Beta interferons improve survival in people with MS

pharmaceutical-journal | April 12, 2019

Beta interferons improve survival in patients with relapsing-onset multiple sclerosis (MS) when used for at least three years, research has shown. The study, published in Brain (18 March 2019), used data from Canada and France on 5,989 people with relapsing-remitting MS who were naïve to disease-modifying therapies at study entry. During an average of 11 years of follow-up, 32% of people were exposed to beta-interferon for at least six months. Overall, there were 742 deaths due to any cause and, of these 649 were matched with between 1 and 20 controls by country, sex, age, year and disability level at study entry. It was found that those who received beta interferons were 32% less likely to die than unexposed individuals. When stratified by duration, those exposed to at least three years’ beta-interferon treatment had a 56% reduced risk of death while shorter exposure durations were not significantly related with survival.

Spotlight

A period of market exclusivity is critical for most novel pharmaceutical products and the duration of that exclusivity has a direct impact on the value of a pharmaceutical asset. There several forms of exclusivity that can apply to pharmaceutical products. This overview is a summary of one of them: the patent term adjustment.

Spotlight

A period of market exclusivity is critical for most novel pharmaceutical products and the duration of that exclusivity has a direct impact on the value of a pharmaceutical asset. There several forms of exclusivity that can apply to pharmaceutical products. This overview is a summary of one of them: the patent term adjustment.

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PHARMACY MARKET

GluCare.Health Partners with Novo Nordisk for Innovative Weight Management Patient Program

Glucare.Health and NovoNordisk: | June 09, 2022

GluCare.Health, one of the Middle East's leading health tech startups, has partnered with global pharmaceutical company Novo Nordisk, market leader in Diabetes & Obesity, to introduce a blueprint for the future of healthcare. The partnership will see a 150-patient weight management pilot program that will combine new digital bio-markers, using wearable technology and devices for continuous data monitoring, with existing therapeutics. It introduces the Middle East's first value-based reimbursement model, and will be the first relationship of its kind for Novo Nordisk globally. This innovative partnership will put accountability for outcomes vs. costs on the provider, rather than on the insurers or patients. The 6-month program, which begins in September, is open to people with obesity who meet certain criteria. Patients will receive an unparalleled level of in-patient and data-driven remote care, with a multidisciplinary clinic team having continuous access to all patient data through an intelligent analytical platform. If patients do not lose at least 10% of their body weight by the end of the program, GluCare.Health and Novo Nordisk will cover all or a portion of the cost under the value-based reimbursement pilot. GluCare.Health is also committed to transparency when it comes to reporting results of the program. With one in three adults affected by obesity in the UAE[1], GluCare.Health's Co-Founder and Managing Director, Dr. Ihsan AlMarzooqi, says that the blueprint for care has the potential to not only save many lives but the UAE economy billions of dollars in costs and lost productivity. "When patients with chronic conditions are not supported properly, it can have a devastating impact on those individuals and their families. Additionally, the cost of treating the health consequences of obesity to the UAE economy alone is approximately $3.6 billion annually[2]. Traditional models of care remain woefully limited when it comes to outcomes. This partnership allows us to embed Novo Nordisk's advanced therapeutics into a companion platform like GluCare.Health, which enhances its efficacy dramatically." About Glucare.Health The first hybrid Digital Therapeutics (DTx)+Human vertically integrated diabetes platform of its kind in the world, GluCare.Health is reinventing metabolic care and transforming lives. Conceptualized in the UAE and opening the doors to its state-of-the-art 10,000 sq foot Dubai clinic in September 2020, it is the world's first healthcare provider to empower both clinicians and patients through Remote Continuous Data Monitoring as part of its standard model of care, an innovative and highly personalized 'continuous healthcare' approach that provides a comprehensive and real-time view of patients. As part of its unique model, GluCare is also an early adopter of - and the region's first clinic to use - Digital Therapeutics (DTx), combining it with wearable and smart technology, data analytics, unique in-clinic workflows, and a caring and connected expert care team. Applying technology as a humanizing force, GluCare.Health's team partners with patients and their families, giving them the tools, knowledge, and continuous support to live longer, healthier, and more fulfilling lives. About NovoNordisk Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 49,300 people in 80 countries and markets its products in around 170 countries. For more information, visit Novo Nordisk UAE.

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BUSINESS INSIGHTS

Astellas and Sutro Biopharma Announce Worldwide Strategic Collaboration to Advance Novel Immunostimulatory Antibody-Drug Conjugates (iADCs)

Sutro Biopharma, Inc.; Astellas Pharma Inc. | June 28, 2022

Astellas Pharma Inc. and Sutro Biopharma, Inc. announced a worldwide, strategic collaboration and licensing agreement focused on the discovery and development of novel immunostimulatory antibody-drug conjugates. The collaboration leverages the unique cancer-fighting potential of iADCs as a novel modality, enabled by Sutro’s ability to engineer complex conjugated antibodies, and Astellas’ global oncology R&D expertise. “We are delighted to work with Astellas, a premier biopharmaceutical company with substantial expertise in immuno-oncology, on this novel modality. iADCs hold promise well beyond the existing success of ADCs. Sutro’s unique conjugation technology enables dual conjugations that site-specifically incorporate a potent cytotoxin that can directly kill tumor cells together with an immunostimulatory component that has the potential to locally prime an immune response to the patient’s particular tumor cells. We look forward to collaboratively exploring the potential of this approach to treat cold tumors and bring new drug therapies to patients who do not respond to existing immunotherapies.” William J. Newell, Sutro’s Chief Executive Officer Naoki Okamura, Chief Strategy Officer, at Astellas commented, "Astellas considers Immuno-Oncology as one of the Primary Focuses of its R&D strategy; our goal is to bring effective drugs to patients who do not respond to existing immune checkpoint inhibitors. Sutro is a leading company in the area of iADCs, a new modality, and has its own original iADC technologies. The strategic partnership with Sutro will help us expand our pipeline and widen the choice of cancer immunotherapies.” A key challenge with cancer immunotherapies, including immune checkpoint inhibitors, is the tumor microenvironment*1 within cold tumors creating barriers to immune cell infiltration and thus preventing the cure. The immune checkpoint inhibitors approved to date are efficacious as a monotherapy in only about 20% of cancer types, which vary widely*1. This strategic partnership will engage in the development of iADCs, a next generation modality with the potential for effective and efficient approaches for treatment of cold tumors so as to bring new drug therapies to patients who do not respond to existing therapies. An iADC, which combines an antibody with a small molecule compound that induces immunogenic cell death*2 in addition to an immune activating molecule, has the potential to boost the anti-cancer action. This partnership will enable Astellas and Sutro to mutually leverage strengths in their respective fields to accelerate iADC development for three distinct biological targets; Sutro will engage in research and preclinical studies to identify candidate compounds and then Astellas will pursue clinical development. Sutro has advanced technologies for linking drugs to antibodies and proprietary component parts, including candidate antibodies and linkable cytotoxins and immunostimulatory molecules. For development of iADCs, Astellas will utilize the strength of its global R&D and commercialization capabilities in the area of antibodies and the small molecular components. These iADCs may have the potential to provide new therapeutic options for treatment of cancers for which no broadly effective therapy is currently available. Under the terms of the agreement, Sutro will receive an upfront cash payment of US$90 million to develop iADCs for three biological targets and may be eligible to receive up to US$422.5 million in development, regulatory and commercial milestones for each product candidate, and tiered royalties ranging from low double-digit to mid-teens on worldwide sales of any commercial products that may result from the collaboration, subject to Sutro’s cost and profit sharing option for the United States. Sutro has the option to share in the costs and profits for developing and commercializing product candidates in the United States. If Sutro exercises this option for a particular product candidate, Astellas and Sutro will equally share the costs of such co-development and co-commercialization, with the resulting profits/losses from co-commercialization also shared equally in the United States.

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BUSINESS INSIGHTS

Fusion Pharmaceuticals and Niowave Announce Actinium-225 Collaboration and Supply Agreement

Fusion Pharmaceuticals Inc. | June 13, 2022

Fusion Pharmaceuticals Inc. a clinical-stage oncology company focused on developing next-generation radio pharmaceuticals as precision medicines, and Niowave, Inc., a manufacturer of medical radioisotopes from radium and uranium, today announced that the companies have entered into a collaboration and supply agreement for the development, production, and supply of actinium-225. Under the agreement, Fusion will invest up to $5 million in Niowave to further develop their technology to increase current production capacity of actinium-225, and in return Fusion will have guaranteed access to a pre-determined percentage of Niowave's capacity of the resulting actinium-225, as well as preferred access to any excess supply produced. As part of the agreement, Fusion will also have an option to invest in future production of actinium-225 to scale with Fusion's needs. "As excitement for the tumor-killing potential of alpha-emitting radio pharmaceuticals increases, we intend to stay at the forefront of actinium development and supply to support our growing pipeline of targeted alpha therapies. We continue to prioritize manufacturing and access to actinium as a critical component of Fusion's platform, and our partnership with Niowave further strengthens and diversifies our supply chain as we advance multiple actinium-based radio pharmaceuticals in the clinic." Fusion Chief Executive Officer John Valliant, Ph.D "The Niowave team has worked hard to scale up our actinium-225 production to the millicurie level and this has allowed us to start working with oncology community partners," said Niowave Chief Executive Officer/Senior Scientist Terry Grimm, Ph.D. "We have been watching Fusion's progress in the development of their pipeline of targeted alpha therapies and we are very excited to partner with them on this journey." Fusion is developing actinium-based TATs leveraging the potency and precision offered by alpha particles. Actinium-225 decay gives off four alpha emissions in relatively rapid succession, maximizing the damage to the DNA of tumor cells, with a 10-day half life that allows for central manufacturing and distribution of products to clinical sites in a ready-to-use form. About Fusion Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434 targeting insulin-like growth factor 1 receptor, is currently in a Phase 1 clinical trial. The pipeline includes FPI-1966, targeting the fibroblast growth factor receptor 3 (FGFR3), advancing to a Phase 1 study following the investigational new drug (IND) clearance; and FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1). In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop novel targeted alpha therapies (TATs) and combination programs between Fusion's TATs and AstraZeneca's DNA Damage Repair Inhibitors (DDRis) and immuno-oncology agents. Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck's KEYTRUDA® (pembrolizumab) in patients with solid tumors expressing IGF-1R. Fusion and Hamilton, Ontario-based McMaster University are building a current Good Manufacturing Practice (GMP) compliant radiopharmaceutical manufacturing facility designed to support manufacturing of the Company's growing pipeline of TATs. About Niowave Niowave manufactures radioisotopes to cure cancer and save lives. Niowave builds and operates superconducting electron linear accelerators and is using that expertise to produce various radioisotopes for nuclear medicine. Niowave is a Cooperative Agreement partner with the National Nuclear Security Administration to develop a domestic supply of molybdenum-99 and currently produces yttrium-90 for use in cancer therapy. Niowave is licensed by the NRC to manufacture radioisotopes from uranium and radium and has partnerships with several universities and national laboratories focused on production and purification of radioisotopes for use in cancer therapy. By using radium targets and electron beams, Niowave is able to produce ultra pure and carrier-free actinium-225. Niowave's R&D facility is currently supplying actinium-225 samples to partners. Production-scale operations are ramping up at a second, FDA-compliant facility capable of meeting the growing actinium-225 market.

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