PHARMACY MARKET, PHARMA TECH
Capsida Biotherapeutics | February 27, 2023
Capsida Biotherapeutics Inc., a fully integrated next-generation gene therapy platform company, and AbbVie, a pharmaceutical company dedicated to discovering and providing innovative medicines to address serious health issues, have recently announced an expanded strategic collaboration.
The collaboration aims to develop genetic medicines for eye diseases with high unmet needs. Capsida's novel adeno-associated virus (AAV) engineering platform and manufacturing capability will be combined with AbbVie's extensive capabilities to identify and advance three programs. This expanded collaboration builds on the neurodegenerative disease partnership established in 2021.
As per the agreement's terms, Capsida will receive $70 million, comprising upfront payments and possible equity investment. Capsida could receive up to $595 million in option fees and research and development milestones for the three programs, with the potential for further commercial milestones. Additionally, Capsida will be eligible to receive mid-to-high single-digit royalty payments on future product sales.
Capsida will be responsible for leading capsid discovery efforts for all programs, utilizing its high throughput AAV engineering platform, and will also be responsible for process development and early clinical manufacturing. AbbVie, on the other hand, will lead innovative therapeutic cargo approaches and be responsible for commercialization and development.
Capsida's CEO Peter Anastasiou commented, "AbbVie has been an excellent partner, and we are excited to expand our collaboration into ophthalmology with the world leader in this therapeutic area." He added, "Combining AbbVie's expertise in eye disease drug development and commercialization with Capsida's fully integrated next-generation AAV engineering platform and manufacturing capabilities offers the potential to provide novel therapies enabling unprecedented benefit to patients with serious eye diseases."
(Source- PR Newswire)
About Capsida Biotherapeutics
Capsida Biotherapeutics Inc. is a leading gene therapy platform company that develops targeted, non-invasive gene therapies for patients suffering from severe and life-threatening genetic disorders. Its innovative approach allows for the treatment of rare and common diseases across all age groups. The company focuses on creating customized therapies that selectively target specific organ systems while minimizing exposure to non-targeted organs. Capsida is a fully integrated biotechnology company with proprietary adeno-associated virus (AAV) engineering, translational biology, advanced manufacturing capabilities, multi-modality cargo development and optimization, process development, as well as extensive clinical development expertise.
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PHARMA TECH
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.
About Lantheus
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.
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BUSINESS INSIGHTS, PHARMA TECH
Lyra Therapeutics | February 08, 2023
On February 6, 2023, Lyra Therapeutics, Inc., a leading clinical-stage biotechnology firm developing novel therapies for the localized treatment of chronic rhinosinusitis (CRS), announced that enrollment in the Phase 2 BEACON clinical trial of LYR-220 in adult patients with CRS who have previously undergone sinus surgery has been completed.
LYR-220 is designed to provide continuous anti-inflammatory medicine (mometasone furoate; MF) to the sinonasal passageways for six months in order to treat CRS. Topline outcomes are expected in the fourth quarter of 2023.
The Phase 2 BEACON trial is a sham-controlled, parallel-group trial designed to assess the efficacy and safety of the LYR-220 (7500g MF) matrix in symptomatic adult CRS patients who have previously had bilateral ethmoid sinus surgery during a 24-week period. The trial is divided into two parts: Part 1 was aimed to examine the feasibility and tolerability of two 7500µg MF matrix designs; in Part 2, 40 patients were randomly assigned 1:1 to receive LYR-220 or sham control.
Lyra revealed positive preliminary findings from the BEACON trial's Part 1, the non-randomized portion, in September 2022, indicating the feasibility and tolerability of bilateral LYR-220 placement in this patient population. In addition, all six patients were given the medication for at least six weeks, and no significant or unexpected side effects were recorded.
Although efficacy evaluation was not the goal of the trial's uncontrolled Part 1 stage, there was a mean improvement of 21 points (37%) from baseline in the 22-item Sino-nasal Outcome Test (SNOT-22) total score at six weeks. This is more than double the minimal clinically significant difference of 8.9 points.
About Lyra Therapeutics
Founded in 2018, Lyra Therapeutics is a clinical-stage firm pioneering a novel therapeutic approach for the treatment of debilitating ear, nose, and throat (ENT) diseases that affect millions of people. Its mission is to change the ENT treatment paradigm by giving physicians effective front-line solutions and innovative therapy alternatives for their patients. The company is working on therapeutics for the localized treatment of chronic rhinosinusitis patients (CRS). Lyra has two investigational product candidates, LYR-210 and LYR-220, in late-stage development for CRS, which is a common inflammatory disease of the paranasal sinuses that causes debilitating symptoms and significant morbidities. It is headquartered in the Boston region and was created by academic luminaries in the disciplines of chemistry, materials science, and biotechnology, and is supported by top life science investors.
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