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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 8-K
Current Report
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
December 20, 2024
FENNEC
PHARMACEUTICALS INC.
(Exact name of registrant as specified in its charter)
001-32295
(Commission File Number)
| British Columbia, Canada |
|
20-0442384 |
|
(State or other jurisdiction of
incorporation) |
|
(I.R.S. Employer Identification No.) |
|
PO Box 13628, 68 TW Alexander Drive,
Research Triangle Park, NC |
|
27709 |
| (Address of principal executive offices) |
|
(Zip Code) |
Registrant’s telephone number, including
area code: (919) 636-4530
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities
Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange
Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b)
under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c)
under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12 of the Act:
| Title of each class |
Trading symbol(s) |
Name of each exchange on which
registered |
| Common shares, no par value |
FENC |
Nasdaq Capital Market |
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange
Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant
to Section 13(a) of the Exchange Act. ¨
On December 20, 2024, Fennec Pharmaceuticals Inc.
issued a press release announcing that Norgine Pharmaceuticals Ltd., a leading European specialist pharmaceutical company, has received
positive final draft guidance from National Institute for Health and Care Excellence (NICE) recommending PEDMARQSIÒ
for the prevention of cisplatin-induced hearing loss in patients (aged 1 month to 17 years) with localized, non-metastatic, solid tumors.
A copy of that press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference. A copy of the news release is
attached as Exhibit 99.1 to this Current Report on Form 8-K.
The
information contained in this Item 8.01, as well as Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes
of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall it be deemed incorporated
by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by
specific reference in such a filing.
| Item 9.01 |
Financial Statements and Exhibits. |
SIGNATURE
Pursuant to the requirements of the Securities
Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| |
|
FENNEC PHARMACEUTICALS INC. |
| |
|
|
| Date: December 20, 2024 |
By: |
/s/ Robert Andrade |
| |
|
Robert Andrade
Chief Financial Officer |
Exhibit 99.1
FENNEC
PHARMACEUTICALS ANNOUNCES PEDMARQSIÒ POSITIVE
RECOMMENDATION BY NICE FOR THE PREVENTION OF CISPLATIN-INDUCED HEARING LOSS IN ENGLAND AND WALES
~
PEDMARQSI® (anhydrous sodium thiosulfate) is the
first and only treatment available within NHS England and Wales for the prevention of cisplatin-induced ototoxicity (hearing loss) in
children and young people (1 month-17 years of age) ~
~ Data from two open-label, randomized Phase
3 trials, SIOPEL 6 (pivotal) and the Clinical Oncology Group (COG) Protocol ACCL0431, demonstrated an approximate 50% reduction in the
occurrence of cisplatin-induced ototoxicity in patients treated with cisplatin and sodium thiosulfate vs. those treated with cisplatin
alone ~
~ There is a clear unmet need for the prevention
of hearing loss caused by cisplatin and until now, there have been no preventative pharmacological interventions available, despite the
significant lifelong impact hearing loss has on cancer patients ~
Research
Triangle Park, NC, December 20, 2024 – Fennec Pharmaceuticals
Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, today announced that Norgine Pharmaceuticals Ltd., a leading European
specialist pharmaceutical company, has received positive final draft guidance from National Institute for Health and Care Excellence (NICE)
recommending PEDMARQSIÒ for
the prevention of cisplatin-induced hearing loss in patients (aged 1 month to 17 years) with localized, non-metastatic, solid tumors.
PEDMARQSIÒ is
the first and only approved therapy in the EU and U.K. for the prevention
of ototoxicity, or hearing loss, induced by cisplatin chemotherapy in patients 1 month to <18 years of age with localized, non-metastatic
solid tumors. In March 2024, Fennec entered into an exclusive licensing agreement under which Norgine will commercialize PEDMARQSI® in Europe, Australia,
and New Zealand.
“Securing
access to PEDMARQSIÒ is
a critical milestone for the cancer community in England and Wales to help reduce the risk of ototoxicity, or permanent hearing loss,
associated with cisplatin treatment,” said Jeff
Hackman, chief executive officer and director of Fennec Pharmaceuticals. “We
congratulate Norgine on their collaboration with NICE to reach this important agreement that recognizes the value of ototoxicity intervention
as part of the cancer treatment journey.”
Under
the terms of the previously announced exclusive licensing agreement with Norgine, Fennec received approximately $43 million in
an upfront payment and will receive up to approximately $230 million in additional commercial and regulatory milestone payments along
with double-digit tiered royalties on net sales of PEDMARQSIÒ starting
in the mid-teens and growing to the mid-twenties.
About Cisplatin-Induced Ototoxicity
Cisplatin
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
cancer.i
| i | Rybak L. Mechanisms of Cisplatin Ototoxicity and Progress in Otoprotection.
Current Opinion in Otolaryngology & Head and Neck Surgery. 2007, Vol. 15: 364-369. |
The incidence
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.ii 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.iii
PEDMARK® (sodium thiosulfate
injection)
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. PEDMARK is also recommended for the Adolescent and Young Adult (AYA)
population by the National Comprehensive Cancer Network® as a preventative treatment option to reduce hearing loss associated
with platinum-based chemotherapy in patients with localized, non-metastatic tumors. PEDMARK is a unique formulation of sodium thiosulfate
in single-dose, ready-to-use vials for intravenous use in pediatric patients. PEDMARK is also the first and only therapeutic agent with
proven efficacy and safety data with an established dosing regimen, across two open-label, randomized Phase 3 clinical studies, the Children’s
Oncology Group (COG) Protocol ACCL0431 and SIOPEL 6.
In the 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.
PEDMARK
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.
Indications
and Usage
PEDMARK®
(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.
Limitations of Use
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.
| ii | Landier W. Ototoxicity and Cancer Therapy. Cancer. June
2016 Vol. 122, No.11: 1647-1658. |
| iii | Bass JK, Knight KR, Yock TI, et al. Evaluation and Management
of Hearing Loss in Survivors of Childhood and Adolescent Cancers: A Report from the Children's Oncology Group. Pediatric Blood &
Cancer. 2016 Jul;63(7):1152-1162. |
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.
About Fennec
Pharmaceuticals
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
European Commission approval in June 2023 and U.K. approval in October 2023 under the brand name PEDMARQSIÒ.
PEDMARK has received Orphan Drug Exclusivity in the U.S. and PEDMARQSI has received Pediatric Use Marketing Authorization in Europe which
includes eight years plus two years of data and market protection. 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 risks and uncertainties inherent
in the Company’s business that could cause actual results to vary, including the risks and uncertainties 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’s patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available
market 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, revenues will not be sufficient to fund further development and clinical studies, our ability to
obtain necessary capital when needed on acceptable terms or at all, 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’s filings with the
Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2023. Fennec disclaims
any obligation to update these forward-looking statements except as required by law.
For
a more detailed discussion of related risk factors, please refer to our public filings available at www.sec.gov and www.sedar.com.
PEDMARK®
and Fennec® are registered trademarks of Fennec Pharmaceuticals Inc.
©2024
Fennec Pharmaceuticals Inc. All rights reserved. FEN-1604-v1
For further
information, please contact:
Investors:
Robert Andrade
Chief Financial Officer
Fennec Pharmaceuticals Inc.
+1 919-246-5299
Corporate and Media:
Lindsay Rocco
Elixir Health Public Relations
+1 862-596-1304
lrocco@elixirhealthpr.com
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