Crescita Therapeutics | December 13, 2021
Crescita Therapeutics Inc. a growth-oriented, innovation-driven Canadian commercial dermatology company, is pleased to announce that it has signed an exclusive commercialization and supply agreement with Egis Pharmaceuticals PLC a leading generic pharmaceutical company in Central Eastern Europe for the rights to Pliaglis in eight countries comprising Hungary, Bulgaria, Czech Republic, Slovakia, Poland, Russia, Latvia and Lithuania.
Under the terms of the agreement, Crescita will receive an upfront payment of €0.65M and is eligible for further cumulative sales and regulatory milestone payments over the term of the agreement. Egis will sell Pliaglis through its own commercial infrastructure in CEE and Russia, where the company is well established. Crescita will be the exclusive supplier of Pliaglis at a defined price per unit and will also provide regulatory support to Egis in seeking approval for Pliaglis in the Territories. Egis expects to launch Pliaglis in Poland in early 2023 and will submit the requisite regulatory filings as soon as practicable to ensure that Pliaglis is launched promptly in the other territories.
“We are extremely pleased to partner with Egis. With its commitment to innovation, strong international presence and robust sales network, Egis represents a partner of choice in these Territories. Yet again, we have further expanded the footprint of Pliaglis worldwide, where it is now licensed in a total of 40 countries. Pliaglis is a pivotal asset for Crescita and is key to helping unlock the long-term value of our company. We look forward to a strong collaboration with Egis as we continue to secure recurring revenue streams,” added Mr. Verreault."
Serge Verreault, President and CEO of Crescita
“We are glad to enter such a great and promising partnership with Crescita. Pliaglis will be a flagship product in our new portfolio providing an excellent therapeutic solution in aesthetic dermatology. With its strong R&D focus in dermatology, we hope to further build this partnership and bring additional value-added medical solutions for patients via Egis’ excellent commercial capabilities in the region,” stated Dr. István Hodász, CEO of Egis.
About Crescita Therapeutics Inc.
Crescita is a growth-oriented, innovation-driven Canadian commercial dermatology company with in-house R&D and manufacturing capabilities. The Company offers a portfolio of high-quality, science-based non-prescription skincare products and early to commercial stage prescription products. We also own multiple proprietary transdermal delivery platforms that support the development of patented formulations that facilitate the delivery of active ingredients into or through the skin.
About Egis Pharmaceuticals PLC
Egis headquartered in Budapest, Hungary, is one of the leading generic pharmaceutical companies in Central and Eastern Europe. The company’s activities extend to every field of the pharmaceutical value chain: from research and development through the production of active pharmaceutical ingredients and finished drug products to sales and marketing. Egis products are available in 60 countries through its network of subsidiaries and representative offices or partners.
Pliaglis is a topical local anaesthetic cream that provides safe and effective local dermal analgesia on intact skin prior to superficial dermatological procedures. The formulation contains a eutectic mixture of 7% lidocaine and 7% tetracaine that utilizes Crescita's proprietary phase-changing topical cream Peel technology. The Peel technology consists of a drug-containing cream which, once applied to a patient's skin, dries to form a pliable layer that releases the active ingredients into the skin. Pliaglis is applied to intact skin 20 to 30 minutes prior to superficial dermatological procedures such as dermal filler injections, non-ablative laser facial resurfacing, or pulsed-dye laser therapy and 60 minutes prior to procedures such as laser-assisted tattoo removal.
Following the application period, the pliable layer is easily removed from the skin allowing the procedure to be performed with minimal to no pain. In clinical studies, the mean duration of anesthesia has been shown to be in the range of 7 to 9 hours after the application of Pliaglis. Pliaglis is currently approved in over 25 different countries and sold by commercial partners in various countries.
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.
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.
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.
Replica Analytics | June 30, 2022
Critical Path Institute and Replica Analytics, an Aetion company, announced a new partnership that involves leveraging synthetic data to further catalyze the generation of actionable solutions to accelerate drug development for rare diseases.
Replica Analytics will help generate synthetic datasets across rare and orphan indications in which patient-level datasets are often quite small, which heightens considerations regarding data privacy and accessibility.
Together with real data, these synthetic data will help maximize the utility of C-Path's Rare Disease Cures Accelerator-Data and Analytics Platform which provides a centralized and standardized infrastructure to support and accelerate rare disease characterization targeted to accelerate drug development. Additionally, the platform includes a framework that supports the rigorous conduct of natural history studies, with attention to established data quality standards, to be most useful to clinical trial design and regulatory review. It includes a robust, integrated database and analytics hub that allows for the aggregation of rare disease data from various sources and the efficient and effective interrogation of that data. Once added to RDCA-DAP, the synthetic data will also represent valuable real-world, electronic health record (EHR) based data available on the platform, opening doors to modeling and research based on longitudinal focused analyses.
"Our collaboration with Replica Analytics is important because synthetic data can add value to real-world data while observing data privacy considerations, which will help accelerate overall rare disease drug development. The goal of RDCA-DAP is to provide a centralized and standardized infrastructure to support and accelerate rare disease characterization and therapy development, this collaboration is in line with our efforts."
RDCA-DAP Scientific Director Alexandre Betourne, Pharm.D., Ph.D
Synthetic data generation is a privacy enhancing technology that has been gaining rapid adoption, particularly in the life sciences sector. SDG uses AI to create machine learning models that learn the statistical patterns and properties of real datasets to generate data that retain the same characteristics as the original dataset, but with no one-to-one mapping back to an identifiable person. SDG can help amplify small datasets, simulate virtual patients to augment patients in existing datasets, and optimize the design of small sample clinical trials.
"We are certainly seeing a growing opportunity to partner with organizations like C-Path for generating datasets that are fit-for-purpose," says Khaled El Emam, Ph.D., SVP and GM of Replica Analytics. "Synthetic data, which preserves the integrity and utility of source data, as well as being privacy-protective, can be a very valuable tool to enable this collaboration."
In May 2022, C-Path hosted a webinar in which the Replica Analytics team introduced SDG and discussed the role the technology can play in researching and treating rare diseases. The event was recorded and can be viewed on C-Path's YouTube channel.
Critical Path Institute is an independent, non-profit organization established in 2005 as a public and private partnership. C-Path's mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world. An international leader in forming collaborations, C-Path has established numerous global consortia that currently include more than 1,600 scientists from government and regulatory agencies, academia, patient organizations, disease foundations, and hundreds of pharmaceutical and biotech companies. C-Path U.S. is headquartered in Tucson, Arizona, C-Path in Europe is headquartered in Amsterdam, Netherlands and C-Path Ltd. operates from Dublin, Ireland with additional staff in multiple other locations.
Critical Path Institute is supported by the Food and Drug Administration of the U.S. Department of Health and Human Services and is 54.2% funded by the FDA/HHS, totaling $13,239,950, and 45.8% funded by non-government sources, totaling $11,196,634. The contents are those by the author(s) and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. Government.
About Replica Analytics, an Aetion company
Replica Analytics is the premier science-based SDG technology provider to the healthcare industry. The company a pioneer in the development of unique technologies for generating privacy-protective synthetic data that maintain the statistical properties of real-world data. The company was acquired in late 2021 by Aetion, the leading regulatory-grade real-world evidence technology provider. Replica Synthesis software provides a full suite of synthetic data generation and evaluation capabilities that can solve multiple grand challenges facing the life sciences industry, and health research in general.
Aetion is a healthcare analytics company that delivers real-world evidence for the manufacturers, purchasers, and regulators of medical treatments and technologies. The Aetion Evidence Platform® analyzes data from the real world to produce transparent, rapid, and scientifically validated answers on safety, effectiveness, and value. Founded by Harvard Medical School faculty members with decades of experience in epidemiology and health outcomes research, Aetion informs healthcare's most critical decisions—what works best, for whom, and when—to guide product development, commercialization, and payment innovation.