| |JANUARY 20248SENSORION TO FOCUS ON PAEDIATRIC PATIENTS FOR GENE THERAPYSANDOZ INK PACT TO ACQUIRE BIOSIMILAR TO TREAT EYE DISORDERS Pioneering clinical-stage biotechnology company Sensorion announces that it has received approval for its Clinical Trial Application (CTA) to initiate a Phase 1/2 clinical trial of SENS-501 (OTOF-GT) in France. The conclusion of Part I of the evaluation report according to Regulation EU 536/2014 of France, Italy and Germany is that the conduct of the clinical trial is acceptable.The phase 1/2 clinical trial (Audiogene) aims to evaluate the safety, tolerability, and efficacy of intra-cochlear injection of SENS-501 for the treatment of OTOF gene-mediated hearing impairment in paediatric patients aged 6 to 31 months at the time of gene therapy treatment. Targeting the first years of life, the time period when the auditory system plasticity is optimal, will maximize the chances of these young children with pre-lingual hearing loss to acquire normal speech and language, as per pharmabiz.Audiogene is also evaluating the clinical safety, efficacy and usability of the delivery device system being developed in collaboration with EVEON. The study design consists of two 2-dose cohorts followed by a dose-selected extension cohort. While safety is the primary endpoint in the dose-escalation cohort, auditory brainstem response (ABR) is the primary efficacy endpoint in the dose-escalation cohort..Nawal Ouzren, Sensorion's chief executive officer, said: "Securing approval to start the phase 1/2 clinical trial for SENS-501 marks a significant milestone for Sensorion and confirms our position of a leading company in the emerging field of gene therapies for hearing loss. Hearing loss caused by mutations of the gene encoding for otoferlin is a challenging disorder and there are no approved curative treatments for children with congenital deafness, so this is a significant unmet medical need. We look forward to continuing to work with healthcare providers, regulatory authorities, patient groups to address unmet and underserved medical needs in the hearing space. POSandoz, a key producer of generics and biosimilars, announced that it has signed an agreement to acquire US biosimilar ranibizumab CIMERLI (ranibizumab-eqrn) from Coherus BioSciences, Inc. For $170 million in cash. According to the company's press statement, this is inclusive of a biologics license application, product inventory, ophthalmology sales and field reimbursement talent, as well as access to proprietary commercial software, as per financialexpress. Keren Haruvi, President Sandoz North America, said: "I am pleased that we can add another high-value product to the growing Sandoz biosimilar portfolio, further strengthening our existing ophthalmology franchise. The addition of CIMERLI reinforces our commitment to biosimilars and represents a huge step towards our goal of pioneering patient access to more affordable and much-needed medicines in the US." Sandoz hopes to offer even more treatment options to American patients with vision loss and deterioration, he said. The agreement to purchase the CIMERLI business from Coherus will allow us to build a stronger ophthalmic platform to support future product launches, he added. Closing is expected to occur in the first half of 2024 in accordance with standard terms and conditions, the company announced. At Sandoz, we are very proud to be pioneers in this field. We started the world's first biosimilar product development program in 1996 and were the first company to receive approval for a biosimilar in Europe, Japan, Canada and the United States. To date, we have eight biosimilar products available and many more in development. PO
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