Cancer Prevention Pharmaceuticals Submits New Drug Application to the FDA for CPP-1X/sul for Treatment of Familial Adenomatous Polyposis

Cancer Prevention Pharmaceuticals, CPP-1X/sul | June 29, 2020

Cancer Prevention Pharmaceuticals Submits New Drug Application to the FDA for CPP-1X/sul for Treatment of Familial Adenomatous Polyposis
Cancer Prevention Pharmaceuticals, Inc. (CPP), a private biotech company developing novel therapeutics to prevent cancer and other diseases, announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for CPP-1X/sul for treatment of adults with familial adenomatous polyposis (FAP).

FAP is a rare genetic disease that if left untreated progresses to colorectal cancer in nearly 100% of patients. The clinical development of CPP-1X/sul was designed to establish this fixed dose combination product as a potential pharmaco-preventive drug treatment specifically for FAP patients.

“The NDA submission for our lead drug candidate, CPP-1X/sul, represents a significant milestone for FAP patients and their families,” said CPP CEO Jeff Jacob. “For most FAP patients, current medical practice involves a lifetime of periodic monitoring as well as highly invasive surgical procedures. If approved, CPP-1X/sul could provide an alternative to surgery for many patients, significantly improving their quality of life.”

Spotlight

Dr. Mark Fishman, president of Novartis Institutes of BioMedical Research (NIBR), talks about the Novartis commitment to science-based innovation and the search for new medicines for unmet patient needs.

Related News

Piramal Pharma Solutions to acquire manufacturing facility of G&W Laboratories in US

livemint | June 20, 2020

Piramal Enterprises Ltd's Pharma Solutions business, a contract development and manufacturing organization, on Saturday announced that it has entered into an agreement with G&W Laboratories Inc. to acquire its solid oral dosage drug product manufacturing facility located in Pennsylvania, USA, for $17.5 million. The all-cash deal is subject to customary pre-closing conditions. According to the terms of the agreement, Piramal Enterprises, through one of its affiliates, would acquire at closing a 100% stake in the entity that operates the facility and owns the related real estate.

Read More

RESEARCH

XtalPi Partners with Excelra for GOSTAR to Enhance its Intelligent Digital Drug Discovery and Development platform

Excelra Knowledge Solutions Pvt Ltd | January 19, 2022

Excelra, a leading global Data & Analytics organization, announced the partnership for its Global Online Structure Activity Relationship Database with XtalPi Inc., an AI-based pharmaceutical biotechnology company reinventing the industry's approach to drug research and development with its Intelligent Digital Drug Discovery and Development platform. Excelra will provide ADMET datasets in the GOSTAR database to XtalPi Inc. as part of the partnership. GOSTAR's ADMET data will power XtalPi's predictive models. The data helps XtalPi with high precision and predictability to confidently tackle clinical failures of new chemical entities. The well-annotated, high-quality ADMET datasets of GOSTAR are built with a proprietary QMS-ISO certified curation process powered by NLP and human intelligence. GOSTAR provides comprehensive information encompassing over 8 million compounds, manually curated from a variety of sources including patents and journal articles. The database contains over 29 million SAR associated data points. The well-structured relational database can be utilized for diverse applications across various stages of drug discovery and development lifecycle and aids in target validation, hit identification, early lead identification, and optimization. "In XtalPi Inc., we develop advanced AI-based algorithms to tackle the challenges in the drug design process. The size and quality of datasets are always a big concern for us to build high-accuracy predictive models. That is why we consider GOSTAR as a unique and precious resource. It has millions of data points covering different compounds' ADMET properties and is also trustful, structured, and updated. We highly recommend GOSTAR to whoever is involved in the innovation of drug design methodologies." Min Xu, Senior Scientist, Research Manager, XtalPi Inc Norman Azoulay, Product Leader, Excelra, said, "Artificial Intelligence and Machine Learning is bringing a paradigm shift to drug discovery and development. This partnership will help train XtalPi's models to accurately predict efficacy and safety parameters and to ultimately increase the success rate of drug design." About XtalPi XtalPi is a pharmaceutical technology company that is reinventing the industry's approach to drug research and development with its Intelligent Digital Drug Discovery and Development platform. With tightly interwoven quantum physics, artificial intelligence, and high-performance cloud computing algorithms, XtalPi's platform provides accurate predictions on the physiochemical and pharmaceutical properties of small-molecule candidates for drug design, solid-form selection, and other critical aspects of drug development. XtalPi is dedicated to improving the efficiency, accuracy, and success rate of drug research and development, and contributing to a healthier society worldwide. About Excelra Excelra's data and analytics solutions empower innovation in life sciences from molecule to market. The Excelra Edge comes from harmonizing heterogeneous data sets, applying innovative bioinformatics know-how and technologies to accelerate your drug discovery & development with reliable and result-oriented insights. Excelra's GOSTAR is available as an application for users to seek, find, and discover compounds. In addition, it is offered via APIs and as a downloadable dataset to power in-house libraries and machine learning models.

Read More

PHARMACY MARKET

Mallax acquires Sana Pharma Medical, Establishing a New Nordic Pharmaceutical Platform

Mallax | July 05, 2021

Mallax Pharmaceuticals AB has acquired Sana Pharma Medical AS, forming a new Nordic pharmaceutical platform. SPM, founded in Norway in 2014, is a rapidly growing OTC company with complete pharmaceutical infrastructure and Nordic distribution coverage. With the well-established brands such as Lunixen and Sedix and additional products based on the chemical melatonin, the Company has a leading position in the fast-growing sleep and anxiety sector. SPM is a well-resourced platform with about 15 FTEs that provides extensive in-house pharmaceutical expertise and experience to serve as an appealing basis for Mallax. Furthermore, the Company has a sizable and steadily growing pipeline of new products that will be released in the future years. Mallax was founded in 2020 by Impilo, a Nordic healthcare-focused investment firm, and Anders Larnholt, a seasoned pharma, and healthcare executive, with the long-term goal of creating a large and diverse platform with established pharmaceuticals and OTC products for customers and patients across Europe. Dr. Peter Sjöstrand, the former deputy CEO and CFO of Astra and the former Chairman of the Boards of Gambro and Meda, is named Chairman of the Board of Mallax as part of the transaction. About Mallax Mallax was founded in 2020 by Impilo and Anders Larnholt with the ambition of building a leading pharma company and investing significant capital and resources behind the right acquisition opportunities across Europe, with a wide size range for any individual deal ranging from EUR 10 million to EUR 300 million. Mallax's strategy is based on three pillars: sustainability, medical need, and profitable growth. Mallax currently has operations in all Nordic markets due to the acquisition of Sana Pharma Medical. About Impilo Impilo is a Nordic investment firm that makes long-term investments in healthcare companies involved in pharmaceuticals, medical technology, healthcare services, and other health-related sectors. Impilo seeks to enhance the value of its assets via long-term active ownership and generate consistent returns for its stakeholders. Impilo has a well-diversified investment portfolio and has raised over SEK 9 billion in capital from leading Nordic and international investors since its inception in 2017.

Read More

Spotlight

Dr. Mark Fishman, president of Novartis Institutes of BioMedical Research (NIBR), talks about the Novartis commitment to science-based innovation and the search for new medicines for unmet patient needs.