Positive results for Novo’s Xultophy

pharmatimes | June 10, 2019

Novo Nordisk’s Xultophy (degludec/liraglutide) has been found to significantly delay time-to-treatment intensification when compared to insulin glargine U100 in adults with type II diabetes inadequately controlled on oral treatments. The DUAL VIII trial results were presented at the 79th Scientific Sessions of the American Diabetes Association (ADA) in San Francisco and simultaneously published in The Lancet Diabetes and Endocrinology. The insulin degludec and liraglutide combination helps patients achieve blood glucose targets, with a well-established safety profile. The data showed that over 104 weeks, around 63% of study participants who received Xultophy did not require additional treatment, compared to approximately 34% of those who received insulin glargine U100. With the goal of mirroring clinical practice, participants were followed on average every three months, and met treatment intensification criteria when HbA1c measurements were ≥7% over two consecutive periods. After the same amount of weeks the Xultophy arm required significantly less insulin units (37 vs 52), experienced a significantly lower weight gain (+1.7 kg vs +3.4 kg), and had a 56% lower rate of severe or blood glucose-confirmed symptomatic low blood sugar. Vanita Aroda, director of Diabetes Clinical Research at Brigham and lead trial investigator said that in the trial they “were not just looking at clinical markers, such as HbA1c or effect on weight, but were addressing a key clinical question: how long would each treatment help patients achieve and maintain effective blood sugar control once initiated”.

Spotlight

The past decade has seen a significant shift in the nature of the products being manufactured and sold by the innovative biopharmaceutical (biopharma) industry. The global biopharmaceutical portfolio of today reflects increased therapeutic competition, a greater prevalence of large molecule drugs, expansion in the number of personalized or targeted products, and a rise of treatments for many orphan diseases.


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BUSINESS INSIGHTS

The Danish National Genome Center Partners with Lifebit to Deliver Nationwide Personalised Medicine

Lifebit Biotech | April 29, 2022

Lifebit, whose leading technology enables secure analysis over sensitive datasets for researchers and interconnects such large patient cohorts worldwide, today announces a long-term partnership with the Danish National Genome Center (NGC). Lifebit will deploy Lifebit CloudOS to create a Federated Trusted Research Environment within the Danish NGC's supercomputing cluster to serve as the scalable and secure data management and analysis platform for Denmark's national researchers, clinical scientists and international collaborators. The Danish NGC, a government agency and authority within the Danish Healthcare system, was created to implement the Danish Government's National Personalised Medicine Strategy. The core vision of the NGC is to develop more precise diagnosis, targeted treatment and strengthen research within the Danish healthcare system. During the first phase of the strategy, the Danish National Genome Center and its collaborators will recruit and sequence whole genomes of 60,000 patients diagnosed with cancer, autoimmune disorders and rare diseases by 2024. The platform will deliver a next-generation computational infrastructure within Denmark's on-premise supercomputing center, allowing the NGC to meet its vision of establishing and operating a state-of-the-art national infrastructure for personalised medicine while keeping the data at all times in the secure national infrastructure. Only Lifebit with both its genomic data expertise as well as its internationally proven ability of managing such complex Government environments through its patented operating system Lifebit CloudOS was deemed capable to deliver this project. The platform will thus enable researchers with secure access, querying and analysis of this sensitive clinico-genomic data in a fully scalable and flexible way; also allowing for them to collaborate at a global scale. Federation will play a crucial role in enabling the future possibility to collaborate with international partners such as Genomics England, France Genomique, Genomic Medicine Sweden and other biobanks from around the world. Virtually connecting these sensitive datasets, enabling joint analysis that is however performed in situ without moving data, can lead to exponentially higher research findings. In some cases, it can be observed that increasing the number of patients in a study by 10x led to ~100x the number of scientific findings and genomic associations making clear how important real connectivity of these datasets is. "Lifebit continues to guide and power the world's largest national and private precision medicine programmes. We are extremely proud to be delivering this flagship programme for the nation of Denmark. This Federated Trusted Research Environment will enable researchers to more effectively collaborate over this rich dataset at scale and drive international collaboration between other government initiatives - many of which already leverage Lifebit's federated technology." Thorben Seeger, Chief Business Development Officer at Lifebit Other examples of Lifebit's data platform at work include Genomics England, NIHR Cambridge and the Hong Kong Genome Institute. About Lifebit Biotech, Ltd. Lifebit builds enterprise data platforms for use by organisations with complex and sensitive biomedical datasets. Lifebit's patented federated technology securely unlocks access to biomedical data. From providing Trusted Research Environments for national precision medicine programmes to enabling pharmaceutical companies to discover new drug targets faster, Lifebit empowers customers to transform how they leverage sensitive biomedical data.

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BUSINESS INSIGHTS

AIkido Pharma Announces Strategic Investment in Social Communications Platform Provider Discord, Inc

AIkido Pharma Inc. | May 05, 2022

AIkido Pharma Inc. announced that the Company has secured an early equity interest in privately-held Discord, Inc. a social communications platform provider that is particularly popular with gamers. Bloomberg Technology reported on March 14, 2022, that Discord "is interviewing bankers about going public as soon as this year." According to the Bloomberg report, "Discord, last valued by private investors at about $15 billion, is especially popular with gamers and young people. Its success caught the attention of potential suitors, including Microsoft Corp., which was rebuffed after offering $12 billion for it last year." According to The Straits Times, Discord has also held discussions with Epic Games and Amazon.com in the past. "This investment fits well into our strategy to maximize opportunity for liquidity and monetization events for our shareholders. We believe the offer by Microsoft to buy the company bodes well for this investment, as does a potential near-term IPO." Anthony Hayes, CEO of AIkido About AIkido Pharma Inc. AIkido Pharma Inc. was initially formed in 1967 and is a biotechnology Company with a diverse portfolio of small-molecule anticancer and antiviral therapeutics. The Company's platform consists of patented technology from leading universities and researchers, and we are currently in the process of developing an innovative therapeutic drug platform through strong partnerships with world renowned educational institutions, including The University of Texas at Austin and University of Maryland at Baltimore. Our diverse pipeline of therapeutics includes therapies for pancreatic cancer, prostate cancer. We are constantly seeking to grow our pipeline to treat unmet medical needs in oncology. The Company is also developing a broad-spectrum antiviral platform that may potentially inhibit replication of multiple viruses including Influenza virus, SARS-CoV MERS-CoV, Ebolavirus and Marburg virus.

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BUSINESS INSIGHTS

Vivera Enters $23 Billion Telehealth Industry with Patent Allowance for MDZone

Vivera Pharmaceuticals, Inc. | April 25, 2022

Vivera Pharmaceuticals, Inc. is pleased to announce that it has received a Notice of Allowance for U.S. Patent Application No. 17/066,985 entitled, "Self-Contained, Portable, Sanitization Device and Telemedicine Station," for the Company's MDZone platform from the United States Patent and Trademark Office. This Notice of Allowance indicates that the patent application has passed its examination for issuance. MDZone will be a HIPAA compliant, portable telemedicine station that will allow patients to access health care and connect with a medical provider remotely. Broadly patented for multiple points of utilization, MDZone will make health care more affordable and accessible than ever for communities across the country. Telehealth services and technology are often more convenient in terms of both scheduling and transportation than in-office visits and have been instrumental in improving access to medical care for many patients. Patients who can benefit from telehealth include those with mobility limitations or other challenges that can make it difficult to attend in-person doctor visits. Virtual care has also been considered a tool to increase accessibility to health care in rural communities where physician shortages are more prevalent. The COVID-19 pandemic accelerated the use of telehealth for various appointment types, including general wellness and preventative care, medication management, and pre-visit lab orders. Lockdowns, social distancing, hospitals at capacity, and delayed surgeries and routine preventative care visits have contributed to a current surge in serious illnesses and even an increased incidence of death from medical complications that could have been prevented. While telehealth won't completely replace in-office appointments, it is helping a health care system, stretched thin on everything from beds to staffing to heightened costs, with a more streamlined and effective touchpoint to provide patients with enhanced access to medical care. "The pandemic prompted a shift in the rapid adoption of telehealth services worldwide. A number of serious illnesses and even deaths could have been prevented if we had technology like MDZone available from the beginning of the pandemic to provide quality care to patients from the comfort of their homes, schools, or offices. Many people developed new medical conditions or experienced worsening of existing ones, and their suffering could have been prevented if we had the right systems in place." Paul Edalat, CEO of Vivera MDZone is designed to be a complete turn-key solution for health screenings. It can measure a patient's biometric data, including heart rate, blood pressure, and blood glucose, and allow the medical provider to provide interactive medical evaluation and feedback. If the measured values were outside of recommended ranges, the patient would be provided with a treatment plan, which could include dietary change suggestions, a prescription for medication, a lab order, or a recommendation for an in-person. "MDZone will give people access to health care as often as they need it without having to visit a doctor's office," said Vivera's Chief Medical Officer, Stephen J. McColgan, M.D., M.B.A. "In turn, they will be able to make real-time decisions about their treatment plan, translating to better patient outcomes." Even with patients returning to in-person doctor's office visits, the need for telehealth services is expected to continue increasing. In 2021, the U.S. telehealth market size was valued at $23.5 billion and is expected to expand at a compound annual growth rate (CAGR) of 44.4% from 2022 to 2028. In addition to making health care more accessible, MDZone will also make it more affordable. Vivera's technology can be life-changing for low-income communities and schools with limited resources. Many schools don't have a full-time on-site nurse. By utilizing the telemedicine station to conduct student health screenings, MDZone may eliminate the need to see a nurse in some instances while still providing quality care. Vivera maintains a solid intellectual property strategy with six patents granted and 26 patents pending. Receiving its patent for MDZone as a self-contained, portable telemedicine station will strengthen and expand the Company's patient-centric patent portfolio. About Vivera Pharmaceuticals Vivera Pharmaceuticals is an innovative, science-driven pharmaceutical company located in Southern California. The Company has global exclusivity to license the patented and patent-pending TABMELT® sublingual drug delivery system for pharmaceutical use and holds its own issued patents on ZICOH®, a smart dose-controlled medical device. It also has patents pending on its telemedicine station, MDZone. With multiple divisions, including its pharmaceutical, neurosciences, medical technology, biosciences, and advanced diagnostics divisions, Vivera Pharmaceuticals is vertically integrated with patented technology, manufacturing capabilities, and distribution for its products.

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PHARMA TECH

IACTA Pharmaceuticals and TALLC Corporation Announce Strategic Collaboration to Utilize Novel SmartCelle Topical Delivery Technology

IACTA Pharmaceuticals, Inc. | December 16, 2021

IACTA Pharmaceuticals, Inc. an innovation leader in ophthalmic therapeutics, and TALLC Corporation Inc. a pioneering ophthalmology company focused on the growing unmet needs of patients with corneal and retinal conditions, announced that they are entering into a strategic collaboration and licensing agreement. The agreement grants IACTA the use of TALLC’s proprietary SmartCelle™ micellar technology, a novel platform for pan-ocular drug delivery, for future clinical development. IACTA plans to utilize TALLC’s SmartCelle technology to deliver one or more of its novel ophthalmic therapeutics, as well as co-develop new ophthalmology therapeutic candidates that leverage IACTA’s formulation and clinical expertise with TALLC’s novel delivery technology. The collaboration also includes an option agreement, granting IACTA exclusive rights to negotiate a separate license agreement for the right to co-develop TALLC’s lead product candidate TA-A001, a novel anti-inflammatory anti-angiogenic molecule with analgesic properties in various disease state models. “I am thrilled to be able to partner with TALLC, a company with a shared vision focused on addressing the growing and significantly underserved ocular pain market. IACTA was formed with the mission of developing and commercializing innovative ocular therapies through novel compounds and utilizing leading drug delivery technologies, and we view this collaboration as the perfect synergy to realize the full potential of our ophthalmology pipeline. We are excited to explore how best to deploy the SmartCelle technology within our current pipeline, as well as the future co-development opportunities this partnership provides.” Damon Burrows, Chief Executive Officer of IACTA Pharmaceuticals TALLC’s proprietary SmartCelle pan-ocular drug delivery technology employs 30nm micelles that enable delivery of difficult to formulate drugs into corneal and retinal tissues after topical delivery. The company’s pipeline is led by SmartCelle TA-A001, a novel CB2 receptor activator, delivered topically to treat the effects of dry eye syndrome and age-related macular degeneration. “We are delighted to partner with the IACTA team for this important program. IACTA, with its in depth scientific and commercial understanding of the ophthalmic space is an ideal partner for TALLC as we drive towards further commercialization of the SmartCelle platform and TA-A001,” said Damon Smith, Ph.D., Chief Executive Officer of TALLC. “We look forward to working closely with the IACTA team and to co-developing SmartCelle versions of the IACTA pipeline.” About TALLC, Inc. TALLC is a Montreal-based developer of ophthalmic medicines actively engaged in the commercialization of SmartCelle TA-A001, and its pipeline of SmartCelle-delivered drug candidates, as treatments for acute and chronic inflammation. Focused initially on unmet needs in inflammatory front of eye indications, TALLC plans also to develop SmartCelle TA-A002 and TA-A003 in other chronic conditions including macular degeneration and glaucoma. SmartCelle enables pan ocular delivery of drug candidates by topical application directly to the ocular surface, by injection or by insufflation. About IACTA Pharmaceuticals, Inc. IACTA is an innovation leader in ophthalmic therapeutics, led by former top executives from one of the leading eye care companies in the world. The company currently has four products in development for major market opportunities. IC 800 is a novel, non-opioid, dual enkephalinase inhibitor, being studied for the treatment of acute ocular pain. In addition, IACTA’s IC 265, is a SYK kinase inhibitor being developed as a potential novel treatment for dry eye disease.

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Spotlight

The past decade has seen a significant shift in the nature of the products being manufactured and sold by the innovative biopharmaceutical (biopharma) industry. The global biopharmaceutical portfolio of today reflects increased therapeutic competition, a greater prevalence of large molecule drugs, expansion in the number of personalized or targeted products, and a rise of treatments for many orphan diseases.

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