BUSINESS INSIGHTS
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.”
Dr. Koleng
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.
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BUSINESS INSIGHTS
Halozyme Therapeutics, Inc. | May 30, 2022
Halozyme Therapeutics, Inc. announced the successful completion of its acquisition of Antares Pharma, Inc.
The tender offer for all of the outstanding shares of Antares common stock expired as scheduled at one minute after 11:59 p.m., Eastern Time, on Monday, May 23, 2022. The minimum tender condition and all of the other conditions to the offer have been satisfied and on May 24, 2022, Halozyme accepted for payment and will promptly pay for all shares validly tendered and not validly withdrawn.
Following its acceptance of the tendered shares, Halozyme completed its acquisition of Antares through the merger of a wholly owned subsidiary of Halozyme with and into Antares, pursuant to Section 251(h) of the General Corporation Law of the State of Delaware, with Antares continuing as the surviving corporation and becoming a wholly owned subsidiary of Halozyme.
In connection with the merger, all Antares shares not validly tendered in the tender offer have been converted into the right to receive the same $5.60 per share in cash, without interest thereon and net of any applicable withholding taxes, that would have been paid had such shares been validly tendered in the tender offer. As of May 24, 2022, Antares common stock will cease to be traded on the NASDAQ Global Select Stock Market.
BofA Securities, Inc. and Wells Fargo Securities LLC acted as financial advisors to Halozyme and Weil, Gotshal & Manges LLP acted as legal advisor. Jefferies LLC acted as financial advisor to Antares and Skadden, Arps, Slate, Meagher & Flom LLP acted as legal advisor.
About Halozyme
Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has touched more than 600,000 patient lives in post-marketing use via five commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, AbbVie, Eli Lilly, Bristol-Myers Squibb, Alexion, argenx, Horizon Therapeutics, ViiV Healthcare and Chugai Pharmaceutical. Halozyme derives revenues from these collaborations in the form of milestones and royalties as Halozyme's partners make progress developing and commercializing their products being developed using ENHANZE®. Halozyme is headquartered in San Diego.
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BUSINESS INSIGHTS
PostEra | May 19, 2022
PostEra, a biotechnology company specializing in machine learning for preclinical drug discovery, announced a multi-year collaboration with the National Institutes of Health to develop small molecule antiviral therapeutics to prevent pandemics. The center will receive initial funding of $68M. PostEra co-leads this initiative with the Drugs for Neglected Diseases Initiative, a global charity with expertise in drug development for global equitable access, and the Memorial Sloan Kettering Cancer Center.
As part of the National Institutes of Health's National Institute of Allergy and Infectious Diseases Antiviral Program for Pandemics, the AI-driven Structure-Enabled Antiviral Platform (ASAP) consortium aims to discover dozens of lead compounds against key viruses of significant pandemic concern, such as flaviviruses (responsible for endemic diseases such as Dengue and Zika), picornaviruses (including potentially debilitating enteroviruses as well as other cold-causing viruses), and coronaviruses. ASAP will further deliver three IND-ready candidates which can be immediately ready for clinical evaluation in the event of a viral outbreak, so that future pandemics can be halted before severe outbreaks occur. The consortium is committed to making resulting antivirals globally and equitably accessible, so that no patient population is left behind.
ASAP will use PostEra's end-to-end AI-first approach to accelerate the discovery process, generating molecules with optimised properties, designing rapid synthesis, and optimally prioritising experiments. In particular, AI approaches are tightly integrated into structural biology to realize next generation structure-based design. ASAP is built on the success of the COVID Moonshot project, a global open-science AI-driven initiative that began in March 2020 and rapidly identified antiviral drug candidates that target the main protease of the SARS-CoV-2 virus.
"We are honored to be co-leading this consortium. We believe that our AI platform will accelerate the discovery of therapeutics that will prevent pandemics."
Dr Alpha Lee, Chief Scientific Officer of PostEra, who co-founded COVID Moonshot
About PostEra
PostEra was founded in 2019 and its technology is built on pioneering academic research done by its founding scientists. PostEra's technology addresses some of the key challenges in drug discovery R&D by integrating molecular design with chemical synthesis. PostEra advances small molecule programs through partnerships with biopharma, working on its own internal pipeline, and also offering some of its synthesis technology via its Manifold web platform. PostEra also helped launch the world's largest open-science drug discovery effort; COVID Moonshot, along with an NIH-funded antiviral research center for the prevention of future pandemics.
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