[ad_1]
Agreement linking Norgine’s commercial expertise and leading European track record with PEDMARQSI®First and only treatment approved in the European Union and UK to reduce the risk of cisplatin-induced hearing loss in pediatric patients with localized non-metastatic solid tumors
Fennec will receive an upfront payment of €40 million, up to €210 million in additional commercial and regulatory milestones, and tiered royalties up to mid-2020.
It strengthens Norgin’s commitment to bringing innovative treatments to patients in Europe, the UK, Australia and New Zealand who currently do not have access to treatments to treat this life-changing condition.
RESEARCH TRIANGLE PARK, N.C. and UX BRIDGE, United Kingdom, March 17, 2024 (Globe Newswire) — Fennec Pharmaceuticals, Inc. (NASDAQ: FENC; TSX: FRX), a commercial stage specialty pharmaceutical company and Norgine, Europe’s leading specialty pharmaceutical company, today announced an exclusive licensing agreement under which Norgine will be commercialized. Pedomarcusi® in Europe, Australia and New Zealand. Pedomarcusi It is the first and only drug approved in the EU and UK for the prevention of ototoxicity (hearing loss) induced by cisplatin chemotherapy in patients aged 1 month to <18 years with localized non-metastatic solid tumors. This is a treatment method.
Under the terms of the license agreement, Fennec will EUR40 million upfront, up to EUR$210 million in additional commercial and regulatory milestone payments and double-digit tiered royalties on net sales Pedomarcusi Up to mid-20s in licensed areas. Norgine is responsible for all commercialization activities in the licensed territories and holds all sales authorizations in the licensed territories.
It is estimated that more than 5,000 pediatric patients are eligible to receive platinum-based chemotherapy annually in Europe. Pedomarcusi received EU marketing authorization by the European Commission in June 2023 and UK approval from the MHRA in October 2023. Approval was based on safety and efficacy data from two open-label, randomized Phase 3 studies, SIOPEL 6 (Pivotal) and a clinical trial.oncology group [COG] Protocol ACCL0431.Compared studies Pedomarcusi Cisplatin-based regimens in addition to cisplatin-based alone regimens are used to alleviate cisplatin-induced hearing loss in pediatric patients. Pedomarcusi has eight years and two years of data and market protection in Europe under its Pediatric Use Marketing Authorization. It is also seeking approval in Switzerland, Australia and New Zealand.
The first study (SIOPEL-6) involved 114 children with hepatoblastoma (liver cancer) with an average age of approximately 19 months. They found that 35% (20 of 57) of children who received PEDMARQSI developed hearing loss 6 hours after each dose of cisplatin, compared with 67% (35 of 52) of children who received cisplatin alone. It was shown that a person) developed hearing loss. The second study included children aged 1 month to 18 years with various types of cancer, including hepatoblastoma, neuroblastoma (a cancer of immature nerve cells), and tumors of the central nervous system. 125 children participated. In this study, 29% (14 of 49) of children who received PEDMARQSI experienced hearing loss after each dose of cisplatin compared to 56% (31 of 55) of children who received cisplatin alone. It turned out that it did.
“We are thrilled to partner with Norgine, a company that shares our belief in the potential of PEDMARQSI to reduce the risk of permanent and irreversible hearing loss that can occur in pediatric patients treated with cisplatin. Furthermore, this partnership is an important step in achieving our mission to expand PEDMARQSI to patients worldwide who are at risk of suffering from cisplatin-induced ototoxicity.” said Cal’s Chief Executive Officer Rosti Lakoff. “From a transaction perspective, these terms include an upfront payment that further strengthens our balance sheet, meaningful participation in PEDMARQSI’s success outside the US, and an experienced partner to successfully launch PEDMARQSI in the licensing space. It offers a number of important benefits, including attractive economic terms that offer
Chris Bath, Chief Executive Officer of Norgine, said: “We are pleased to announce our partnership with Fennec to bring this important medicine to pediatric patients across Europe and Australia who are being treated with cisplatin. We look forward to launching PEDMARQSI in our region within the next month and establishing it as the standard of care in this critical patient population with high unmet need. This important milestone for our company It builds on our 30-year track record of building valuable partnerships and further underlines Norgine’s position as the specialty pharma partner of choice across Europe and Australia.”
Moelis & Company LLC served as financial advisor and LaBarge Weinstein LLP served as legal advisor to Fenech. Arnold & Porter served as legal advisor to Norgine.
About Fennec Pharmaceutical
Fennec Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the development and commercialization of PEDMARK.® and Pedomarcusi® Reduces the risk of platinum-induced ototoxicity in pediatric patients. PEDMARK received FDA approval in September 2022 and European Commission marketing authorization in June 2023. Pedomarcusi. Additionally, PEDMARQSI received UK approval in October 2023. PEDMARK received his seven-year market protection and orphan drug exclusivity in the United States. Pedomarcusi received marketing authorization for pediatric use in Europe, which includes eight years and two years of data and market protection. For more information, please visit www.fennecpharma.com.
About Norgin
Norgine is a leading European specialty pharmaceutical company that has been providing innovative medicines to patients for more than a century. A commitment to changing people’s lives drives everything Norgine does, with a fully integrated infrastructure and unparalleled partnership approach, enabling creative solutions to help patients who otherwise wouldn’t have access. can bring life-changing medicines to the world. Norgine helps more than 25 million patients annually worldwide and is proud to have net product sales of over €500 million in 2023.
Norgine has direct presence in 18 European countries, Australia and New Zealand, and a strong global partnership network in markets outside of Norgine. Norgine has a flexible and fully integrated pharmaceutical business with sales and marketing infrastructure, as well as manufacturing (Hengoed in Wales and Dreux in France), third-party supply network and significant product development capabilities. doing.
NORGINE and the sail logo are trademarks of the Norgine group of companies.
Forward-looking statements
Other than historical information contained 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 these words. Shapes, and similar expressions are for identification purposes. Forward-Looking Statements. These forward-looking statements include the Company’s commercialization plans for PEDMARK® and PEDMARQSI®, the market opportunity and market impact for PEDMARK® and PEDMARQSI, the potential impact on patients and patients; Line and other statements regarding goals, plans and prospects. the anticipated benefits associated with its use and the possibility of access to further funds after the date of this release. Forward-looking statements are subject to changes due to the development of regulations and guidelines, and involve risks and uncertainties such as the possibility that scientific data or manufacturing capacity may not be sufficient, and actual results may vary. Our business may be subject to certain risks and uncertainties inherent in our business. regulatory standards and receipt of necessary regulatory clearances and approvals, clinical results may not be reproducible in an actual patient setting, unexpected global instability, including political instability, or the novel coronavirus (COVID-19). 19) or related to the duration and severity of outbreaks, the protection provided by our patents and patent applications may be challenged, invalidated or circumvented by competitors; The available market for our products may not be as large as anticipated and may not be sufficient to fund further development or clinical studies if we We may not be able to generate adequate returns, be unable to obtain the capital we need when we need it, on acceptable terms, or at all, and we may be unable to meet our future capital requirements. Various national, local, and other risks are described in detail from time to time in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2022. I am. Fennec undertakes no obligation to update this forward-looking information. View statements unless required by law.
For more information on the relevant risk factors, please refer to our public documents available at www.sec.gov and www.sedar.com.
pedomark®Pedo Marci® and fennec® is a registered trademark of Fennec Pharmaceutical Co., Ltd.
Fennec contact information:
Investor:
robert andrade
CFO
Fennec Pharma Co., Ltd.
+1 919-246-5299
media:
lindsay rocco
Elixir Health Public Relations Department
+1 862-596-1304
Norgin contact information:
Mathilde Corchet
chief human resources officer
contact@norgine.com
[ad_2]
Source link
