Vifor Pharma acquires Priority Review Voucher

Business Wire | February 17, 2020

Vifor Pharma today announced that it has agreed to purchase a US Food and Drug Administration (FDA) priority review voucher (PRV). Vifor Pharma Group is a global speciality pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is the partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care); and OM Pharma. 

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Telix Pharmaceuticals Announces Licence Agreement with Lilly for Olaratumab

Telix Pharmaceuticals Limited | April 11, 2022

Telix Pharmaceuticals Limited announces that it has entered into a licence agreement with Eli Lilly and Company under which Telix is granted exclusive worldwide rights to develop and commercialise radiolabelled forms of Lilly's olaratumab antibody for the diagnosis and treatment of human cancers. Telix's initial development focus will be on a rare type of cancer known as soft tissue sarcoma. Olaratumab was originally developed by Lilly as a monoclonal antibody targeting Platelet Derived Growth Factor Receptor Alpha. PDGFRα is expressed in multiple tumour types including STS. STS is generally a radiation susceptible cancer that may be inherently amenable to systemic radionuclide therapy and olaratumab's ability to target PDGFRα makes it a highly novel and potentially exciting candidate for use as a radionuclide targeting agent. The exclusive worldwide licence will allow Telix to repurpose olaratumab as a targeting agent for radiopharmaceutical imaging and therapy of cancer. Olaratumab has an established safety profile that underpins its potential use as a radionuclide targeting agent. Material terms of the agreement Under the terms of the agreement Telix will pay Lilly an upfront payment of US$5M for the grant of an exclusive licence to Lilly's intellectual property related to the development of a radiolabelled olaratumab, as well as access to material for use by Telix in initial pre-clinical and early-phase clinical studies in application to potential uses for the diagnosis and treatment of human cancers. Lilly may be eligible for up to US$225M in payments based upon the achievement of pre-specified development, regulatory and commercial milestones. Lilly would also be eligible to receive industry standard royalties on net sales. The agreement also includes an option for Lilly to be granted an exclusive licence to a radiolabelled companion diagnostic which would be developed by Telix. If exercised, Lilly will pay Telix US$5M and up to US$30M in potential development milestones, as well as industry standard royalties. The agreement has typical termination rights for breach and related corporate issues. Telix retains termination rights typical to licence agreements of this nature to enable the Company to exit the agreement based on a development or commercial basis. "This in-licence transaction with Lilly is a valuable – and rare – opportunity to acquire an asset which has demonstrated clinical safety. In our pre-transaction diligence and research, we have identified that a radiolabelled version of olaratumab could be efficacious in patients with STS, particularly as it is a highly radiation-sensitive cancer. The safety data generated by Lilly in relation to the original development program significantly de-risks the program for Telix. We anticipate that early clinical translation with a radiolabeled olaratumab as an imaging agent may also provide valuable clinical information as to whether this asset has potential therapeutic efficacy, demonstrating the advantage of Telix's "theranostic" approach. Telix Group CEO and Managing Director, Dr. Christian Behrenbruch "This acquisition mirrors the approach that Telix has taken in building its existing pipeline by in-licencing or acquiring assets that have already been proven to be safe for use in humans that can be harnessed as novel radiolabelled targeting agents. This partnership also demonstrates the value that Telix can bring as a capable partner with the expertise in radiopharmaceutical development and manufacturing, to help repurpose or expand the use of promising candidates to better target, find and treat cancer." About Soft Tissue Sarcoma Soft tissue sarcoma is a complex disease that encompasses a diverse group of relatively rare cancers, with more than 50 histological subtypes. In the United States, it is estimated that 13,040 new cases and 5,150 deaths were caused by STS in 2019, representing 0.75% of overall cancer incidence and 0.84% of overall cancer mortality.1 In Europe, nearly 23,600 new STS cases rose annually, and the crude incidence rate was 4.7 per 100,000.2 Approximately 39,900 new STS cases occurred nationwide in China in 2019, accounting for 1.05% of overall cancer incidence.3 The crude incidence rate was 2.91/100,000 and generally increased with age. Standard treatment for soft tissue sarcoma includes surgery, radiation therapy and/or chemotherapy. For patients with advanced, unresectable, or metastatic disease, treatment typically involves chemotherapy with single agents or anthracycline-based combination regimens. However, the prognosis for these patients remains poor, with treated patients with metastatic disease having a median overall survival of around 12–18 months. About olaratumab Olaratumab was originally developed as a monoclonal antibody targeting PDGFRα. Olaratumab was granted "Accelerated Approval" in the US and "Conditional Approval" in the EU based on Phase 2 trial data which showed a 1-year survival benefit in patients with STS, when given in combination with standard chemotherapy. Olaratumab was voluntarily withdrawn from the market by Lilly following the failure of the Phase 3 ANNOUNCE clinical trial, in which olaratumab did not improve survival for patients. About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic products using Molecularly Targeted Radiation. Telix is headquartered in Melbourne, Australia with international operations in Belgium, Japan, Switzerland, and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange.

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Suvoda and N-SIDE Announce Agreement to Deliver Integrated Clinical Trial Optimization and IRT Solutions for Real-Time Demand Planning

Suvoda LLC | May 13, 2022

Suvoda LLC, a global clinical trial technology company that specializes in complex studies in therapeutic areas such as oncology, central nervous system, and rare disease, today announced they have entered into an agreement to partner with N-SIDE — a deeptech company that empowers organizations in the clinical trials industry to make better decisions and optimize the use of critical resources.  To date, the two companies have successfully partnered on more than 100 clinical trials in drug development, activating machine learning based on real-time data and increased efficiency in trial supply. Suvoda's IRT enables the implementation of optimized resupply strategies with adapted IRT algorithms that seamlessly integrate N-SIDE's forecasting and mathematical optimization recommendations. This results in significant cost savings through reduced drug wastage and accelerated trial timelines. Partnership Delivers Faster Start and Flexible Supply Strategy The most successful forecasting and optimization strategies consider the end-to-end supply chain, including impact assessments of trial design decisions. Efficient strategies — like the ones jointly deployed by N-SIDE and Suvoda — must be carefully evaluated and implemented, and have the flexibility to adapt in real-time to the unknowns that come with clinical trials. "As global clinical trials grow more complex, clinical trial professionals need the right partners and tools to help them gain control and account for the 'what ifs' as quickly as possible. N-SIDE has a history of excellence in clinical supply optimization that is unrivaled in the industry, and Suvoda is known for delivering clinical trial technology solutions that are built to manage change quickly. Our seamless integration and deep expertise will enable study teams to focus on other day-to-day decisions, while giving them peace of mind in their drug supply strategy." Anthony Encarnacao, Vice President, Global Partnerships for Suvoda This partnership allows for the inclusion of a flexible IRT solution during the development of the trial protocol, giving Suvoda greater visibility into the supply chain parameters based on the protocol discussions and finalization. Moving IRT more upstream in the startup process helps mitigate the risks and time constraints associated with last minute IRT implementations. Clients also gain access to N-SIDE's real-time monitoring of recruitments, demands, and inventories, supported by Suvoda's data. Coupled with N-SIDE's optimization, sponsors and CROs will experience an expedited IRT contracting, set-up, and build process, with greater optimization after study go-live. "In a world where decisions are made every day by different teams, with different objectives, it is easy to forget the impact that decisions have outside of one's team," explains Amaury Jeandrain, head of BD engineering at N-SIDE. "We connect clinical operations, supply chain, manufacturing, and IRT to ensure a global optimum that reduces drug waste while increasing patient centricity and accelerating trial timelines. And, working with partners like Suvoda, who understand this challenge and are able to bring flexibility and efficiency within their solutions, is a big step towards this objective." About Suvoda Suvoda is a global clinical trial technology company that specializes in complex, life-sustaining studies in therapeutic areas like oncology, central nervous system (CNS), and rare disease. Founded in 2013 by experts in eClinical technologies, Suvoda empowers clinical trial professionals to manage the most urgent moments in the most urgent trials through advanced software solutions delivered on a single platform. Headquartered outside Philadelphia, Suvoda also maintains offices in Portland, OR, Barcelona, Spain, Bucharest, Romania and Tokyo, Japan. The company consistently boasts a Net Promoter Score (NPS) of close to 70, far exceeding the technology industry average of 50, and has been selected by trial sponsors and CROs to support more than 1000 trials across 65 countries. About N-SIDE N-SIDE is a deeptech company that empowers organizations in the life sciences to make better decisions and optimize the use of critical resources. We're doing so by combining deep industry expertise with applied mathematics and artificial intelligence into easy to use and cutting-edge software that transforms uncertainty and complexity into clear decisions. We have been an active player in clinical trial supply chain management for over 20 years and work with the majority of the top 20 pharmaceutical companies. With our software solution, the N-SIDE Suite, and expert services, we streamline the clinical supply of pharmaceutical and biotech companies by accelerating clinical plans, mitigating risks and curbing drug waste. We empower clinical leaders to make better, faster, and safer decisions for patients waiting for life-changing medications. Our successes on over 10,000 trials include an average of 20%-60% of drug waste and cost reduction, with no delays due to drug shortages and an acceleration of 2-6 months of clinical trial timelines.

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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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PHARMACY MARKET

MediPharm Labs Enters United States Pharmaceutical Market with Submission of FDA DMF

MediPharm Labs Corp. | February 24, 2022

MediPharm Labs Corp. a pharmaceutical company specialized in precision-based cannabinoids, is pleased to announce it has completed a US FDA DMF for pure natural CBD API. The DMF will enable MediPharm to supply approved API to pharmaceutical companies currently conducting late-stage research. The cannabis-based drug opportunity is predicted to be over USD$25 billion by 2025, and there are over 20 strong novel cannabinoid-based drugs currently in the late-stage research process. These projects will all require pharmaceutical approved API if commercialized. MediPharm has already shipped good manufacturing practice ("GMP") CBD for development purposes to multiple established pharmaceutical companies. "The filing of a US DMF further advances MediPharm toward its ultimate objective of becoming a dominant supplier of API to pharmaceutical companies. This is a high value, high margin opportunity, and with the only purpose-built facility in North America to receive a domestic GMP licence specifically for the extraction of natural cannabinoids, MediPharm is positioned to capture share in this growing market. In the short to medium term, the DMF unlocks new sales channels and will enable us to further leverage the investments made to date on our high-quality pharmaceutical manufacturing platform. Over the longer-term, it ensures the Company is positioned as the go-to cannabinoid partner for pharmaceutical companies around the world." Bryan Howcroft, CEO, MediPharm About MediPharm Labs Founded in 2015, MediPharm specializes in the development and manufacture of purified, pharmaceutical-quality cannabis concentrates, API and advanced derivative products utilizing a Good Manufacturing Practices certified facility with ISO standard-built clean rooms. MediPharm has invested in an expert, research driven team, state-of-the-art technology, downstream purification methodologies and purpose-built facilities with five primary extraction lines for delivery of pure, trusted and precision-dosed cannabis products for its customers. Through its wholesale and white label platforms, MediPharm formulates, develops (including through sensory testing), processes, packages and distributes cannabis extracts and advanced cannabinoid-based products to domestic and international markets.

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