Lantheus | February 07, 2023
On February 6, 2023, Lantheus Holdings, Inc. (Lantheus), a company dedicated to improving patient outcomes through radiotherapy, diagnostics, and AI solutions that help clinicians to Find, Fight, and Follow® diseases, announced the acquisition of Cerveau Technologies, Inc. (Cerveau).
Cerveau's primary asset is MK-6240, which is a second-gen F 18-labeled positron emission tomography (PET) imaging agent that targets Tau tangles present in Alzheimer's disease.
Alzheimer's disease is a neurodegenerative condition that causes a steady and gradual deterioration in cognition and function. Alzheimer's disease affects an estimated 6.5 million people in the United States. As the population ages, the frequency of this disease is expected to climb further, and by 2050, the number of persons 65 and older with Alzheimer's disease may reach 12.7 million.
MK-6240 is a clinical-stage PET development candidate that is designed to identify Tau protein that accumulates as neurofibrillary tangles in the brains of individuals suffering or suspected of Alzheimer's disease. MK-6240 has the potential to help in Alzheimer's disease diagnosis, staging, treatment selection and response to therapy. Despite being in clinical development, MK-6240 is now being employed in over 60 academic and industrial clinical studies worldwide for various late-stage Alzheimer's disease therapeutic candidates, being explored by more than 16 pharmaceutical firms.
Following the terms of the agreement, Lantheus will make an upfront payment as well as potential further development and commercial milestone payments. It will also pay double-digit royalties on research revenue and commercial sales. In addition, the deal, which is structured as a stock acquisition, stipulates, among other things, that the seller would offer transition and clinical development services for a specified period after the conclusion of the transaction.
In this transaction, Chestnut Partners, Inc. served as the exclusive financial advisor to Cerveau. At the same time, Lantheus was advised by Foley Hoag LLP in connection with the acquisition.
Founded in 1956, Lantheus offers novel diagnostics, targeted medicines, and artificial intelligence (AI) solutions to help clinicians Find, Fight, and Follow® diseases. It has been delivering life-changing research to patients and clinicians for over 60 years, going above and beyond to enhance lives and outcomes. Lantheus Holdings is the parent company of Progenics Pharmaceuticals, Lantheus Medical Imaging, Inc., Inc. and EXINI Diagnostics AB. Headquartered in North Billerica, Massachusetts, the company has offices in New Jersey, Canada and Sweden.
BUSINESS INSIGHTS, PHARMACY MARKET
Xeris Pharmaceuticals, Inc. | January 31, 2023
On January 30, 2023, Xeris Biopharma Holdings, Inc., a leading biopharmaceutical company, announced that the Food and Drug Administration (FDA) granted orphan-drug exclusivity (ODE) to its subsidiary Xeris Pharmaceuticals, Inc. for Recorlev® (levoketoconazole) a cortisol synthesis inhibitor for the treatment of endogenous Cushing's syndrome in adult patients for whom surgery is not viable or has not been effective.
levoketoconazole (Recorlev) being the first FDA-approved therapeutic for the treatment of endogenous hypercortisolemia, Xeris Pharmaceutical is permitted to have seven years of orphan-drug market exclusivity beginning from December 30, 2021. The FDA's Orphan Drug Designation program intends to accelerate the development of medications that treat a disease that affects 200,000 or fewer people in the United States each year. This regulatory exclusivity with the patent exclusivity under Xeris' U.S. patents for Recorlev is valid until at least March 2040.
To serve and assist this community, Xeris is dedicated to ensuring that everyone who needs access to their medications receives them. Xeris has developed Xeris CareConnection™ to provide patients and caregivers with a comprehensive program that includes financial support, one-on-one assistance, and educational materials throughout the treatment journey. Additionally, Xeris CareConnection assists healthcare providers and their teams with education on access and reimbursement.
About Xeris Pharmaceuticals, Inc.
Founded in 2005, Xeris is a growth-oriented biopharmaceutical firm dedicated to improving patients' lives via the development and commercialization of novel products in a range of therapies. Its unique technology makes medicines easier to use for patients & caregivers. The company has three commercially available products; Gvoke®, a ready-to-use liquid glucagon for treating severe hypoglycemia (very low blood sugar); Keveyis®, the first and only FDA-approved therapy for primary periodic paralysis; and Recorlev® for the treatment of endogenous hypercortisolemia. In addition, it has an increasingly broad pipeline of research and partnered projects utilizing its unique formulation technology platforms, XeriSol™ and XeriJect™, bringing forward innovative products for the firm and its partners.
BUSINESS INSIGHTS, PHARMACY MARKET
PCI Pharma Services | March 20, 2023
PCI Pharma Services (PCI), a leading global contract development and manufacturing organization (CDMO), announced plans for a new 200,000-square-foot facility in Rockford, Illinois to enhance the organization’s capacity in injectable drug-device combination product assembly of both biologics and small molecules. Building on PCI’s leadership in this space with its Philadelphia Biotech Center of Excellence, the new facility is the second expansion building off the success in Philadelphia and will house over 20 dedicated customer suites with multiformat machines for the assembly and packaging of vials, pre-filled syringes, auto-injectors, and pen-cartridge combinations. This machinery can be used for the glucagon-like peptide 1 agonists (GLP-1) class of drugs prescribed to treat diabetes and obesity, as well as those needed for oncology treatment and autoimmune diseases.
PCI’s Rockford location will have extensive product testing capability, state-of-the art top-load cartoning technology, and industry leading injector and pen assembly equipment. Additional capabilities include on-site cold storage, high-speed vial labeling, assembly, and packaging of multiformat autoinjectors, serialization, testing, and drug product release.
“We see the tremendous impact that we can make with patients with this investment,” said Salim Haffar, CEO of PCI Pharma Services. “The need for injectable drug-delivery device combination product capacity and expertise is critical, and we are responding with a world-class facility to address the future demands of our global clients so they can focus on developing therapies to improve the lives of patients with serious chronic conditions.”
The $50 million investment in Rockford will amplify PCI’s specialty drug leadership presence in the Midwest, adding to clinical and commercial sterile fill-finish capabilities in Madison, Wisconsin. The new facility will provide a second hub within the U.S., expanding from PCI’s foundation in the Northeast, with Bedford, New Hampshire’s campus growth in aseptic processing. PCI also has sterile fill-finish capabilities at its Leon, Spain; San Diego, California; and Melbourne, Australia locations. The expansion in Rockford is expected to bring 250 jobs to the region in the next two years, with continued growth over three to five years. The site is expected to be fully operational in summer 2024.
“With this new facility, we will be able to serve all clients focused on injectable drug products including biologics with the equipment and capacity to make life-changing medicines,” said Gil Valadez, Senior Vice President, Commercial Packaging Technology, PCI Pharma Services. “We want to help our clients by managing the technical aspects of drug manufacturing, engineering, and delivery, so they can focus on what’s most important: delivering quality products to meet patient needs. That's what PCI is ultimately all about.”
About the Rockford, IL Facility
Rockford is the largest of PCI’s 30 locations across the U.S., European, and Asia Pacific regions, providing industry-leading services for the clinical and commercial packaging of a diverse portfolio of products and specialized delivery forms destined to reach more than 100 countries across the world. The gated secured facility is classified by the Drug Enforcement Administration (DEA) as Schedule 3. It features temperature and humidity control, an approved Foreign Trade Zone (FTZ) and offers TF1 and Uhlmann blistering, vibratory and slat filler bottling, powder filling, cartoning, carding, kitting and serialization capabilities. Warehouse storage includes freezer storage -15°C to -30°C and cold storage 2°C to 8°C.
About PCI Pharma Services
PCI is a leading global CDMO, providing clients with integrated end-to-end drug development, manufacturing and packaging capabilities that increase their products’ speed to market and opportunities for commercial success. PCI brings the proven experience that comes with more than 50 successful product launches each year and over five decades in the healthcare services business. We currently have 30 sites across seven countries (Australia, Canada, U.S., Ireland, Wales, Germany and Spain) and over 5,000 employees that work to bring life-changing therapies to patients. Leading technology and continued investment enable us to address global drug development needs throughout the entire product life cycle – from manufacturing capabilities through the clinical trial supply chain and into commercialization. Our clients view us as an extension of their business and a collaborative partner with the shared goal of improving patients’ lives.