BUSINESS INSIGHTS, PHARMA TECH
EyePoint Pharmaceuticals | February 28, 2023
On February 27, 2023, EyePoint Pharmaceuticals, Inc., a leading pharmaceutical firm committed to the development and commercialization of therapeutics to help improve the lives of patients with severe eye disorders and Rallybio Corporation, a clinical-stage biotechnology company dedicated to identifying and accelerating the development of life-transforming therapeutics for patients with severe and rare diseases, announced a research collaboration to explore the sustained delivery of Rallybio's complement component 5 (C5) inhibitor for the treatment of geographic atrophy, an advanced form of age-related macular degeneration that can cause irreversible vision loss. The research will use EyePoint's proprietary Durasert® technology, which is designed for sustained intraocular drug delivery.
Approximately one million individuals in the United States suffer from geographic atrophy, which is characterized by atrophic lesions in the central region of the macula. Geographic atrophy can cause irreversible vision loss and can lead to legal blindness. Currently, geographic atrophy treatments are limited in choice and duration of action, leaving a significant unmet need for safe and effective treatment options.
Under the terms of the research partnership, EyePoint and Rallybio will assess and explore the viability of utilizing Rallybio's C5 inhibitor in EyePoint's Durasert technology, with the intention to increase the collaboration upon mutual agreement following the evaluation.
EyePoint Pharmaceuticals' M.D., President and Chief Operating Officer Jay Duker commented, "We are excited to begin this research collaboration to explore the combination of Rallybio's C5 inhibitor with our bioerodible Durasert sustained release drug delivery technology to develop a potential long-acting treatment for geographic atrophy," He further emphasized, "Geographic atrophy associated with dry macular degeneration is a devastating eye disease, and the inhibition of complement is a proven treatment pathway. We hope to leverage our Durasert technology in this collaboration to create a potential best-in-class, long-acting intravitreal insert, which we believe could provide a more desirable option for patients given that the existing approved therapy is injected every one to two months."
(Source – Business Wire)
About EyePoint Pharmaceuticals
EyePoint Pharmaceuticals is a leading pharmaceutical company that develops and commercializes therapeutic products to help patients suffering from serious eye disorders. Headquartered in Watertown, Massachusetts, it is committed to using its innovative drug delivery platform to improve patients' quality of life. The company's pipeline utilizes its proprietary Durasert technology, which enables sustained intraocular drug delivery. Its current pipeline includes EYP-1901, a potential six-month intravitreal anti-VEGF treatment aimed at treating wet age-related macular degeneration. Durasert technology has been successfully used across four FDA-approved products, including YUTIQ®, which treats chronic non-infectious uveitis affecting the posterior segment of the eye.
BUSINESS INSIGHTS, PHARMA TECH
ClinChoice | March 03, 2023
ClinChoice, a leading global clinical CRO, recently announced that it has acquired CROMSOURCE S.r.l., an ISO-certified full-service contract research organization. CROMSOURCE has its corporate headquarters in Verona, Italy, its US headquarters in Cary, NC, and subsidiaries in the US and seven countries throughout eastern and western Europe.
With a proven track record of providing excellent clinical research and staffing services to multinational pharmaceutical, biotechnology, and medical device clients, CROMSOURCE's acquisition will strengthen ClinChoice's global network and further enhance its full-service capabilities.
ClinChoice is known for its commitment to providing high-quality services and timely delivery, resulting in the successful completion of clinical trials and functions, including regulatory, biometrics, safety, medical, and clinical operations across various sectors such as drug, medical devices, vaccines, cosmetics, and consumer health using both project-based and FSP models.
The company offers services covering the development lifecycle for biotechnology, pharmaceutical, consumer products and medical device companies worldwide. With a broad clientele ranging from the largest multinationals to startup and emerging companies, ClinChoice has completed over 1,500 clinical studies in various therapeutic areas such as CNS, oncology, ophthalmology, rare disease, respiratory and metabolic.
CROMSOURCE's acquisition was advised by Fairmount Partners, while Crosstree Capital represented ClinChoice.
ClinChoice is a leading global clinical CRO that provides comprehensive services to biotechnology, pharmaceutical, medical device, and consumer products clients worldwide. With a successful 25-year track record, it is considered the standard for excellence in clinical operations, biostatistics, data management, CDISC, statistical programming, regulatory affairs, medical affairs, and pharmacovigilance. The company has established major delivery centers in Europe, the US, Canada, China, India, Japan, and the Philippines, employing over 3,000 people worldwide. ClinChoice has a strong and talented team and is expanding its clinical operations in seven countries across North America, Asia, and Europe.
RESEARCH, PHARMA TECH
Ionis Pharmaceuticals, Inc. | March 10, 2023
Ionis Pharmaceuticals, a leading RNA-targeted therapy firm, recently announced that the USFDA has accepted for review a new drug application (NDA) for eplontersen. Eplontersen is an investigational antisense medicine designed to reduce the production of transthyretin (TTR) protein and treat hereditary and non-hereditary forms of ATTR amyloidosis (ATTR).
The NDA has been given a Prescription Drug User Fee Act (PDUFA) action date of December 22, 2023. The FDA has declared that no review concerns were detected and made no new data requests. The FDA also stated that it does not intend to conduct a meeting of the advisory committee to discuss the application.
ATTR amyloidosis is a systemic disease caused by the accumulation of TTR protein in organs, leading to progressive organ damage and eventually death. Patients with hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN) experience ongoing debilitating nerve damage throughout their bodies, resulting in the progressive loss of motor function.
The NDA for eplontersen is based on results from the global Phase 3 NEURO-TTRansform study showcased at the International Symposium on Amyloidosis (ISA). In the study, eplontersen showcased a statistically significant and clinically meaningful change relative to the baseline for its co-primary and critical secondary endpoints compared to the external placebo group. In addition, Eplontersen also demonstrated a favorable safety and tolerability profile.
Ionis and AstraZeneca announced a strategic partnership to develop and commercialize eplontersen in December 2021. Eplontersen is being developed and commercialized jointly by both businesses in the United States and will be created and commercialized by AstraZeneca throughout the rest of the globe, except Latin America.
The FDA granted eplontersen Orphan Drug Designation in the United States in January 2022. Eplontersen is also being studied in the worldwide Phase 3 CARDIO-TTRansform trial for transthyretin amyloid cardiomyopathy (ATTR-CM), a systemic, progressive, and deadly disorder leading to progressive heart failure and death within 3 to 5 years after disease start.
About Ionis Pharmaceuticals, Inc.
Ionis Pharmaceuticals, Inc. is a leading biopharmaceutical company headquartered in Carlsbad, California. Its unique antisense technology platform allows them to develop RNA-targeted therapies that modify the production of disease-causing proteins, leading to the development of treatments for rare genetic disorders, cardiovascular diseases, and neurodegenerative diseases. The company's most significant achievement is developing and commercializing Spinraza, the first approved treatment for spinal muscular atrophy. Ionis Pharmaceuticals has also developed drugs for other rare diseases, including transthyretin amyloidosis, Huntington's disease, and myotonic dystrophy type 1.