VIEWS AND ANALYSIS, PHARMACY MARKET
PRNewswire | July 31, 2023
LSPedia, a leading SaaS provider specializing in product traceability solutions for the pharmaceutical industry, has partnered with Altro Pharmaceuticals, enabling Altro customers to easily comply with the Drug Supply Chain Security Act (DSCSA) ahead of the FDA's final deadline on November 27, 2023.
Altro provides expertise and services to pharmaceutical manufacturers and wholesale distributors, helping them expand their businesses, streamline supply chain operations, increase efficiency, and more. Now, its services include proven, worry-free turnkey DSCSA compliance, thanks to LSPedia's easy-to-use, comprehensive OneScan software suite.
Sandy Greco, President of Altro Pharmaceuticals, noted, "Getting DSCSA right is essential to the smooth flow of business in the pharma supply chain, so we take it incredibly seriously, and we absolutely want our customers to succeed with it. LSPedia has the industry's best track record for user experience, scalability, and success – we can say for sure we're offering the best service available."
LSPedia's OneScan Suite enables manufacturers and wholesalers to quickly achieve full compliance with all DSCSA requirements, including serialization, sending and receiving EPCIS data, verification, and interoperability. Further, the solution includes access to LSPedia's Investigator for Exceptions Management, the industry's gold standard for alerting, resolving, and preventing EPCIS transaction errors.
"Altro is a perfect partner for LSPedia," said LSPedia CEO Riya Cao. "With so little time left before the compliance deadline, access and convenience are essential. Altro supports its customers with a deep service portfolio, and there's every reason it should include easy, complete DSCSA compliance."
LSPedia is a leading provider of turnkey DSCSA compliance and SaaS solutions in the pharmaceutical industry. CMOs, manufacturers, 3PLs, wholesale distributors, dispensers, and healthcare providers use LSPedia's OneScan solution to make, move, track, verify, ship, and receive serialized products at every point in the supply chain.
As the largest processor of serialized data in the industry, LSPedia builds solutions with workflow, automation, and data security at their core. OneScan delivers flexible integrations, high-performance product verification, and state-of-the-art EPCIS data exchange; LSPedia's Investigator platform is the gold standard for serialization exceptions management, as the first collaborative platform to resolve EPCIS errors and supply chain issues in real time.
Newswire | July 05, 2023
Cipher Pharmaceuticals Inc. ("Cipher" or "the Company") today announced that the Company's partner, Moberg Pharma AB, ("Moberg Pharma") has obtained European Union approval for MOB-015 (nail fungus treatment) as a result of demonstrating superior levels of mycological cure (76% vs. 42% for comparators) and a significantly better complete cure rate.
MOB-015 has been recommended for national approval in 13 European countries, which will be commercialized through partners such as Bayer and Allderma, and is expected to be launched in Nordic countries such as Sweden during 2023.
Cipher holds the exclusive Canadian rights to MOB-015, a new topical treatment of Onychomycosis (nail fungus) based on Moberg's patented proprietary formulation of terbinafine. In Canada, according to IQVIA, the total prescription market for Onychomycosis was greater than $82 million CDN at December 31, 2022 with a single product having over 90% market share.
Craig Mull, Interim CEO of Cipher commented, "This is a fantastic achievement whereby the European Union has recognised MOB-015 as delivering quick visible improvements to patients living with nail fungus. We are excited about our partnership with Moberg Pharma, who have a strong track record developing and commercializing nail fungus products previously in both Europe and North America. This approval is a tremendous step in the right direction towards ultimately receiving market approval in Canada and the United States. We will continue to work closely with Moberg in making this clinically proven effective treatment available to Canadians as soon as possible."
Moberg Pharma continues to invest and advance MOB-015 through an additional phase 3 trial of a total of 350 patients with sites across the United States and Canada. The purpose of this study is to facilitate market approval in North America as well as further strengthen the product's clinical evidence beyond the mycological and complete cure rates already demonstrated to the European Union. Patient enrollment in the clinical trial is progressing according to plan with full enrollment expected in 2023.
About Cipher Pharmaceuticals Inc.
Cipher Pharmaceuticalsis a specialty pharmaceutical company with a robust and diversified portfolio of commercial and early to late-stage products. Cipher acquires products that fulfill unmet medical needs, manages the required clinical development and regulatory approval process, and currently markets those products either directly in Canada or indirectly through partners in Canada, the U.S., and South America.
About Moberg Pharma
Moberg Pharma AB is a Swedish pharmaceutical company focused on commercializing proprietary innovations based on drug delivery of proven compounds. The company's main asset, MOB-015, is a novel topical treatment for onychomycosis. Data from phase 3 clinical trials in more than 800 patients for MOB-015 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 Europe and Japan, among others, and the company's goal is to receive its first market approval and launch MOB-015 in 2023.
PRNewswire | August 17, 2023
Frontage Laboratories, Inc. and its wholly-owned subsidiary, Frontage Canada, Inc., completed the acquisition of Nucro-Technics Inc. and its affiliate Nucro-Technics Holdings, Inc.
Nucro-Technics is a pharmaceutical contract research organization that conducts analytical chemistry, microbiology, toxicology, bioanalytical, and stability sample storage and testing services. In addition, it provides consulting services, especially in quality control and assurance as well as in Natural Health Product Regulations.
Nucro-Technics, located in the Toronto, Canada metropolitan area, operates in a state-of-the-art 60,000 square foot facility and employs personnel having expertise in testing both large and small molecules designed to treat various medical conditions. For over 50 years, Nucro-Technics has been conducting studies for various clients including major pharmaceutical, biotech, and medical device companies, as well as smaller organizations including industry trade groups and academia. Nucro-Technics has successfully developed and validated numerous methods, as well as participated in providing comprehensive IND packages to clients for regulatory submissions. Nucro-Technics, an ISO 9001:2015 certified organization, conducts studies that are in compliance with GLP and GMP regulations.
"Today marks a momentous and an exciting occasion. It is a day to celebrate two great companies coming together. It is with great pleasure that I welcome the extraordinary Nucro-Technics team to the Frontage family," said Dr. Abdul Mutlib, CEO of Frontage. "Nucro-Technics has been recognized as a leader in the Canadian CRO market for over 50 years, and its unparalleled client services is a perfect match for the culture of Frontage Laboratories. This acquisition not only significantly strengthens our presence in Canada, but also will enable the combined organization to offer a more expansive suite of services to clients across the globe. We are looking forward to partnering with the Nucro team to deliver the world-class expertise that clients have come to expect from us."
According to Dr. Song Li, Founder and Chairman of Frontage: "Nucro has developed a remarkable platform with a truly impressive team of experts. The closing of this transaction marks the next step in our ongoing effort to build Frontage into one of the major players in the global CRO market. In doing so, we will continue our focus on delivering the highest levels of quality, technology and expertise to our clients."
"I'm delighted to announce that we will be partnering with Frontage Labs for the next phase of Nucro Technics' growth journey. Since founding the business in 1970, we've worked hard to become the North American boutique in pre-clinical and drug product release testing services. Partnering with Frontage Labs marks an exciting chapter in the evolution of our efforts to support and accelerate pharmaceutical research and development," said John Fanaras of Nucro Technics.
Frontage was advised by Borden Ladner Gervais LLP (BLG) while Nucro-Technics was advised by Dentons and PricewaterhouseCoopers Corporate Finance Inc.
Frontage Holdings Corp (1521.HK), together with its wholly owned subsidiary Frontage Laboratories, Inc., is a global Contract Research Organization (CRO) which provides integrated, science-driven, product development services from drug discovery to late phase clinical process to enable biopharmaceutical companies to achieve their development goals. Comprehensive services include drug metabolism and pharmacokinetics, analytical testing and formulation development, preclinical and clinical trial material manufacturing, bioanalysis, preclinical safety and toxicology assessment and early phase clinical studies. Frontage has enabled many biotechnology companies and leading pharmaceutical companies of varying sizes to advance a myriad of new molecules through development and to successfully file global regulatory submissions.