Ototoxicity

RESEARCH TRIANGLE PARK, N.C., March 19, 2024 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a commercial stage specialty pharmaceutical company, today announced that the Company will release its full year and fourth quarter 2023 financial results before the opening of the U.S. financial markets on Thursday, March 21, 2024. Management will host a conference call and webcast that day to discuss the Company’s financial and business results. Conference Call & Webcast Detail: Date: Time: Link: Thursday, March 21, 2024 8:30 a.m. Eastern Time To access the conference call, please register using . Upon registration, a dial-in number and unique PIN will be provided to join the call. To access the live webcast link, log onto and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to listen to the webcast. A webcast replay of the conference call will also be archived on for thirty days. About Fennec Pharmaceuticals Fennec Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the development and commercialization of PEDMARK® and Pedmarqsi to reduce the risk of platinum-induced ototoxicity in pediatric patients. Further, PEDMARK received FDA approval in September 2022 and European Commission Marketing Authorization in June 2023 for Pedmarqsi. PEDMARK has received Orphan Drug Exclusivity in the U.S. for seven years of market protection 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 . Corporate and Media: Lindsay Rocco Elixir Health Public Relations +1 862-596-1304 lrocco@elixirhealthpr.com

SAN DIEGO, March 18, 2024 /PRNewswire/ -- Sony Group ("Sony") announced today that it will have an exhibit at the world's largest international conference on accessibility, the "CSUN Assistive Technology Conference 2024" March 18 to 22 in Anaheim, California. Based on its Purpose, to "fill the world with emotion, through the power of creativity and technology," Sony aims to help build an inclusive future where everyone can share the moment, promoting accessibility with the theme of "Delivering innovation for an accessible future." Towards this goal, Sony intends to implement inclusive design that incorporates this perspective into their product commercialization processes by fiscal 2025. The exhibit will showcase Sony's accessible products and various inclusive design initiatives, including Access™ controller for the PlayStation® 5 (PS5®) console, which can be customized to suit each player's needs, and Float Run off-ear headphones, which is designed with speakers floating in front of the ear to allow users to enjoy music and other audio entertainment while hearing ambient sounds around them naturally. Main Exhibits PlayStation 5 Console The PS5 console features display and customization options like zoom, color correction and text size adjustments, a screen reader feature, closed captions, and chat transcription. In addition, PlayStation Studios creates a variety of industry-defining software titles with an array of vision, hearing, and motor accessibility settings. On the PlayStation Store on the PS5 console, players can explore Accessibility Tags to get detailed insight on supported accessibility features in PS5 and PS4 games. Access Controller for the PlayStation 5 Console Developed in collaboration with the accessibility community, the Access controller features an expansive array of hardware and software customization options. It allows players with disabilities to create personalized control configurations using interchangeable button and stick caps, enabling longer and more comfortable gaming sessions. This customization caters to each player's unique strength, range of motion, and physical needs. Float Run Off-Ear Wireless Headphones Float Run has a novel headphone style that positions the speaker near, but without touching, the ear canal, while leaving the ear safely uncovered while still delivering a rich sound experience. The off-ear design of Float Run provides a comfortable fit and high sound quality without needing to insert anything in the ear and keeps you in touch with your surroundings. For extended comfort, a pressure-free design sits on the ears of the wearer, so runners can enjoy comfort for longer, and without disruption. LinkBuds® Truly Wireless Earbuds LinkBuds have been created with a unique open-ring design that lets users tune into the outside world whenever they want, without compromising the listening experience. The ring driver unit features an open central diaphragm for audio transparency, so chatting with friends and connecting to surroundings is easy. Because the earbuds are small, light and do not block ears, users can keep them in all the time, confident they will not miss ambient sounds from the environment even while listening to music or participating in online meetings. With Wide Area Tap*1, users can double or triple tap in front of either of their ears to adjust playback. BRAVIA™ 4K OLED TV BRAVIA offers a variety of accessibility features based on feedback from people with disabilities who want to use the TV more independently, including the TalkBack screen reader for initial settings, a menu timeout function that allows users to keep menus on the screen longer, and color inversion and grayscale modes for people with low vision or visual sensitivities. Digital Cameras A selection of Sony's digital cameras carry a Screen Reader Function*2 and an Enlarge Screen Function*3. Users can confirm menus and operation screens audibly instead of visually and can easily change the magnification of the screen display with the simple press of a button operation. Retina Projection Camera kit Sony created the retina projection camera kit "DSC-HX99 RNV kit" with a laser retinal projection technology that is less affected by eye's focusing ability. By combining Cyber-shot® "DSC-HX99" and QD Laser Co., Ltd.'s viewfinder "RETISSA NEOVIEWER" *4, a digital image from the camera is directly projected to the retina, allowing people with difficulty using a conventional viewfinder a new, sharper way to view and photograph the world. Xperia 1 V Since 2021, Sony's software team has been playing a central role in improving a selection of original applications with input from employees with disabilities at Sony/Taiyo Corporation. For example, when the user engages the photo shooting feature, Photography Pro, it can inform them of the horizontal orientation information of the screen through sound cues. Self-fitting Over-the-Counter (OTC) Hearing Aids (only in the U.S. market) Sony launched two self-fitting OTC hearing aids*5 in the U.S. market in October 2022 with a different appearance from conventional hearing aids, which were developed while considering user feedback before and during development in collaboration with WS Audiology. The CRE-C10, with a sleek and discreet design that is virtually invisible, and the CRE-E10, which has a rechargeable battery and is Bluetooth® compatible*6 letting users easily connect to streaming audio or music (iOS only). *7A dedicated smartphone application allows users to easily setup their OTC hearing aids and customize to their hearing needs. Accessible Retail Display Sony will showcase a storefront display with Braille and audio product description capabilities, created in cooperation with the Braille Institute, a non-profit organization that supports the lives of people with visual impairment. The retail display with audio description capability has been installed in 10 stores in the U.S., and the Braille printing feature will be added in the near future. In addition to the above exhibits, Sony will hold Conference Sessions to showcase a selection of accessibility initiatives. Delivering Innovation for an Accessible Future Shiro Kambe, Senior Executive Vice President, Sony Group Corporation, and Neal Manowitz, President and COO of Sony Electronics North America, will share video messages regarding accessibility at Sony. Sony's ongoing accessibility initiatives will be introduced, such as collaboration with organizations for people with disabilities and the latest accessible products. Designing Tactile Dots for Sony's BRAVIA Products From the Home Entertainment area, Sony will introduce inclusive design initiatives that the position of terminals on TVs and soundbars that can be identified by touch when connecting cables, based on the concept of "Possible to do by myself", "Possible to do everything" and "Possible to enjoy together." In addition, Sony will share how its inclusive design approach not only solves issues for users with disabilities but also provides ease of use for a diverse range of users. Sony's Solutions to Accessible Imaging From the Imaging area, Sony will introduce initiatives that enable diverse users to express their creativity. In addition, Sony host a panel discussion about the importance of accessible content creation available for all creators with Sean Dougherty, a Director of Accessible User Experience Services at a non-profit organization Lighthouse for the Blind, Inc., and James Rath, a YouTuber with low vision. Accessibility Innovations from Sony Interactive Entertainment Sony Interactive Entertainment, the company behind the PlayStation brand of products, will introduce their latest efforts in accessibility, including the Access controller for the PlayStation 5 console. For further details on Sony's exhibit, please refer to the website. *1 To adjust the operation of your LinkBuds, tap between the beginning of the ear (fovea) and earlobe, and from the top of the ear (auricle) to below the earlobe. *2 Currently available on Alpha 7C II, Alpha 7CR, Alpha 7R V, Alpha 7 IV, Alpha 9 III, ILX-LR1, FX3, FX30, and Vlog camera ZV-1F, ZV-E1, ZV-1 II sold in North America. Supported languages vary depending on models and regions/countries where sold. *3 Available on Alpha 7C II, Alpha 7CR, Alpha 9 III. *4 The RETISSA NEOVIEWER is not medical equipment and is not intended to treat or assist in specific diseases or to correct vision. It may be difficult to recognize images depending on the part and degree of impairment (such as when the function of the retina is degraded). *5 FDA cleared as OTC self-fitting hearing aid intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. *6 Interoperability and compatibility among Bluetooth® devices vary. *7 Sony | Hearing control app – Use app on smartphone to personalize settings. Download app at Google Play and the App Store. Network services, content, and operating system and software subject to terms and conditions and may be changed, interrupted or discontinued at any time and may require registration. "Sony," "SONY" logo and any other product names, service names or logo marks used in this website are registered trademarks or trademarks of Sony Group Corporation or its affiliates. Other product names, service names, company names or logo marks are trademarked and copyrighted properties of their respective owners and/or licensors. SOURCE Sony Electronics, Inc.

Agreement pairs Norgine’s commercial expertise and leading European footprint with PEDMARQSI®, the first and only approved therapy in the European Union and U.K. for reducing the risk of cisplatin-induced hearing loss in pediatric patients with localized, non-metastatic solid tumors Fennec will receive €40 million in upfront and up to €210 million in additional commercial and regulatory milestones, and tiered royalties up to the mid-twenties Enhances Norgine’s commitment to bringing transformative therapies to patients in Europe, U.K., Australia, and New Zealand who currently do not have access to a therapy to treat this life altering condition RESEARCH TRIANGLE PARK, N.C. and UXBRIDGE, United Kingdom, March 17, 2024 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a commercial stage specialty pharmaceutical company, and Norgine, a leading European specialist pharmaceutical company, today announced an exclusive licensing agreement under which Norgine will commercialize PEDMARQSI® in Europe, Australia and New Zealand. PEDMARQSI is the first and only approved therapy in the EU and U.K. for the prevention of ototoxicity (hearing loss) induced by cisplatin chemotherapy in patients 1 month to < 18 years of age with localized, non-metastatic solid tumors. Under the terms of the licensing agreement, Fennec will receive €40 million in upfront consideration and up to €210 million in additional commercial and regulatory milestone payments and double-digit tiered royalties on net sales of PEDMARQSI in the licensed territories up to the mid-twenties. Norgine will be responsible for all commercialization activities in the licensed territories and will hold all marketing authorizations in the licensed territories. It is estimated that more than 5,000 pediatric patients annually are eligible for platinum-based chemotherapy in Europe. PEDMARQSI was granted EU marketing authorization by the European Commission in June 2023, and received UK approval from the MHRA in October 2023. Approvals were based on safety and efficacy data from two open-label, randomized Phase 3 trials, SIOPEL 6 (pivotal) and Clinical Oncology Group [COG] Protocol ACCL0431. The studies compared PEDMARQSI plus cisplatin-based regimens to cisplatin-based regimens alone for the reduction of cisplatin-induced hearing loss in pediatric patients. PEDMARQSI holds eight years plus two years of data and market protection in Europe based on its Pediatric Use Marketing Authorization. Approval in Switzerland, Australia and New Zealand will also be pursued. The first study (SIOPEL-6) involved 114 children with hepatoblastoma (a cancer of the liver), with an average age of about 19 months. The results showed that 35% (20 out of 57) of children who received PEDMARQSI 6 hours after each dose of cisplatin developed hearing loss compared with 67% (35 out of 52) of children who only received cisplatin. The second study involved 125 children aged 1 month to 18 years with different types of cancer, including hepatoblastoma, neuroblastoma (a cancer of immature nerve cells) and tumours of the central nervous system. The study found that hearing loss was experienced by 29% (14 out of 49) of children who received PEDMARQSI after each cisplatin dose compared with 56% (31 out of 55) of those who received only cisplatin. “We are delighted to partner with Norgine, who shares our belief in the potential of PEDMARQSI to mitigate the risk of permanent and irreversible hearing loss that can occur in pediatric patients treated with cisplatin. Further, this partnership is an important step in achieving our mission of expanding PEDMARQSI to patients across the globe who are at risk of suffering from cisplatin-induced ototoxicity,” said Rosty Raykov, Chief Executive Officer of Fennec Pharmaceuticals. “From a deal perspective, the terms provided us many important benefits, including an upfront payment further solidifying our balance sheet, attractive economic terms providing meaningful participation in the ex-US success of PEDMARQSI and an experienced partner to successfully launch PEDMARQSI in the licensed territory.” Chris Bath, Chief Executive Officer of Norgine, said, “We are thrilled to announce our partnership with Fennec, to bring this vital medicine to pediatric patients who are being treated with cisplatin, across Europe and ANZ. We look forward to working with the Fennec team and launching PEDMARQSI in our territories in the coming months, establishing it as the standard of care in this critical patient population with high unmet need. This important milestone for our company builds on our 30-year track record of creating partnerships of enduring value and further underscores Norgine’s position as the specialty pharma partner of choice across Europe and ANZ.” Moelis & Company LLC acted as financial advisor, and LaBarge Weinstein LLP acted as legal advisor to Fennec. Arnold & Porter acted as legal advisor to Norgine. About Fennec Pharmaceuticals Fennec Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the development and commercialization of PEDMARK® and PEDMARQSI® to reduce the risk of platinum-induced ototoxicity in pediatric patients. PEDMARK received FDA approval in September 2022 and European Commission Marketing Authorization in June 2023 for PEDMARQSI. Further, PEDMARQSI received U.K. approval in October 2023. PEDMARK has received Orphan Drug Exclusivity in the U.S. for seven years of market protection 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. About Norgine Norgine is a leading European specialist pharmaceutical company that has been bringing transformative medicines to patients for over a century. Commitment to transforming people’s lives drives everything Norgine does with fully integrated infrastructure and exceptional partnership approach enabling creative solutions to bring life-changing medicines to patients that they may not otherwise be able to access. Norgine is proud to have helped more than 25 million patients annually around the world and generated over €500 million in net product sales in 2023. Norgine has a direct presence in 18 European countries, as well as Australia and New Zealand and has a strong global network of partnerships in non-Norgine markets. Norgine possesses a flexible and fully integrated pharmaceutical business, with manufacturing (Hengoed, Wales and Dreux, France), third party supply networks and significant product development capabilities, in addition to sales and marketing infrastructure. NORGINE and the sail logo are trademarks of the Norgine group of companies. 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® and PEDMARQSI®, the market opportunity for and market impact of PEDMARK and PEDMARQSI, 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, 2022. 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®, PEDMARQSI® and Fennec® are registered trademarks of Fennec Pharmaceuticals Inc. Fennec Contacts: Investors:Robert AndradeChief Financial OfficerFennec Pharmaceuticals Inc.+1 919-246-5299 Media:Lindsay RoccoElixir Health Public Relations+1 862-596-1304 Norgine Contacts: Matilde CorucheChief People Officercontact@norgine.com