Fennec Pharmaceuticals Inc. (NASDAQ: FENC)

Fennec Pharmaceuticals Inc. is a commercial stage specialty pharmaceutical company dedicated to preventing cisplatin induced ototoxicity in pediatric cancer patients.

The company’s lead product PEDMARK® is an FDA approved sodium thiosulfate injection indicated to reduce the risk of hearing loss associated with cisplatin treatment in children one month of age and older with localized non metastatic solid tumors.

In Europe the same molecule is marketed as PEDMARQSI® under a licensing agreement with Norgine and has received European Commission Marketing Authorization and United Kingdom approval.

PEDMARK® is administered as a short intravenous infusion and has demonstrated an approximate 50% relative reduction in cisplatin induced hearing loss compared to cisplatin alone in pivotal Phase 3 trials without compromising antitumor efficacy.

The product benefits from orphan drug exclusivity in the United States which provides 7 years of market exclusivity from its September 2022 approval and from pediatric use marketing authorization in the European Union which offers 10 years of exclusivity.

Fennec Pharmaceuticals Inc. maintains a patent portfolio that includes 6 United States patents listed in the FDA Orange Book and corresponding foreign patents covering formulation and methods of use with expiration dates in 2039.

Fennec Pharmaceuticals Inc. generates revenue primarily from the sale of PEDMARK® in the United States through a dedicated field force of Regional Pediatric Oncology Specialists and Medical Science Liaisons.

The company supports patient access and reimbursement through its Fennec HEARS® program which provides copay assistance patient assistance prior authorization help and care coordination services.

In the United States revenue also comes from specialty pharmacy partnerships home infusion services and white bag delivery arrangements that facilitate product distribution to hospitals and clinics.

Outside the United States Fennec receives licensing income consisting of an upfront payment, potential milestone payments, and tiered royalties on net sales of PEDMARQSI® in Europe Australia and New Zealand under its exclusive agreement with Norgine.

Under the Norgine deal Fennec received approximately $43 million in upfront consideration and is eligible to receive up to $230 million in additional commercial and regulatory milestone payments plus royalties of up to 25 percent of net sales.

Additionally Fennec has a distribution agreement with Inpharmus for the commercialization of PEDMARK® in Turkey and the Gulf Cooperation Council countries where it receives payments based on supply and the achievement of regulatory and commercial milestones.

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Fennec Pharmaceuticals Inc. holds a leading position as the first and only FDA approved therapy to reduce cisplatin induced hearing loss in pediatric patients with localized non metastatic solid tumors.

In Europe the product is similarly the first and only EMA approved treatment for the same indication under the brand name PEDMARQSI®.

While there are experimental agents such as D methionine, SPI 3005, N acetylcysteine, amifostine, Vitamin E, salicylate, tiopronin, and DB 020 none have demonstrated comparable efficacy in clinical trials and cochlear implants remain a suboptimal alternative for managing hearing loss.

The company’s competitive advantages include orphan drug exclusivity, regulatory exclusivity, strong patent portfolio, established patient support programs, and a first mover status in a niche oncology indication.

Fennec Pharmaceuticals Inc. serves pediatric oncology hospitals treatment centers and group purchasing organizations across the United States and Europe.

The company also works with specialty pharmacy providers home infusion companies and patient assistance programs to reach patients caregivers and healthcare providers.

Specific customer names are not disclosed in the filing but the company notes that approximately 90% of pediatric cancer patients receive care at approximately 200 key pediatric hospital centers including institutions within the Children’s Oncology Group National Cancer Institute and National Comprehensive Cancer Network.