PBOS | September 30, 2022
Kubota Vision Inc. a clinical-stage specialty ophthalmology company and a wholly-owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. announced today that the Company and Joslin Diabetes Center have entered into a material transfer and collaboration agreement for our Patient Based Ophthalmology Suite in-home optical coherence tomography device.
Joslin Diabetes Center is conducting two clinical studies to evaluate the ability of PBOS to identify cases of diabetic macular edema that may need treatment compared to a commercially-available OCT device. The studies will be led by Dr. Paolo S. Silva at Joslin Diabetes Center. Dr. Silva is the Co-Chief of Telemedicine at the Beetham Eye Institute of the Joslin Diabetes Center. His work is focused on innovative and investigative work in a field at the intersection of clinical care and technology with the hope of providing an ideal model for the delivery of evidence-based, highly effective, and efficient diabetes eye care to the population that needs it the most.
Joslin Diabetes Center, which is affiliated with Harvard Medical School, is a one-of-a-kind institution on the front lines of the world epidemic of diabetes — leading the battle to conquer diabetes in all of its forms through cutting-edge research and innovative approaches to clinical care and education.
Dr. Silva stated, “Through these studies, we will determine if home-based in-home optical coherence tomography is useful in the evaluation of diabetic macular edema and how we monitor patients at risk for losing vision from the condition.”
“Diabetic retinopathy is one of the most common diseases in the world. The use of our technology brings us great excitement as we continue to focus on the development of medical devices and explore further possibilities.”
Ryo Kubota, MD, PhD, Chairman, President, and CEO of Kubota Vision Inc.
PBOS is a low cost, home-based, ophthalmic self-monitoring OCT device. This small handheld device addresses needs in mobile Health applications for self-monitoring of retina health by patients, in the home and in remote field locations. The PBOS aims to improve ophthalmic treatment outcomes in patients diagnosed with and treated for wet age-related macular degeneration, diabetic macular edema and other neovascular retinal diseases. PBOS is being designed to detect nascent disease progression and support patient re-treatment prior to irreversible vision loss due to disease progression. Key features are low cost and a patient-friendly design, to be used directly by patients at home. PBOS is being designed to capture changes in retinal anatomy. Network connectivity and cloud-based technologies are used to alert the patients and their physicians of disease progression and re-treatment needs.
About Kubota Vision Inc.
Kubota Vision Inc. is a wholly owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. committed to translating innovation into a diverse portfolio of drugs and devices to preserve and restore vision for millions of people worldwide. Kubota Pharmaceutical group’s pipeline includes a wearable device for myopia control using Kubota GlassTM technology and a handheld OCT device for the monitoring of neovascular retinal diseases, to be used directly by patients.
Everest Medicines | September 19, 2022
Everest Medicines a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, announced that it has appointed Rogers Yongqing Luo as Chief Executive Officer of the Company, effective immediately. Mr. Luo will also serve as an Executive Director on Everest's Board of Directors.
Mr. Luo brings to Everest more than 25 years of experience in the healthcare industry with an extensive leadership track record across clinical development, regulatory affairs and commercialization. Previously, Mr. Luo served as President and General Manager, Greater China at Brii Biosciences and CEO of TSB Therapeutics where he spearheaded the rapid registration approval, GMP certification and successful commercialization of the amubarvimab/romlusevimab combination, the first COVID-19 neutralizing antibody treatment in China. Prior to that, he was Global Vice President and China General Manager at Gilead Sciences where he led the clinical development, regulatory approval and successful commercial launch of eight innovative therapeutics, and efforts that rapidly expanded patient access across China. Mr. Luo previously oversaw the successful launch of several high-profile medicines. He managed sales, marketing, government affairs and market access functions for various leading multinational pharmaceutical companies including Roche and Novartis, and worked two years at Novartis headquarter in Switzerland.
"As Everest Medicines continues to evolve our business strategy and expand our novel product pipeline at a rapid pace, we are thrilled to have Rogers join the Company to lead Everest through its next phase of growth in becoming a fully-integrated biopharma company in China. With his robust background as a top executive at both biotech startup and large multinational pharma companies, Rogers brings to Everest a unique set of expertise including comprehensive scientific insight, proven outstanding leadership and excellent commercialization capabilities in patient access, and a demonstrated history of successfully advancing early- and late-stage innovative pipeline to commercial launch in Greater China. In particular, Rogers' leadership will strengthen Everest's new product development and commercial capabilities as we progress toward potential approvals of our late-stage anchor product candidates, including Nefecon, Xerava, etrasimod and mRNA vaccines. We look forward to leveraging Rogers' leadership and industry expertise to generate long-term growth and success across the business."
Mr. Wei Fu, Chairman of Everest Medicines and Chief Executive Officer of CBC Group
"I'm very excited to join Everest and I look forward to working with this talented, world-class team of scientists and industry professionals to further the Company's industry leadership. We will continue to advance our late-stage pipeline towards commercialization and with our strong balance sheet, we aim to execute synergistic business development deals to accelerate our path to become an integrated biopharma," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "We will continue to invest into our discovery platform to build an innovative therapeutic pipeline for the benefit of patients with unmet needs in Greater China and other Asia Pacific markets, and to create sustained, long-term value for our shareholders."
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules, many of which are in late-stage clinical development. The Company's therapeutic areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases.
LOVE Pharma | September 09, 2022
Love Pharma Inc. an international mental health and sexual wellness company, remains extremely active in shaping itself into a real competitor in the biotech/pharmaceutical space. The company’s growth and development plan took a major leap forward this week with the announcement that Love Pharma is establishing a “strategic alliance” with Starton Therapeutics a leading clinical-stage biotechnology company in the United States.
It’s a relationship that finds Starton ideally aligned with Love Pharma’s mission of improving “quality of life” for its customers. And the benefit to Love Pharma is that Starton is well on its way to transforming standard of care therapies with its proprietary dermal drug delivery technology that allows cancer patients to receive continuous treatment so they can live better, longer.
Love Pharma’s investment in Starton Therapeutics is primarily based upon “the company’s interest in innovative drug delivery technology, such as transdermal patches that can reduce side effects, transforming patient outcomes with established, approved medicines allowing for streamlined market entry with long-term IP protections.”
A partnership with Starton offers a host of advantages to Love Pharma and its shareholders, including a wealth of experience from industry leaders, proven clinical trials using its proprietary technology, and a “continuous drug delivery” platform that Love Pharma could exploit in the development of its own clinical portfolio—especially in the “addiction” space. The company’s strategic investment certainly makes a lot of sense for the future of this young global brand.
“This investment provides our shareholders with exposure to a rapidly developing therapeutics business, which just reported positive data from a phase 1 clinical trial evaluating the pharmacokinetics and safety of the company’s continuous delivery lenalidomide program. Starton is also entering a phase 2 trial, which the U.S. Food and Drug Administration has already cleared an Investigational New Drug application for STAR-OLZ in Chemotherapy Induced Nausea and Vomiting (CINV).
Love Pharma’s Chief Executive Officer (CEO), Zachary Stadnyk, said of the relationship
“With this investment in Starton, we are building our relationship, forming an alliance, and look to Starton’s expert management team to reduce risk in our own portfolio of clinical pursuits and focus more on the addiction space.”
So, what made Starton Therapeutics an attractive investment now? Well, earlier this year, Love Pharma partnered with researchers at Johns Hopkins University. This research initiative aligns with key principles in Love Pharma’s strategy as it aims to develop innovative products that establish new consumer applications based upon science and efficacy. And to further its meticulous plan, the company likely sees a much smoother path forward by expanding its development strategy to include guidance from a vast selection of industry and clinical experts and a highly de-risked avenue into the clinic by way of this strategic alliance with Starton.
It's no secret that Love Pharma wants to develop its own clinical portfolio, and specifically, has its eye on developing therapeutic treatments for addiction. Pharmaceutical applications for addiction and recovery treatment are an unmet need and represent a growing market, including in the cannabis space where the Johns Hopkins research initiative is focused. With Starton’s mission of delivering meaningful patient outcomes by leveraging the untapped potential of continuous delivery and dermal technology, it’s obvious that Love Pharma sees this platform technology and its endless opportunities for expansion, as an ideal platform on which it can develop its own therapeutic treatment(s) for addiction.
The benefit to partnering with Starton and having access to its platform technology is that the “proof of concept” is complete, and the technology has proven it can address unmet medical needs using already FDA-approved drugs to transform patient outcomes. For Love Pharma and its shareholders, this means much of the hard work is already done.
Starton’s proprietary continuous delivery technology can increase efficacy of approved drugs, make them more tolerable, and expand their potential use. Starton uses three different delivery technologies to provide continuous, low-dose delivery as part of its strategic platform that provides a controlled, sustained release over multiple days. Starton uses proven transdermal and subcutaneous technologies to transform approved medicines–establishing superiority or new indications. It is the potential to establish a new indication/use for already approved drugs using the delivery technology, namely in the addiction space that is enticing to Love Pharma.
And Love Pharma isn’t stopping there. The company announced that “to further accelerate its planned strategic alliance with Starton, and to bolster the company’s own biotech initiatives in the area, Love Pharma is in discussions with TRPL Laboratory, the lab that develops and supports Starton’s transdermal drug delivery programs and is a global leader in transdermal delivery systems.”
Investors in Love Pharma couldn’t ask for a better way to reduce the risk associated with the company developing its own clinical portfolio than by surrounding itself with a plethora of industry and clinical leaders. That expertise begins with Pedro Lichtinger, the CEO and Chairman of the Board at Starton. Lichtinger has spent almost 40-years in the biotechnology arena, including 16 years at Pfizer as President of Global Primary Care and as Pfizer’s President of Europe.
Additionally, Love Pharma can draw from the experiences of the former Global Lead, Multiple Myeloma at Celgene, world-renowned scientific leaders in their field leading each program at Dana Farber/Harvard, Mayo Clinic, and Moffitt Cancer Center, and a breadth of operational expertise in regulatory, clinical development, manufacturing, and intellectual property.
The company stated that it is currently identifying and assessing disruptive opportunities within the transdermal biotechnology field, which it believes can be a superior delivery system in many cases for new and existing pharmaceutical therapeutic drugs. With its initial investment in Starton, the company believes it can leverage their expertise and proven success to credibly evaluate potential acquisitions in the transdermal field of advanced drug delivery systems. This news should be seen as extremely encouraging by the company’s investors as it could dramatically accelerate Love Pharma’s path to the clinic and the development of its own clinical portfolio. After all, it is these relationships in the biopharma industry that can lead to promising results and real shareholder value.
About Love Pharma Inc.
With a focus on the global sexual Health and Wellness markets, Love Pharma Inc. was founded in 2020, with a mission to bring to market innovative products that enhance sexual health and wellness while providing an improved quality of life. Love Pharma holds exclusive licenses to produce, market, package, sell, and distribute patent-protected therapeutic and pharmaceutical products throughout Europe, the United Kingdom, and North America.
About Starton Therapeutics
A clinical-stage biotechnology company focused on transforming standard of care therapies with proprietary dermal technology, so people with cancer can receive continuous treatment to live better, longer. Starton’s proprietary transdermal technology is intended to increase efficacy of approved drugs, to make them more tolerable and expand their potential use.
About Stock Market Media Group
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ICON plc | October 07, 2022
ICON plc. a world-leading healthcare intelligence and clinical research organisation, announces that it has been selected by the US Biomedical Advanced Research and Development Authority part of the Administration for Strategic Preparedness and Response in the Department of Health and Human Services to execute an anthrax vaccine clinical trial.
BARDA is providing funding to the Government and Public Health Solutions team at ICON to develop and execute a clinical trial that will evaluate the immune response to the next-generation anthrax vaccine AV7909. The team will support the evaluation of AV7909 immunogenicity kinetics by conducting clinical trial activities including but not limited to project management, clinical operations and quality assurance.
ICON has extensive experience in supporting vaccine clinical trials. It has participated in over 160 vaccine studies in the past five years. ICON’s vaccine clinical research professionals are therapeutically aligned with a leadership team that brings more than 200 years of combined experience in vaccine clinical development for commercial businesses, government, NGOs and multinational health organisations.
“We are pleased to have been selected to execute this important clinical trial. The potential for an anthrax attack is still a very real and serious threat, and we are proud to be playing our part to increase the understanding of treatment options for anthrax exposure, ultimately supporting human health.”
Edward Wright, President, ICON Government and Public Health Solutions
This clinical study will inform operational logistics and use of AV7909 should an anthrax emergency occur. The clinical studies will not expose participants to anthrax. The trial will enrol healthy adults aged 18 and older and will be conducted in the United States starting in early 2023.
BARDA, part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, is responsible for developing medical countermeasures to secure the U.S. against chemical, biological, radiological, and nuclear threats, as well as pandemic influenza and emerging infectious diseases. Since 2014, ICON has been a member of BARDA’s Medical Countermeasures Clinical Studies Network (CSN). The network is responsible for planning and executing clinical studies to support medical countermeasure development.
Bacillus anthracis, the agent that causes anthrax, is a serious bioterrorism threat due to the delivery of aerosolised spores that can cause high-mortality disease through gastrointestinal, cutaneous, inhalational or injection routes. Although clinical manifestations of the disease differ by route, inhalational anthrax is the most lethal. Inhalational anthrax infection usually develops within a week after exposure but can take up to two months. Without treatment, only about 10% to 15% of patients survive after exposure to inhaled B. anthracis spores.
Since 2015, BARDA has supported the late-stage development of AV7909, a next-generation anthrax vaccine which uses the U.S. Food and Drug Administration licensed anthrax vaccine Biothrax in combination with an immune system stimulant or adjuvant. The vaccine is being developed in partnership with its manufacturer Emergent Biosolutions Inc. to protect against anthrax post-exposure when used in combination with the recommended antibiotics.
About ICON plc
ICON is the world’s leading clinical research organisation, powered by healthcare intelligence. From molecule to medicine, we advance clinical research providing outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We develop new innovations, drive emerging therapies forward and improve patient lives. With headquarters in Dublin, Ireland, ICON employed approximately 40,500 employees in 119 locations in 53 countries as at June 30, 2022.
About ICON Government & Public Health Solutions
ICON Government & Public Health Solutions is ICON's business unit focused on direct US Government engagement, Non-Government Organisations (NGOs) and academia, providing full service and functional research solutions. In addition, ICON GPHS coordinates a Government Centre of Excellence (CoE) to lend internal federal government subject matter expertise that can be leveraged by other ICON business units when commercial clients receive federal funding on ICON awarded contracts.
About BARDA’s Medical Countermeasures Clinical Studies Network (CSN)
The CSN provides BARDA partners and medical countermeasure developers with essential tools and services to develop vaccines, therapeutics, diagnostics, and medical devices. The CSN provides comprehensive (Phases 1-4) clinical study services.