Medexus Pharmaceuticals | July 13, 2021
Medexus Pharmaceuticals Inc. announced today that it has entered into a licensing deal with medac GmbH to commercialize treosulfan, a bifunctional alkylating agent, in Canada.
Treosulfan will be sold in Canada as Trecondyv and will be used in conjunction with fludarabine as part of a conditioning regime before allogeneic hematopoietic stem cell transplantation. Medexus will be in charge of selling and promoting the product, while Medac will manufacture and supply it.
Medexus has been distributing treosulfan in Canada through the Special Access Program, and Health Canada recently approved Trecondyv for the treatment of adult patients with Acute Myeloid Leukemia or Myelodysplastic Syndromes who are at increased risk for standard conditioning therapies, as well as pediatric patients older than one year with AML or MDS.
About medac GmbH
medac GmbH is a privately owned global pharmaceutical firm that is expanding its pharmaceutical and diagnostics businesses. Since its inception in Germany in 1970, medac has specialized in treating diseases related to oncology, hematology, urology, and auto-immune disorders. medac is dedicated to improving current therapeutic products and creating new ones to enhance patients' quality of life. In addition, medac has earned a reputation for developing novel medicines in less common indications. This dedication has resulted in a diverse range of pharmaceutical goods that positively impact the lives of patients. medac is constantly investing in product development and manufacturing and logistical capacities to fulfill the requirements of both patients and healthcare professionals.
Medexus is a market leader in novel rare disease treatment solutions, with a solid commercial platform in North America. We are building a highly distinctive business with a portfolio of innovative and high-value orphan and rare disease medicines that will support our growth for the next decade, based on a foundation of proven best-in-class medications. Through our key principles of Quality, Innovation, Customer Service, and Teamwork, the Company's goal is to offer the finest healthcare products to healthcare professionals and patients. Medexus Pharmaceuticals specializes in the treatment of auto-immune illness, hematological, and allergies. Rasuvo and Metoject, a unique methotrexate formulation (auto-pen and pre-filled syringe) designed to treat rheumatoid arthritis and other auto-immune diseases; IXINITY, an intravenous recombinant factor IX therapeutic for use in patients 12 years of age or older with Hemophilia B – a hereditary bleeding disorder characterized by a deficiency of clotting factor
Stevanato Group | November 18, 2021
Stevanato Group, a global provider of drug containment, drug delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries, today announced the expansion of its corporate headquarters with the construction of a new facility in Piombino Dese, Italy to advance operations and growth of the Company.
The new 6,750 square meter facility is expected to support the optimization of Stevanato Group’s industrial footprint, with about 2,500 square meters dedicated to increasing the production of high-value products. In addition to hosting offices, the Italian analytical services site, and R&D space, it is also expected to include new glass syringe forming lines devoted to boosting the production of EZ-fill® solutions, which are pre-sterilized drug containment solutions that reduce total cost of ownership and time-to-market for pharmaceutical companies.
“We are very proud of the global growth and evolution that Stevanato Group has achieved over the recent years, and we are always exploring new opportunities and ways to meet our customers’ needs. Further increasing our production capabilities here at home through this new space we expect to be able to bridge capacity demands while our exciting projects in the U.S. and China are underway. Importantly, this expansion is further validation of the hard work of our employees, the demand for our innovative products and the continued growth of our business, and we expect it to allow us to be well positioned to build on our current momentum and advance development initiatives that are expected to directly benefit all of our customers and stakeholders around the world.”
Franco Moro, CEO of Stevanato Group
Construction of the new building began in September 2021. The Company expects to install and validate new lines in the second quarter of 2022, and expects industrial production to begin between late second quarter and early third quarter of 2022.
Stevanato Group’s new flagship building represents an important development in its 2020-2023 Industrial Plan, including efforts to meet increasing global demand for premium products. As part of these efforts, the Company recently operationalized two additional lines for EZ-fill® vials and syringes manufacturing in Italy and, in 2022, plans to add two more lines devoted to EZ-fill® syringes as well as one dedicated line for Alba® syringes, the breakthrough solution for biologics. The expansion underway is part of the Company’s expected plans to triple production of EZ-fill® pre-fillable sterile syringes by 2023 and to increase production of EZ-fill® sterile vials and cartridges 19x by 2023, compared to 2016 numbers.
Stevanato Group’s new building also marks the Company’s ongoing dedication to and investment in the local Piombino Dese community, where it has been headquartered for more than 60 years. The new building is expected to act as the counterpart to another facility at the Piombino Dese headquarters, recently completed in 2020, also used for the production of syringes and that hosts solar electric panels. These panels produce 160kWp of electricity per year and are intended to provide electricity to both buildings, as Stevanato Group remains committed to sustainability. To that end, the new building is also intended to have a partial recovery system enabling it to reuse water used for washing in production.
About Stevanato Group
Founded in 1949, Stevanato Group is a leading global provider of drug containment, drug delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries. The Group delivers an integrated, end-to-end portfolio of products, processes and services that address customer needs across the entire drug life cycle at each of the development, clinical and commercial stages. Stevanato Group’s core capabilities in scientific research and development, its commitment to technical innovation and its engineering excellence are central to its ability to offer value added solutions to clients.
This press release may include forward-looking statements. The words "expected", "expects", “intended”, "plans" and similar expressions (or their negative) identify certain of these forward-looking statements. These forward-looking statements are statements regarding the Company's intentions, beliefs or current expectations concerning, among other things, the size and use of the plant, the construction and timing of its plant, impact of the plant of the Company’s business and results of operations and the nature of the plant once complete. The forward-looking statements in this press release are based on numerous assumptions regarding the Company’s present and future business strategies and the environment in which the Company will operate in the future. Forward-looking statements involve inherent known and unknown risks, uncertainties and contingencies because they relate to events and depend on circumstances that may or may not occur in the future and may cause the actual results, performance or achievements of the Company to be materially different from those expressed or implied by such forward looking statements. Many of these risks and uncertainties relate to factors that are beyond the Company's ability to control or estimate precisely, such as future market conditions, currency fluctuations, the behavior of other market participants, the actions of regulators and other factors such as the Company's ability to continue to obtain financing to meet its liquidity needs, changes in the political, social and regulatory framework in which the Company operates or in economic or technological trends or conditions. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. Except as required by law, the company assumes no obligation to update any such forward-looking statements.
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.