AstraZeneca spinoff Viela Bio scored its first FDA nod. Can it face down heavyweight rivals?

Fiercepharma | June 16, 2020

Two years after launching, AstraZeneca spinoff Viela Bio has its first FDA approval in Uplinza following Friday's nod to treat certain patients with neuromyelitis optica spectrum disorder. Analysts expect that the medicine, which won approval to treat patients who are anti-AQP4 antibody positive, can generate $586 million by 2026, according to Evaluate. But the competitive landscape could pose a challenge for the biotech's first launch. Doctors could prescribe Roche’s Rituxan or its biosimilars off label before trying Uplinza, Evaluate Vantage reports, or payers could require them to try the cheaper options first. Uplinza is a B cell depleter like Rituxan, so if those older options don’t work, docs might go another route and try Alexion’s Soliris rather than move on to Uplinza, Vantage said.

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The R&D-based Pharmaceutical Industry's response to the H1N1 influenza pandemic.

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The R&D-based Pharmaceutical Industry's response to the H1N1 influenza pandemic.

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BUSINESS INSIGHTS

Alira Health Expands North American Capabilities with the Acquisition of Artisan Healthcare Consulting

Alira Health and Artisan Healthcare Consulting | September 07, 2022

Alira Health, a patient-centric, global health care advisory, clinical research and technology company, announced the acquisition of Artisan Healthcare Consulting, a US-based consulting firm that provides strategic insights to healthcare companies. Artisan serves 12 of the top 15 pharmaceutical companies in the US, supports the C-Suite of leading biotechnology companies, and has deep expertise in over 30 therapeutic areas. The acquisition of Artisan strengthens and extends Alira Health’s Market Access and Management Consulting advisory practices in North America and globally. Clients of Alira Health and Artisan Healthcare Consulting now have access to the full breadth of advisory offerings from both firms. Alira Health clients can leverage Artisan’s deep expertise in brand strategy and analytics, new product differentiation, US market access, go-to-launch strategies, and product lifecycle management. Artisan Healthcare Consulting clients can benefit from Alira Health’s clinical operations, real-world evidence, and patient-centric technology offerings, including decentralized clinical trials (DCT), patient support programs (PSP) and digital therapeutics (DTx). “Artisan Healthcare Consulting is recognized for delivering the highest level of strategic and quantitative analysis to help healthcare leaders act decisively across their business. Artisan Healthcare Consulting’s leadership has decades of experience serving as a long-term partner to healthcare executives. We welcome them to the Alira Health team.” Jean-Francois Ricci, Chief Access Officer at Alira Health “We are delighted to join a company with such a broad and complementary set of capabilities,” said Bob Delise, CEO and Founder of Artisan Healthcare Consulting. “It is a pleasure to work with our new colleagues, and we now have access to an international team of strategists and experts who can help our customers succeed. We embrace Alira Health’s mission to humanize healthcare and look forward to offering new capabilities to all our clients.” Artisan Healthcare Consulting partners Bob Delise, Brad Ship, and Greg Wolfe will join Alira Health’s global consulting leadership team as they continue to work with their long-term clients. About Artisan Healthcare Consulting, Inc. Artisan Healthcare Consulting Inc. was founded in 2009 on the principle that outstanding client service differentiates a great consulting firm from a good one. Artisan provides strategic and analytic advice to a wide range of healthcare product companies. Artisan works across the biopharma industry to help clients steer emerging therapies through clinical development, launch them successfully, and drive success throughout the life cycle of their products. About Alira Health Alira Health is an international patient-centric, global health care advisory, clinical research, and technology company, whose mission is to humanize healthcare. We work with healthcare and life sciences organizations looking for support across their entire solutions lifecycle. From development to medical care, we complement our clients’ expertise with a full spectrum of services including research and clinical development solutions, technology-powered consulting, and real-world evidence. Our integrated and multidisciplinary team of over 600 scientists, strategists, economists, clinicians, and biostatisticians collaborate across our North American, European, and Asian offices and advise 80% of the top 50% of MedTech companies and 75% of the top 50% of Pharma companies.

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PHARMA TECH

KiOmed Pharma and Hansoh Pharma Announce License Agreement for KiOmedinevsOne in China’s Mainland, Macau and Taiwan

KiOmed Pharma and Hansoh Pharma | September 27, 2022

KiOmed Pharma, a Belgian biotechnology company with a focus on the development, manufacture and distribution of safe and effective medical devices based on a medical-grade highly pure natural chitosan-derivative, and Hansoh Pharmaceutical Group Company Limited a leading biopharmaceutical company in Asia, today announced a license agreement for the development and commercialization of KiOmedinevsOne, a carboxymethyl chitosan injection that has been launched in Europe for the treatment of knee osteoarthritis, in China’s mainland, Macau and Taiwan. Under the terms of the agreement, KiOmed will receive an upfront payment and will be eligible to receive development, regulatory and commercial milestones of up to € 66 million, as well as tiered royalties on future product sales. Hansoh will receive exclusive rights to develop and commercialize KiOmedinevsOne and its future extensions in the territory. KiOmed retains the right to develop and commercialize KiOmedinevsOne in all other global markets. Osteoarthritis is a progressive and disabling disease affecting about 250 million people worldwide. According to a recent epidemiology report, the prevalence of knee osteoarthritis in China is 8.1%. As the population in China is aging rapidly, disease burden caused by knee osteoarthritis continues to rise while safe and effective treatment options are still lacking. “We are very excited to partner with Hansoh Pharma, one of the largest biopharmaceutical entities in Greater China. We believe that with Hansoh’s impactful presence in China, their support will be essential to bring this long-acting treatment to the large population of patients suffering from osteoarthritis in China. We launched KiOmedinevsOne last year in several regions of Europe, and the feedback we continue to receive from osteoarthritis patients and physicians is great. With just one single injection to the knee, it can provide symptoms relief including pain, stiffness, and function improvement for more than 6-month. It is the world-first next generation non-animal sourced chitosan injection with a potential safety advantage over animal-sourced chitosan,” added Dr. Houtaï Choumane, CEO and Managing Director of KiOmed. Mr. François Blondel, Founder and Executive Chairman of the Board of KiOmed Pharma “KiOmed is a leader and an expert in developing natural chitosan products to fulfill unmet medical needs in different spaces. Osteoarthritis negatively impacts an individual’s quality of life and creates a large burden for the patients and their families. We are very glad to see KiOmed’s product (KiOmedinevsOne) will help to solve this problem,” said Eliza Sun, Executive Director of the Board of Hansoh Pharma. “We are also very excited to partner with them and bring this unique product to much needed patients in China.” About KiOmedinevsOne KiOmedinevsOne is a new generation single injection for the treatment of knee osteoarthritis based on world-first exclusive animal free KiOmedine® CM-Chitosan. KiOmedine® CM-Chitosan is a highly purified polysaccharide derived from Agaricus Bisporus (button mushroom) and a patented technology made in Belgium, resulting from years of research and innovation. Different from hyaluronic acid, KiOmedinevsOne has dual mechanism of action to tackle osteoarthritis discomfort and other symptoms by reducing oxidative stress and enhancing joint lubrication. Clinical studies have shown that after a single injection of KiOmedinevsOne, significant pain reduction was observed within 2 weeks and the WOMAC pain score was reduced by 66%, with a long-lasting osteoarthritis symptom reduction for at least 6 months. KiOmedinevsOne is a regulated health product which bears the CE mark under this regulation. It has been launched in Europe in 2021. About KiOmed Pharma Based in Belgium, KiOmed Pharma has a history of innovation and expertise in exclusive natural chitosan chemistry. The company develops a unique pipeline of medical devices that address unmet medical needs in high impact pathologies and major social burdens such as osteoarthritis, skin aging and ophthalmology. KiOmed Pharma's innovative pipeline is based on a solid building block exclusive technology: KiOmedine®, a medical-grade highly pure natural chitosan-derivative. About Hansoh Pharmaceutical Group Hansoh Pharma one of the largest biopharmaceutical companies in China, is committed to discovering and developing life-changing medicines to help patients conquer serious diseases and disorders.

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PHARMACY MARKET

Eyenovia's Novel Optejet® Dispenser Puts People's Eyes First

Eyenovia | September 06, 2022

Eyenovia, Inc. an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics, brings human-centric design to ophthalmology with its novel Optejet® dispenser. Traditional eye drops normally overdose the patient's eye with medication and preservatives. Eyenovia's easy-to-use, novel Optejet® dispenser administers precisely 8µL of medication to the eye, effectively treating the patient's condition while creating a more gentle dosing experience. "The unique delivery mechanism of the Optejet® will fundamentally change how we think about eye medication. Right now, traditional eye drops can result in significant dose-related side effects for the treatment of chronic illnesses like glaucoma. The Optejet® dispenser is designed for patients to experience easier administration and fewer side effects with similar efficacy." Michael Rowe, CEO of Eyenovia The Optejet® dispenser administers ophthalmic solutions horizontally using Eyenovia's proprietary Microdose Array Print (MAP™) technology. The system functions similar to an inkjet printer, delivering accurate microdoses through a precision spray. Traditional eye drops deliver four to five times larger volume than the human eye can actually hold, which causes eye drops to roll down the face and overdose the eye with preservatives. Poor delivery of eye drops is more than an inconvenience; it can prevent patients from using necessary medication because of the side effects. For example, with medication to help dilate the pupils for eye exams, up to 23% of patients experienced stinging and burning with the eye drops, causing patients to forgo eye exams. In Eyenovia studies, less than 1% of patients experienced stinging and burning. "Medications only work if patients take them, and with the Optejet, we have designed a way for patients to benefit from an easy-to-use, appropriate, lower dose spray that results in similar efficacy. We're excited for physicians and providers to be able to offer this revolutionary technology in the near future to patients who deserve a more positive experience," said Rowe. Eyenovia's first marketed invention is expected to be MydCombi™, a first-in-class drug-device combination microdose for in-office pupil dilation. This potentially will help save physician's chair time, eliminating the traditional three eyedrops used for a patient's eye exam. Other exciting innovations in the Eyenovia pipeline include MicroLine and MicroPine. About Eyenovia, Inc. Eyenovia, Inc. is an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics. Eyenovia is currently focused on the late-stage development of microdosed medications for mydriasis, presbyopia, and myopia progression.

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