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, PHARMA TECH
Dalton Pharma Services | February 17, 2023
On February 16, 2023, Dalton Pharma Services, a leading cGMP pharmaceutical firm, announced a significant strategic expansion of its sterile filling and pharmaceutical manufacturing capabilities. The capital expansion plan includes a brand-new, state-of-the-art, and fully automated cGMP sterile filling line that can fill syringes, vials and cartridges under isolator technology. The sterile fill line is integrated with a new cGMP lyophilizer to provide customers with complete sterile finished dosage form manufacturing capabilities.
In compliance with cGMP aseptic filling regulations, the newly launched sterile filling line supports small-scale commercial production to cater to the global market. Additionally, the capital expansion plan comprises further cGMP non-sterile powder filling capacity, enhanced multi-kilogram API manufacturing capabilities, and a better infrastructure for handling and storing organic solvents.
The company's capital expansion plan supports the goal of establishing it as a leading Contract Development and Manufacturing Organization (CDMO). As part of the Seikagaku Group, Dalton's long-term strategy is to provide pharmaceutical and biotechnology customers with high-quality integrated drug discovery, development, and manufacturing services through its North American facility.
Dalton Pharma Services CEO Peter Pekos commented, "This major investment in the expansion of our sterile manufacturing capabilities enables us to meet the needs of our customers as their critical products advance to commercialization." He added, "It also represents a leap forward in both scale and technology for us, placing Dalton at the leading edge of sterile manufacturing capabilities."
(Source – PR Newswire)
About Dalton Pharma Services
Founded in 1986, Dalton is a leading contract pharmaceutical manufacturer that offers integrated chemistry, development, and manufacturing services to biotechnology and pharmaceutical clients worldwide. The company operates from a 42,000 sq. ft. facility where they provide cGMP manufacturing of APIs, sterile injectables, finished drug products, and solid oral dosage forms. It has the capability to produce APIs in gram-to-kilogram quantities, including sterile APIs, and supports clients at any stage of the regulatory process. Dalton's development services include analytical method development, formulation, and polymorphism screening, among others. Additionally, the company offers over 2,500 reference standards, building blocks, metabolites, and impurities via its Dalton Research Molecules business to support the industry's pharmaceutical research programs.
BUSINESS INSIGHTS, PHARMA TECH
ADC Therapeutics | January 03, 2023
Sobi® and ADC Therapeutics SA informed that Zynlonta® (loncastuximab tesirine) has recently received conditional marketing authorization from the European Commission (EC) for the treatment of diffuse large B-cell lymphoma ((DLBCL) that has relapsed or become resistant. The approval comes after the European Medicines Agency's Committee for Medicinal Products for Human Use issued a favorable opinion in September.
Sobi has said that it wants to give Zynlonta, a new treatment for diffuse large B-cell lymphoma, to people in the European Union who have this debilitating blood cancer.
The approval was granted based on the findings from LOTIS-2, which was a large (n=145), phase 2 multinational, single-arm clinical study of Zynlonta for treating adult patients who had relapsed or refractory DLBCL following two or more prior lines of systemic therapy. Zynlonta was granted accelerated approval by the United States Food and Drug Administration in April 2021. This approval made it the first CD19-targeted antibody-drug conjugate to be used as a single-agent treatment for adult patients who had relapsed or been resistant to two or more lines of systemic therapy for their DLBCL.
Sobi announced an exclusive license agreement with ADC Therapeutics to develop and commercialize Zynlonta in Europe and other international markets. The license aims to boost Sobi's presence in hematology, one of its two main disease areas. Besides, Zynlonta will be sold with other Sobi hematology drugs.
ADC Therapeutics added that this approval expands Zynlonta's global reach. Zynlonta will fill a critical unmet need for DLBCL patients in Europe. The EU decision applies to Iceland, Norway, and Liechtenstein.
According to the terms of the license agreement and as previously communicated, Sobi will pay ADC Therapeutics USD 50 million as a result of the EU's approval of DLBCL. Sobi's clinical development and product supply are handled by ADC Therapeutics.
About ADC Therapeutics
ADC Therapeutics next-generation, targeted antibody-drug conjugates help cancer patients. With a deep understanding of oncology and an ADC platform that the FDA's approval of Zynlonta has proven, the company is working to meet unmet medical needs and improve outcomes for people with hard-to-treat hematological cancers and solid tumors. ADC Therapeutics' highly skilled global team is committed to fighting cancer with science, bringing targeted therapies and hope to patients and their families.