PHARMA TECH

LEO Pharma and Veeva Systems Partner for Digital Patient-Centered Trials

LEO Pharma | September 30, 2021

LEO Pharma , a global leader in medical dermatology, and Veeva Systems announced a strategic technology partnership to enable scalable digital trials, paperless and patient-centered.

Building on its success with the Veeva Clinical Operations suite, LEO Pharma will complete its standardization on existing Veeva clinical technology, be an early adopter of future Veeva solutions, and help shape the Veeva digital trials roadmap. By adopting technology and optimized business processes, LEO Pharma plans to achieve the following goals while maintaining the highest standards in data accuracy, regulatory compliance and patient safety:
  • Significant improvement in the patient experience
  • Increased patient diversity through decentralized trials
  • Greater precision of clinical data
  • 25% reduction in the cost of clinical trials
  • 25% reduction in clinical trial time

LEO Pharma will use the integrated suite of Veeva clinical products, including eTMF, CTMS, CDMS, Site Connect, eConsent, ePRO, Virtual Visits and eSource.

We were exploring ways to transform clinical trials, but COVID-19 has accelerated this process. By responding quickly to changing market dynamics, we allowed our testing to continue without delay. The partnership with Veeva supports our 2030 strategy because it will help us deliver innovative treatments to patients faster while supporting a more sustainable business. Veeva's results in terms of product excellence make it the ideal long-term partner to help us achieve this goal, which allows us to help patients better and faster. 

- Jörg Möller, Executive Vice President and Head of R&D at LEO Pharma.

We are excited and honored to extend our long-standing partnership with LEO Pharma to be an early adopter of our comprehensive digital testing platform, We intend to help the industry move forward with a scalable digital trials platform that dramatically improves the clinical trial process for patients, sites and sponsors. 

- Peter Gassner , Founder and CEO of Veeva

About Veeva Systems
Veeva is the global leader in cloud software for the life sciences industry. Committed to innovation, product excellence and customer success, Veeva has more than 1,000 customers, from the world's largest pharmaceutical companies to emerging biotechnology companies. As a public benefit company, Veeva is committed to balancing the interests of all stakeholders, including customers, employees, shareholders and the industries it serves.

About LEO Pharma
LEO Pharma helps people achieve healthy skin. The company is a leader in the field of medical dermatology, with a strong R&D portfolio, a wide range of therapies and a pioneering spirit. Founded in 1908 and majority-owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advancing the science of dermatology, setting new standards of care for people with skin diseases. LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 93 million patients in 130 countries. In 2020, the company achieved net sales of 1,359 million euros.

Spotlight

The cost of developing a new drug can be as much as $11 billion. With these high costs, the mature pharma markets are stagnating. There is, however, an opportunity with emerging markets. Over the next five years, emerging markets will make up two-thirds of sales growth in the pharmaceutical industry.

Spotlight

The cost of developing a new drug can be as much as $11 billion. With these high costs, the mature pharma markets are stagnating. There is, however, an opportunity with emerging markets. Over the next five years, emerging markets will make up two-thirds of sales growth in the pharmaceutical industry.

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PHARMACY MARKET

Eyenovia's Novel Optejet® Dispenser Puts People's Eyes First

Eyenovia | September 06, 2022

Eyenovia, Inc. an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics, brings human-centric design to ophthalmology with its novel Optejet® dispenser. Traditional eye drops normally overdose the patient's eye with medication and preservatives. Eyenovia's easy-to-use, novel Optejet® dispenser administers precisely 8µL of medication to the eye, effectively treating the patient's condition while creating a more gentle dosing experience. "The unique delivery mechanism of the Optejet® will fundamentally change how we think about eye medication. Right now, traditional eye drops can result in significant dose-related side effects for the treatment of chronic illnesses like glaucoma. The Optejet® dispenser is designed for patients to experience easier administration and fewer side effects with similar efficacy." Michael Rowe, CEO of Eyenovia The Optejet® dispenser administers ophthalmic solutions horizontally using Eyenovia's proprietary Microdose Array Print (MAP™) technology. The system functions similar to an inkjet printer, delivering accurate microdoses through a precision spray. Traditional eye drops deliver four to five times larger volume than the human eye can actually hold, which causes eye drops to roll down the face and overdose the eye with preservatives. Poor delivery of eye drops is more than an inconvenience; it can prevent patients from using necessary medication because of the side effects. For example, with medication to help dilate the pupils for eye exams, up to 23% of patients experienced stinging and burning with the eye drops, causing patients to forgo eye exams. In Eyenovia studies, less than 1% of patients experienced stinging and burning. "Medications only work if patients take them, and with the Optejet, we have designed a way for patients to benefit from an easy-to-use, appropriate, lower dose spray that results in similar efficacy. We're excited for physicians and providers to be able to offer this revolutionary technology in the near future to patients who deserve a more positive experience," said Rowe. Eyenovia's first marketed invention is expected to be MydCombi™, a first-in-class drug-device combination microdose for in-office pupil dilation. This potentially will help save physician's chair time, eliminating the traditional three eyedrops used for a patient's eye exam. Other exciting innovations in the Eyenovia pipeline include MicroLine and MicroPine. About Eyenovia, Inc. Eyenovia, Inc. is an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics. Eyenovia is currently focused on the late-stage development of microdosed medications for mydriasis, presbyopia, and myopia progression.

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BUSINESS INSIGHTS

TFF Pharmaceuticals Expands R&D Operations with New Austin Facility

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 to Acquire Metrics Contract Services for $475 Million to Expand High-Potent Capabilities and Oral Development and Manufacturing Capacity

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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