Conjunctivitis, Bacterial

RTI International congratulates Lao PDR in eliminating LF — a disabling disease impacting the lives of millions of people around the world RESEARCH TRIANGLE PARK, N.C., Oct. 18, 2023 /PRNewswire/ -- RTI International, a nonprofit research institute and leading international development organization, joins the Lao People's Democratic Republic (Lao PDR), World Health Organization, and the U.S. Agency for International Development (USAID) in celebrating Lao PDR's achievement of eliminating lymphatic filariasis as a public health problem. Also known as elephantiasis, lymphatic filariasis is a neglected tropical disease (NTD) that can cause swollen extremities in a person and lead to severe disfigurement and disability, as well as social and economic discrimination against those affected. As of the latest data released by WHO last week, more than 793 million people required treatment for this disease across 44 countries in Asia, Africa, the Western Pacific, and parts of the Caribbean and South America. WHO officially confirmed this week that the people of Lao PDR are no longer at risk of contracting the disease. "RTI sends our sincerest congratulations to the government of Lao PDR and its people for solving this pressing public health problem," said Tim Gabel, president and CEO of RTI International. "It is particularly significant given that Lao PDR achieved the elimination of trachoma as public health problem in 2017, demonstrating the power of national commitment to ending neglected tropical diseases." RTI supported this milestone through its leadership of USAID's Act to End NTDs | East program, which has advanced the sustainable control and elimination of NTDs in 13 countries across Africa, Asia and Latin America. RTI worked with the government of Lao PDR to compile the data and information needed to establish proof that the country had eliminated lymphatic filariasis as a public health problem. Additionally, with USAID support, RTI assisted the government to develop a plan to monitor and track progress against the disease to ensure elimination is sustained in the future. "Lao PDR is the latest example of a country that worked hard to go the last mile to reach lymphatic filariasis elimination and free its people from this disabling disease," said  Lisa Rotondo, Director of USAID's Act to End NTDs | East program at RTI. "Global momentum towards eliminating lymphatic filariasis as a public health problem, led by countries themselves, is only growing. We are proud to be among the partners that supported the Lao PDR Ministry of Health to achieve this important milestone for its people." The elimination of lymphatic filariasis in Lao PDR was supported by many partners including USAID, RTI, FHI360, WHO, Mac Foundation, and the Asian Development Bank. In addition, albendazole treatments were donated by GlaxoSmithKline through the WHO donation program for NTD medicines. The Southeast Asian country now becomes the 19th country to have achieved validation of lymphatic filariasis elimination, marking another important public health milestone for the country and globally. Recently, Bangladesh also eliminated lymphatic filariasis with support from the Act to End NTDs | East program, led by RTI. Learn more about RTI's work to control and eliminate NTDs around the globe Media Contact: Kerry Branon 919 708-8205 [email protected] SOURCE RTI International

U.S. Food and Drug Administration grants temporary discretion to import critical Erythromycin ophthalmic ointment for treatment of newbornsBOUCHERVILLE, Québec, Oct. 18, 2023 (GLOBE NEWSWIRE) -- LSL Pharma Group Inc. (TSXV: LSL), (the “Company” or “LSL Pharma Group”), a Canadian integrated pharmaceutical company, announced today that it has entered into an exclusive agreement with Fera Pharmaceuticals, LLC (“Fera”), a U.S. specialty pharmaceutical company, to provide Erythromycin ophthalmic ointment USP (5mg/g) for the treatment of newborns in U.S. hospitals. Given the scarcity of Erythromycin ophthalmic ointment south of the border, the U.S. Food and Drug Administration (“FDA”) granted Fera temporary discretion to import this vital medication used in the prevention of gonococcal ophthalmia neonatorum. The agreement essentially focuses on fulfilling the need in the one-gram tube market. Under the terms of the agreement, LSL Pharma Group, via its manufacturing subsidiary Steri-Med Pharma Inc. (“Steri-Med”), could initially supply up to 25% of the four million doses required annually in the U.S. hospital market. More Erythromycin ophthalmic ointment may become available if the drug shortage persists. “LSL Pharma Group is pleased to respond to this urgent healthcare need by making our eye medication readily available to the U.S. market,” stated François Roberge, President and Chief Executive Officer of LSL Pharma Group. “The priority, after all, is safeguarding the health and well-being of vulnerable newborns. This opportunity is a testament to the solid reputation that Steri-Med is gaining in the global market for sterile ophthalmic medications. We hope that this collaboration will go a long way in meeting patient needs today and opening new doors for the future.” “We appreciate the collaboration with FDA and Steri-Med in order to ensure adequate supply in the U.S. of this important product,” said Frank DellaFera, President and Chief Executive Officer of Fera. About LSL Pharma Group LSL Pharma Group is a Canadian integrated pharmaceutical company specializing in the development, manufacturing and distribution of high-quality natural health products and dietary supplements in solid dosage forms, as well as high quality sterile ophthalmic pharmaceutical products. For more information, please visit www.groupelslpharma.com, www.laboratoirelsl.com and www.sterimedpharma.com. About Fera Pharmaceuticals, LLC Fera Pharmaceuticals, LLC is a privately held U.S. specialty pharmaceutical company committed to expanding valuable treatment choices for the people who need them—to ensure the future is filled with quality therapeutic options to improve care, health and lives. Fera’s focus is in ophthalmology, with the potential to expand into other therapeutic arenas as the needs and opportunities arise. For more information about Fera go to www.ferapharma.com. Forward-Looking Statements Information provided and statements contained in this press release that are not purely historical are forward-looking statements within the meaning of the applicable securities laws. Certain statements in this press release may constitute forward-looking information within the meaning of securities laws. Forward-looking information may relate to LSL Pharma Group’s future outlook and anticipated events, business, operations, financial performance, financial condition or results and, in some cases, can be identified by terminology such as “may”; “will”; “should”; “expect”; “plan”; “anticipate”; “believe”; “intend”; “estimate”; “predict”; “potential”; “continue”; “foresee”, “ensure” or other similar expressions concerning matters that are not historical facts. The reader should not place undue importance on forward-looking information and should not rely upon this information as of any other date. LSL Pharma Group will not update these statements unless applicable securities laws require LSL Pharma Group to do so. LSL Pharma Group ContactFrançois Roberge, President and Chief Executive Officer Telephone: 514-664-7700Email: Investors@groupelslpharma.com Fera Pharmaceuticals ContactSusan McDougal, Executive Vice PresidentTelephone: 516-277-1449Email: contact@ferapharma.com

Phalguni Deswal @Phalguni_GD Eylea has been approved in the US for multiple indications, including wAMD, macular oedema following retinal vein occlusion, diabetic macular oedema (DME), and retinopathy of prematurity in adult and paediatric populations. Image Credit: CGN089 / Shutterstock. Sandoz is planning to file for regulatory approval in the US and EU for its Eylea (aflibercept) biosimilar in the next few months. In Q2 2023, Sandoz generated $2.4bn from biosimilar sales . To that end, the company has plans to launch four high-profile biosimilars, including Eylea, and increase their access over the coming years as part of its Act4Biosimilars initiative , especially as it is expected to split completely from its parent company Novartis by the end of 2023. Recommended Reports Reports Bacterial Vaginosis Drugs in Development by Stages, Target, MoA, RoA, Molecule Type and Key Playe... GlobalData Reports Bacterial Conjunctivitis Drugs in Development by Stages, Target, MoA, RoA, Molecule Type and Key ... GlobalData View all Companies Intelligence Bayer AG Novartis AG Amgen Inc Sandoz Inc SAMSUNG View all The approval for the biosimilar would be based on the randomised Phase III trial (NCT04864834) showing the non-inferiority of the biosimilar compared to Bayer and Regeneron ’s Eylea in wet age-related macular degeneration (wAMD). The study’s primary endpoint was met when it showed the mean change in best corrected visual acuity (BCVA) at week eight, compared to baseline, was similar for both therapies. Additionally, there was no reported difference in the safety, immunogenicity, and pharmacokinetics between the two therapies. Eylea is a vascular endothelial growth factor (VEGF) inhibitor that has been approved in the US for multiple indications , including wAMD, macular oedema following retinal vein occlusion, diabetic macular oedema (DME), and retinopathy of prematurity in adult and paediatric populations. In a press release , Sandoz chief scientific officer Claire D’Abreu-Hayling said: “This important milestone, confirming the therapeutic equivalence of the biosimilar aflibercept with the reference biologic, takes us one step closer to providing patients with a key treatment in an area of high unmet need within ophthalmology. “It also underscores our ability to provide high-quality, affordable biologics to individuals to help the treatment of their disease and highlights the rich Sandoz pipeline of biologics.” Multiple Eylea biosimilars are in the pre-registration clinical development for multiple indications, including Amgen’s biosimilar and Samsung Bioepis’ biosimilar for wAMD, Johnson & Johnson’s biosimilar for DME, and Amgen ’s biosimilar for macular oedema . Other biosimilars in Sandoz’s catalogue include the Tysabri (natalizumab) biosimilar for relapse-remitting multiple sclerosis (RRMS) , the Hyrimoz (adalimumab) biosimilar for rheumatoid arthritis and other indications, and the Denosumab biosimilar for post-menopausal women .