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.
SCA Pharma | July 15, 2022
SCA Pharma, a nationally recognized leader in the 503B compounding pharmaceuticals outsourcing industry providing quality, service, and value to hospitals nationwide, has announced today the addition of Louis Pace as Chief Financial Officer and Chief Information Officer. Pace brings over 30 years of experience serving several successful private equity backed businesses in functional and P&L leadership roles.
Most recently, Mr. Pace served as Chief Financial Officer at Orchid Orthopedic Solutions where he successfully led strategy deployment efforts that focused on growth and profitability improvement.
"I am extremely excited to welcome Louis to the team and to partner with him as we continue to accelerate growth at SCA Pharma. SCA Pharma is committed to providing innovative solutions for our 503B customers that help health systems manage their drug supply chain and pharmacy operations more efficiently. That evolution requires a more strategic and diversified approach, which suits Louis' background. Louis will manage our finance and accounting teams as well as our information technology strategy. He will concentrate on prioritizing internal and external business opportunities."
Scott Luce, CEO of SCA Pharma
"I am looking forward to working with the exceptional team at SCA Pharma. I am excited to build on SCA Pharma's current success and be a part of the company's future growth," said Louis Pace.
Mr. Pace holds an AB in Economics from Harvard University and an MBA from Northwestern Kellogg Graduate School of Management.
About SCA Pharma
SCA Pharma is a nationally recognized leader in the FDA 503B outsourcing industry, specializing in providing the highest quality sterile admixture services and pre-filled syringes to hospital and health-care facility pharmacies. The company serves all therapeutic areas of pharmacy — including critical care, labor and delivery, anesthesia, and pain management — and maintains a wide portfolio of products, including ready-to-use and drug-shortage medications.
IAMA Therapeutics | July 26, 2022
IAMA Therapeutics, a preclinical-stage pharmaceutical company focused on the discovery, development, and commercialization of novel medicines to make a difference in the lives of individuals suffering from brain disorders, and PsychoGenics Inc., a leader in AI-enabled phenotypic drug discovery and preclinical CRO services, today announced that the companies have entered into a service agreement to identify the efficacy of novel drug candidates in drug-resistant epilepsy.
Under the terms of the agreement, PsychoGenics will evaluate the preclinical anti-seizure efficacy of first-in-class selective-NKCC1 inhibitors, which aims to reduce intracellular chloride concentration and restore the physiological hyperpolarizing and inhibitory GABAergic transmission in an animal model of refractory epilepsy.
"PsychoGenics is a leader in preclinical behavioral neurobiology with a successful track record of anti-epilepsy drug testing through translational EEG approaches, including electrographic and behavioral identification of seizure. We look forward to leveraging our collective expertise in neuroscience drug development to identify and evaluate the anti-seizure efficacy of new drug candidates, to enhance further and complement our pipeline of differentiated therapeutic opportunities for epilepsy, neurodevelopmental and cognitive disorders."
Andrea P. Malizia, Ph.D., MBA, Chief Executive Officer of IAMA Therapeutics
“We are excited to embark of these studies with IAMA Therapeutics” said Stephen Morairty, Ph.D., Vice President of Translational Neuroscience at PsychoGenics. “Using our pre-clinical MTLE model, will carefully evaluate the efficacy of these first-in-class selective-NKCC1 inhibitors.”
About IAMA Therapeutics
IAMA Therapeutics is a preclinical-stage pharmaceutical company focused on discovering, developing, and commercializing novel medicines to make a difference in the lives of children and adults suffering from epilepsy, neurodevelopmental and cognitive disorders. IAMA Therapeutics couples emerging advances in drug discovery and neurobiology to build a leading, next-generation neuroscience pipeline to selectively inhibit the sodium-potassium chloride cotransporter and other therapeutic targets relevant to brain disorders characterized by neuronal imbalance.
The company's preclinical pipeline consists of the lead candidate IAMA-6 for the treatment of idiopathic autism, IAMA-097 for the treatment of secondary and rare forms of autism, and other compounds for treating refractory epilepsy and other brain disorders.
About PsychoGenics Inc.
PsychoGenics is a leader in vivo phenotypic drug discovery. The company applies its proprietary technology platforms in partnership with pharmaceutical and biotechnology companies to discover the next generation of drugs for neuropsychiatric disorders. PsychoGenics' capabilities include standard behavioral testing, electrophysiology, translational EEG, molecular biology, and state-of-the-art microdialysis. In addition, the company offers a variety of in-licensed transgenic mouse models that support research in areas such as Huntington's disease, Autism spectrum disorders, psychosis/schizophrenia, Alzheimer's disease, Parkinson's disease, sleep, and Spinal Muscular Atrophy muscular dystrophy and other muscle disorders.
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.