Terbinafine

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Lonza is expanding its manufacturing sites in Rewari, India, and Suzhou, China, for hard gelatin capsules, the CDMO said Thursday, despite the company flagging last week that it is looking to exit the capsule and health ingredients market. The new manufacturing lines will be online in the third quarter of 2025. BioCentriq is building a new 60,000-square-foot headquarters in Princeton, NJ, which will have cell therapy manufacturing, the CDMO said Tuesday. The factory also has potential for future clinical and commercial manufacturing expansions up to 30,000 square feet. The site will be fully operational in the second quarter of next year. Thermo Fisher Scientific is divesting its commercial samples business to Knipper Health for an undisclosed sum. Knipper will absorb Thermo Fisher’s Memphis, TN, facility as well as an undisclosed number of employees. The transaction will be completed by September 2025 and will expand Knipper’s cold chain footprint, according to a Wednesday press release. New York’s first cell and gene therapy manufacturing facility has opened at the Roswell Park Comprehensive Cancer Center in Buffalo, according to a Monday release. The factory cost $98 million to build, with $30 million from Empire State Development. Eli Lilly and EVA Pharma have won approval for their insulin glargine injection from the Egyptian Drug Authority, Lilly said Tuesday. The companies started their partnership in December 2022, with Lilly supplying APIs to EVA, who manufactures the insulin products locally. Bavarian Nordic is licensing its mpox vaccine to the Serum Institute of India under a new partnership, it announced Monday. Bavarian will allow SII to manufacture and distribute the MVA-BN vaccine in India. Valneva is also licensing its single-shot chikungunya vaccine to SII, who will manufacture and seek approval for the asset in India and other parts of Asia, according to a Thursday release. Samsung Biologics is investing , via its Life Science Fund, in the Flagship-founded company Generate:Biomedicines, according to a Wednesday release. Generate uses AI software to discover and design protein therapies. No financial details were disclosed. Celltrion has launched a new CDMO arm, dubbed Celltrion BioSolutions, the company said Tuesday. Theratechnologies has submitted a Prior Approval Supplement to the FDA outlining the changes it made to the manufacturing of its drug Egrifta, which is approved in the US to reduce belly fat in HIV and lipodystrophy patients. The FDA has four months to OK the manufacturing changes, the company said Wednesday. VaxSen has drawn support from the US International Development Finance Corporation, the African Development Bank, and the International Finance Corporation worth $45 million to improve local vaccine supply chains in Africa, according to a Tuesday release. Polyrizon has tapped the CDMO Eurofins, also called Amatsiaquitaine, to supply material for its PL-14 allergy blocker, which is entering a study next year, according to a Wednesday release. French pharma company Biocodex tapped the logistics firm Kinaxis to access its supply chain platform, according to a Monday release. BioVaxys has secured 48 kgs of lipids to start its antigen packaging platform, the company said Tuesday. The platform can package mRNA, proteins, peptides and small molecules. Moberg Pharma has secured a new manufacturer and supplier of an ingredient (terbinafine) for its nail fungus drug named MOB-015, according to a Wednesday release.

Over the past year, Moberg Pharma qualified a new terbinafine manufacturer with an authorized EU Certificate of Suitability (CEP) now available for MOB-015. Three product batches have been produced using terbinafine from the new supplier where available stability data confirm the shelf-life profile of MOB-015. The status is unchanged for the previously communicated approval process regarding the first additional terbinafine supplier, submitted in April. Moberg Pharma has earlier responded to all questions received from the Medical Products Agency and awaits the agency´s decision. As a result, Moberg Pharma expects to have several alternate terbinafine suppliers secured in the near future. Each of these suppliers has the capacity to meet the company's global terbinafine demand. “Securing a new terbinafine manufacturer for MOB-015 represents a key milestone that enables future launches. It means that the timeline for the company's launch rollout can be maintained, and that access to terbinafine is no longer a limiting factor for MOB-015. MOB-015 is already available to Swedish patients under the brand name Terclara® and we look forward to reaching patients in all 13 approved countries in the future, as there is a great need for a topical treatment that truly cures the nail infection", says Anna Ljung, CEO of Moberg Pharma AB. For additional information, please contact: Anna Ljung, CEO, telephone: +46 70 766 60 30, e-mail: anna.ljung@mobergpharma.se About this information This information is information that Moberg Pharma AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication at 8.00 am CET on December 18th, 2024, through the contact person above. About Moberg Pharma, www.mobergpharma.com Moberg Pharma AB (publ) is a Swedish pharmaceutical company focused on commercializing proprietary innovations based on drug delivery of proven compounds. The company’s drug MOB-015 is a novel topical treatment for onychomycosis (nail fungus) with market approval in 13 EU countries. MOB-015 is sold in Sweden under the brand name Terclara® and is available at all pharmacy chains. Phase 3 clinical trials for MOB-015 involving more than 800 patients indicate that the product has the potential to become the future market leader in onychomycosis. Moberg Pharma has agreements with commercial partners in place in various regions including Europe and Canada. Moberg Pharma is headquartered in Stockholm and the company's shares are listed under Small Cap on Nasdaq Stockholm (OMX: MOB).