Otitis Externa

BERWYN, Pa.--( BUSINESS WIRE )--Amring Pharmaceuticals Inc. (Amring), a subsidiary of Nordic Group B.V. (Nordic Pharma), announced today that preeminent ophthalmologist Eric D. Donnenfeld, MD will Chair its U.S. Medical Advisory Board (MAB) which includes Richard Lindstrom, MD (Minnesota), Vance Thompson, MD (South Dakota), Preeya Gupta, MD (North Carolina), Paul Karpecki, OD (Kentucky), Lisa Nijm, MD, JD (Illinois), and Selina McGee, OD (Oklahoma). Dr. Donnenfeld joins the MAB as Nordic Pharma prepares to launch a novel therapy for Dry Eye Disease, LACRIFILL® canalicular gel. The FDA-cleared hyaluronic acid derivative LACRIFILL is intended to temporarily block tear drainage by the occlusion of the canalicular system. “Nordic Pharma continues to build a world class group of key opinion leaders with Eric agreeing to lead our esteemed MAB in the U.S. as we prepare to bring LACRIFILL to market. With over 30 years of clinical experience as an internationally recognized expert and pioneer in refractive, cornea and cataract surgery he brings invaluable insights for developing physician led strategies, enhancing the patient experience and phase IV study initiatives,” said Philip Gioia, President of the U.S. team that will launch LACRIFILL under the Nordic Pharma brand. “As one of the leading refractive and cataract surgeons in the United States he shares Nordic Pharma’s commitment to making a sustainable impact on the health of people with dry eye disease.” "I have been fortunate to work closely with Eric over the last 20 years. He is an outstanding clinician and surgeon with a pulse on new technology," said Jai G. Parekh, MD, MBA, Chief Commercial Officer of Nordic Pharma Eye Care U.S. "Eric is responsible for many of the most successful launches in eye care and our team looks forward to collaborating with him. He will be instrumental in guiding us during LACRIFILL's introduction to eye care providers and patients." “I’m excited to be part of the LACRIFILL launch as this technology is disruptive and will change the way we practice ophthalmology and optometry,” said Dr. Donnenfeld. “It’s an honor to be working with Nordic Pharma’s leadership and our highly respected Medical Advisory Board to bring this novel dry eye disease therapy to ophthalmologists and optometrists across the U.S. and then around the world.” In addition to Dr. Donnenfeld’s appointment, Nordic Pharma has proudly accepted an invitation to join the American-European Congress of Ophthalmic Surgery (AECOS) and will have a significant presence at the AECOS Winter Symposium this week. Dr. Vance Thompson will be sharing benefits of LACRIFILL with physicians and leaders in ophthalmology. Select pre-order opportunities will also be discussed. Dr. Thompson will also be presenting the Dry Eye Disease Update session. About Eric D. Donnenfeld, M.D. Dr. Donnenfeld is the founding partner of Ophthalmic Consultants of Long Island and Ophthalmic Consultants of Connecticut. He has authored more than 210 papers on the cornea, external disease, cataracts, and refractive surgery, 500 scientific articles, and 50 books and book chapters on a range of subjects pertaining to corneal transplants, cataract care, and laser vision correction. Dr. Donnenfeld is on the editorial board of nine journals and has participated in over 40 FDA studies. He is one of the first 5 people in the world to perform both laser vision correction and laser cataract surgery. Dr. Donnenfeld is a Fellow of the American Academy of Ophthalmology and has received its Honor Award, Senior Honor Award, Life Achievement Honor Award, and Secretariat Award. He is past President of the American Society of Cataract and Refractive Surgery, President-elect of the International Intraocular Implant Society, and Editor in Chief of EyeWorld. He was named #1 on Newsweek’s America’s Best Eye Doctors list in 2022 and 2021. In addition, Cataract & Refractive Surgery Today recognized Dr. Donnenfeld as one of the Top 50 Most Influential Ophthalmologists in the United States; The Ophthalmologist named Dr. Donnenfeld to their Power List in 2022, 2020 and 2018; and he was also selected as Ophthalmology Management’s 25 Leaders in Innovation. About Nordic Group B.V. Nordic Group B.V. is a privately owned, medium-size international pharmaceutical company which focuses on the development and commercialization of specialty products. Portfolio enhancement has been accomplished through targeted developments and focused acquisitions to build a foundation in Eye Care, Rheumatology and Women’s Health. Nordic Pharma has established deep roots throughout Europe, and more recently, expanded outside of Europe with increased acquisitions worldwide. Nordic Pharma is a part of SEVER Life Sciences, a holding company created in 2019 that brings together three diverse but complementary companies that offer a wide range of products, pharmaceutical development services and delivery technologies. About Amring Pharmaceuticals Inc. Amring Pharmaceuticals Inc., subsidiary of Nordic Group B.V., is partnered with well-established global biopharmaceutical companies and is uniquely positioned to leverage its expertise in bringing biotechnology derived medicines, sterile manufacturing and other state-of-the-art technologies to the marketplace. Safe Harbor This press release contains forward-looking statements, including, without limitation, statements related to Amring/Nordic Pharma’s business developments and the implementation of Amring/Nordic Pharma’s strategic initiatives. Because these statements reflect Amring/Nordic Pharma’s current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties that could cause actual developments and results to differ materially from Amring/Nordic Pharma’s expectations. These factors include, but are not limited to, general market conditions, regulatory trends, changes in the financial conditions of third parties dealing with Amring/Nordic Pharma, and other factors that could affect Amring/Nordic Pharma’s business and financial performance. Amring/Nordic Pharma does not assume any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

LONDON and NEW YORK, Jan. 31, 2024 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage biopharmaceutical company developing innovative therapies for the treatment of inflammatory dry eye disease (DED), a multi-billion-dollar market, and for neuropathic corneal pain (NCP), a severe ocular condition without an FDA approved therapy, announces that following its positive safety and efficacy results in its Phase 2 trial of OK-101, distinguished ophthalmologists, Victor Perez, M.D. and Anat Galor, M.D., both from the Bascom Palmer Eye Institute, and Mark Milner, M.D., of the Goldman Eye in Palm Beach Gardens, Florida, have joined OKYO’s Scientific Advisory board. These prominent corneal surgeons and leaders in the field of ophthalmology will advise OKYO’s management on OK-101 clinical development for the treatment of dry eye disease and neuropathic corneal pain. Dr Victor Perez is a Director of Cornea Research at Bascom Palmer Eye Institute, at the University of Miami Miller School of Medicine. He is a clinician-scientist investigator in the field of ocular immunology and ocular surface diseases and served as Director of Duke Eye Center’s Ocular Immunology Center before joining Bascom Palmer Eye Institute. Dr. Anat Galor is a cornea and uveitis trained specialist with dual appointments at the Bascom Palmer Eye Institute and the Miami VA medical center. Dr. Galor completed an ophthalmology residency at the Cole Eye Cleveland Clinic, a uveitis fellowship at the Wilmer Eye Institute, and a cornea and external diseases fellowship at Bascom Palmer Eye Institute. Dr. Galor currently runs the ocular surface pain program at the Bascom Palmer Eye Institute and the Miami VA and has focused her research on understanding mechanisms of pain in dry eye, with an emphasis on studying new diagnostic and treatment modalities. Dr. Mark Milner is Director of Cornea at Goldman Eye in Palm Beach Gardens, Florida with a focused interest in dry eye disease and dysfunctional tear syndrome. Dr. Milner completed his ophthalmology residency at the New York Eye and Ear Infirmary and his fellowship in cornea, external disease and uveitis at Francis I. Proctor Foundation at the University of California, San Francisco. Dr. Milner served as an Associate Clinical Professor at Yale University Medical School, Department of Ophthalmology, and was previously the Director of the Cornea Clinic at The Veterans Administration Medical Center in West Haven, CT. "Following our positive safety and efficacy results in our Phase 2 trial in DED, we are pleased to add eminent physicians with a deep understanding of ocular surface diseases and neuropathic corneal pain to OKYO’s Scientific Advisory Board," said Gary S. Jacob PhD, CEO of OKYO Pharma. "As we continue to focus our efforts on the advancement of OK-101 for the millions of patients who suffer from DED and NCP, Drs. Perez, Galor, Milner, and our existing Scientific Advisory Board Members Drs. Pedram Hamrah and Jay Pepose, can offer unmatched insight into their respective clinical development programs. OKYO's Scientific Advisory Board now has an ideal blend of clinical expertise, including ocular surface disease and neuropathic corneal pain, from the leading experts in those fields." On January 8, 2024, OKYO announced positive safety and efficacy results in its Phase 2, randomized, double-masked, placebo-controlled trial evaluating the safety and efficacy of OK-101 ophthalmic solution in subjects with DED. This first-in-human trial of OK-101 established a clear and informed path for further development of OK-101 in Phase 3 registration trials. OKYO management plans to host a conference call to provide further data on the trial results once the Company has finished a more comprehensive analysis of the data from the trial. The conference call is planned for Q1, 2024. About Dry Eye DiseaseDry eye disease is a common condition that occurs when an individual’s tears are unable to adequately lubricate the eyes. This condition affects approximately 49 million people in the U.S. alone and has been a difficult one to positively diagnose and to treat due to the multifactorial nature of the condition. Several contributing factors can lead to this condition, including age, sex, certain medical conditions, reduced tear production and tear film dysfunction. Tear film instability typically leads to inflammation and damage to the ocular surface. About NCPNeuropathic corneal pain (NCP) is a condition that causes the eyes, face, or head to be painful and overly sensitive. The exact cause of NCP is unknown but thought to result from nerve damage to the cornea combined with inflammation. NCP, which can exhibit as a severe, chronic, or debilitating condition in patients suffering from a host of ophthalmic conditions, is presently treated by various topical and systemic treatments in an off-label fashion. There are no approved commercial treatments currently available for this condition. About OK-101OK-101 is a lipid conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor which is typically found on immune cells of the eye responsible for the inflammatory response. OK-101 was developed using a membrane-anchored-peptide technology to produce a novel long-acting drug candidate for treating dry eye disease. OK-101 has been shown to produce anti-inflammatory and pain-reducing activities in mouse models of dry eye disease and corneal neuropathic pain (NCP), respectively, and is designed to combat washout through the inclusion of the lipid anchor built into the drug molecule to enhance the residence time of OK-101 within the ocular environment. OK-101 showed clear statistical significance in multiple endpoints in a recently completed Phase 2, multi-center, double-blind, placebo-controlled trial to treat dry eye disease. About OKYOOKYO Pharma Limited (NASDAQ: OKYO) is a clinical stage biopharmaceutical company developing innovative therapies for the treatment of DED and NCP, with ordinary shares listed for trading on the NASDAQ Capital Market. OKYO is focused on the discovery and development of novel molecules to treat inflammatory DED and ocular pain. In addition to the recently completed Phase 2 DED trial, OKYO also has plans underway for the opening of a Phase 2 trial for OK-101 to treat NCP in patients with this debilitating condition. For further information, please visit www.okyopharma.com. Forward-Looking StatementsCertain statements made in this announcement are forward-looking statements, including with respect to the anticipated timing of completion of enrolment of the Company’s Phase 2 trial of topical ocular OK-101 to treat DED and the release of top-line data therefrom. These forward-looking statements are not historical facts but rather are based on the Company’s current expectations, estimates, and projections about its industry, its beliefs, and assumptions. Words such as ‘anticipates,’ ‘expects,’ ‘intends,’ ‘plans,’ ‘believes,’ ‘seeks,’ ‘estimates,’ and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company’s control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority. Enquiries: OKYO Pharma LimitedGary S. Jacob, Chief Executive Officer917-497-7560Business Development & Investor RelationsPaul Spencer+44 (0)20 7495 2379

CINCINNATI, Aug. 28, 2023 (GLOBE NEWSWIRE) -- Blue Water Biotech, Inc. (“Blue Water” or the “Company”), a biotechnology and pharmaceutical company spanning multiple sectors, today announced that it received a delinquency notification letter (“Notice”) from the Listing Qualifications staff of the Nasdaq Stock Market LLC (“Nasdaq”) on August 22, 2023 due to the Company’s non-compliance with Nasdaq Listing Rule 5250(c)(1) as a result of the Company’s failure to timely file its Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2023 (the “Form 10-Q”). Nasdaq Listing Rule 5250(c)(1) requires listed companies to timely file all required periodic financial reports with the Securities and Exchange Commission (the “SEC”). The Notice states that the Company has 60 calendar days to submit to Nasdaq a plan to regain compliance with the Nasdaq Listing Rules. If Nasdaq accepts the Company’s plan, then Nasdaq may grant the Company up to 180 calendar days from the prescribed due date for filing the Form 10-Q or until February 20, 2024, to regain compliance. If Nasdaq does not accept the Company’s plan, then the Company will have the opportunity to appeal that decision to a Nasdaq Hearings Panel. As previously disclosed, the Company requires additional time to prepare, review and finalize its financial statements. The Company is working diligently to complete the Form 10-Q as soon as practicable, but due to the ongoing review of Company employee expenditures and the classification thereof, as previously announced in a Form 8-K filed on August 22, 2023, the Company is not currently in a position to advise when the Form 10-Q will be filed. This announcement is made in compliance with Nasdaq Listing Rule 5810(b). About Blue Water Biotech Blue Water Biotech, Inc. is a biotechnology and pharmaceutical company focused on developing and commercializing transformational therapies to address significant health challenges globally. Headquartered in Cincinnati, OH, the Company owns ENTADFI®, an FDA-approved, once daily pill that combines finasteride and tadalafil for the treatment of benign prostatic hyperplasia. This combination allows men to receive treatment for their symptoms of benign prostatic hyperplasia without the negative sexual side effects typically seen in patients on finasteride alone. The Company is also in the process of acquiring the approved therapies from WraSer, LLC, and Xspire Pharma, LLC, including ZONTIVITY® (reduction of thrombotic cardiovascular events in patients with myocardial infarction or with peripheral arterial disease), OTOVEL® (acute otitis media with tympanostomy tubes), CETRAXAL® (acute otitis externa), CONJUPRI® (hypertension), TREZIX™ (moderate to severe pain) and NALFON® (NSAID treatment for pain and inflammation). The Company also has a robust preclinical vaccine pipeline. Blue Water holds the rights to proprietary technology developed at the University of Oxford, Cincinnati Children’s Hospital Medical Center, St. Jude Children’s Hospital, and The University of Texas Health Science Center at San Antonio. Blue Water is developing a Streptococcus pneumoniae vaccine candidate, designed to specifically prevent highly infectious middle ear infections, known as AOM, in children, and prevention of pneumonia in the elderly. The Company is also developing a universal flu vaccine that will provide protection from all virulent strains in addition to licensing a novel norovirus S&P nanoparticle versatile virus-like particle vaccine platform from Cincinnati Children’s to develop vaccines for multiple infectious diseases, including Marburg and monkeypox, among others. Additionally, the Company is developing a Chlamydia vaccine candidate with UT Health Science Center San Antonio to prevent infection and reduce the need for antibiotic treatment associated with contracting Chlamydia disease. For more information about Blue Water, visit www.bwbioinc.com. Media Contact Information:Blue Water Media RelationsTelephone: (646) 942-5591Email: Nic.Johnson@russopartnersllc.com Investor Contact Information:Blue Water Investor RelationsEmail: investors@bwbioinc.com