and hearing aids only occurred after hearing loss had been detected
and these interventions do not return normal hearing.3
The Marketing Authorization
Application (MAA) for sodium thiosulfate (tradename PEDMARQSI) is currently under evaluation by the European Medicines Agency (EMA).
Prior to its approval in the U.S., the FDA granted PEDMARK Priority Review designation in 2020 and Orphan Drug designation in 2004.
Cisplatin-Induced Ototoxicity
and other platinum compounds are essential chemotherapeutic agents for the treatment of many pediatric malignancies. Unfortunately, platinum-based
therapies can cause ototoxicity, or hearing loss, which is permanent, irreversible, and particularly harmful to the survivors of pediatric
of ototoxicity depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids or cochlear
implants, which can be helpful for some, but do not reverse the hearing loss and can be costly over time.5 Infants and young
children that are affected by ototoxicity at critical stages of development lack speech and language development and literacy, and older
children and adolescents often lack social-emotional development and educational achievement.6
PEDMARK (sodium thiosulfate
PEDMARK is the first and only
U.S. Food and Drug Administration (FDA) approved therapy indicated to reduce the risk of ototoxicity associated with cisplatin treatment
in pediatric patients with localized, non-metastatic, solid tumors. It is a unique formulation of sodium thiosulfate in single-dose,
ready-to-use vials for intravenous use in pediatric patients.7 PEDMARK is also the only therapeutic agent with proven efficacy
and safety data with an established dosing paradigm, across two open-label, randomized Phase 3 clinical studies, the Clinical Oncology
Group (COG) Protocol ACCL0431 and SIOPEL 6.
U.S. and Europe, it is estimated that, annually, more than 10,000 children may receive platinum-based chemotherapy. 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.
has been studied by co-operative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, COG 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. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.
(sodium thiosulfate injection) is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1
month of age and older with localized, non-metastatic solid tumors.
The safety and efficacy of PEDMARK have not been
established when administered following cisplatin infusions longer than 6 hours. PEDMARK may not reduce the risk of ototoxicity when
administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred.
Important Safety Information
PEDMARK is contraindicated in patients with history
of a severe hypersensitivity to sodium thiosulfate or any of its components.
Hypersensitivity reactions occurred in 8% to
13% of patients in clinical trials. Monitor patients for hypersensitivity reactions. Immediately discontinue PEDMARK and institute appropriate
care if a hypersensitivity reaction occurs. Administer antihistamines or glucocorticoids (if appropriate) before each subsequent administration
of PEDMARK. PEDMARK may contain sodium sulfite; patients with sulfite sensitivity may have hypersensitivity reactions, including anaphylactic
symptoms and life-threatening or severe asthma episodes. Sulfite sensitivity is seen more frequently in people with asthma.
PEDMARK is not indicated for use in pediatric
patients less than 1 month of age due to the increased risk of hypernatremia or in pediatric patients with metastatic cancers.
Hypernatremia occurred in 12% to 26% of patients
in clinical trials, including a single Grade 3 case. Hypokalemia occurred in 15% to 27% of patients in clinical trials, with Grade 3
or 4 occurring in 9% to 27% of patients. Monitor serum sodium and potassium levels at baseline and as clinically indicated. Withhold
PEDMARK in patients with baseline serum sodium greater than 145 mmol/L.
Monitor for signs and symptoms of hypernatremia
and hypokalemia more closely if the glomerular filtration rate (GFR) falls below 60 mL/min/1.73m2.
Administer antiemetics prior to each PEDMARK
administration. Provide additional antiemetics and supportive care as appropriate.
The most common adverse reactions ( 25% with
difference between arms of >5% compared to cisplatin alone) in SIOPEL 6 were vomiting, nausea, decreased hemoglobin, and hypernatremia.
The most common adverse reaction ( 25% with difference between arms of >5% compared to cisplatin alone) in COG ACCL0431 was hypokalemia.
Please see full Prescribing Information for PEDMARK
at: www.PEDMARK.com.
Fennec Pharmaceuticals Inc. is a specialty pharmaceutical
company focused on the development and commercialization of PEDMARK to reduce the risk of platinum-induced ototoxicity
in pediatric patients. Further, PEDMARK received FDA approval in September 2022 and has received Orphan Drug Designation in the U.S.
Fennec has a license agreement with Oregon Health and Science University (OHSU) for exclusive worldwide license rights to intellectual
property directed to sodium thiosulfate and its use for chemoprotection, including the reduction of risk of ototoxicity induced by platinum
chemotherapy, in humans. For more information, please visit www.fennecpharma.com.
Forward Looking Statements
Except for historical information described
in this press release, all other statements are forward-looking. Words such as "believe," "anticipate," "plan,"
"expect," "estimate," "intend," "may," "will," or the negative of those terms,
and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include statements about
our business strategy, timeline and other goals, plans and prospects, including our commercialization plans respecting PEDMARK ,
the market opportunity for and market impact of PEDMARK , its potential impact on patients and anticipated benefits associated
with its use, and potential access to further funding after the date of this release. Forward-looking statements are subject to certain