SiO2 Materials Science | December 27, 2021
Doosan Corporation, founded in 1896, one of South Korea's largest diversified conglomerates, and SiO2 Materials Science, a privately-owned U.S. advanced materials science corporation introducing breakthrough disruptive technology for packaging biological pharmaceuticals and vaccines, announced an exclusive partnership to sell, market, and distribute SIO2's vial, syringes and blood collection tubes in Asia/Oceania. The partnership will focus initially on the pharmaceutical and diagnostics markets but will extend to other markets through the joint development of new technologies.
As part of the strategic partnership, Doosan will invest $100 million into SiO2 and will additionally invest in substantial infrastructure and human resources for the acceleration of the business in Asia/Oceania. The partners have defined key volume milestones over a 15 year period.
"The Asia and Oceania region represents a significant market opportunity for vials and syringes specifically designed for biologic drugs and vaccines. South Korea has become a world leader in biological drug manufacturing, so it makes sense to establish a strong presence with a respected partners in the market,"
says Lawrence Ganti, President of SiO2 Materials Sciences
The SiO2 Materials Sciences technology platform combines the benefits of glass and plastic while eliminating the drawbacks of both. The technology has been commercially validated through the packaging of hundreds of millions of COVID-19 vaccine doses around the world and is working with more than 100 active projects with leading pharmaceutical and diagnostic companies to bring their products to market in a safer container. The company was a key collaborator and part of the US Government's COVID-19 Response (formerly known as Operation Warp Speed) and has expanded its manufacturing footprint in Auburn, Alabama, more than 12-fold in the last 18 months.
"South Korea is a strategic hub for biologic drug manufacturing. Doosan believes that the SiO2 technology would greatly support the packaging of these new drugs and vaccines and are proud to exclusively represent the technology in Asia," says Han Lee, Vice President of Doosan.
"There is so much potential in the SiO2 technology, and we will also jointly develop new technologies and products by bringing our existing technologies and engineering minds together," says Chief Business Officer of Doosan Corporation.
About SiO2 Materials Science
SiO2 Materials Science is an advanced materials science corporation introducing breakthrough disruptive technology serving the biopharma, molecular diagnostic, and consumer healthcare industries. The company is located in Auburn, Alabama. The company has deep partnerships with leading professors at the foremost research universities such as University of California - Santa Barbara, University of Chicago, and MIT / Harvard.
Doosan Corporation is Korea's oldest conglomerate, founded in 1896. The company operates across multiple divisions such as: Electro-Materials, Industrial Vehicles, Fuel Cell Power, Retail, and Digital Innovation. The company is always developing innovative new business in support of materials science.
Telix Pharmaceuticals Limited | April 11, 2022
Telix Pharmaceuticals Limited announces that it has entered into a licence agreement with Eli Lilly and Company under which Telix is granted exclusive worldwide rights to develop and commercialise radiolabelled forms of Lilly's olaratumab antibody for the diagnosis and treatment of human cancers. Telix's initial development focus will be on a rare type of cancer known as soft tissue sarcoma.
Olaratumab was originally developed by Lilly as a monoclonal antibody targeting Platelet Derived Growth Factor Receptor Alpha. PDGFRα is expressed in multiple tumour types including STS. STS is generally a radiation susceptible cancer that may be inherently amenable to systemic radionuclide therapy and olaratumab's ability to target PDGFRα makes it a highly novel and potentially exciting candidate for use as a radionuclide targeting agent. The exclusive worldwide licence will allow Telix to repurpose olaratumab as a targeting agent for radiopharmaceutical imaging and therapy of cancer. Olaratumab has an established safety profile that underpins its potential use as a radionuclide targeting agent.
Material terms of the agreement
Under the terms of the agreement Telix will pay Lilly an upfront payment of US$5M for the grant of an exclusive licence to Lilly's intellectual property related to the development of a radiolabelled olaratumab, as well as access to material for use by Telix in initial pre-clinical and early-phase clinical studies in application to potential uses for the diagnosis and treatment of human cancers.
Lilly may be eligible for up to US$225M in payments based upon the achievement of pre-specified development, regulatory and commercial milestones. Lilly would also be eligible to receive industry standard royalties on net sales. The agreement also includes an option for Lilly to be granted an exclusive licence to a radiolabelled companion diagnostic which would be developed by Telix. If exercised, Lilly will pay Telix US$5M and up to US$30M in potential development milestones, as well as industry standard royalties.
The agreement has typical termination rights for breach and related corporate issues. Telix retains termination rights typical to licence agreements of this nature to enable the Company to exit the agreement based on a development or commercial basis.
"This in-licence transaction with Lilly is a valuable – and rare – opportunity to acquire an asset which has demonstrated clinical safety. In our pre-transaction diligence and research, we have identified that a radiolabelled version of olaratumab could be efficacious in patients with STS, particularly as it is a highly radiation-sensitive cancer. The safety data generated by Lilly in relation to the original development program significantly de-risks the program for Telix. We anticipate that early clinical translation with a radiolabeled olaratumab as an imaging agent may also provide valuable clinical information as to whether this asset has potential therapeutic efficacy, demonstrating the advantage of Telix's "theranostic" approach.
Telix Group CEO and Managing Director, Dr. Christian Behrenbruch
"This acquisition mirrors the approach that Telix has taken in building its existing pipeline by in-licencing or acquiring assets that have already been proven to be safe for use in humans that can be harnessed as novel radiolabelled targeting agents. This partnership also demonstrates the value that Telix can bring as a capable partner with the expertise in radiopharmaceutical development and manufacturing, to help repurpose or expand the use of promising candidates to better target, find and treat cancer."
About Soft Tissue Sarcoma
Soft tissue sarcoma is a complex disease that encompasses a diverse group of relatively rare cancers, with more than 50 histological subtypes. In the United States, it is estimated that 13,040 new cases and 5,150 deaths were caused by STS in 2019, representing 0.75% of overall cancer incidence and 0.84% of overall cancer mortality.1 In Europe, nearly 23,600 new STS cases rose annually, and the crude incidence rate was 4.7 per 100,000.2 Approximately 39,900 new STS cases occurred nationwide in China in 2019, accounting for 1.05% of overall cancer incidence.3 The crude incidence rate was 2.91/100,000 and generally increased with age. Standard treatment for soft tissue sarcoma includes surgery, radiation therapy and/or chemotherapy. For patients with advanced, unresectable, or metastatic disease, treatment typically involves chemotherapy with single agents or anthracycline-based combination regimens. However, the prognosis for these patients remains poor, with treated patients with metastatic disease having a median overall survival of around 12–18 months.
Olaratumab was originally developed as a monoclonal antibody targeting PDGFRα. Olaratumab was granted "Accelerated Approval" in the US and "Conditional Approval" in the EU based on Phase 2 trial data which showed a 1-year survival benefit in patients with STS, when given in combination with standard chemotherapy. Olaratumab was voluntarily withdrawn from the market by Lilly following the failure of the Phase 3 ANNOUNCE clinical trial, in which olaratumab did not improve survival for patients.
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic products using Molecularly Targeted Radiation. Telix is headquartered in Melbourne, Australia with international operations in Belgium, Japan, Switzerland, and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange.
Agilent Technologies Inc. | January 25, 2022
Agilent Technologies Inc. announced the release of the Agilent Seahorse XF Pro Analyzer, featuring new pharma-oriented workflow solutions incorporating advanced experimental design and analysis tools. With enhanced performance, more robust and efficient workflows, and an optimized user experience, the XF Pro enables operators at any skill level to access the most advanced cellular metabolism analysis technology for understanding cellular fate, fitness, and function.
Preclinical therapeutic discovery workflows place high demands on cellular analysis, with immunology and disease researchers increasingly using rare, ex vivo, and genetically engineered cells to build better disease models. To address the increasing interest in monitoring live cells in real-time, the new XF Pro Analyzer incorporates a suite of hardware and software enhancements that improve measurement performance and data interpretation. These enhancements will make it easier to identify novel drug targets, validate target effect on cellular function, optimize disease models, and determine drug safety and antitumor potential of T cell therapies.
“With dedicated workflow solutions the XF Pro provides enhanced performance and customer experience, particularly within pharma and biopharma therapeutic development, and toxicity programs. This underlines Agilent’s commitment towards developing intentional end-to-end solution-focused innovations that continue to lead the way for applied analytical and research applications, including direct metabolic analysis.”
Richard Fernandes, associate vice president and general manager of Agilent’s Cell Analysis, Seahorse, Luxcel, and microplates businesses
"The launch of the XF Pro is very much a customer-driven event. Through collaboration and intentional conversations with our customers and key opinion leaders, we recognized the need for a live-cell metabolic analysis platform which makes sophisticated analysis even more accessible for both experienced users as well as novices,” added Chris Braun, associate vice president of Marketing for Agilent’s Cell Analysis Division. “Primarily targeting the pharma/biopharma sector, but beneficial to all our customers, the XF Pro incorporates critical metabolic insights into researchers’ discovery workflows to facilitate even higher quality data where it matters most.”
The XF Pro Analyzer is expected to enhance critical aspects of live-cell analysis, particularly for researchers working in immunotherapy, early drug discovery, and preclinical safety assessment. By delivering better precision at a low oxygen consumption rate (OCR), the XF Pro Analyzer allows analysts to confidently interrogate more immune cell types, as well as cell types that are bioenergetically compromised. The instrument also features pharma-tailored workflows for harnessing robust cellular metabolism measurements while handling suspension cell types, along with simplified automation enablement and analytical instrument qualification (AIQ).
About Agilent Technologies
Agilent Technologies Inc. is a global leader in the life sciences, diagnostics, and applied chemical markets, delivering insight and innovation that advance the quality of life. Agilent’s full range of solutions includes instruments, software, services, and expertise that provide trusted answers to our customers' most challenging questions. The company generated revenue of $6.32 billion in fiscal 2021 and employs 17,000 people worldwide.
Breckenridge Pharmaceutical, Inc. | April 23, 2022
Breckenridge Pharmaceutical, Inc. announces today that it has signed a new-product agreement with PTS Pharma, LLC. under which PTS will support a technology transfer to Towa Pharmaceutical Europe, S.L. of a complex "For Suspension" product developed by PTS. The remainder of development and commercialization will be performed at the Towa facility. According to industry sales data, the product and its generics had annual sales of approximately $75 million during the twelve months ending February 2022. The companies are actively negotiating and look forward to collaborating on additional complex formulations under the same business model.
Breckenridge Pharmaceutical, Inc., a subsidiary of Towa Pharmaceutical, partners with manufacturers nationwide and around the world to bring quality, cost-effective generic pharmaceuticals to U.S. patients. With our dedication to customer service, on-time delivery, reliable supply and quality manufacturing, we improve the health and quality of life of the patients we and our customers serve.
About PTS Pharma, LLC
PTS Consulting, LLC and PTS Pharma LLC., is a formulation development, clinical trial production, regulatory services and analytical control laboratory based in Kansas. PTS Consulting is actively involved in regulatory consulting services. PTS Pharma operations include the capability and expertise to develop complex formulations of tablets, capsules, granules, modified dosage forms, topical dosage forms, suppositories, film products, solution, and suspension formulations and sterile injectables, with involvement in multiple aNDA and NDA filings over the years. The activities are housed in dedicated GMP suites in the facility in Kansas City, USA. PTS Pharma is also involved in active raw material clinical production by fermentation technology processes. The firm was founded in 2003 by Paul Sudhakar, an industry veteran who is the Owner, President, and CEO of the firm.