PHARMACY MARKET
Cascade Chemistry | February 19, 2021
Cascade Chemistry, a main pharmaceutical contract development and manufacturing organization, today declared inception of development of new offices intended to expand the organization's ability to manufacture APIs (dynamic pharmaceutical ingredients) under cGMP (current Good Manufacturing Practices standards and procedures).
The new offices, expected to be operational in the main quarter of 2022, will eventually expand the organization's floor space just about three-overlay and essentially add to its cGMP manufacturing limit and scale. The extension likewise incorporates 2,200 square feet of new insightful labs, a powerful quality framework and extra office space.
“This $14 million expansion reflects our growing success as a reliable, experienced and flexible outsourcing partner with exceptional chemistry problem-solving expertise,” said Jeremiah Marsden, PhD, President of Cascade Chemistry. “Our customers are increasingly requesting our assistance in producing APIs for their clinical trials, and demand has outstripped our cGMP manufacturing capacity. We were fortunate to acquire two suitable buildings just 10 minutes from our current facility, and construction of new cGMP manufacturing suites that will greatly increase our clinical trial API production capacity is now underway.”
The 28,000-square-foot fabricating currently under development will at first incorporate five suites for Phase 1 and Phase 2 cGMP manufacturing with stream hydrogenation and reactors up to 400 liters. Extra limit with respect to API Phase 3 and business scale cGMP manufacturing up to 1,000 liters will be included 2022. The subsequent structure, with 7,000 square feet, is saved for future development.
Dr. Marsden continued, “We ultimately will expand into the second new building to build further cGMP capacity for commercial-stage low-volume, high-value pharmaceuticals. We are grateful for the support from our customers that is driving this expansion, as well as our employees’ dedication to excellence and their creativity and hard work that make it all possible.”
About Cascade Chemistry
Cascade Chemistry specializes in active pharmaceutical ingredient (API) process development, scale-up and cGMP (current Good Manufacturing Practices) manufacturing. Most of our chemists have advanced degrees and are capable of crafting process solutions tailored to the specific needs of our clients, while adhering to strict FDA quality standards. We offer cost effective and rapid solutions for the development and manufacturing of API cGMP batches at 1-10 kg scale, and we will begin offering greater capacity at our new facility in 2022. It has been our philosophy for almost 40 years that quality is a key component of successful cGMP manufacturing. We view quality as a guiding principle, achieved by rigorous due diligence at each step of the development and manufacturing process. Cascade Chemistry is headquartered in Eugene, Oregon.
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PRACTICE MANAGEMENT
Infant Bacterial Therapeutics | December 28, 2021
Infant Bacterial Therapeutics AB announces that the Patent Offices of Brazil and Hong Kong have approved a patent of Lactobacillus reuteri covering IBP-9414. IBT is currently developing its drug candidate IBP-9414 in Phase III for the prevention of necrotizing colitis and improvement of feeding tolerance in preterm infants.
The patent covers a novel way to activate the bacteria. Corresponding patent applications are currently pending across several important future markets. This patent reinforces the existing protection of IBT’s drug candidate IBP-9414. Additional market protection, beyond patent exclusivity, is also anticipated in the form of Orphan Drug Exclusivity and biological data protection in the US and EU.
The patent provides coverage until 2036. IBP-9414 is intended to be marketed in Brazil and Hong Kong upon marketing authorization.
“We are pleased to have strengthened our intellectual property protection for IBP-9414 through the approved patents in Brazil and Hong Kong. Brazil is in particular a substantial market with about 215 million inhabitants, which makes it a very interesting commercial opportunity for our future product",
CEO Staffan Strömberg, IBT
About Infant Bacterial Therapeutics AB
Infant Bacterial Therapeutics AB is a public company domiciled in Stockholm. The company’s Class B shares are listed on Nasdaq Stockholm, Mid-cap.
Infant Bacterial Therapeutics AB is a pharmaceutical company with a product in clinical phase III with a vision to develop drugs influencing the infant microbiome, and thereby prevent or treat rare diseases affecting infants.
IBT is currently developing the drug candidate IBP-9414. The ambition for IBP-9414 is to become the world’s first approved probiotical drug with the goal to prevent life threatening diseases in premature infants including NEC and sepsis by promoting healthy stomach-and bowel development in premature infants. IBP-9414 contains the active compound Lactobacillus reuteri, which is a human bacterial strain naturally present in breast milk. The product portfolio also includes another project, IBP-1016, for the treatment of gastroschisis, a severe and rare disease affecting infants. By developing these drugs, IBT has the potential to fulfill unmet needs for diseases where there are currently no prevention or treatment therapies available.
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PHARMACY MARKET
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.
About Medexus
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
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