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
Catalent, Inc. | August 10, 2022
Catalent, Inc. the global leader in enabling biopharma, cell, gene, and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities, today announced that it has reached an agreement to acquire Metrics Contract Services a full-service specialty Contract Development and Manufacturing Organization with a facility in Greenville, North Carolina, for $475 million from Mayne Pharma Group Limited. Upon completion, the acquisition will strengthen Catalent’s capabilities in integrated oral solid formulation development, manufacturing, and packaging to help customers simplify and accelerate their programs, while also expanding Catalent's capacity to handle highly potent compounds.
The 333,000 square-foot Greenville facility features comprehensive capabilities to accelerate and de-risk customer programs from early development through commercial launch through a streamlined one-site solution. Over the past five years, the facility has seen more than $100 million in capital improvements and now includes 16 manufacturing suites, with 11 designed to handle highly potent compounds, as well as two packaging lines that can support a large variety of development and commercial supply programs. The facility’s estimated annual production capacity exceeds one billion oral solid dose units.
“This acquisition will further expand Catalent’s ability to meet our customers’ expectations in fast-growing areas of the business and patient need. The experienced team and consistently improved, state-of-the-art facility in Greenville will provide Catalent’s customers with immediate, fit-for-scale capacity for in-demand highly potent drugs and other oral solid small-to-mid-size batch needs. This capacity is particularly important for customers with R&D pipelines featuring accelerated, orphan, and rare disease programs for oncology and other important therapeutic areas,” said Dr. Aris Gennadios, Group President of Catalent’s Pharma & Consumer Health segment.
“Over the past several years, Metrics has undergone a period of transformational change to expand its footprint and service offering, becoming a global end-to-end novel oral solid CDMO. Catalent, a global leader in advanced drug development and manufacturing, is well-positioned to continue to invest in and accelerate the growth of Metrics and we believe this transaction will be extremely positive for our Greenville team and customers,”
Scott Richards, Chief Executive Officer of Mayne Pharma
The new facility will seamlessly integrate into Catalent’s industry-leading oral development and manufacturing network, which includes flagship sites for large-scale and controlled release oral solids manufacturing in Winchester, Kentucky; softgel development and manufacturing in St. Petersburg, Florida; and additional facilities with bioavailability enhancement technologies and complex oral solids manufacturing platforms.
The acquisition is expected to close before the end of this calendar year, subject to customary closing conditions, and the entire team of over 400 employees will join Catalent. Mayne Pharma and Catalent have also agreed on the terms of a long-term supply agreement whereby the Greenville facility will continue to manufacture multiple Mayne Pharma products. Catalent will pay the purchase price for this all-cash acquisition using a combination of cash on hand, existing credit facilities, and, depending on market conditions, potentially new debt financing. The closing of the acquisition is not contingent on any financing activity.
ABOUT CATALENT
Catalent, Inc. an S&P 500® company, is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is the industry’s preferred partner for personalized medicines, consumer health brand extensions, and blockbuster drugs. Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply over 70 billion doses of nearly 7,000 products to over 1,000 customers annually. Catalent’s expert workforce of approximately 19,000 includes more than 2,500 scientists and technicians. Headquartered in Somerset, New Jersey, the company generated $4 billion in revenue in its 2021 fiscal year.
ABOUT METRICS CONTRACT SERVICES
Metrics Contract Services, a division of Mayne Pharma Group Limited, is a full-service pharmaceutical development and manufacturing organization serving clients worldwide delivering proven scientific and operational excellence for novel oral dosage forms. Metrics provides formulation development, analytical testing and commercial manufacturing from its single-campus facility in Greenville, North Carolina
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BUSINESS INSIGHTS
LTS Lohmann Therapie-Systeme AG | August 23, 2022
LTS LOHMANN Therapie-Systeme AG announces the closing of the acquisition of Tapemark Inc. located in St. Paul, MN, USA. This acquisition combines Tapemark, a world-class CDMO specialized in transdermal drug delivery systems and oral thin films as well as unit dose semi-solid drug and iontophoresis products with LTS, a leading pharmaceutical technology company that develops and manufactures innovative drug delivery systems such as Transdermal Patches Oral Thin Films and Micro Array Patches (MAP) for major Bio- /Pharmaceutical, Generic, and Consumer Health companies.
With the acquisition, Tapemark´s St. Paul facility will become part of the worldwide operations network of LTS, along with LTS' existing facilities in Andernach, Germany and West Caldwell, NJ in the US.
Bas van Buijtenen, CEO of LTS, commented, "We are very pleased to welcome the Tapemark team to the LTS family. This strategic acquisition demonstrates our commitment to continue to set the standard as the best CDMO in TTS and OTF and to strengthen our footprint in the US, the world's most important pharma market. We will offer an even more complete portfolio of drug delivery expertise and expanded manufacturing capabilities to our customers and their patients, and we are excited to welcome Tapemark's customers to LTS' global network. The acquisition strengthens our R&D capabilities in North America, allowing us to bring ever more innovation and development support to players developing innovative therapies and new drug delivery systems. With that, we're even better positioned to address our customers' desire for a single partner to support them from feasibility through commercialization.
We are particularly pleased that such a talented team is joining our organization. I am delighted that Beau Garrett will be strengthening our Global Leadership Team in the role of SVP Strategy and Corporate Development. His track record as a leader successfully driving growth will bolster our LTS Growth Journey."
"Joining LTS strengthens our ability to craft the best product development and manufacturing strategy to deliver complex drugs for our customers who ultimately bring these to market and help patients around the world. Having spoken to our customers, I know they are excited to benefit from the breadth of LTS's global technology portfolio, its product development capabilities, and the vast global network. Together, we will reach more pharmaceutical partners and ultimately help more patients. Personally, I am pleased our executive team is joining such a strong team at LTS. From the day I met Bas and several of the senior leaders at LTS, I knew this was the right fit for both companies, our employees, and our customers."
Beau Garrett, CEO of Tapemark
The transaction has obtained the necessary regulatory approvals and has closed as of August 19, 2022. Financial details of the transaction are not disclosed. Bourne Partners served as the exclusive financial advisor to Tapemark.
About LTS
LTS LOHMANN Therapie-Systeme AG is a leading pharmaceutical technology company that develops and manufactures innovative drug delivery systems such as Transdermal Patches and Oral Thin Films for the pharmaceutical industry. LTS maintains its leading position through the continuous refinement of its core TTS and OTF technologies and by advancing emerging drug delivery technologies, including Micro Array Patches for the transdermal delivery of large molecule, biological actives and vaccines. Founded in 1984, LTS operates today from three sites: in Andernach, Germany, West Caldwell, NJ, USA and St. Paul, MN, USA. LTS has also a representative office in Shanghai, China.
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