PHARMACY MARKET
Aizon | February 02, 2021
Aizon launches its Bioreactor Application, the pharma industry's first predictive analysis and profound knowledge management application. The Aizon Bioreactor Application adds the bioreactor process to the "Smart Manufacturing" transformation that is accelerating across the Pharma and Biotech industry. Aizon is extraordinarily able to achieve GxP compliance and give an audit trail from the start of the process. The turnkey application allows pharmaceutical and biotech companies to leverage rich datasets generated during upstream manufacturing to identify and accurately anticipate deviations and results potentially leading to countless dollars in expense savings, diminished danger, and additional income potential gain.
Intended to work with both persistent and took care of batch bioreactors, the Aizon Bioreactor Application gives a profound understanding of the client's bioprocess manufacturing lifecycle. The application leverages specialized Edge AI and contextualization, which is a prerequisite to make the data actionable. Contextualized data is harnessed, analyzed, and visualized through a persona-based lens for faster root cause analysis (RCA), real-time monitoring, and predictive insight across any number of bioreactor units and manufacturing sites.
AI models for bioreactor analytics are ready for use within the application or can be configured by customers within the GxP cloud-based application. “It is clear that biotech and pharmaceutical companies need an accessible, industry-specific tool that accelerates their path to value. Customers seek a seamless way to analyze complex data sets in real-time and to predict with accuracy the yield from bioreactor units that span multiple sites and global regions,” said Pep Gubau, CTO, Aizon. “Biotech and pharmaceutical companies can now more easily leverage the power of AI/ML in a GxP environment with an end-to-end lifecycle governance of data, models, and applications in order to understand and optimize bioreactor processes in commercial manufacturing.”
Aizon’s CEO, John Vitalie adds, ”Our focus is to empower customers to innovate and rapidly achieve their targeted outcomes without the overhead burden of tracking changes, revalidation, and on-going development to maintain compliance. By building the process knowledge framework, compliance, and scalability into the application, customers benefit significantly from the streamlined industrialization of their digital solutions. We see that this is key for pharma and biotech to realize the vision of smart manufacturing and accelerate their progress toward realizing the promise of the adaptive plant.”
About Aizon
Aizon is an enterprise software provider that transforms manufacturing operations with the use of advanced analytics, artificial intelligence, and other smart factory technologies focused on optimizing production within Pharma and other highly regulated industries. The Aizon AI platform and native GxP based applications seamlessly integrate unlimited sources of structured and unstructured data to deliver actionable, real-time insights across all manufacturing sites. Aizon brings deep domain expertise and works closely with Global System Integrators and technology partners to provide enterprise solutions to customers.
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BUSINESS INSIGHTS
Actinium Pharmaceuticals, Inc. | April 13, 2022
Actinium Pharmaceuticals, Inc., a leader developing targeted radiotherapies for patients and Immedica Pharma AB announced that they signed a license and supply agreement for Iomab-B. It is being developed for targeted conditioning to facilitate bone marrow with topline data expected in the third quarter of 2022. For individuals with active, relapsed, or refractory acute myeloid leukemia, BMT is the only possibly curative therapy option.
"Immedica has established a strong team and impressive capabilities to commercialize specialty products in Europe, the Middle East and North Africa. Europe and the MENA countries are key commercial markets for Iomab-B, with a large addressable AML patient population and access to a strong BMT community that is highly concentrated with select leading centers performing a majority of the BMT procedures. Despite multiple drug approvals for patients with AML in recent years, curative outcomes and access to potentially curative BMT are severely lacking, particularly for patients with active, relapsed or refractory disease. We are excited to partner with Immedica to work to bring Iomab-B to patients with AML in Europe, the Middle East and North Africa who may benefit from a potentially curative transplant."
Sandesh Seth, Actinium's Chairman and CEO
"We are excited about the opportunity to make Iomab-B accessible for patients in Europe, the Middle East and North Africa. It is clear there is a large medical need for these AML patients, which we believe will be addressed by this new innovative treatment. We also look forward to deepening our collaboration with Actinium to bring the best possible support to AML treatment centers and health care professionals in Europe, the Middle East and North Africa", says Anders Edvell, CEO at Immedica.
Actinium will receive a $35 million upfront payment and will be eligible for an additional $417 million in regulatory and marketable milestone payments and royalties in the mid-twenty percent range on net sales, per the terms of the agreement. Immedica has been granted commercialization rights in Europe and, the Middle East and North Africa (MENA). Actinium will maintain all rights to Iomab-B in the United States and around the world and will be accountable for clinical and regulatory operations, as well as Iomab-B manufacturing.
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PHARMACY MARKET
Fusion Pharmaceuticals Inc. | August 13, 2021
Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, and TRIUMF, Canada's particle accelerator centre, today announced that the companies have entered into the next phase of their collaboration agreement for the development, production, and supply of actinium-225. Fusion will provide to TRIUMF funding to further develop technology to produce actinium-225 and in return Fusion will have rights, including preferred access and pricing, to the resulting alpha-emitting medical isotope.
"As we advance our growing pipeline of actinium-based targeted alpha therapies (TATs), we are focused on expanding our manufacturing capabilities and continuing to proactively address and prioritize actinium supply. This supports our strategic plans to develop differentiated radiopharmaceuticals to treat a broad range of cancers with high unmet medical need," said Fusion Chief Executive Officer John Valliant, Ph.D. "We are excited to expand our collaborative relationship with TRIUMF, a leader in isotope production, marking an important step to further expand actinium-225 production and supply."
"Through its TAT platform technology, Fusion has the opportunity to unlock the full potential of actinium, an alpha-emitting isotope with the ability to deliver a potent, highly localized payload to cancer cells, " said TRIUMF Innovations CEO, Kathryn Hayashi. "With this next phase, we are solidifying our partnership with a premier developer of innovative actinium radiopharmaceuticals to deepen TRIUMF's leadership position in isotope production and impact the cancer treatment landscape."
TRIUMF Director and CEO, Nigel Smith, Ph.D. added, "This marks an important milestone in the existing collaboration between Fusion and TRIUMF. Our partnership is generating new ideas and innovations that validate the important role TRIUMF has at the forefront of the global medical isotope ecosystem. Together TRIUMF and Fusion are laying the groundwork for major breakthroughs that will benefit the lives of countless patients around the world."
In December 2020, Fusion and TRIUMF entered a collaboration and supply agreement to develop, produce and procure the supply of actinium-225 to Fusion. As part of this agreement, Fusion will continue its investment of up to $25 million (CAD) in TRIUMF to advance technology and processes for actinium-225 production.
About Fusion
Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear™ linker technology, 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); 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 recently entered into an agreement with Hamilton, Ontario-based McMaster University to build a 27,000 square foot current Good Manufacturing Practice (GMP) compliant radiopharmaceutical manufacturing facility designed to support manufacturing of the Company's growing pipeline of TATs.
About TRIUMF
TRIUMF is Canada's particle accelerator centre. The lab is a hub for discovery and innovation, inspired by a half-century of ingenuity in answering some of nature's most challenging questions. From the hunt for the smallest particles in the universe to the development of new technologies, TRIUMF is pushing frontiers in research, while training the next generation of leaders in science, medicine, and industry.
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