Audit body warns of risks to medicine supplies in no-deal Brexit, despite preparations

Pharmaphorum | September 27, 2019

Amid the political chaos and bitter recriminations in Westminster in the build-up to Brexit, there is still a risk of delays to health and social care supplies if the UK leaves the EU without a deal, the UK’s National Audit Office (NAO) has warned. An independent Parliamentary body, the NAO audits central government departments, government agencies, and non-departmental public bodies as well as assessing value for money audits of public policy. In a report published today the NAO reviewed the Department for Health and Social Care’s (DHSC) preparations to ensure a steady flow of supplies for the sector when it leaves the EU, and acknowledged the considerable efforts made so far to mitigate the impact of a no-deal Brexit. Although the NAO said there are huge uncertainties about the impact of a no-deal Brexit, it noted the government’s “reasonable worst case” assumption that flow of goods across the Channel could be reduced to 40-60% of current levels at day one. According to the NAO, suppliers said that they had only found shipping arrangements away from the short channel crossings for 25% of medicine product lines, as of 20th September. According to the NAO, suppliers have at least six weeks’ stock for 72% of product lines, and 91% of additional freight capacity procured by the government so far is for priority supplies to the health and social care sector.

Spotlight

Since the approval of the first PD-1 checkpoint inhibitor, Keytruda, in 2014, there has been an explosion of the numbers of trials testing these drugs, both alone and in combination. The latest figure, coming from the Cancer Research Institute (CRI) in the US, sets the number in over 1,500 trials.


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PHARMA TECH

Therorna completes Series A financing to accelerate pipeline development and clinical transformation of circRNA-based platform

Therorna Inc. | June 21, 2022

Therorna Inc., a China-based biotech company specialized in the development of cutting-edge circular RNA technology-based new vaccines and therapies, announced the completion of a US$42 million Series A financing round. The round was co-led by a well-known industrial investment firm and MSA Capital, with participation from Sherpa Healthcare Partners, 3H Health Investment, and existing investors Quan Capital and Cenova Capital, demonstrating their continuous commitment to supporting Therorna's growth. With the new funding, Therorna plans to accelerate the build-out of its technology platform and the development of its product pipeline, as well as the clinical trials, regulatory applications, and international collaborations. Therorna was founded in Beijing in April 2021. The company focuses on leveraging its proprietary circRNA technology platform to develop next-generation vaccines and innovative therapies. The company has established a strong pipeline of novel prophylactic and therapeutic drugs aiming to address high unmet medical needs. When combined with the previously completed angel and pre-A rounds, the company has to date raised over US$60 million. "We really appreciate the support of our investors. As the world continues to suffer from the COVID-19, scientists are obliged to shoulder the responsibility to provide scientific solutions to end this pandemic. We are devoted to accelerating the clinical application of our circRNA-based vaccines against SARS-CoV-2 and its variants." The scientific founder of Therorna, Professor Wensheng Wei Therorna Chief Executive Officer, Dr. Daniel Tang commented, "I am very grateful for the support of our new and existing investors in this financing round. The successful completion of this round will play a key role in helping Therorna accelerate the development of a new broad-spectrum COVID-19 vaccine and the discovery of additional novel therapies for a variety of diseases. Our team will continue to spare no effort to advance the circRNA platform technology to develop the next-generation of breakthrough therapies and quickly deliver meaningful social benefits." MSA Capital founder and managing partner Yu Zeng added, "We are confident in the potential of circRNA technology for drug development in the area of protein expression and regulation. Compared with linear RNA, circRNA boasts breakthroughs in expression, stability, immunogenicity, and production. In terms of the technology, Chinese scientists have proven their internationally recognized capabilities at innovation and efficient transformation. MSA Capital is impressed by Therorna's strong team of scientists and entrepreneurs. As a serial entrepreneur, Professor Wei has deep expertise in gene editing and circRNA technology application, and Therorna's management team has rich experience in drug R&D and industrial management. MSA Capital will make use of its resources to support the expansion of Therorna in international markets." Sherpa Healthcare Partners investment VP Dr. Changzu Cai said, "mRNA drugs have achieved notable success in the application of COVID-19 vaccines, but challenges in terms of side effects remain to be addressed. Linear RNA is easily degraded and its application beyond vaccines is still under exploration. Thanks to its unique structure, the circRNA as a tool for protein expression has been proven to maintain a relatively stable protein expression level in vivo for a longer time, which is expected to further expand the application scenarios of RNA therapy. The team led by Professor Wei is leveraging their experience in applying circRNA as a gene editing tool to support the development of the circRNA expression tool. The proprietary circularization method developed by Therorna has demonstrated its advantages in terms of dosage, and activation of cellular immunity by being first applied in COVID-19 vaccines. We are pleased to continue supporting the efforts of Wei Lab in converting innovations into benefits for patients and communities, while looking forward to transforming Therorna into a platform-based circRNA technology-focused company with an international presence." 3H Health partner Dr. Minchuan Wang said, "circRNA has better stability and long-lasting expression with a potential for creating a new RNA therapy platform. The combination of Professor Wei's team with strong technical expertise in circRNA and the management team established at an earlier stage of the company with members having rich experience in promoting the adoption of new technologies will help accelerate the clinical transformation of circRNA. We are honored to support Therorna in this financing round, and we will work with the company's team, and their new and existing investors, to help the company assume a leadership role in the realm of circRNA, providing patients with pioneering therapies and addressing unmet clinical needs." Exclusive financial advisor for this transaction and CEC Capital Managing Director, Echo Zhang commented, "circRNA has attracted widespread attention as an emerging technology for RNA drugs. Therorna is expected to take the lead in advancing the technology into clinical applications. We are honored to help Therorna complete this round of financing, and we believe that Therorna will lead the development of the global circRNA sector." About MSA Capital Founded in 2014, MSA Capital is an independent global private equity and venture capital firm with over $2.0 billion under management. The firm manages capital from the world's top sovereign wealth funds, international asset managers, pension funds, university endowments, fund of funds and family offices, as well as China's leading new economy entrepreneurs. MSA actively partners with outstanding entrepreneurs in China and other technology markets to build leading, innovative companies that aim to deliver strong financial returns and meaningful, positive impact. The firm is headquartered in Beijing, with resident teams in Shanghai, Hong Kong, Singapore, Middle East, North Africa and the United States. About Sherpa Healthcare Partners Sherpa Healthcare Partners ("Sherpa") was founded in 2018, the founders previously worked together in one of China's leading venture capital firms, built and led its professional medical investment team since 2011, set up the dedicated healthcare investment fund and responsible for healthcare investment. The founders have been teamed together in close co-operation, built on shared values, mutual trust, and complementary capabilities. Sherpa has now become an influential healthcare VC firm in the industry. Sherpa has invested in leading companies in many key areas, such as Pharma, GeneTech, MedTech and Medical services. From 2011 to 2020, the team has gone through 4 vintage year cycles of multiple U.S dollar funds and RMB funds and made 100 investments. Sherpa has the honor to work with many outstanding entrepreneurs and grow together with them. About 3H Health Investment 3H Health Investment is a Hong Kong and Shanghai based healthcare venture capital firm. It focuses on unmet medical needs and invests in emerging fields of science and medicine to deliver breakthroughs to patients. Leveraging its extensive resources with clinical institutions, industry partners and policy institutes, 3H builds leading innovative healthcare companies together with its partners. About Quan Capital Quan capital is a life sciences venture capital firm with strong China expertise and global capabilities. We discover, incubate, and grow next-generation life science companies in early and growth stage, worldwide. Our portfolio companies pioneer differentiated therapies and enabling technologies to address major human diseases with high unmet medical needs. Quan has offices in Shanghai, Menlo Park and Boston. Our investment professionals combine their strong expertise in both science and business with their diverse experiences in global drug development and healthcare investments, and they leverage their broad network worldwide to help maximize the company's value across geographies and development stages. Visit www.quancapital.com to learn more about us. About Cenova Capital Cenova Capital is one of the earliest healthcare funds dedicated to early and growth-stage investments in the life sciences and healthcare sectors in China. Since inception in 2010, Cenova Capital now has six funds under management with investments in over 80 companies in pharmaceuticals, medical devices,healthcare services and digital heath. Cenova Capital's investors are mainly large domestic and international institutional investors including Asian sovereign wealth investors, government institutions, insurance companies, financial institutions and multinational companies. About CEC Capital CEC Capital is a leading Chinese FA with a focus on the global TMT, consumption and health sectors. In addition to investment banking, CEC Capital is managing a RMB fund and a dollar fund with offices in Beijing, Shanghai, Los Angeles and San Francisco, and it also has a license to the US securities market. The healthcare industry is an advantageous industry that CEC Capital is concerned about. Meanwhile, CEC Capital has the largest and most professional health investment banking team in China with the most complete industry chain.

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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

Optomed signs an industrial partnership with a French AI company OphtAI

Optomed Oyj | March 21, 2022

Optomed and a French artificial intelligence company OphtAI have signed a commercial collaboration agreement, where both parties sell OphtAI artificial intelligence for screening of most common eye diseases together with Optomed Aurora handheld cameras as a complete solution for eye screening. The agreement is focusing mostly on European countries and Canada, where OphtAI has a strong presence. OphtAI offers artificial intelligence for detection of diabetic retinopathy, glaucoma and AMD, which is CE-marked for use in Europe and also regulatory authorization for commercialization in Canada. This collaboration supports both companies in their goals to provide more accessible and easier screening of various eye diseases. "The partnership with OphtAI supports Optomed's vision to bring AI enabled eye screening to primary care. We are happy to work with OphtAI who have a strong clinical validation and existing market approvals for EU and Canada." Optomed Vice President Devices, Laura Piila OpthAI CTO, Bruno Lay, comments: "This partnership with Optomed will bring OphtAI to the next level of its growth. OphtAI has been successfully integrated in the Optomed Aurora camera and the software suite, validated by key ophthalmologists, and it is now used on a daily basis for mass screening of diabetic retinopathy. This portable solution is easy to use, intuitive, and quite powerful for end-users. We are really excited to work with the leading company of portable cameras".

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BUSINESS INSIGHTS

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

Since the approval of the first PD-1 checkpoint inhibitor, Keytruda, in 2014, there has been an explosion of the numbers of trials testing these drugs, both alone and in combination. The latest figure, coming from the Cancer Research Institute (CRI) in the US, sets the number in over 1,500 trials.

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