Big Pharma Deal Making – The Beginning of a New Dawn?

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It’s useful to review deal trends periodically to gain insight in how behaviours are changing from the perspective of numbers and value of deals as well as how emphasis shifts from one therapeutic area to another. The majority of small and mid-size development companies will still seek a deal with one of the major pharmaceutical companies in order to commercialise their asset.

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Allchem Pharma

At Allchem Pharma our expertise lies in the sourcing and supply of raw materials and ingredients to manufacturers of pharmaceutical, nutraceutical, veterinarian, medical and supplement products.

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PHARMA TECH

Use of AI: Reshaping the Pharmaceutical Industry

Article | July 15, 2022

For decades, the pharmaceutical industry has counted on state-of-the-art technologies to ensure the market entry of safe and dependable medications. The recent pandemic has shown how important it is for drug companies to get new drugs and vaccines on the market as soon as possible. The incorporation of artificial intelligence and machine learning technologies has greatly benefited the consumer healthcare business and the pharmaceutical industry. These technologies have been indispensable in the field of augmented intelligence, where they are used for applications such as disease detection and diagnosis, research and development, drug manufacturing, and others. How is AI Being Used Across the Pharmaceutical Sector? AI and ML are finding a plethora of applications across the pharmaceutical sector, starting from managing the process of clinical trial databases to drug discovery and disease diagnosis and treatment. These advanced technologies have further gained immense popularity with the advent of the COVID pandemic and the race to discover effective vaccines. The top-level uses of AI across the pharmaceutical sector are as follows Personalized Treatment/ Digital Therapeutics – AI is extensively being used to identify and assist drug developers to provide reliable and accurate insights for developing personalized therapeutics. Disease Identification/ Suggestive Treatment – With robust assessing abilities, AI is finding applications for the diagnosis of diseases ranging from Covid-19 to oncology to degeneration in the eyes. Drug Discovery and Manufacturing – AI assists in screening and comparing the predicted success rate of drug compounds based on biological factors with the results of the initial screening process such as rapid RNA and DNA quantification. Clinical Trials – The technology helps in identifying the most suitable candidate for the clinical trial on the basis of disease conditions, history, and additional attributes covering infection rates, ethnicity, and demographics to study the impact of the drug. The Way Ahead With growing applications in the development of novel therapeutic medications, shifting patient inclination toward personalized medicines, and the introduction of advanced medical fields such as gene therapy, AI is estimated to transform the pharmaceutical

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PHARMA TECH

How Pharma Is Utilizing AI and Analytic Capabilities to Produce Positive Results

Article | July 19, 2022

Applications for AI are as diverse as the industries that employ them, and pharma has identified the particular varieties of AI that are most effective in attaining quicker, more fruitful results across a variety of business activities. In a world where every second counts, pharma and biotech businesses are under pressure to shorten the time to insight and deliver success. As a result, leading organizations quickly realize the potential of artificial intelligence (AI) as a crucial tool for advancing their operations. Leading pharma and biotech firms have realized the potential of AI and are utilizing it to boost productivity and innovation across the board, from production to drug discovery. Their procedures have significantly benefited from the application of machine learning (ML) and natural language processing (NLP), and the results are only becoming better because AI gets stronger and "smarter" the more data it processes. Advantages Pharma Industry Can Leverage Increased effectiveness across the spectrum in the pharmaceutical industry Drug discovery accelerates Superior disease surveillance, detection, and prevention Clinical trials with lower risk Greater insight into the client NLP is used to turn clinical trial data that is text-intensive and highly categorized into the data utilized in machine learning (ML) models, allowing the computer system to apply patterns to the data and generate insights. Clinical trial data is structured and enriched, making it possible to analyze and visualize the data for use in successful plans and strategies for clinical trial design, manufacturing, marketing, and other areas. Faster time to insight and improved business outcomes are the end results. A particularly true principle of machine learning applications is that the outcomes from using AI applications are only as reliable as the data itself. The Pharma Intelligence offering, which combines high-quality, extensive data from the pharmaceutical and biotechnology industries with advanced analytics and AI applications, has assisted customers with high-value products in resolving some of their most difficult key problems, including target prioritization, modalities innovation, competitive benchmarking, clinical trial design and deployment, and more.

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PHARMA TECH

Why Is Diversity of Thought Essential for Developing a Winning Strategy?

Article | August 9, 2022

In developing or evolving a strategy, there are key decision moments. Those are the moments where you are deciding where you need to focus, what you need to excel at to win there, and where and how to allocate resources to get to a point in the future. At these moments, it is the contest of ideas that matters. Having choices matters. Having a cross-functional team participating in the development of strategy is one way of ensuring that you are going to be more successful at generating choices before you start making choices. What Is a Cross-functional Team? A cross-functional team is a collection of individuals with varied skillsets from different areas of a business collaborating to achieve a common goal. Why Are Cross-functional Teams Essential for Business Success? Having this diverse set of minds analysing the situation, considering the big picture and the organisation’s capabilities, and the needs of all stakeholders, inspires teams to think about the choices they have differently and more creatively. For example, in a pharmaceutical setting, the medical affairs team brings knowledge of the data, unmet needs, and insight into clinical practice. Access and reimbursement teams identify the right data and take the lead in building that value story to accelerate market access and product uptake. It is incumbent upon commercial to hear their ideas, obtain their perspective and secure their alignment to all strategy decisions. Cross-functional collaboration can help break down silos. Research suggests that working in silos and not sharing data with team members from other departments can cost a company close to $8,000 per day in wasteful expenses. Time is widely recognised as a scarce resource: we need quick access to accurate and real-time insights to make effective business decisions. Real time insight will come from those closest to the customer, so it is important for cross-functional members from different geographies to participate in the development of strategy. Improved insight is a source of sustainable competitive advantage. One single version of the truth is what is required for the right narrative to take place. The right narrative will lead to the right decisions. One single version of the truth is more easily achieved by cross-functional team members working closely together. Better Innovation & Creativity: Individuals with diverse skillsets often explore a problem in different ways. When different people working in different capacities come together, they think outside the box to significantly improve outcomes. It is a great way to come up with concepts that distinguish companies from their competitors. Achieving alignment with strategy across functions and geographies: Today, businesses are moving faster than ever and organisations are seeing possible competitors in areas they never knew existed before. With so much choice about where to focus, you really want your workforce to align around one strategy. Underperformance is inevitable if everybody is off working in ten different directions. Improving the customer experience: Creating an effective customer experience is about more than just ensuring your customers receive the products and services they desire in a timely and efficient manner. It’s also about creating touchpoints with real people who can organically evangelise and grow your brand through their social media and offline interactions with friends and family. Your customers are engaging with multiple communication channels– official websites, social platforms, virtual platforms, medical science liaisons, sales reps, and more. Everyone needs to be aware of, and understand, the moments that matter to your customer and the business along that customer journey and how they contribute to delivering that positive experience. This is more likely to be achieved with a cross-functional approach to strategy development. Business Agility: Cross-functional teams are typically small, adaptable, and flexible. Such teams can move faster as they don’t have to wait and rely on other departments or external sources. They can help in tackling any silo mentality and bridge gaps between team members. They can come together to consider new information and/or changes to adapt the strategy if necessary and/or react to any setbacks immediately. They are better placed to make decisions when problem-solving amidst uncertainty. In summary, the rapidly changing environment and new information requires medical affairs, along with access and reimbursement and commercial, to work together, to ensure that patient’s benefit from the value of new innovative therapies. Companies stand a better chance of creating a winning strategy if it is created by a cross-functional and geographically diverse team. With every team member bringing their abilities and knowledge to the table, the strategy over time can only move from strength to strength. However, if not supported correctly, a cross-functional team working on strategy can be dysfunctional and chaotic, and result in a laborious and time-consuming approach to strategy development. Digital strategy platforms such as Nmblr offer an inclusive and structured process to facilitate a strategy discussion and allow people to bring forward ideas. They do this by: working against silos – the structure provided, levels the playing field. The guidance provided equips people from different disciplines to contribute to the conversation.

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PHARMA TECH

Modern Phenotypic Drug Discovery

Article | June 2, 2022

Nature Reviews Drug Discovery makes these points well. It goes over historical and recent successes of the phenotypic approach, and discusses some areas that it's opening up for discussion and research. One of these is the long-vexed question of polypharmacology: what do you do when your active compound doesn't seem to have a single target, but rather hits a whole list of stuff at varying degrees of potency? Seen from a pure target-based viewpoint, this is a failure, and you'd better start working on something else. But to be honest, there are a lot of drugs out there (and not all of them ancient legacy compounds by any means) that work this way, even if their developers didn't think so at the time. So it's not to be disparaged on principle, but that said, it's still a difficult area to make progress in because of all the variables. A good enough phenotypic hit, though, makes its own case that it's worthy of further investigation and development, even if it's not "clean" by rigorous target-based standards. But as always, your phenotypic screen had better be a good one. That is, it had really better model the human disease in a useful way, and have a good signal/noise. The authors note that you're much better off with assays that involve a gain-of-function/gain-of-signal readout, as opposed to ones that could read out just through cellular stress or cytotoxicity, which is an invitation to chase your tail. Another area the paper brings up is searching lower-molecular-weight compounds than are usually screened, down to fragment-sized. There are quite a few useful drugs out there with really low molecular weights - ibuprofen, aspirin, metformin, dimethyl fumarate, lacosamide and more - and any screening program would be happy to have discovered something as useful as those. As the authors note, hits like these in phenotypic screens might be another case of polypharmacology, or they might be hitting pathways whose "tone" we have not understood well (and for which micromolar inhibitors might work out just fine). At any rate, there might be an opportunity for fragment phenotypic screening, and even of covalent fragments (which will call for even more attention to the validity of the underlying screening model, I'd say). The paper discusses the question of target ID, which for most phenotypic programs feels like a natural progression. Most of us are innately biased towards thinking in terms of drug targets, so when a phenotypic compound emerges we want to know what it's "really" doing. And most of the time, there is such a target in there somewhere, although finding it can be quite a haul. I know of several compounds that have been kicking around for years that are obviously doing something in the assays, but no one has ever been able to pin down quite what that is! This paper makes the case for getting out of a binary mindset for target identification. They point out, correctly, that target ID is a means to an end, and that you do not actually need to identify your target to go on to clinical trials and go to the FDA for approval. I always find it surprising to find how many people are surprised by that, but it's true. You also need to realize that knowing a target may not tell you nearly as much as you would want about a compound's mechanism of action, if your new target lands in the middle of a bunch of not-well-worked-out biology. There's a good case to be made that modern chemical biology and imaging techniques have made it easier to progress things, even if you're not quite sure how they're working. We can extract huge amounts of information about the cellular effects of a given compound, and if you do a good job of matching this against a closely related structure that's phenotypically inactive, you can make a lot of headway. This doesn't mean that you shouldn't bother trying to find the target - as mentioned, this is a great way to expand the knowledge of the underlying disease, and can lead to other new programs spinning off of the phenotypic effort. But it does mean that you shouldn't freeze in fear if you don't have a target to point to. The FDA wants to see safety and efficacy, and that's what we should want to see, too, for starters. But as the paper notes at the end, phenotypic screening is going to advance at the pace of good model development. Many of these same chem-bio tools can be brought to bear on this question as well, along with advances in cell culture, organoids, and other new assay technologies. You're not going to be able (realistically) to recapitulate all the features of a human disease, so you will probably find yourself concentrating on certain features that you can make the case for driving a project on. I was very happy to see this paper reference Jack Scannell's paper on translatability (blogged about here), because its point is crucial to the whole phenotypic screening endeavour. If your underlying assay is flawed, there is nothing you can do in any other part of the project to make up for it. A poorly translatable assay is a sign that you should spend your time trying to fix it, or to go do something entirely different instead. It is not a sign that you should just keep on going, because "it's the best thing we've got". If it isn't good enough, it isn't good enough. I don't get to quote A. E. Houseman much around here, but he's right: "The toil of all that be. Helps not the primal fault; It rains into the sea. And still the sea is salt." If you don't fix your assay up front, you are raining into the sea.

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Allchem Pharma

At Allchem Pharma our expertise lies in the sourcing and supply of raw materials and ingredients to manufacturers of pharmaceutical, nutraceutical, veterinarian, medical and supplement products.

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Standigm names Carl Foster chief business officer to expand strategic partnerships for AI drug discovery

Standigm | August 19, 2022

Standigm Inc. the leading workflow artificial intelligence (AI) drug discovery company, announced the appointment of Chief Business Officer Carl Foster. Based in our U.S. office, Foster will be responsible for expanding strategic partnerships for novel drug target discoveries and first-in-class lead candidate identifications. "Carl has established a reputation for increasing company value. He has significant experience building and growing biotech companies, like Standigm, through creative deal-making. We're confident Carl can help us meet our aggressive goals." Jinhan Kim, CEO of Standigm Foster spent over 30 years working for drug and platform technology companies in various areas including genomics, proteomics and antibodies. Throughout his career, he has built a strong track record of business planning, establishing strategic relationships and financial modeling. Foster began his career with Merck and Co., Inc. where he had spent nine years in business development, marketing, and sales. Most recently, he was executive vice president, business development for Cempra Pharmaceuticals. Prior to that, he was CEO of Jurilab, a European-based genomics company. Foster has also held vice president-level positions at Nanogen, King Pharmaceuticals, Oxford GlycoSciences and Praecis Pharmaceuticals. In addition, he was general manager of Intracel BV, a Netherlands-based immunology company and managing director of Ferghana Partners, a New York-based investment banking group. Foster holds an MBA in marketing and an M.S. in biochemistry from the University of Kansas. "Our goal is to shorten the drug discovery process, reduce costs and increase the probability of success by combining the Standigm AI platform with disease-specific data from our strategic partners," said Foster. "I believe combining AI with drug discovery will result in major advances in how we understand diseases and create solutions. Standigm's first-class AI platform is backed by a strong team of biologists, chemists and AI engineers who have collectively created a tremendous opportunity for me. I look forward to helping them build a novel and industry-leading company." About Standigm Standigm is a workflow AI-driven drug discovery company headquartered in Seoul, South Korea and subsidiarized in Cambridge, U.K. and Cambridge, MA. Standigm has proprietary AI platforms encompassing novel target identification to compound design, to generate commercially valuable drug pipelines. Founded in 2015, Standigm has established an early-stage drug discovery workflow AI to generate multiple First-in-Class compounds within average seven months. Pursuing full-stack, AI-driven industrializing drug discovery, Standigm has achieved the automation of molecular design workflow, and the automation effort has been expanding to the whole drug discovery process based on Standigm AI platforms, including Standigm ASK™ for novel target discovery, Standigm BEST™ for novel compound generation and Standigm Insight ™ for novel indication.

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BUSINESS INSIGHTS

U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant

Astellas Pharma Inc | August 19, 2022

Astellas Pharma Inc. announced that the U.S. Food and Drug Administration has accepted the company's New Drug Application for fezolinetant, an investigational oral, nonhormonal compound seeking approval for the treatment of moderate to severe vasomotor symptoms associated with menopause. VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.1,2 The PDUFA target action date is February 22, 2023, following use of a priority review voucher (PRV). Astellas booked ¥13.1 billion of amortization of the intangible asset relating to PRV as R&D expense in the first quarter of fiscal year 2022. "The FDA's acceptance of our NDA for fezolinetant brings us one step closer to advancing care for women in the U.S. who experience VMS. We look forward to the FDA's review of our application, and the potential to offer a first-in-class nonhormonal treatment option to reduce the frequency and severity of moderate to severe VMS associated with menopause." Ahsan Arozullah, M.D., M.P.H., Senior Vice President and Head of Development Therapeutic Areas, Astellas The NDA is supported by results from the BRIGHT SKY™ program, which included three Phase 3 clinical trials that collectively enrolled over 2,800 women with VMS across the U.S., Canada and Europe. Results from the SKYLIGHT 1™ and SKYLIGHT 2™ pivotal trials characterize the efficacy and safety of fezolinetant for the treatment of moderate to severe VMS associated with menopause. Data from the SKYLIGHT 4™ safety study further characterizes the long-term safety profile of fezolinetant. Within the NDA, Astellas proposes a 45 mg daily dose, which is subject to the FDA's review. Fezolinetant is an investigational nonhormonal selective neurokinin 3 (NK3) receptor antagonist. The safety and efficacy of fezolinetant are under investigation and have not been established. The impact of this acceptance on Astellas' financial results of the current fiscal year ending March 31, 2023, is expected to be minor. About the BRIGHT SKY™ Phase 3 Program The BRIGHT SKY pivotal trials, SKYLIGHT 1™ (NCT04003155) and SKYLIGHT 2™ (NCT04003142), enrolled over 1,000 women with moderate to severe VMS. The trials are double-blinded, placebo-controlled for the first 12 weeks followed by a 40-week treatment extension period. Women were enrolled at over 180 sites within the U.S., Canada and Europe. SKYLIGHT 4™ (NCT04003389) is a 52-week double-blinded, placebo-controlled study designed to investigate the long-term safety of fezolinetant. For SKYLIGHT 4, over 1,800 women with VMS were enrolled at over 180 sites within the U.S., Canada and Europe. About VMS Associated with Menopause VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.1,2 In the U.S., about 60% to 80% of women experience these symptoms during or after the menopausal transition and, worldwide, more than half of women 40 to 64 years of age experience VMS.3,4,5,6 VMS can have a disruptive impact on women's daily activities and overall quality of life. About Fezolinetant Fezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS associated with menopause. Fezolinetant works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin/dynorphin (KNDy) neuron to moderate neuronal activity in the thermoregulatory center of the brain (the hypothalamus) to reduce the frequency and severity of moderate to severe VMS associated with menopause.7,8,9 The safety and efficacy of fezolinetant are under investigation and have not been established. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated. About Astellas Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients.

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PHARMA TECH

Gerresheimer and Zollner enter into a strategic partnership for electronically controlled medtech systems from a single source

Gerresheimer AG | August 18, 2022

Gerresheimer AG and Zollner Elektronik AG are pooling their market-leading pharmaceutical and medical technology expertise under a strategic partnership. Starting immediately, they will offer pharmaceutical, healthcare and biotech companies their conceptual design, development and manufacturing capacities for drug delivery and medical technology systems, including complete electronics, from one single source. Gerresheimer serves as the central point of contact for customers. The market-leading partners combine the expertise of Gerresheimer in innovative devices for the administration of medicines and medical technology systems with the globally established electronics expertise of Zollner. Together they want to further develop their expertise in the healthcare sector and open up new markets. With this strategic partnership, Gerresheimer and Zollner are counting on the global trend toward electronic, digitally controllable and connected drug delivery and diagnostic systems. These include insulin pens, inhalators, like for people suffering with asthma, Point-of-Care systems and medicine pumps. The demand for medical and pharmaceutical devices with electronic components mostly for the treatment of chronic illnesses will significantly increase in coming years. According to studies, the market for digital and connected solutions for the treatment of diabetes alone is expected to grow to around EUR 11bn by 2025. Zollner Elektronik AG is one of the world's largest manufacturing service providers for electronic and mechatronic components (Electronic Manufacturing Services or EMS). It generated revenues of around 1.9 billion Euros with just over 12,000 employees at 23 locations in Germany and abroad, 18.3% of that in the area of Healthcare & Life Sciences. "The future belongs to digital treatment support with electronic systems and connected platforms. The partnership with Zollner helps us provide our pharma customers with innovative one-stop medtech solutions. For patients, using these solutions means better treatment and enhanced quality of life. At the same time, the healthcare system also benefits by way of permanently reduced treatment costs." Dietmar Siemssen, CEO of Gerresheimer AG "Digitalization of medical devices is advancing at a very fast tempo. At Zollner, we are happy to have found an ideal partner in Gerresheimer for the expansion of our successful Healthcare & Life Sciences efforts," says Markus Aschenbrenner, Managing Board Member at Zollner. "Together we will expand access to existing markets, exploit new growth markets and support our mutual customers along the entire life cycle of the products." Zollner and Gerresheimer have collected much cooperation experience in numerous projects. The electronics specialist in Zandt already supplies Duesseldorf-based Gerresheimer with components and assemblies for medicine pumps in Parkinson's therapy. Gerresheimer and Zollner are now further developing this cooperation and will act as equal partners for the healthcare system of the future. Through the integration of concept design, development and manufacturing, the products of both sides can be brought to market faster and more efficiently. Also gained is permanent, secure access to electronic components. The cooperation initially covers the development of inhalers for chronic lung disease sufferers, autoinjectors, ophthalmology systems and drug pumps, as well as contract manufacturing for these and similar devices.

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BUSINESS INSIGHTS

Standigm names Carl Foster chief business officer to expand strategic partnerships for AI drug discovery

Standigm | August 19, 2022

Standigm Inc. the leading workflow artificial intelligence (AI) drug discovery company, announced the appointment of Chief Business Officer Carl Foster. Based in our U.S. office, Foster will be responsible for expanding strategic partnerships for novel drug target discoveries and first-in-class lead candidate identifications. "Carl has established a reputation for increasing company value. He has significant experience building and growing biotech companies, like Standigm, through creative deal-making. We're confident Carl can help us meet our aggressive goals." Jinhan Kim, CEO of Standigm Foster spent over 30 years working for drug and platform technology companies in various areas including genomics, proteomics and antibodies. Throughout his career, he has built a strong track record of business planning, establishing strategic relationships and financial modeling. Foster began his career with Merck and Co., Inc. where he had spent nine years in business development, marketing, and sales. Most recently, he was executive vice president, business development for Cempra Pharmaceuticals. Prior to that, he was CEO of Jurilab, a European-based genomics company. Foster has also held vice president-level positions at Nanogen, King Pharmaceuticals, Oxford GlycoSciences and Praecis Pharmaceuticals. In addition, he was general manager of Intracel BV, a Netherlands-based immunology company and managing director of Ferghana Partners, a New York-based investment banking group. Foster holds an MBA in marketing and an M.S. in biochemistry from the University of Kansas. "Our goal is to shorten the drug discovery process, reduce costs and increase the probability of success by combining the Standigm AI platform with disease-specific data from our strategic partners," said Foster. "I believe combining AI with drug discovery will result in major advances in how we understand diseases and create solutions. Standigm's first-class AI platform is backed by a strong team of biologists, chemists and AI engineers who have collectively created a tremendous opportunity for me. I look forward to helping them build a novel and industry-leading company." About Standigm Standigm is a workflow AI-driven drug discovery company headquartered in Seoul, South Korea and subsidiarized in Cambridge, U.K. and Cambridge, MA. Standigm has proprietary AI platforms encompassing novel target identification to compound design, to generate commercially valuable drug pipelines. Founded in 2015, Standigm has established an early-stage drug discovery workflow AI to generate multiple First-in-Class compounds within average seven months. Pursuing full-stack, AI-driven industrializing drug discovery, Standigm has achieved the automation of molecular design workflow, and the automation effort has been expanding to the whole drug discovery process based on Standigm AI platforms, including Standigm ASK™ for novel target discovery, Standigm BEST™ for novel compound generation and Standigm Insight ™ for novel indication.

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BUSINESS INSIGHTS

U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant

Astellas Pharma Inc | August 19, 2022

Astellas Pharma Inc. announced that the U.S. Food and Drug Administration has accepted the company's New Drug Application for fezolinetant, an investigational oral, nonhormonal compound seeking approval for the treatment of moderate to severe vasomotor symptoms associated with menopause. VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.1,2 The PDUFA target action date is February 22, 2023, following use of a priority review voucher (PRV). Astellas booked ¥13.1 billion of amortization of the intangible asset relating to PRV as R&D expense in the first quarter of fiscal year 2022. "The FDA's acceptance of our NDA for fezolinetant brings us one step closer to advancing care for women in the U.S. who experience VMS. We look forward to the FDA's review of our application, and the potential to offer a first-in-class nonhormonal treatment option to reduce the frequency and severity of moderate to severe VMS associated with menopause." Ahsan Arozullah, M.D., M.P.H., Senior Vice President and Head of Development Therapeutic Areas, Astellas The NDA is supported by results from the BRIGHT SKY™ program, which included three Phase 3 clinical trials that collectively enrolled over 2,800 women with VMS across the U.S., Canada and Europe. Results from the SKYLIGHT 1™ and SKYLIGHT 2™ pivotal trials characterize the efficacy and safety of fezolinetant for the treatment of moderate to severe VMS associated with menopause. Data from the SKYLIGHT 4™ safety study further characterizes the long-term safety profile of fezolinetant. Within the NDA, Astellas proposes a 45 mg daily dose, which is subject to the FDA's review. Fezolinetant is an investigational nonhormonal selective neurokinin 3 (NK3) receptor antagonist. The safety and efficacy of fezolinetant are under investigation and have not been established. The impact of this acceptance on Astellas' financial results of the current fiscal year ending March 31, 2023, is expected to be minor. About the BRIGHT SKY™ Phase 3 Program The BRIGHT SKY pivotal trials, SKYLIGHT 1™ (NCT04003155) and SKYLIGHT 2™ (NCT04003142), enrolled over 1,000 women with moderate to severe VMS. The trials are double-blinded, placebo-controlled for the first 12 weeks followed by a 40-week treatment extension period. Women were enrolled at over 180 sites within the U.S., Canada and Europe. SKYLIGHT 4™ (NCT04003389) is a 52-week double-blinded, placebo-controlled study designed to investigate the long-term safety of fezolinetant. For SKYLIGHT 4, over 1,800 women with VMS were enrolled at over 180 sites within the U.S., Canada and Europe. About VMS Associated with Menopause VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.1,2 In the U.S., about 60% to 80% of women experience these symptoms during or after the menopausal transition and, worldwide, more than half of women 40 to 64 years of age experience VMS.3,4,5,6 VMS can have a disruptive impact on women's daily activities and overall quality of life. About Fezolinetant Fezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS associated with menopause. Fezolinetant works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin/dynorphin (KNDy) neuron to moderate neuronal activity in the thermoregulatory center of the brain (the hypothalamus) to reduce the frequency and severity of moderate to severe VMS associated with menopause.7,8,9 The safety and efficacy of fezolinetant are under investigation and have not been established. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated. About Astellas Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients.

Read More

PHARMA TECH

Gerresheimer and Zollner enter into a strategic partnership for electronically controlled medtech systems from a single source

Gerresheimer AG | August 18, 2022

Gerresheimer AG and Zollner Elektronik AG are pooling their market-leading pharmaceutical and medical technology expertise under a strategic partnership. Starting immediately, they will offer pharmaceutical, healthcare and biotech companies their conceptual design, development and manufacturing capacities for drug delivery and medical technology systems, including complete electronics, from one single source. Gerresheimer serves as the central point of contact for customers. The market-leading partners combine the expertise of Gerresheimer in innovative devices for the administration of medicines and medical technology systems with the globally established electronics expertise of Zollner. Together they want to further develop their expertise in the healthcare sector and open up new markets. With this strategic partnership, Gerresheimer and Zollner are counting on the global trend toward electronic, digitally controllable and connected drug delivery and diagnostic systems. These include insulin pens, inhalators, like for people suffering with asthma, Point-of-Care systems and medicine pumps. The demand for medical and pharmaceutical devices with electronic components mostly for the treatment of chronic illnesses will significantly increase in coming years. According to studies, the market for digital and connected solutions for the treatment of diabetes alone is expected to grow to around EUR 11bn by 2025. Zollner Elektronik AG is one of the world's largest manufacturing service providers for electronic and mechatronic components (Electronic Manufacturing Services or EMS). It generated revenues of around 1.9 billion Euros with just over 12,000 employees at 23 locations in Germany and abroad, 18.3% of that in the area of Healthcare & Life Sciences. "The future belongs to digital treatment support with electronic systems and connected platforms. The partnership with Zollner helps us provide our pharma customers with innovative one-stop medtech solutions. For patients, using these solutions means better treatment and enhanced quality of life. At the same time, the healthcare system also benefits by way of permanently reduced treatment costs." Dietmar Siemssen, CEO of Gerresheimer AG "Digitalization of medical devices is advancing at a very fast tempo. At Zollner, we are happy to have found an ideal partner in Gerresheimer for the expansion of our successful Healthcare & Life Sciences efforts," says Markus Aschenbrenner, Managing Board Member at Zollner. "Together we will expand access to existing markets, exploit new growth markets and support our mutual customers along the entire life cycle of the products." Zollner and Gerresheimer have collected much cooperation experience in numerous projects. The electronics specialist in Zandt already supplies Duesseldorf-based Gerresheimer with components and assemblies for medicine pumps in Parkinson's therapy. Gerresheimer and Zollner are now further developing this cooperation and will act as equal partners for the healthcare system of the future. Through the integration of concept design, development and manufacturing, the products of both sides can be brought to market faster and more efficiently. Also gained is permanent, secure access to electronic components. The cooperation initially covers the development of inhalers for chronic lung disease sufferers, autoinjectors, ophthalmology systems and drug pumps, as well as contract manufacturing for these and similar devices.

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