Ionis Pharmaceuticals, Inc. | December 30, 2021
Ionis Pharmaceuticals, Inc. the leader in RNA-targeted therapies, announced the closing of the collaboration agreement with AstraZeneca to develop and commercialize eplontersen, Ionis' investigational antisense medicine for the treatment of transthyretin amyloidosis, following expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.
Eplontersen, formerly known as IONIS-TTR-LRx, is designed to reduce the production of transthyretin, or TTR protein, to treat ATTR, a systemic, progressive and fatal disease. It uses Ionis' advanced LIgand-Conjugated Antisense technology.
As previously announced, the companies will jointly develop and commercialize eplontersen in the U.S. AstraZeneca has an exclusive license for eplontersen outside the U.S., except certain countries in Latin America. Under the terms of the agreement, Ionis will receive a $200 million upfront payment, up to $485 million in development and approval milestones, and up to $2.9 billion in sales-related milestone payments. The collaboration includes territory-specific development, commercial and medical affairs cost-sharing provisions. Ionis is also eligible to earn royalties in the range of low double-digit to mid-20s percentage depending on region. Additional details about the agreement can be found in Ionis' Form 8-K filed with the Securities and Exchange Commission on Dec. 7, 2021.
About Ionis Pharmaceuticals, Inc.
For more than 30 years, Ionis has been the leader in RNA-targeted therapy, pioneering new markets and changing standards of care with its novel antisense technology. Ionis currently has three marketed medicines and a premier late-stage pipeline highlighted by industry-leading neurological and cardiometabolic franchises. Our scientific innovation began and continues with the knowledge that sick people depend on us, which fuels our vision of becoming one of the most successful biotechnology companies.
Parexel, Veeva Systems | May 04, 2021
Parexel and Veeva Systems announced a strategic partnership today to accelerate clinical trials through technological and process innovation. The unique partnership blends the best of each company's expertise through thousands of tests worldwide – Parexel as a pioneering CRO and Veeva as the technological innovator powering trials – to boost study performance and bring innovative therapies to patients faster.
Parexel is standardizing Veeva's suite of clinical operations software, including Veeva Vault eTMF, Vault CTMS, and Vault Study Startup, as part of the agreement to streamline operations. Parexel's clients will now have access to Veeva Vault CDMS for clinical data storage as a free product.
The companies will work together to continually develop Veeva's cloud technology and Parexel's clinical trial delivery processes based on the insights from sponsors, sites, and patients. Parexel will provide early access to and give feedback on Veeva's clinical products, such as innovations to support sites and patients in decentralized clinical trials (DCT), risk-based quality management (RBQM), and community-based sites.
"By implementing Veeva's clinical solutions, we can streamline trial procedures, increase performance, and make trial implementation and attendance simpler for promoters, locations, and patients," Parexel CEO Jamie Macdonald said. "Through this extended relationship with Veeva, we hope to have more value to customers and have a much greater effect on the lives of patients."
"We're happy to work with Parexel to fuel customer success and accelerate clinical research innovation," said Peter Gassner, Veeva's founder, and CEO. "By working together, we will help our customers get new vaccines, diagnostics, devices, and therapies to patients in need"
Parexel encourages the development of new innovative drugs to improve patient health. It provides services to clients in the life sciences and biopharmaceutical industries all over the world to help them transform scientific discoveries into new treatments. The therapeutic, technological, and functional ability is underpinned by a strong conviction in what we do, from decentralized clinical trials to regulatory advisory services to exploiting real-world insights. An independent council for Informa Pharma Intelligence voted Parexel the "Best Contract Research Organization" in December 2020.
About Veeva Systems
Veeva is the world's leading provider of cloud software for the life sciences industry. Veeva represents over 975 clients, ranging from the world's leading pharmaceutical firms to new biotechs, and is dedicated to innovation, product excellence, and customer success. Veeva is committed to balancing the needs of all stakeholders, including customers, employees, shareholders, and the industries it serves, as a Public Benefit Corporation.
Stevanato Group | November 18, 2021
Stevanato Group, a global provider of drug containment, drug delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries, today announced the expansion of its corporate headquarters with the construction of a new facility in Piombino Dese, Italy to advance operations and growth of the Company.
The new 6,750 square meter facility is expected to support the optimization of Stevanato Group’s industrial footprint, with about 2,500 square meters dedicated to increasing the production of high-value products. In addition to hosting offices, the Italian analytical services site, and R&D space, it is also expected to include new glass syringe forming lines devoted to boosting the production of EZ-fill® solutions, which are pre-sterilized drug containment solutions that reduce total cost of ownership and time-to-market for pharmaceutical companies.
“We are very proud of the global growth and evolution that Stevanato Group has achieved over the recent years, and we are always exploring new opportunities and ways to meet our customers’ needs. Further increasing our production capabilities here at home through this new space we expect to be able to bridge capacity demands while our exciting projects in the U.S. and China are underway. Importantly, this expansion is further validation of the hard work of our employees, the demand for our innovative products and the continued growth of our business, and we expect it to allow us to be well positioned to build on our current momentum and advance development initiatives that are expected to directly benefit all of our customers and stakeholders around the world.”
Franco Moro, CEO of Stevanato Group
Construction of the new building began in September 2021. The Company expects to install and validate new lines in the second quarter of 2022, and expects industrial production to begin between late second quarter and early third quarter of 2022.
Stevanato Group’s new flagship building represents an important development in its 2020-2023 Industrial Plan, including efforts to meet increasing global demand for premium products. As part of these efforts, the Company recently operationalized two additional lines for EZ-fill® vials and syringes manufacturing in Italy and, in 2022, plans to add two more lines devoted to EZ-fill® syringes as well as one dedicated line for Alba® syringes, the breakthrough solution for biologics. The expansion underway is part of the Company’s expected plans to triple production of EZ-fill® pre-fillable sterile syringes by 2023 and to increase production of EZ-fill® sterile vials and cartridges 19x by 2023, compared to 2016 numbers.
Stevanato Group’s new building also marks the Company’s ongoing dedication to and investment in the local Piombino Dese community, where it has been headquartered for more than 60 years. The new building is expected to act as the counterpart to another facility at the Piombino Dese headquarters, recently completed in 2020, also used for the production of syringes and that hosts solar electric panels. These panels produce 160kWp of electricity per year and are intended to provide electricity to both buildings, as Stevanato Group remains committed to sustainability. To that end, the new building is also intended to have a partial recovery system enabling it to reuse water used for washing in production.
About Stevanato Group
Founded in 1949, Stevanato Group is a leading global provider of drug containment, drug delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries. The Group delivers an integrated, end-to-end portfolio of products, processes and services that address customer needs across the entire drug life cycle at each of the development, clinical and commercial stages. Stevanato Group’s core capabilities in scientific research and development, its commitment to technical innovation and its engineering excellence are central to its ability to offer value added solutions to clients.
This press release may include forward-looking statements. The words "expected", "expects", “intended”, "plans" and similar expressions (or their negative) identify certain of these forward-looking statements. These forward-looking statements are statements regarding the Company's intentions, beliefs or current expectations concerning, among other things, the size and use of the plant, the construction and timing of its plant, impact of the plant of the Company’s business and results of operations and the nature of the plant once complete. The forward-looking statements in this press release are based on numerous assumptions regarding the Company’s present and future business strategies and the environment in which the Company will operate in the future. Forward-looking statements involve inherent known and unknown risks, uncertainties and contingencies because they relate to events and depend on circumstances that may or may not occur in the future and may cause the actual results, performance or achievements of the Company to be materially different from those expressed or implied by such forward looking statements. Many of these risks and uncertainties relate to factors that are beyond the Company's ability to control or estimate precisely, such as future market conditions, currency fluctuations, the behavior of other market participants, the actions of regulators and other factors such as the Company's ability to continue to obtain financing to meet its liquidity needs, changes in the political, social and regulatory framework in which the Company operates or in economic or technological trends or conditions. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. Except as required by law, the company assumes no obligation to update any such forward-looking statements.