Catalent, Inc | July 06, 2022
Catalent, Inc. the global leader in enabling biopharma, cell, gene, and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities, today announced changes to its operating structure and executive leadership team that went into effect July 1. This new organizational structure includes a shift from four reporting segments to two, each representing roughly half of the total company revenue.
According to Alessandro Maselli, Catalent’s President and Chief Executive Officer since July 1, the segment changes reflect evolving customer and industry trends and position the company to deliver its next level of growth and achievement.
“Our industry continues to demonstrate steady growth, and this new structure will allow us to be more agile in meeting and anticipating customer needs and expectations. Among other benefits, it will create commercial synergies for our customers, as they will be better able to access the full range of Catalent services applicable to their molecules.”
Dr. Aris Gennadios was named Group President of Catalent’s newly formed Pharma and Consumer Health segment. The new segment consolidates the company’s prior Softgel & Oral Technologies segment, which Gennadios had led since 2013, and its Oral & Specialty Delivery and Clinical Supply Services segments.
“Combining our businesses focused on the development and supply of pharmaceutical and consumer health products will provide our customers with more integrated solutions, streamlined service, and simplified delivery of the solutions they need to accelerate their path to patients and consumers,” said Dr. Gennadios.
The new Pharma and Consumer Health segment will encompass the offerings of the three prior segments, including the company’s market-leading softgels, Zydis® fast-dissolve technologies, gummy dosage forms, clinical development and trial supply services, and global pharma manufacturing platforms. Dedicated teams will focus on Catalent’s pharmaceutical, consumer health, and clinical development and supply solutions to further drive value for customers and the opportunity for accelerated growth of these businesses.
The scope of Catalent’s other reporting segment, Biologics, continues without any change.
This organizational restructuring has also been accompanied by a few additional leadership changes. Jonathan Arnold, who previously served as President, Oral & Specialty Delivery, since 2017, is Catalent’s new Senior Vice President, Chief Commercial Officer, and Head of Transformation. He will be dedicated to ensuring a best-in-class customer experience and working closely with others on the leadership team to optimize the company’s growing portfolio.
Additionally, Steven Fasman, who previously served as Senior Vice President and General Counsel since 2014, will be Catalent’s Executive Vice President and Chief Administrative Officer, a newly created position. Mr. Fasman will oversee certain administrative functions of the company, including legal & compliance, information technology, engineering, procurement, governmental affairs, and various ESG-related departments.
Finally, Karen Flynn has announced her decision to retire from her role as Catalent’s Senior Vice President and Chief Commercial Officer. “Karen has played a critical role on the Executive Leadership Team since joining Catalent in early 2020. I am immensely grateful for her leadership, innovative thinking, and steadfast commitment to the company,” said Maselli.
About Catalent, Inc.
Catalent, Inc. an S&P 500® company, is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is the industry’s preferred partner for personalized medicines, consumer health brand extensions, and blockbuster drugs. Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply over 70 billion doses of nearly 7,000 products to over 1,000 customers annually. Catalent’s expert workforce exceeds 19,000, including more than 2,500 scientists and technicians. Headquartered in Somerset, New Jersey, the company generated $4 billion in revenue in its 2021 fiscal year.
ApiJect Systems Corp. | May 19, 2022
ApiJect Holdings, Inc., the parent company of ApiJect Systems, Corp., a medical technology public-benefit corporation transforming the fill and finish and delivery of injectable vaccines and medicines, announced today that it had completed a $111 million private round of investment.
This investment round values ApiJect at approximately $300 million.
The new round was led by Royalty Pharma and Jefferies Financial Group (NYSE: JEF), which acquired a revenue interest in addition to equity. Jefferies and ApiJect's other lenders also converted all of their debt into ApiJect equity, such that following this transaction, ApiJect has no debt on its balance sheet.
The funds will be used for continued development of ApiJect's proprietary Blow-Fill-Seal (BFS) plastic prefilled injection system, to deploy its equipment and proprietary technologies to licensees, and for general working capital purposes. Royalty Pharma and Jefferies are represented on ApiJect's Board of Directors, along with ApiJect co-founders Jay Walker and Marc Koska, and Hanjin In, the CEO of Tae-Chang Industrial Co., Ltd., ApiJect's South Korean cannula supplier.
ApiJect is developing an innovative portfolio of drug delivery devices using high-speed BFS manufacturing, which is recognized by the FDA as an advanced aseptic process that forms, fills and seals a single unit dose in a continuous, automated manufacturing step. BFS technology greatly reduces the risk of contamination and error during one of the most critical steps of drug production. BFS is cost-efficient for short and long runs, and highly suitable to scale quickly in order to meet unexpected spikes in demand such as for a rapid response to population-scale health emergencies. Advancements developed by ApiJect for temperature management now enable BFS manufacturing of a vast array of sterile injectable drugs, including ultra-cold mRNA vaccines.
"This is an important day for injection device innovation, and, with that, the future health of billions of people throughout the world. The investment provided by Royalty Pharma and Jefferies supports further development of an injection technology that can scale rapidly and efficiently to meet global demand for injectable medicines."
ApiJect Chief Executive Officer Jay Walker
Mr. Walker further said: "We welcome Royalty Pharma's commitment to the ApiJect mission. Royalty Pharma has a proven track record in selecting successful partners and in assisting in advancing its partners' goals. We could not ask for a better strategic partner from within the pharma industry. In Jefferies, we have a partner that has been with us from virtually the beginning of ApiJect."
"We are delighted to form this win-win partnership with ApiJect," said Pablo Legorreta, Royalty Pharma's Founder and Chief Executive Officer. "The global pandemic highlighted the clear unmet need for a new kind of prefilled syringe that can be rapidly produced to respond to public health threats, and at massive scale that would be capable of delivering hundreds of millions, potentially billions, of doses to people in the U.S. as well as globally. ApiJect is developing a truly innovative technology, that could transform the manufacturing and delivery of life-saving injectable drugs in a way that would also make these medicines safer and more readily accessible for patients around the world."
"We are proud of our association with ApiJect and believe strongly that their solutions will be a positive gamechanger in many of the most critical aspects of improving health globally," said Rich Handler, CEO of Jefferies.
The first potential device made on the ApiJect Platform is the Prefilled ApiJect Injector, a single-dose prefilled injector designed to efficiently deliver a 0.5mL dose into a patient with a simple squeeze of the BFS container by the healthcare professional. This new type of prefilled injector will be ApiJect's first product submitted for regulatory review and approval. The Prefilled ApiJect Injector and its manufacturing process include
An aseptically filled single-dose container, designed to enable efficient and intuitive injection administration.
A pen-needle-style hub that turns the BFS container into an injection device.
Innovations in temperature management to expand the range of medicines and vaccines suitable for BFS packaging.
ApiJect recently launched its Technology Development Center in the greater Orlando area to bring to the U.S. critical capabilities for device design and engineering, and BFS mold development, as well as for small-scale manufacturing of single-dose, prefilled injectors and other injectable devices. Its purpose is to dramatically reduce the time and processes necessary for product development. ApiJect's Technology Development Center supports the company's existing fill-finish lines at its manufacturing partner site in South Carolina, which currently has the capacity to produce up to 540 million single-dose prefilled injectors annually.
About ApiJect Systems
ApiJect Systems, Corp., is a public-benefit medical technology company working to use our platform to bring more prefilled, single-dose injections to patients everywhere. The ApiJect Platform enables pharmaceutical and biotech companies to design scalable prefilled injectors and efficiently fill-finish them with their injectable drug products. This can be done either on one of their own Blow-Fill-Seal packaging lines with ApiJect-licensed technology, or at one of ApiJect's world-class manufacturing partners.
Integral Molecular | June 09, 2022
Integral Molecular and Optimeos Life Sciences announce a partnership to develop next-generation mRNA and DNA therapeutics that will use antibody-based molecular targeting to direct vaccines and gene therapies to relevant tissues in a patient's body. This partnership combines Integral Molecular's experience in antibody discovery and mRNA immunization with Optimeos' technology for nanoparticle-based drug delivery systems.
DNA and mRNA therapeutics harness a patient's own molecular machinery to encode proteins. Integral Molecular and Optimeos plan to encapsulate these therapeutic molecules within nanoparticle spheres that are decorated with antibodies on the outer surface. The antibodies can then target the particles to specific tissues. Currently, gene therapies and mRNA vaccines are delivered into the body via infusion or injection, but only a fraction of the molecules arrive at their intended site. The proposed molecular targeting strategy has the potential to transform the delivery of vaccines and therapeutics by dramatically reducing dosages, decreasing toxicity, and enabling scalable administration.
Integral Molecular will apply its industry-leading antibody discovery expertise against complex cell-surface proteins to provide targeting moieties for the therapies. Its specialized MPS Antibody Discovery platform is tailored to work with challenging membrane protein targets and routinely uses mRNA-based immunization strategies. "Precision targeting of an isolated cell type with gene therapy holds great promise for genetic diseases and may provide brand-new directions in cancer immunotherapy including in vivo CAR-T cell therapeutics," said Joseph Rucker, Co-founder and VP of R&D at Integral Molecular.
Optimeos' technology allows the robust and scalable incorporation of mRNA and DNA therapeutics and other biologics into customizable nanoparticles. "We are excited to work with Integral Molecular towards the next generation of gene-therapy that no longer relies on viral-based delivery systems," said Robert Prud'homme, Co-founder and Chief Technical Officer of Optimeos.
Integral Molecular and Optimeos will be attending the BIO International Convention in San Diego later this month.
About Integral Molecular
Integral Molecular is the industry leader in developing and applying innovative technologies that advance the discovery of therapeutics against difficult protein targets. With 20 years of experience focused on membrane proteins and antibodies, Integral Molecular's technologies have been integrated into the drug discovery pipelines of over 400 biotech and pharmaceutical companies to help discover new therapies for cancer, diabetes, autoimmune disorders, and viral threats such as SARS-CoV-2, Ebola, Zika, and dengue viruses.
About Optimeos Life Sciences
Optimeos Life Sciences has developed a novel, highly differentiated, non-viral, nanoparticle technology, for delivery of new therapeutic drugs to address important unmet medical needs. The technology is a patented and scalable polymeric drug delivery system, which was developed and refined in Professor Prud'homme's lab at Princeton University over 20 years. Optimeos' technology enables encapsulation of mRNA, DNA, peptides, proteins or small molecules, as well as their targeted delivery to cells and tissues beyond the liver.
Calyx | June 10, 2022
Calyx, the eClinical and Regulatory solutions and services provider relied on for solving complex data challenges in clinical research, announced it has been named an approved provider of centralized medical imaging services by Clinscience, a full service CRO offering smart, end-to-end clinical trial services to the global pharmaceutical industry.
"Calyx's commitment to reliably solving the complex aligns with our focus on designing integrated, smart solutions that are tailored to our customers' needs. Clinscience and Calyx are both motivated to help global clinical trial sponsors achieve their clinical development objectives in an agile, expeditious, and smart way."
Megan O'Keefe, Chief Commercial Officer at Clinscience
"The Clinscience team understands what's important to pharmaceutical and biotech organizations," said Elizabeth Dalton, Vice President, Channel Partnerships Solutions, Calyx. "We're honored to work with Clinscience and to deliver the reliable imaging services their customers need to accelerate and optimize their clinical trials."
Clinscience joins a long list of global pharmaceutical companies and CROs who repeatedly leverage Calyx's scientific expertise and experience to assess the safety, efficacy, and effectiveness of their compounds. To date, Calyx Medical Imaging has been used in over 2,600 clinical trials worldwide and has supported the approvals of over 270 medical treatments across a broad range of therapeutic areas.
Through innovative eClinical and Regulatory solutions and services, Calyx turns the uncertain into the reliable, helping bring new medical treatments to market reliably. With deep expertise in clinical development and 30 years supporting trial sponsors and clinical research organizations, Calyx harnesses its intelligence and experience to solve complex problems, deliver fast insights, and get new drugs to market every day.
Clinscience is a global CRO company offering smart CRO Services, from protocol creation to final study report development. The Company has offices in Poland, Spain, Italy, Germany, and the US and provides its services in 6 European countries. More than 150 Biotechnology companies across Europe and the US trust the Clinscience brand. The Company's procedures and Data-driven approach, harnessed with the Genius Suite™ technology, work together to give the Clients power and flexibility to address even the most unique needs. Clinscience is part of a publicly-traded parent company, Neuca Plc, an organization in the pharmaceutical wholesaling and healthcare industry that provides the structure to meet the needs of commercial and non-commercial studies.