Seven new data hubs to be rolled out across UK

PharmaTimes | September 13, 2019

Seven “pioneering data research centres” are being rolled out across the UK next month, in order to speed up research for new medicines, treatments, and technologies that support quicker diagnosis and save lives. The hubs will be the home of “cutting-edge research” for health discoveries, with an aim to improve the lives of people with debilitating conditions. The potential benefits to patients include earlier diagnosis, the development of more effective treatments and more efficient management of the health service, all of which have the potential to improve outcomes, helping patients enjoy longer and healthier lives. The hubs have been announced as part of a four-year £37million investment from the UK Government Industrial Strategy Challenge Fund (ISCF) announced in November 2017, led by UK Research and Innovation, which aims to create a UK-wide system for the safe and responsible use of health-related data on a large scale. There will be a cancer hub, an eye health hub, inflammatory bowel disease hub, acute care, clinical trials, respiratory and real world data hubs.

Spotlight

Ifotam CO.Ltd is one of the first spin off type companies in Poland, created on the basis of knowledge and experience of the research staff of the Center of Molecular and Macromolecular Studies (Polish Academy of Sciences, Lodz) and the Pharmaceutical Institute (Warsaw). The company was founded in 1989. Our activities are focused on search for, and development of, new methods of synthesis, transfer of technologies, production of APIs and sales of pharmaceutical substances. Many years of work on the company development have resulted in our current position of the one of more important manufacturers of first generation cytostatics in Europe.

Spotlight

Ifotam CO.Ltd is one of the first spin off type companies in Poland, created on the basis of knowledge and experience of the research staff of the Center of Molecular and Macromolecular Studies (Polish Academy of Sciences, Lodz) and the Pharmaceutical Institute (Warsaw). The company was founded in 1989. Our activities are focused on search for, and development of, new methods of synthesis, transfer of technologies, production of APIs and sales of pharmaceutical substances. Many years of work on the company development have resulted in our current position of the one of more important manufacturers of first generation cytostatics in Europe.

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Aptar Expands Pharmaceutical Services Announces Exclusive Collaboration Between Aptar Pharma and Fluidda

Aptar Pharma and Fluidda | September 23, 2022

Nanopharm, an Aptar Pharma company and leader in contract research and development services for orally inhaled and nasal drug products announced an exclusive collaboration with Fluidda, a leader in the field of Functional Respiratory Imaging. The companies will leverage their respective proprietary technology platforms to help accelerate U.S. Food & Drug Administration approvals for orally inhaled generic products via the alternative bioequivalence pathway. Nanopharm was acquired by Aptar in 2019, as part of the company’s strategy to expand its services offerings and partner with pharmaceutical companies earlier in the drug development process. Nanopharm has pioneered the development of the alternative bioequivalence regulatory pathway for U.S. FDA approval of generic OIDPs for Asthma and Chronic Obstructive Pulmonary Disease using its proprietary in vitro and in silico service platform, SmartTrack™. Fluidda’s proprietary in silico platform FRI delivers quantitative predictions of regional drug deposition in disease state lungs using Computational Fluid Dynamics. The FRI platform provides critical information to help understand the availability and activity of the drug at the site of action in the lungs, when complemented by Nanopharm’s local lung physiologically-based pharmacokinetic model platform and its in vitro data. This novel approach is intended to allow pharma companies to file Abbreviated New Drug Application dossiers without the need to perform time-consuming, costly and often unpredictable clinical end-point studies. Similarly, it can support 505(b)(2) filings, by derisking and abbreviating clinical studies. “We are pleased to solidify our relationship with Fluidda and its world-leading FRI technology. A company would have to spend several years to achieve the current combined expertise and experience of Nanopharm and Fluidda. The collaboration between Nanopharm and Fluidda has the potential to revolutionize this arduous regulatory pathway,” Dr. Jag Shur, Vice President, Science & Technology at Nanopharm Having already worked together closely for a number of years, Nanopharm and Fluidda have gained a unique insight into the complex and continually evolving regulatory requirements. This exclusive collaboration deepens the relationship between Fluidda and Nanopharm, benefiting both patients and customers with an uncompromised and holistic approach in developing the scientific rationale to demonstrate bioequivalence using only in vitro and in silico methodologies. The first potential approval of an OIDP using the alternative bioequivalence approach is pending, and, when approved, will further validate Nanopharm’s SmartTrack™ as the go-to solution for alternative bioequivalence studies and should accelerate demand for the companies’ collective services. With momentum building for the transition to new lower global warming potential (GWP) propellants for pMDIs, SmartTrack™ will also help companies to understand and modulate the impact of these new propellants on drug deposition and dissolution in the lungs, giving confidence in the performance of the reformulated product before embarking on any necessary clinical studies. Dr. Jan de Backer, CEO of Fluidda, stated, “Fluidda has already demonstrated the applicability of its FRI platform to provide more objective data for evaluating and administering inhaled drug products accurately. Nanopharm’s unique SmartTrack™ platform provides us with clinically-relevant input data without having to actually go into the clinic, which really adds another level of confidence to the models, and provides an integrated perspective.” Guillaume Brouet, Vice President, Analytical, Regulatory and Scientific Affairs at Aptar Pharma, commented, “Aptar Pharma is delighted to collaborate with Fluidda on this important development, which reinforces our mission to help customers derisk and accelerate their drug product development programs.” About Aptar Aptar Pharma is part of AptarGroup, Inc., a global leader in the design and manufacturing of a broad range of drug delivery, consumer product dispensing and active material science solutions and services. Aptar’s innovative solutions and services serve a variety of end markets including pharmaceutical, beauty, personal care, home care, food and beverage. Aptar Pharma’s analytical, laboratory and regulatory services add value at every stage of the drug development process, accelerating and de-risking the program along the way. Nanopharm, an Aptar Pharma company, is a leading provider of specialized analytical and product development services, with a focus on orally inhaled and nasal drug products. Aptar is headquartered in Crystal Lake, Illinois and has 13,000 dedicated employees in 20 countries. About Fluidda FLUIDDA, founded in 2005, is the world leader in the field of Functional Respiratory Imaging (FRI). This technique combines HRCT scans and Computational Fluid Dynamics technology (CFD), which offers vast improvements by making clinical trials shorter, faster and thus, more cost effective. FRI also helps patients and healthcare providers in offering a unique entry point in personalized medicine, by optimizing diagnosis, monitoring disease progression and the effects of therapy including accurate assessment of the deposition of inhalation medication. Fluidda’s mission is to optimize treatment pathways, reduce healthcare costs and to limit the go-to-market time of respiratory drugs, pulmonology medical devices and therapies. Fluidda has offices in Belgium, the United States and Portugal.

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invoX Pharma Extends Tender Offer to Acquire F-star Therapeutics, Inc.

invoX Pharma Limited | August 05, 2022

invoX Pharma Limited a wholly owned subsidiary of Sino Biopharmaceutical Limited focused on research and development and business development activities outside of China, and F-star Therapeutics, Inc. a clinical-stage biopharmaceutical company pioneering bispecifics in immunotherapy so more people with cancer can live longer and improved lives, today announced that invoX has extended the expiration of its previously announced tender offer for all of the issued and outstanding shares of F-star common stock for a price of $7.12 per share. The tender offer is now scheduled to expire at 05:00 p.m., Eastern Time, on September 19, 2022, unless it is further extended. The tender offer was previously scheduled to expire at one minute after 11:59 P.M., Eastern time, on August 3, 2022. The tender offer is being extended in order to allow additional time for the satisfaction of the regulatory conditions to the offer. The depositary for the tender offer has advised invoX that as of the previous expiration time there were validly tendered and not withdrawn a total of approximately 13,026,582 shares of F-star common stock, and approximately 2,704,867 shares of F-star common stock tendered pursuant to a notice of guaranteed delivery. All terms and conditions of the tender offer remain unchanged during the extension period. F-star shareholders who have already tendered their shares do not have to re-tender their shares or take any other action as a result of the extension. Complete terms and conditions of the tender offer are set forth in the Offer to Purchase, Letter of Transmittal and other related materials, which have been filed by invoX with the Securities and Exchange Commission on July 7, 2022, as amended. In addition, F-star filed a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC on July 7, 2022, as amended, which includes, among other things, the recommendation of F-star’s board of directors that F-star stockholders tender all of their shares in the tender offer. The Information Agent for the tender offer is Innisfree M&A Incorporated. The Depositary and Paying Agent for the tender offer is Computershare Trust Company, N.A. For all questions relating to the tender offer, please call the Information Agent, Innisfree M&A Incorporated toll-free at (888) 750-5830; banks and brokers may call collect at (212) 750-5833. About invoX invoX was incorporated in March 2021 and is a wholly owned subsidiary of Sino Biopharm, a global top 40 pharmaceutical company with more than 24,000 employees. United Kingdom-based invoX is Sino Biopharm’s international expansion platform, focusing on R&D and business development activities outside of China, with a core focus on oncology and respiratory therapeutics. At its core, invoX aspires to improve patients’ lives by creating access to innovative medicine. About Sino Biopharm Sino Biopharm, together with its subsidiaries, is a leading, innovative research and development driven pharmaceutical conglomerate in China, with a business scope that is vertically integrated including research and development, manufacturing and sales and marketing infrastructure. Sino Biopharm’s product offerings include a variety of biologics and small molecule drugs, and in therapy areas that include hepatology, oncology, cardiovascular and cerebrovascular diseases, orthopaedics, digestive and immune and respiratory diseases. About F-star F-star is a clinical-stage biopharmaceutical company pioneering bispecifics in immunotherapy so more people with cancer can live longer and have improved lives. F-star is committed to working towards a future free from cancer and other serious diseases, through the use of tetravalent (2+2) bispecific antibodies to create a paradigm shift in treatments. F-star has four second-generation immuno-oncology therapeutics in the clinic, each directed against some of the most promising immuno-oncology targets in drug development, including LAG-3 and CD137. F-star’s proprietary antibody discovery platform is protected by an extensive intellectual property estate. F-star has over 500 granted patents and pending patent applications relating to its platform technology and product pipeline. F-star has attracted multiple partnerships with biopharma targeting significant unmet needs across several disease areas, including oncology, immunology, and CNS.

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WuXi STA Breaks Ground for New Pharmaceutical Manufacturing Facility in Middletown, Delaware

WuXi AppTec | August 17, 2022

WuXi STA, a leading Contract Research, Development, and Manufacturing Organization is pleased to announce the groundbreaking for its new 190-acre pharmaceutical manufacturing campus in Middletown, Delaware. First announced in June 2021, this site will be WuXi STA's second facility in the United States, offering expanded capacity and greater flexibility to meet the needs of customers in the U.S. and around the world. The WuXi STA Middletown site is located in the Middletown Business Center at 1091 Industrial Drive, and the new state-of-the-art facility will create approximately 500 full-time jobs by 2026. Phase I of the new campus will provide formulation development, clinical and commercial drug product manufacturing services for a variety of oral and injectable dosage forms, as well as packaging, labeling, storage and distribution services for clinical trial materials and commercial drug products. WuXi STA has 12 sites across the U.S., Europe and Asia that offer a range of services and meet or exceed all regulatory standards. Together with three other drug product manufacturing sites in Couvet Wuxi City (China) and Shanghai this new facility will further enhance the company's global drug production capacity and capabilities. "The biopharmaceutical industry is part of Delaware's DNA. Over the next five years, WuXi STA plans to build a state-of-the-art pharmaceutical manufacturing campus in one of Delaware's fastest-growing communities, bringing with it good jobs and economic growth. This campus is only possible because of Delaware's world-class, innovative workforce. Thank you to WuXi STA, Middletown Mayor Kenny Branner and everyone who made this project possible." Delaware Governor John Carney "The First State continues to be a first-rate destination for businesses looking to innovate and grow," said Senator Tom Carper. "This investment by WuXi STA helps position Delaware as a continued global leader in biopharmaceuticals, further cementing the manufacturing might of one of our fastest growing communities. Delaware's workforce is ready to help build the future of our life-saving pharmaceuticals. This state-of-the-art campus will create good jobs and help fortify our supply chains here at home." "This biopharmaceutical facility is one most significant private sector investment ever in the Middletown region," said Senator Chris Coons. "I am excited about WuXi STA's decision to choose Middletown for one of their new manufacturing facilities. This isn't just the largest private-sector investment in Middletown's history – it's a defining moment that will bring many more good-paying jobs to Delaware and will further cement the First State as a world leader in biopharmaceutical research and manufacturing. Thanks are due to everyone from Middletown to Dover to Washington who helped us get to this point, whether by making continued investments in NIIMBL, improving our education system from kindergarten to our universities, or ensuring that Delaware workers have the skills manufacturers like WuXi AppTec are looking for." "As the First State, Delaware has always had a spirit of innovation – constantly seeking new opportunities and ventures that will strengthen our economy and our state as a whole," said Rep. Lisa Blunt Rochester. "Today's groundbreaking of the WuXi STA pharmaceutical manufacturing plant represents another step in that spirit of innovation – bringing good-paying jobs to Middletown and strengthening communities throughout Delaware. The state-of-the-art facility will bring 500 full-time jobs over the next several years, growing our state's workforce and allowing us to manufacture more goods domestically - enhancing our economic competitiveness on the global stage." "We are truly looking forward to our partnership with WuXi STA, as the groundbreaking today marks the kick-off to them making their new home in Middletown, Delaware. WuXi STA will be joining our bustling industrial area, just steps away from Clarios, Datwyler, Amazon and Breakthru Beverage, just some of the companies that have invested in Middletown. When asked by WuXi STA about our business-friendly attitude, these businesses expressed their wholehearted support for how we do business and we couldn't be more excited about WuXi STA wanting to join them, and the Town of Middletown, in our journey together," said Middletown Mayor Ken Branner. Branner added he was thankful for the support of Gov. John Carney and the Delaware Prosperity Partnership. "I would like to thank our federal, state and local partners in Delaware for their continued support in the establishment of this site," said Dr. Minzhang Chen, co-CEO of WuXi AppTec and CEO of WuXi STA. "WuXi STA continues to increase our capabilities and capacities to better serve our customers through a more robust and reliable supply chain. With our integrated Contract Research, Development, and Manufacturing Organization platform and proven quality system, we look forward to working with our customers to swiftly deliver their innovative therapies to market in order to save lives and improve healthcare for patients." About WuXi STA WuXi STA a subsidiary of WuXi AppTec is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life sciences industry, with global operations. As a premier Contract Research, Development, and Manufacturing Organization WuXi STA offers its worldwide partners efficient, flexible and high-quality solutions for integrated chemical, manufacturing and controls from preclinical to commercial uses, including the development and manufacturing of small molecule, oligonucleotide, peptide and various complex chemical conjugate. About WuXi AppTec As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable the global pharmaceutical and healthcare industry to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec's integrated, end-to-end services include chemistry drug CRDMO biology discovery, preclinical testing and clinical research services, cell and gene therapies CTDMO helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received AA ESG rating from MSCI in 2021 and its open-access platform is enabling more than 5,850 collaborators from over 30 countries to improve the health of those in need – and to realize the vision that "every drug can be made and every disease can be treated."

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