KiOmed Pharma and Hansoh Pharma | September 27, 2022
KiOmed Pharma, a Belgian biotechnology company with a focus on the development, manufacture and distribution of safe and effective medical devices based on a medical-grade highly pure natural chitosan-derivative, and Hansoh Pharmaceutical Group Company Limited a leading biopharmaceutical company in Asia, today announced a license agreement for the development and commercialization of KiOmedinevsOne, a carboxymethyl chitosan injection that has been launched in Europe for the treatment of knee osteoarthritis, in China’s mainland, Macau and Taiwan.
Under the terms of the agreement, KiOmed will receive an upfront payment and will be eligible to receive development, regulatory and commercial milestones of up to € 66 million, as well as tiered royalties on future product sales. Hansoh will receive exclusive rights to develop and commercialize KiOmedinevsOne and its future extensions in the territory. KiOmed retains the right to develop and commercialize KiOmedinevsOne in all other global markets.
Osteoarthritis is a progressive and disabling disease affecting about 250 million people worldwide. According to a recent epidemiology report, the prevalence of knee osteoarthritis in China is 8.1%. As the population in China is aging rapidly, disease burden caused by knee osteoarthritis continues to rise while safe and effective treatment options are still lacking.
“We are very excited to partner with Hansoh Pharma, one of the largest biopharmaceutical entities in Greater China. We believe that with Hansoh’s impactful presence in China, their support will be essential to bring this long-acting treatment to the large population of patients suffering from osteoarthritis in China. We launched KiOmedinevsOne last year in several regions of Europe, and the feedback we continue to receive from osteoarthritis patients and physicians is great. With just one single injection to the knee, it can provide symptoms relief including pain, stiffness, and function improvement for more than 6-month. It is the world-first next generation non-animal sourced chitosan injection with a potential safety advantage over animal-sourced chitosan,” added Dr. Houtaï Choumane, CEO and Managing Director of KiOmed.
Mr. François Blondel, Founder and Executive Chairman of the Board of KiOmed Pharma
“KiOmed is a leader and an expert in developing natural chitosan products to fulfill unmet medical needs in different spaces. Osteoarthritis negatively impacts an individual’s quality of life and creates a large burden for the patients and their families. We are very glad to see KiOmed’s product (KiOmedinevsOne) will help to solve this problem,” said Eliza Sun, Executive Director of the Board of Hansoh Pharma. “We are also very excited to partner with them and bring this unique product to much needed patients in China.”
KiOmedinevsOne is a new generation single injection for the treatment of knee osteoarthritis based on world-first exclusive animal free KiOmedine® CM-Chitosan. KiOmedine® CM-Chitosan is a highly purified polysaccharide derived from Agaricus Bisporus (button mushroom) and a patented technology made in Belgium, resulting from years of research and innovation. Different from hyaluronic acid, KiOmedinevsOne has dual mechanism of action to tackle osteoarthritis discomfort and other symptoms by reducing oxidative stress and enhancing joint lubrication. Clinical studies have shown that after a single injection of KiOmedinevsOne, significant pain reduction was observed within 2 weeks and the WOMAC pain score was reduced by 66%, with a long-lasting osteoarthritis symptom reduction for at least 6 months. KiOmedinevsOne is a regulated health product which bears the CE mark under this regulation. It has been launched in Europe in 2021.
About KiOmed Pharma
Based in Belgium, KiOmed Pharma has a history of innovation and expertise in exclusive natural chitosan chemistry. The company develops a unique pipeline of medical devices that address unmet medical needs in high impact pathologies and major social burdens such as osteoarthritis, skin aging and ophthalmology. KiOmed Pharma's innovative pipeline is based on a solid building block exclusive technology: KiOmedine®, a medical-grade highly pure natural chitosan-derivative.
About Hansoh Pharmaceutical Group
Hansoh Pharma one of the largest biopharmaceutical companies in China, is committed to discovering and developing life-changing medicines to help patients conquer serious diseases and disorders.
WuXi AppTec | August 12, 2022
WuXi Advanced Therapies a wholly owned subsidiary of WuXi AppTec, announced a licensing agreement with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Under this agreement, WuXi ATU will license to Janssen its TESSA™ technology, a high-performance system that can produce 10 times more adeno-associated viral vectors than traditional AAV manufacturing systems. Janssen will also have access to work on WuXi ATU's proprietary clonal suspension HEK293 cell line. This agreement was facilitated by Johnson & Johnson Innovation.
AAV vectors are commonly used for the delivery of gene therapies to patients due to their ability to transduce numerous cell and tissue types. WuXi ATU's TESSA™ technology responds to industry demand for large scale AAV manufacturing by producing higher quality AAV particles more efficiently. WuXi ATU has also successfully scaled up the TESSA™ technology to 200L; this achieved a 10-fold higher yield and a significantly higher percentage of full AAV capsids, greatly reducing overall AAV production costs compared to traditional plasmid-based AAV production systems.
"We are honored that Janssen selected WuXi ATU's TESSA™ technology. We remain committed to improving the TESSA™ platform to produce faster and more cost-effective AAV products for patients."
Dr. David Chang, Chief Executive Officer of WuXi Advanced Therapies
As a Contract Testing, Development and Manufacturing Organization with global operations, WuXi ATU will continue to enhance its capability and capacity to help customers develop and deliver life-changing cell and gene therapies faster for patients in need.
About WuXi Advanced Therapies (WuXi ATU)
As the advanced therapies business unit of WuXi AppTec, WuXi Advanced Therapies is a Contract Testing, Development and Manufacturing Organization (CTDMO) that offers integrated platforms to transform the discovery, development, testing, manufacturing, and commercialization of cell and gene therapies. Our services and solutions accelerate time to market and support customer programs around the world.
About WuXi AppTec
As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable global pharmaceutical and healthcare industry to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec's integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, cell and gene therapies CTDMO (Contract Testing, Development and Manufacturing Organization), helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received AA ESG rating from MSCI in 2021 and its open-access platform is enabling more than 5,850 collaborators from over 30 countries to improve the health of those in need – and to realize the vision that "every drug can be made and every disease can be treated."
TFF Pharmaceuticals, Inc. | July 16, 2022
TFF Pharmaceuticals, Inc. a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced a significant expansion of its R&D operations through the lease of a new research and development facility located in Austin, Texas.
The new facility of over 3,500 square feet significantly increases TFF’s total lab space, adding a dedicated lab for downstream processing of products created via Thin Film Freezing, which will complement the company’s existing formulation development capabilities. As TFF expands its in-house and partnered research, including applications in biologics, the additional laboratory space will also provide significantly more real estate to accommodate larger equipment to facilitate scale-up and manufacturing, as well as to produce supplies for preclinical studies.
The new space will be supervised by Donald Owens, Ph.D., Director of Product Development at TFF, and supported by John Koleng, Ph.D., R.Ph., Vice President of Product Development and Manufacturing. The company also plans to expand the product development team in Austin, which will be based at the new facility, to support the growing number of partnered projects. The lease arrangement used to finance the facility is also a major advantage, providing TFF with a highly flexible and capital efficient approach in expanding its R&D operations while preserving capital resources.
“The opening of our new Austin R&D facility represents an important evolution of TFF’s operations, reflecting growing demand for our Thin Film Freezing technology and product development services. The Austin facility will enable us to increase testing capacity so that we can run a larger number of feasibility studies, including a focus on biologics where demand has continued to grow. Additionally, as many of our partnered programs move to clinical evaluation, the ability to scale-up manufacturing in parallel becomes mission critical. We expect the new Austin facility will allow us to meet the current growing demand for Thin Film Freezing-based products.”
The addition of this facility also cements Austin as a central hub of TFF’s research operations. The company maintains a close relationship and research collaborations with academic institutions, including the University of Texas at Austin, where TFF has extensive early-stage formulation capabilities.
“As our internal programs advance and our network of partnerships expands, establishing this additional research space in Austin is a natural next step,” added Glenn Mattes, CEO of TFF Pharmaceuticals. “I’m confident that Don and John will spearhead a successful expansion and scale-up of TFF’s capabilities to meet growing demand. We will also continue to work closely with our partners, including Dr. Robert O. Williams, Special Advisor to TFF and Co-Inventor of the Thin Film Freezing technology, who continues to advance new research demonstrating the broad applications and advantages of our technology from his home base at UT Austin.”
ABOUT TFF PHARMACEUTICALS’ THIN FILM FREEZING TECHNOLOGY PLATFORM
TFF Pharmaceuticals’ proprietary Thin Film Freezing (TFF) technology allows for the transformation of both existing compounds and new chemical entities into dry powder formulations exhibiting unique characteristics and benefits. The Thin Film Freezing process is a particle engineering process designed to generate dry powder particles with advantageous properties for inhalation, as well as parenteral, nasal, oral, topical and ocular routes of administration. The process can be used to engineer powders for direct delivery to the site of need, circumventing challenges of systemic administration and leading to improved bioavailability, faster onset of action, and improved safety and efficacy. The ability to deliver therapies directly to the target organ, such as the lung, allows TFF powders to be administered at lower doses compared to oral drugs, reducing unwanted toxicities and side effects. Laboratory data suggests the aerodynamic properties of the powders created by Thin Film Freezing can deliver as much as 75% of the dose to the deep lung. Thin Film Freezing does not introduce heat, shear stress, or other forces that can damage more complex therapeutic components, such as fragile biologics, and instead enables the reformulation of these materials into easily stored and temperature-stable dry powders, making therapeutics and vaccines more accessible for distribution worldwide. The advantages of Thin Film Freezing can be used to enhance traditional delivery or combined to enable next-generation pharmaceutical products.
ABOUT TFF PHARMACEUTICALS
TFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company engaging patented rapid freezing technology to develop and transform medicines into potent dry powder formulations for better efficacy, safety and stability. The company’s versatile Thin Film Freezing (TFF) technology platform has broad applicability to convert any drug, including vaccines, small and large molecules and biologics, into an elegant dry powder highly advantageous for inhalation, with improved absorption so drugs can also be delivered to the eyes, nose and topically to the skin. TFF has two lead drug candidates in the clinic: Voriconazole Inhalation Powder and Tacrolimus Inhalation Powder, and continues to expand its pipeline by collaborating with a broad array of pharmaceutical companies, academic institutions and government partners to revolutionize healthcare around the globe. The TFF Platform is protected by 120+ patents issued or pending in the U.S. and internationally.