New Dimensions of Clinical Trial Optimization

April 20, 2021 | 336 views

For much of the past three decades, even as methodologies for clinical trial design have advanced and refined, the idea of the optimized clinical trial has centered on optimal patient samples, target enrollment rates, and generally the most efficient uses of scarce resources in the form of patients. Yet anyone who has had to design and optimize a clinical trial, knows that trial optimization occurs within an ecosystem of choices; a series of choices that stretch from the time it takes to implement a clinical trial and submit clinical data for analysis, to general concerns about the cost and power of a clinical trial. A true clinical trial optimization process would try to unify a number of these choices into a single framework for trial optimization.

The complexity of clinical trial optimization comes from the need to align priorities on the one hand, and to understand opportunities on the other. We know that at a very general level, clinical operations specialists benefit from simplicity in clinical trial design, and that commercial teams prefer shorter clinical trials to longer ones. We also know that the statistical design of a clinical trial can influence both simplicity and duration. Yet how many sponsors have their clinical operations and commercial teams, sit with their R&D teams to review various statistically nuanced design options?

For many sponsors, the reason this process does not occur as often as it should, is because the nuanced statistical parameters of a clinical trial design are very difficult to communicate to non-statisticians. Yet a trial optimization tool like Solara, equipped with data visualizations and the ability to see tradeoffs intuitively, can overcome this challenge. The real challenge is often convincing the non-statistician that they have a stake in clinical trial design.

Cytel recently had a client that thought it needed a sample size re-estimation design, because it had a very strict limit on the number of patients it could enroll. After a few hours of working with Solara, though, a statistician discovered that a much simpler Group Sequential Design would deliver comparable power using about the same number of patients. The gains from the more complex design were minimal from the optimization perspective, when understood as the eco-system of choices.

Similarly, most commercial teams pressure their clinical trial designers to have the most accelerated clinical trial imaginable, but as we all know, the longer the clinical trial the more likely there will be a higher number of events that demonstrate the effectiveness of a new medicine. So commercialization teams have a stake in longer clinical trials, even when their rule of thumb is to shorten them.

Therefore, it is absolutely essential to communicate the benefits of various statistical designs to multiple stakeholders in a way that makes tradeoffs clear. Aligning on priorities early during the clinical trial design process is essential to selecting the optimal clinical trial. Yet for this statisticians need to be equipped for both a strategic and communicative role in the R&D process.

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Universal Healthcare (Pty) Ltd.

Universal Healthcare offers healthcare management and technology solutions, serving more than 40 healthcare funders in the public and private healthcare sector. Having established Universal as an industry trailblazer through our empirical and theoretically sound approach to integrated healthcare services, the Universal Healthcare team is distinguished by its commitment to superior quality, innovation and performance.

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Tips for Managing Chronic Pain Beyond Prescription Painkillers

Article | June 30, 2022

Painkillers like Oxycontin, Percocet, and Vicodin, have been prescribed by primary physicians, surgeons, dentists, and other healthcare providers to patients suffering from varying levels of pain. Though these medications have proven to be an effective source of pain relief, they have also proven to be highly addictive. In fact, it has even been reported that there are more cases of a drug overdose and deaths from prescription painkillers than heroin or cocaine. While there are a number of factors that play into this opioid epidemic, educating doctors and patients on alternative solutions to managing chronic pain is a great place to start combatting this nationwide crisis.

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PCD Pharma stands for propaganda distribution. A PCD company gives brand name and support to its franchises. They also provide distribution rights and monopoly rights within a particular region. If a person wants to establish their business, it is a must for them to know the pros and cons of the business to make a sound decision. Needless to mention that PCD company has a lot to contribute in the medical filed. Worldwide in a medical field, A PCD Pharma Company is playing an essential and crucial role in the rapid growth. The pharma industry is progressing t a fast pace. The company uses the latest technologies for each brand which ensures the safety of products and accepts the responsibility of human health & life by providing better outcomes. To have a drug license number and company registration, the cost to establish the company is quite cost-effective that is15000-20000rs. So this gives people a brilliant opportunity to have their unit without digging a big hole in their bank balance. Indian produces exquisite quality products, which make pharma companies a considerable success.

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Article | September 29, 2022

The drugstore chain agreed to pay $7.5 million in fines after an unlicensed pharmacist at several San Francisco Bay locations illegally filled more than 700,000 prescriptions over a ten-year period. According to California prosecutors, Kim Thien Le stole license numbers from other pharmacists to fill prescriptions for Fentanyl, morphine, and other painkillers. Le pleaded guilty to multiple felony impersonation counts. Walgreen’s agreed to the settlement to avoid being charged with consumer fraud in Alameda and Santa Anna Counties. Prosecutors alleged that Walgreen’s failed to verify Le’s license and did not conduct a thorough background check. The company insisted it has taken remedial measures.

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Pain management is one of the most common reasons for the use of medical cannabis products. However, despite many jurisdictions – including Canada, Germany, and the Netherlands – now allowing the prescription of medical cannabis for this purpose, there remains little ‘high-quality’ evidence to support, or oppose its efficacy. Madden et al. (2018) set out to review the evidence available in order to determine the efficacy of medical cannabis when employed in the management of various forms of musculoskeletal pain. The researchers analysed various studies that assessed the use of cannabinoids in the treatment of arthritis pain; back pain; postoperative pain; and trauma-related pain. It is estimated that up to 30% of the population may suffer from a non-cancer-related pain condition. As such a high percentage of people suffer from these conditions, the development of simple and safe therapies is an essential area of research. This is particularly important as the therapeutic options for people with chronic pain are increasingly limited.

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Universal Healthcare (Pty) Ltd.

Universal Healthcare offers healthcare management and technology solutions, serving more than 40 healthcare funders in the public and private healthcare sector. Having established Universal as an industry trailblazer through our empirical and theoretically sound approach to integrated healthcare services, the Universal Healthcare team is distinguished by its commitment to superior quality, innovation and performance.

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Rancho BioSciences Welcomes BenevolentAI as Fifth Member of SCDS Consortium

Rancho BioSciences | February 02, 2023

On February 1, 2023, Rancho Biosciences, a leading provider of data sciences services, announced that BenevolentAI has joined the SCDS consortium as its fifth member. Rancho Biosciences launched its Single Cell Data Science (SCDS) pre-competitive consortium on February 26, 2022, with four Charter Members: Bristol Myers Squibb, Janssen Research & Development LLC, a subsidiary of Johnson & Johnson's Janssen Pharmaceutical Companies, Novartis, and Vesalius Therapeutics. The consortium's mission is to establish a uniform industry standard for creating and formatting single-cell datasets through a systematic effort to build data models and ensure that public data are curated consistently. Due to the evident impact of single-cell transcriptomics technology on drug discovery, pharmaceutical firms continue to adopt single-cell sequencing techniques at an exponential rate. The availability of ever-increasing volumes of single-cell datasets in the public domain enables pharmaceutical companies to vastly increase their universe of single-cell experiments over those generated internally. However, harnessing this enormous public data lake by locating, downloading, and curating single-cell data is difficult and time-consuming compared to the resources required for scientists to analyze data to derive value for biomedical research collectively. To date, Rancho has provided 83 analysis-ready datasets by using its extensive curation knowledge and expertise. Each dataset contains 79 columns of curated metadata that have been verified against a 4-entity data model developed by Rancho for SCDS. Based on member priorities, Rancho will continue to contribute a steady stream of harmonized single-cell datasets to the consortium. With this shared cost model, these may be supplied at a far higher throughput and much more cost-effectively than a single company could do. About Rancho BioSciences Founded in 2012, Rancho BioSciences is a global fee-for-service data curation firm that provides analysis and development services to clients, including pharma, foundations, government, and biotech. With a global team of qualified Ph.D. and Ph.D./MD scientists that provide high-quality work based on their expertise and domain knowledge in biology, diseases, and clinical data, it strives to find cures for diseases by serving its clients and saving lives through Data. It aims to be the world's leading provider of data services and harness domain skills and expertise to address complex problems.

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Hovione and GEA announce a strategic collaboration to advance Continuous Tableting

HOVIONE | December 15, 2022

Hovione and GEA announced a strategic collaboration to advance Continuous Tableting. This partnership stemmed from a successful customer-supplier relationship spanning several years. It combines GEA´s engineering expertise with Hovione´s development and manufacturing experience and both parties commit to partner to accelerate the adoption of Continuous Tableting technology. The advantages of continuous over batch manufacturing are well known. Continuous production systems allow for leaner and risk-reduced development paths, leaner supply chains, increased built-in quality, and in general, manufacturing processes of greater flexibility and reduced complexity. In the context of this strategic collaboration, Hovione and GEA will combine their strengths to further advance the technology and contribute to the establishment of new standards and new levels of market acceptance. "Hovione has a track record in industrializing and democratizing emerging pharmaceutical technologies, such as amorphous solid dispersions by spray drying, and turn them into dependable and scalable offerings that are available to all. We have been committed to Continuous Tableting for the last 7 years and we are now ready to contribute decisively to the advancement of one of the most promising technologies in pharma manufacturing. This collaboration with GEA, gives us the opportunity to link up with a leading designer and supplier of Continuous Tableting equipment solutions and bring Continuous Tableting to the next levels of reliability, flexibility and adoption." Jean-Luc Herbeaux, CEO of Hovione. He adds Navin Lakhanpaul, Global Head Pharma-Solid Dosage, GEA, adds: "As a leading supplier of process technology, GEA has established itself as a trusted solution provider in the pharmaceutical industry, and as a pioneer in the development of Continuous Tableting technology." He adds "Our relationship with Hovione over many years has clearly demonstrated the value in further collaborating and developing synergies in our respective areas of expertise. We share a common objective of enabling the wider use of Continuous Tableting in the Pharmaceutical Industry, and firmly believe that our partnership with Hovione will accelerate the growth of this exciting technology." About Hovione Hovione is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization with a fully integrated offering of services for drug substance, drug product intermediate and drug product. The company has four FDA inspected sites in the USA, Portugal, Ireland and China as well as development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione is the only independent company offering a complete range of services, from API to formulation development and devices. Hovione is a company with a culture based on innovation, quality and delivery. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards. About GEA GEA is one of the world's largest suppliers of systems and components to the food, beverage and pharmaceutical industries. The international technology­ group, founded in 1881, focuses on machinery and plants, as well as advanced process technology, components, and comprehensive services. With more than 18,000 employees working across five divisions and 62 countries, the group generated revenues of more than EUR 4.7 billion in fiscal year 2021. GEA plants, processes, components and services enhance the efficiency and sustainability of production processes across the globe. They contribute significantly to the reduction of CO2 emissions, plastic usage and food waste. In doing so, GEA makes a key contribution toward a sustainable future, in line with the company's purpose: "Engineering for a better world".This partnership stemmed from a successful customer-supplier relationship spanning several years. It combines GEA´s engineering expertise with Hovione´s development and manufacturing experience and both parties commit to partner to accelerate the adoption of Continuous Tableting technology. The advantages of continuous over batch manufacturing are well known. Continuous production systems allow for leaner and risk-reduced development paths, leaner supply chains, increased built-in quality, and in general, manufacturing processes of greater flexibility and reduced complexity. In the context of this strategic collaboration, Hovione and GEA will combine their strengths to further advance the technology and contribute to the establishment of new standards and new levels of market acceptance. "Hovione has a track record in industrializing and democratizing emerging pharmaceutical technologies, such as amorphous solid dispersions by spray drying, and turn them into dependable and scalable offerings that are available to all." Says Jean-Luc Herbeaux, CEO of Hovione. He adds "We have been committed to Continuous Tableting for the last 7 years and we are now ready to contribute decisively to the advancement of one of the most promising technologies in pharma manufacturing. This collaboration with GEA, gives us the opportunity to link up with a leading designer and supplier of Continuous Tableting equipment solutions and bring Continuous Tableting to the next levels of reliability, flexibility and adoption." Navin Lakhanpaul, Global Head Pharma-Solid Dosage, GEA, adds: "As a leading supplier of process technology, GEA has established itself as a trusted solution provider in the pharmaceutical industry, and as a pioneer in the development of Continuous Tableting technology." He adds "Our relationship with Hovione over many years has clearly demonstrated the value in further collaborating and developing synergies in our respective areas of expertise. We share a common objective of enabling the wider use of Continuous Tableting in the Pharmaceutical Industry, and firmly believe that our partnership with Hovione will accelerate the growth of this exciting technology." About Hovione Hovione is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization (CDMO) with a fully integrated offering of services for drug substance, drug product intermediate and drug product. The company has four FDA inspected sites in the USA, Portugal, Ireland and China as well as development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione is the only independent company offering a complete range of services, from API to formulation development and devices. Hovione is a company with a culture based on innovation, quality and delivery. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards. About GEA GEA is one of the world's largest suppliers of systems and components to the food, beverage and pharmaceutical industries. The international technology­ group, founded in 1881, focuses on machinery and plants, as well as advanced process technology, components, and comprehensive services. With more than 18,000 employees working across five divisions and 62 countries, the group generated revenues of more than EUR 4.7 billion in fiscal year 2021. GEA plants, processes, components and services enhance the efficiency and sustainability of production processes across the globe. They contribute significantly to the reduction of CO2 emissions, plastic usage and food waste. In doing so, GEA makes a key contribution toward a sustainable future, in line with the company's purpose: "Engineering for a better world".

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VIEWS AND ANALYSIS, PHARMA TECH

Novavax Announces Pricing of $150 Million Offering of Convertible Senior Notes

Novavax, Inc. | December 16, 2022

Novavax, Inc. a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the pricing of an offering of $150 million aggregate principal amount of its 5.00% convertible senior notes due 2027. The notes are being offered and sold only to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended. In connection with the offering of the notes, Novavax has granted to the initial purchasers a 30-day option to purchase up to an additional $25.25 million aggregate principal amount of the notes. The offering of the notes is expected to close on December 20, 2022, subject to customary closing conditions. The notes will represent senior unsecured obligations of Novavax and will accrue interest payable semi-annually in arrears and will mature on December 15, 2027, unless earlier converted, redeemed or repurchased. Novavax will settle conversions by paying or delivering, as applicable, cash, shares of its common stock, par value $0.01 per share or a combination of cash and shares of its common stock, at Novavax' election. The notes will be redeemable, in whole or in part for cash at Novavax' option at any time, and from time to time, on or after December 22, 2025, if the last reported sale price of common stock has been at least 130% of the conversion price then in effect for at least 20 trading days during any 30 consecutive trading day period ending on and including the trading day immediately preceding the date on which Novavax provides notice of redemption at a redemption price equal to 100% of the principal amount of the notes to be redeemed, plus any accrued and unpaid interest to, but excluding, the redemption date. The notes will be convertible at an initial conversion rate of 80.0000 shares of common stock per $1,000 principal amount of notes. J.P. Morgan, Jefferies and Cowen are acting as joint book-running managers and representatives of the initial purchasers for the offering of the notes. J. Wood Capital Advisors served as financial advisor to the Company in relation to the offering of the notes. Concurrently with the offering of the notes, Novavax also announced today the pricing of its previously announced underwritten public offering to sell up to 6,500,000 shares of its common stock at a public offering price of $10.00 per share, or $65 million worth of shares of its common stock. In connection with the common stock offering, Novavax granted the underwriters a 30-day option to purchase up to an additional 975,000 shares of its common stock at the public offering price, less underwriting discounts and commissions. The offering of the notes is not contingent upon the consummation of the concurrent common stock offering, and the concurrent common stock offering is not contingent upon the consummation of the offering of the notes. The concurrent common stock offering is expected to close on December 20, 2022, subject to customary closing conditions. Novavax may use the net proceeds from the offering of the notes and, if consummated, the concurrent common stock offering, for general corporate purposes, including but not limited to the continued global commercial launch of Nuvaxovid, repayment or repurchase of a portion of the $325 million in outstanding principal amount of its 3.75% convertible senior unsecured notes due February 1, 2023, working capital, capital expenditures, research and development expenditures, clinical trial expenditures, repayments under its supply agreements, as well as acquisitions and other strategic purposes. Novavax estimates that the net proceeds from the offering of the notes will be approximately $142.2 million after deducting the initial purchasers' discounts and estimated offering expenses payable by Novavax. The offer and sale of the notes are not being registered under the Securities Act of 1933, as amended any state securities laws. The notes may not be offered or sold in the U.S. except pursuant to an exemption from the registration requirements of the Securities Act and any applicable state securities laws. The notes are being offered only to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act. The offer and sale of the notes and any shares of common stock issuable upon conversion of the notes have not been, and will not be, registered under the Securities Act or any other securities laws, and the notes and any such shares cannot be offered or sold absent registration or except pursuant to an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and any other applicable securities laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction. About Novavax Novavax, Inc. is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. The Novavax COVID-19 vaccine has received authorization from multiple regulatory authorities globally, including the U.S. Food and Drug Administration, the European Commission, and the World Health Organization.

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BUSINESS INSIGHTS, VIEWS AND ANALYSIS

Rancho BioSciences Welcomes BenevolentAI as Fifth Member of SCDS Consortium

Rancho BioSciences | February 02, 2023

On February 1, 2023, Rancho Biosciences, a leading provider of data sciences services, announced that BenevolentAI has joined the SCDS consortium as its fifth member. Rancho Biosciences launched its Single Cell Data Science (SCDS) pre-competitive consortium on February 26, 2022, with four Charter Members: Bristol Myers Squibb, Janssen Research & Development LLC, a subsidiary of Johnson & Johnson's Janssen Pharmaceutical Companies, Novartis, and Vesalius Therapeutics. The consortium's mission is to establish a uniform industry standard for creating and formatting single-cell datasets through a systematic effort to build data models and ensure that public data are curated consistently. Due to the evident impact of single-cell transcriptomics technology on drug discovery, pharmaceutical firms continue to adopt single-cell sequencing techniques at an exponential rate. The availability of ever-increasing volumes of single-cell datasets in the public domain enables pharmaceutical companies to vastly increase their universe of single-cell experiments over those generated internally. However, harnessing this enormous public data lake by locating, downloading, and curating single-cell data is difficult and time-consuming compared to the resources required for scientists to analyze data to derive value for biomedical research collectively. To date, Rancho has provided 83 analysis-ready datasets by using its extensive curation knowledge and expertise. Each dataset contains 79 columns of curated metadata that have been verified against a 4-entity data model developed by Rancho for SCDS. Based on member priorities, Rancho will continue to contribute a steady stream of harmonized single-cell datasets to the consortium. With this shared cost model, these may be supplied at a far higher throughput and much more cost-effectively than a single company could do. About Rancho BioSciences Founded in 2012, Rancho BioSciences is a global fee-for-service data curation firm that provides analysis and development services to clients, including pharma, foundations, government, and biotech. With a global team of qualified Ph.D. and Ph.D./MD scientists that provide high-quality work based on their expertise and domain knowledge in biology, diseases, and clinical data, it strives to find cures for diseases by serving its clients and saving lives through Data. It aims to be the world's leading provider of data services and harness domain skills and expertise to address complex problems.

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BUSINESS INSIGHTS, VIEWS AND ANALYSIS

Hovione and GEA announce a strategic collaboration to advance Continuous Tableting

HOVIONE | December 15, 2022

Hovione and GEA announced a strategic collaboration to advance Continuous Tableting. This partnership stemmed from a successful customer-supplier relationship spanning several years. It combines GEA´s engineering expertise with Hovione´s development and manufacturing experience and both parties commit to partner to accelerate the adoption of Continuous Tableting technology. The advantages of continuous over batch manufacturing are well known. Continuous production systems allow for leaner and risk-reduced development paths, leaner supply chains, increased built-in quality, and in general, manufacturing processes of greater flexibility and reduced complexity. In the context of this strategic collaboration, Hovione and GEA will combine their strengths to further advance the technology and contribute to the establishment of new standards and new levels of market acceptance. "Hovione has a track record in industrializing and democratizing emerging pharmaceutical technologies, such as amorphous solid dispersions by spray drying, and turn them into dependable and scalable offerings that are available to all. We have been committed to Continuous Tableting for the last 7 years and we are now ready to contribute decisively to the advancement of one of the most promising technologies in pharma manufacturing. This collaboration with GEA, gives us the opportunity to link up with a leading designer and supplier of Continuous Tableting equipment solutions and bring Continuous Tableting to the next levels of reliability, flexibility and adoption." Jean-Luc Herbeaux, CEO of Hovione. He adds Navin Lakhanpaul, Global Head Pharma-Solid Dosage, GEA, adds: "As a leading supplier of process technology, GEA has established itself as a trusted solution provider in the pharmaceutical industry, and as a pioneer in the development of Continuous Tableting technology." He adds "Our relationship with Hovione over many years has clearly demonstrated the value in further collaborating and developing synergies in our respective areas of expertise. We share a common objective of enabling the wider use of Continuous Tableting in the Pharmaceutical Industry, and firmly believe that our partnership with Hovione will accelerate the growth of this exciting technology." About Hovione Hovione is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization with a fully integrated offering of services for drug substance, drug product intermediate and drug product. The company has four FDA inspected sites in the USA, Portugal, Ireland and China as well as development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione is the only independent company offering a complete range of services, from API to formulation development and devices. Hovione is a company with a culture based on innovation, quality and delivery. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards. About GEA GEA is one of the world's largest suppliers of systems and components to the food, beverage and pharmaceutical industries. The international technology­ group, founded in 1881, focuses on machinery and plants, as well as advanced process technology, components, and comprehensive services. With more than 18,000 employees working across five divisions and 62 countries, the group generated revenues of more than EUR 4.7 billion in fiscal year 2021. GEA plants, processes, components and services enhance the efficiency and sustainability of production processes across the globe. They contribute significantly to the reduction of CO2 emissions, plastic usage and food waste. In doing so, GEA makes a key contribution toward a sustainable future, in line with the company's purpose: "Engineering for a better world".This partnership stemmed from a successful customer-supplier relationship spanning several years. It combines GEA´s engineering expertise with Hovione´s development and manufacturing experience and both parties commit to partner to accelerate the adoption of Continuous Tableting technology. The advantages of continuous over batch manufacturing are well known. Continuous production systems allow for leaner and risk-reduced development paths, leaner supply chains, increased built-in quality, and in general, manufacturing processes of greater flexibility and reduced complexity. In the context of this strategic collaboration, Hovione and GEA will combine their strengths to further advance the technology and contribute to the establishment of new standards and new levels of market acceptance. "Hovione has a track record in industrializing and democratizing emerging pharmaceutical technologies, such as amorphous solid dispersions by spray drying, and turn them into dependable and scalable offerings that are available to all." Says Jean-Luc Herbeaux, CEO of Hovione. He adds "We have been committed to Continuous Tableting for the last 7 years and we are now ready to contribute decisively to the advancement of one of the most promising technologies in pharma manufacturing. This collaboration with GEA, gives us the opportunity to link up with a leading designer and supplier of Continuous Tableting equipment solutions and bring Continuous Tableting to the next levels of reliability, flexibility and adoption." Navin Lakhanpaul, Global Head Pharma-Solid Dosage, GEA, adds: "As a leading supplier of process technology, GEA has established itself as a trusted solution provider in the pharmaceutical industry, and as a pioneer in the development of Continuous Tableting technology." He adds "Our relationship with Hovione over many years has clearly demonstrated the value in further collaborating and developing synergies in our respective areas of expertise. We share a common objective of enabling the wider use of Continuous Tableting in the Pharmaceutical Industry, and firmly believe that our partnership with Hovione will accelerate the growth of this exciting technology." About Hovione Hovione is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization (CDMO) with a fully integrated offering of services for drug substance, drug product intermediate and drug product. The company has four FDA inspected sites in the USA, Portugal, Ireland and China as well as development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione is the only independent company offering a complete range of services, from API to formulation development and devices. Hovione is a company with a culture based on innovation, quality and delivery. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards. About GEA GEA is one of the world's largest suppliers of systems and components to the food, beverage and pharmaceutical industries. The international technology­ group, founded in 1881, focuses on machinery and plants, as well as advanced process technology, components, and comprehensive services. With more than 18,000 employees working across five divisions and 62 countries, the group generated revenues of more than EUR 4.7 billion in fiscal year 2021. GEA plants, processes, components and services enhance the efficiency and sustainability of production processes across the globe. They contribute significantly to the reduction of CO2 emissions, plastic usage and food waste. In doing so, GEA makes a key contribution toward a sustainable future, in line with the company's purpose: "Engineering for a better world".

Read More

VIEWS AND ANALYSIS, PHARMA TECH

Novavax Announces Pricing of $150 Million Offering of Convertible Senior Notes

Novavax, Inc. | December 16, 2022

Novavax, Inc. a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the pricing of an offering of $150 million aggregate principal amount of its 5.00% convertible senior notes due 2027. The notes are being offered and sold only to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended. In connection with the offering of the notes, Novavax has granted to the initial purchasers a 30-day option to purchase up to an additional $25.25 million aggregate principal amount of the notes. The offering of the notes is expected to close on December 20, 2022, subject to customary closing conditions. The notes will represent senior unsecured obligations of Novavax and will accrue interest payable semi-annually in arrears and will mature on December 15, 2027, unless earlier converted, redeemed or repurchased. Novavax will settle conversions by paying or delivering, as applicable, cash, shares of its common stock, par value $0.01 per share or a combination of cash and shares of its common stock, at Novavax' election. The notes will be redeemable, in whole or in part for cash at Novavax' option at any time, and from time to time, on or after December 22, 2025, if the last reported sale price of common stock has been at least 130% of the conversion price then in effect for at least 20 trading days during any 30 consecutive trading day period ending on and including the trading day immediately preceding the date on which Novavax provides notice of redemption at a redemption price equal to 100% of the principal amount of the notes to be redeemed, plus any accrued and unpaid interest to, but excluding, the redemption date. The notes will be convertible at an initial conversion rate of 80.0000 shares of common stock per $1,000 principal amount of notes. J.P. Morgan, Jefferies and Cowen are acting as joint book-running managers and representatives of the initial purchasers for the offering of the notes. J. Wood Capital Advisors served as financial advisor to the Company in relation to the offering of the notes. Concurrently with the offering of the notes, Novavax also announced today the pricing of its previously announced underwritten public offering to sell up to 6,500,000 shares of its common stock at a public offering price of $10.00 per share, or $65 million worth of shares of its common stock. In connection with the common stock offering, Novavax granted the underwriters a 30-day option to purchase up to an additional 975,000 shares of its common stock at the public offering price, less underwriting discounts and commissions. The offering of the notes is not contingent upon the consummation of the concurrent common stock offering, and the concurrent common stock offering is not contingent upon the consummation of the offering of the notes. The concurrent common stock offering is expected to close on December 20, 2022, subject to customary closing conditions. Novavax may use the net proceeds from the offering of the notes and, if consummated, the concurrent common stock offering, for general corporate purposes, including but not limited to the continued global commercial launch of Nuvaxovid, repayment or repurchase of a portion of the $325 million in outstanding principal amount of its 3.75% convertible senior unsecured notes due February 1, 2023, working capital, capital expenditures, research and development expenditures, clinical trial expenditures, repayments under its supply agreements, as well as acquisitions and other strategic purposes. Novavax estimates that the net proceeds from the offering of the notes will be approximately $142.2 million after deducting the initial purchasers' discounts and estimated offering expenses payable by Novavax. The offer and sale of the notes are not being registered under the Securities Act of 1933, as amended any state securities laws. The notes may not be offered or sold in the U.S. except pursuant to an exemption from the registration requirements of the Securities Act and any applicable state securities laws. The notes are being offered only to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act. The offer and sale of the notes and any shares of common stock issuable upon conversion of the notes have not been, and will not be, registered under the Securities Act or any other securities laws, and the notes and any such shares cannot be offered or sold absent registration or except pursuant to an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and any other applicable securities laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction. About Novavax Novavax, Inc. is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. The Novavax COVID-19 vaccine has received authorization from multiple regulatory authorities globally, including the U.S. Food and Drug Administration, the European Commission, and the World Health Organization.

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