Roche trumpets data for Soliris rival in NMOSD after US, EU filings

pharmaphorum | December 02, 2019

Roche has continued to build the case for satralizumab, its experimental therapy for rare disease neuromyelitis optica spectrum disorder (NMOSD), which is heading for approval decision in the US and Europe next year. The results of the pivotal SAkuraSky trial have now been published in the New England Journal of Medicine (NEJM) website, showing that the anti-interleukin-6 antibody cut the relapse rate in NMOSD compared to conventional immune-suppressing drugs over nearly three years of follow-up. NMOSD is an autoimmune disease of the central nervous system that primarily affects the optic nerves and spinal cord, causing blindness, muscle weakness and paralysis. Progression of the disease is characterised by unpredictable and severe relapses that lead to nerve damage, and it can often be misdiagnosed as multiple sclerosis. Roche is building the case for satralizumab as it approaches potential approvals of the drug and a market showdown with Alexion’s rare disease blockbuster Soliris (eculizumab), which became the first drug approved by the FDA for NMOSD in June. For now there are no approved therapies for NMOSD in Europe. Soliris is cleared for use in patients who are anti-aquaporin-4 (AQP4) antibody positive in the US, but Roche is hoping to get a green light for all patients with NMOSD, regardless of their anti-AQP4 status. That could make it a good first-line option if approved for marketing, as patients would not need to be screened for anti-AQP4 status.

Spotlight

The monitoring of biotechnological fermentation processes, used for the production of modern biopharmaceutical drugs, is becoming ever more relevant for the promotion of economic production, particularly within the manufacturing sector. Up until now, biotechnical techniques have typically been monitored through off-line analysis, which is laborious, costly and frequently delivers results too late to allow for corrective actions.


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Pack4U acquires leading pharmacy technology company Catalyst Healthcare

Pack4U | January 07, 2022

Pack4U, a connected health services company, acquires long-time technology partner Catalyst Healthcare whose patented AdhereNet® platform links pharmacists, patients, and care teams to effectively manage drug complexity and improve medication adherence. "We are dedicated to improving patient outcomes at scale. Bringing this domain knowledge in-house is vital for Pack4U. Catalyst's CEO Shane Bishop is a pharmacy thought leader and we are excited about building the next phase of Pack4U with the Catalyst team on board. Catalyst's proprietary and patented platform strengthens our ability to meet the needs of patients, providers and health plans by offering a full, end-to-end, connected care solution seamlessly integrated with our vast clinical team across all states." Pack4U President, Rahul Chopra Pack4U provides in-home and virtual services that connect patients with pharmacists for oversight, medication delivery, remote monitoring, and care coordination. Our complete suite of connected health IP fortifies Pack4U's ability to personalize care, improve health outcomes, and lower total cost of care across North America. "I am extremely excited to see these organizations come together and to join the team that is transforming in-home healthcare," said Shane Bishop. "Pack4U's extensive and diverse team of pharmacists combined with Catalyst's adherence solutions, create opportunity for a new patient monitoring paradigm. With central fills for scale and community pharmacy adoption, we will reach more people to change more lives." "This collaboration follows our aggressive growth in 2021. It expands our vision of in-home care via a full suite of managed services featuring patient specific, in-home medicine dispensing, always-on patient engagement, electronic medicine administration record and supply chain software for centralized filling," said Rahul Chopra. About Pack4U Pack4U Inc is a tech-enabled health services company. We connect people with community pharmacists to manage drug complexity and maximize health benefits through personalized medication delivery, virtual monitoring, and proactive care. Our fully automated, high-volume central fill pharmacy hubs, proprietary health platform and medication adherence network power a robust, scalable solution to chronic condition management that leads to better patient outcomes and total cost of care reduction.

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Avidien Technologies Receives $4M Investment from BroadOak Capital Partners

Avidien Technologies | February 02, 2022

Avidien announced a new financing round of $4M from BroadOak Capital Partners. The investment will help Avidien expand its product roadmap, scale commercial production, and better serve research and pharmaceutical clients. "The partnership with BroadOak is exciting and ushers in the next phase for Avidien by creating the opportunity to quickly scale up the business with investments in new products, sales, marketing, and manufacturing." Avidien CEO and Founder Rich Cote Avidien's flagship product, the microPro 300, provides precision semi-automated 96 and 384 channel pipetting to hundreds of biotech, medical testing, and research laboratories worldwide. The compact and portable liquid handling platform has built a loyal customer base thanks to its innovative design, intuitive interface, and industry-leading capabilities. The microPro 300 fills gaps in automation workflows by streamlining repetitive pipetting tasks and ensuring accurate, repeatable liquid transfers. BroadOak Capital Partners is a life sciences focused financial institution with a track record of supporting companies at the forefront of major industry trends. "Aviden's affordable pipette automation platform sets a new standard for common research methods and is at the cutting edge of laboratory automation technology. We're proud to partner with the Avidien team to help them achieve even greater growth," said Bryan Poltilove, Operating Partner at BroadOak Capital Partners. Mr. Poltilove is also joining Avidien's Board of Directors to guide the company's next phase of business expansion. About Avidien Technologies Avidien Technologies is a Massachusetts based company that manufactures innovative and precision liquid handling solutions that are deployed in life science labs around the world. About BroadOak Capital Partners BroadOak Capital Partners, with headquarters in Washington, DC and San Francisco, is a life sciences focused financial institution that provides direct investment and investment banking services to companies in the research tools and consumables, diagnostics, biopharma services, and adjacent markets. BroadOak has led or participated in investments in more than 50 companies across multiple funds and investment vehicles.

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ALR Technologies Completes Definitive Manufacturing Agreement with Infinovo Medical for the GluCurve Pet CGM Hardware

ALR Technologies | June 30, 2022

ALR Technologies SG Pte. Ltd the diabetes management company, announces the completion of a definitive manufacturing agreement with Infinovo Medical Co. Ltd to manufacture and supply the Continuous Glucose Monitor hardware that will be utilized as part of the ALRT GluCurve Pet CGM. The Manufacturing Agreement gives ALRT the exclusive global rights to distribute the Infinovo CGM hardware for the animal health market, providing long-term production and supply. Subject to the satisfaction of all closing conditions it is expected that initial deliveries of product by Infinovo will be made during Q4 of 2022 “Executing the Manufacturing Agreement with Infinovo marks another major milestone in our path to commercialization and profitability. Our next targeted milestone is securing distribution for the ALRT GluCurve Pet CGM. We have been working with many of the largest global distributors and pharmaceutical companies in animal health, evaluating different distribution opportunities ranging from joint venture partnerships to sales and distribution agreements. We believe we have narrowed in on the right company and right deal structure to best bring value to our shareholders and to those who care for diabetic pets. We hope to announce the details of this pivotal next step in the near future.” Sidney Chan, Chairman and CEO of ALRT The Manufacturing Agreement is subject to certain closing conditions including the completion of a distribution agreement with a third party by July 31, 2022. About Infinovo Medical Co. Ltd Founded in 2016, Infinovo is an innovative medical technology company, focusing on developing an accurate and affordable CGM for patients which will be available for both Type 1 and Type 2 Diabetics. ALR Technologies SG Pte. Ltd. ALRT is a data management company that developed the ALRT Diabetes Solution, a comprehensive approach to diabetes care that includes an FDA-cleared and HIPAA compliant diabetes management system that collects data directly from blood glucose meters and continuous glucose monitoring devices, and a patent pending Predictive A1C algorithm to track treatment success between lab reports and an FDA-cleared Insulin Dosing Adjustment program. ALRT also offers an algorithm to provide prescribers support for timely non-insulin medication advancements. The overall goal is to optimize diabetes drug therapies to drive improved patient outcomes. The program tracks performance of all clinical activities to ensure best practices are followed. The ALRT Diabetes Solution gives healthcare providers a platform for remote diabetes care, helping to minimize patient exposure to potential infections in clinical settings. Currently, the Company is focused on diabetes and intends to expand its services to cover other chronic diseases anchored on verifiable data. In addition, the animal health division of ALRT has identified an unmet need in diabetes care and has developed GluCurve; a solution to assist Veterinarian Doctors to determine the efficacy of insulin and to help to identify the appropriate dose and frequency of administration of insulin for companion animals, thereby delivering the same optimization of diabetic drug therapies to pets as to humans. ALR Technologies SG Pte. Ltd. is controlled by ALR Technologies Inc., a Company with its shares traded on the OTC:QB under the symbol “ALRT”. On May 17, 2022, ALR Technologies Inc. announced an Agreement and Plan of Merger and Reorganization for the sole purpose of changing the Company’s jurisdiction of incorporation from Nevada to Singapore (the “Redomicile Merger Agreement”). The Redomicile Merger Agreement is subject to the required approval of the Company’s stockholders, requisite regulatory approvals, the effectiveness of the registration statement on Form F-4 filed by ALRT related to the Redomicile Merger, and other customary closing conditions. The Redomicile Merger is expected to be completed during the third quarter of 2022. See the Form 8-K filed May 20, 2022, by ALR Technologies Inc. for further information about the Redomicile Merger Agreement.

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Breckenridge Signs New-Product Agreement with PTS Pharma

Breckenridge Pharmaceutical, Inc. | April 23, 2022

Breckenridge Pharmaceutical, Inc. announces today that it has signed a new-product agreement with PTS Pharma, LLC. under which PTS will support a technology transfer to Towa Pharmaceutical Europe, S.L. of a complex "For Suspension" product developed by PTS. The remainder of development and commercialization will be performed at the Towa facility. According to industry sales data, the product and its generics had annual sales of approximately $75 million during the twelve months ending February 2022. The companies are actively negotiating and look forward to collaborating on additional complex formulations under the same business model. About Breckenridge Breckenridge Pharmaceutical, Inc., a subsidiary of Towa Pharmaceutical, partners with manufacturers nationwide and around the world to bring quality, cost-effective generic pharmaceuticals to U.S. patients. With our dedication to customer service, on-time delivery, reliable supply and quality manufacturing, we improve the health and quality of life of the patients we and our customers serve. About PTS Pharma, LLC PTS Consulting, LLC and PTS Pharma LLC., is a formulation development, clinical trial production, regulatory services and analytical control laboratory based in Kansas. PTS Consulting is actively involved in regulatory consulting services. PTS Pharma operations include the capability and expertise to develop complex formulations of tablets, capsules, granules, modified dosage forms, topical dosage forms, suppositories, film products, solution, and suspension formulations and sterile injectables, with involvement in multiple aNDA and NDA filings over the years. The activities are housed in dedicated GMP suites in the facility in Kansas City, USA. PTS Pharma is also involved in active raw material clinical production by fermentation technology processes. The firm was founded in 2003 by Paul Sudhakar, an industry veteran who is the Owner, President, and CEO of the firm.

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Spotlight

The monitoring of biotechnological fermentation processes, used for the production of modern biopharmaceutical drugs, is becoming ever more relevant for the promotion of economic production, particularly within the manufacturing sector. Up until now, biotechnical techniques have typically been monitored through off-line analysis, which is laborious, costly and frequently delivers results too late to allow for corrective actions.

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