Prnewswire | August 18, 2020
Kimera® Labs Inc, a privately held clinical stage biotechnology company, announces the filing of an extended FDA Investigational New Drug (IND) application to study the treatment of COVID-19 related inflammatory disease using Kimera's first-in-class XoGlo® isolated placental mesenchymal stem cell-based exosomes. Founded in 2012, Kimera® generated the first publicly available isolated exosome product and has treated over 35,000 thousand patients for a variety of investigational uses. Kimera currently employs 40 PhDs, technicians and staff at its Miramar Florida 27,000 sq. ft. GMP manufacturing facility, the first and only laboratory dedicated solely to exosome R&D and production in the US.
Healio | April 27, 2020
In this guest editorial, Pinar Keskinocak, PhD, director of the Center for Health and Humanitarian Systems and a professor in the H. Milton Stewart School of Industrial and Systems Engineering at Georgia Institute of Technology, and Evren Ozkaya, PhD, founder and CEO of the management consulting and digital solutions firm Supply Chain Wizard, discuss how pandemics create chaos in global medical supply chains and ways to alleviate this burden. Pandemics encumber the supply of medications needed to fight them and also the supply of other critical pharmaceuticals with potentially grave consequences for public health. Pandemics do this by disrupting global supply chains in general, and pharmaceutical supply chains are particularly vulnerable. America’s medical supply chain is not prepared for this. But government and industry can help it cope if they react rapidly.
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.