Pharmaceutical Technology Editors

Catalent announced on March 22, 2021 that it has entered into an agreement with Cybin, a Canadian biotech company focused on psychedelic therapeutics, to use Catalent’s Zydis orally disintegrating tablet (ODT) technology for the delivery of Cybin’s novel deuterated tryptamine, CYB003, a potential therapy for treatment-resistant psychiatric disorders.

Catalent’s Zydis technology formulates a freeze-dried tablet that dissolves in the mouth without water, allowing for pre-gastric delivery of CYB003 and the prevention of first pass metabolism, thus improving the pharmacokinetic profile of the drug, Catalent said in a company press release. Due to begin in April 2021, the agreement will include feasibility studies for the manufacturing and analytical testing of ODT doses containing varying amounts of CYB003, alongside different excipients.

“We look forward to working with Cybin to potentially develop a novel and fast-acting therapy for treatment-resistant psychiatric disorders,” said Jonathan Arnold, president of Oral and Specialty Delivery at Catalent, in the press release. “The Zydis platform is an ideal technology to leverage for this type of drug formulation, as pre-gastric absorption is crucial for efficacy.”

“We are excited to partner with the team at Catalent with the aim of developing fast-acting, shorter-duration formulations of CYB003, recently acquired as part of our acquisition of Adelia Therapeutics,” added Doug Drysdale, Cybin’s CEO, in the press release. “Our focus on reducing the need for health system resources, such as in-clinic therapist time, is an important part of our goal to create scalable, more accessible treatments for mental health disorders.”

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Cybin will use Catalent’s Zydis orally disintegrating tablet technology for the delivery of its novel deuterated tryptamine, CYB003, a potential therapy for treatment-resistant psychiatric disorders. 

Catalent to Partner with Cybin for Fast-Dissolve Formulation of Psychiatric Disorders Treatment

Evotec and Takeda announced on March 22, 2021 that they have entered into a multi-RNA target alliance to discover and develop RNA-targeting small-molecule therapeutics for targets that are difficult to address with more typical approaches.

Through the agreement, Evotec will receive research funding along with discovery, pre-clinical, clinical, commercial, and sales milestone payments of up to $160 million per program, Evotec said in a company press release. Evotec will also be entitled to tiered royalties on the net sales of any products from the collaboration.

The companies will work together to identify and develop small molecules using Evotec’s RNA-targeting platform to classify RNA sequences with small molecule ligands that can be developed into potential first-in-class therapeutics, according to the press release.

“Many highly validated targets have proven to be intractable via conventional protein targeting approaches. For this reason, Evotec has been pioneering RNA-targeting strategies and approaches for quite some time,” said Cord Dohrmann, chief scientific officer, Evotec, in the press release. “We are very excited about the opportunity to collaborate with Takeda in this field as both companies share the vision to jointly develop small-molecule therapeutics against high-value RNA targets that will deliver long awaited therapeutics.”

“Takeda recognizes targeting RNA with small molecules as a promising new modality that has tremendous potential for much needed medicines for patients through modulating historically undruggable targets,” added Larry Hamann, head, Drug Discovery Sciences, Takeda, in the press release. “We are excited to be working with Evotec and their impressive capabilities.”

The companies will work to discover and develop RNA-targeting small-molecule therapeutics for difficult-to-address indications.

Evotec and Takeda Enter into Multi-RNA Target Alliance

Fujifilm announced on March 19, 2021 that it has selected Holly Springs, NC, as the location for its new $2-billion North American large-scale cell culture production site.

The new facility, which is expected to be operational by spring 2025, will feature 8 x 20,000-L bioreactors with the potential to add further 24 x 20,000-L bioreactors based on market demand, Fujifilm said in a company press release. The facility will also offer commercial scale, automated fill-finish and assembly, packaging, and labeling services.

“Holly Springs, North Carolina is a suitable location for us, as it is one of the most active communities in the [United States] in addressing environmental and social issues,” said Kenji Sukeno, president of Fujifilm, in the press release. “Fujifilm will contribute to realizing a sustainable society by collaborating with the Holly Springs community and stimulating the local economy. The new site is strategically important to accelerate the growth of our bio CDMO [contract development and manufacturing organization] business.”

“We are passionate about the tremendous value that this new facility will bring to our partners in producing life-impacting therapies. To build what will be the largest end-to-end cell culture CDMO facility in North America requires commitment and partnership. We are delighted to have received the strong support from the town of Holly Springs and the state of North Carolina. This is building for the future, both in infrastructure and in talent, as part of the vibrant North Carolina biotech hub,” added Martin Meeson, CEO of Fujifilm Diosynth Biotechnologies, in the press release.

The new facility, which is expected to be operational by spring 2025, will feature 8 x 20,000-L bioreactors with the potential to add further 24 x 20,000-L bioreactors based on market demand.

Fujifilm Chooses North Carolina for New $2-Billion Cell Culture Facility

The Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom and the European Medicines Agency (EMA) have confirmed that the benefits of the AstraZeneca COVID-19 vaccine continue to outweigh the risk of side effects.

After a scientific review, MHRA concluded that there was no evidence of blood clots in veins occurring more than would be expected in the absence of vaccination. EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has also concluded that there is no increased overall risk of blood clots with the AstraZeneca COVID-19 vaccine. A causal link between thromboembolic events and the vaccine has not been established and is not proven.

In a March 18, 2021 press release, AstraZeneca confirmed that it will continue to work closely with regulators to ensure the COVID-19 vaccine is used appropriately and will implement the recommendations of PRAC, which include updated product information. Additionally, the company has stated it will continue to work on the understanding behind the nature and relevance of the thromboembolic events to ensure the safe delivery of the vaccine continues.

“Vaccine safety is paramount and we welcome the regulators’ decisions which affirm the overwhelming benefit of our vaccine in stopping the pandemic,” said Ann Taylor, chief medical officer, in the press release. “We trust that, after the regulators’ careful decisions, vaccinations can once again resume across Europe.”

MHRA and EMA have confirmed that the benefits of the AstraZeneca COVID-19 vaccine continue to outweigh the risk of side effects.

Regulators Confirm Benefits of AstraZeneca Vaccine Outweigh Risks

Hovione has successfully completed the Phase II clinical trial of its ophthalmic formulation of minocycline, Meizuvo, aimed at the treatment of dry eye caused by Meibomian Gland Dysfunction (MGD). The company announced the trial completion at the Ophthalmology Innovation Summit Dry Eye Showcase.

Meizuvo is the first ophthalmic formulation of minocycline in clinical development and targets MGD patients with ocular inflammation demonstrated by an MMP-9 based diagnostic. The Phase II trial, which included 270 patients across 26 clinical sites, assessed two different strengths of minocycline against vehicle in a 1:1:1 randomization.

The trial results demonstrated a statistically significant improvement in the Visual Analogue Scale (VAS) discomfort greater than 50% by the end of treatment for more than two thirds (70%) of patients with positive inflammatory biomarker at baseline. Additionally, a statistically significant improvement in inferior Cornea Fluorescein Staining was seen with both treatment arms versus vehicle at day 57. The product was found to be safe and well-tolerated with less than 3% of patients reporting blurring vision or eye irritation.

“The correlation between the patients with a positive MMP-9 assay at baseline and the clinical improvement observed in both signs and symptoms of dry-eye was groundbreaking,” said Carla Vozone, vice-president of the innovative proprietary portfolio at Hovione in a March 17, 2021 press release.

“We were thrilled with the opportunity to work on this exciting project. Minocycline is a well-known molecule for ophthalmologists and there is significant excitement from the ophthalmology community regarding the potential for a topical alternative,” added George Magrath, CEO of Lexitas Pharma Services, in the press release. “The results in the overall population were encouraging in both signs and symptoms. The results in the inflamed group of subjects were impressive with consistent statistically significant results in key dry eye signs and symptoms.”

Hovione has successfully completed the Phase II clinical trial of its ophthalmic formulation of minocycline, Meizuvo.

Hovione Successfully Completes Phase II Trial of Minocycline Ophthalmic

Romaco, supplier of processing and packaging equipment, has acquired STE Tecpharm, S. L., a Spanish manufacturer of processing technology. The acquisition was announced in a March 18, 2021 press release.

Following the transaction, Tecpharm, which employs approximately 30 people at its site near Barcelona, Spain, will operate as an independent business unit of Romaco Group. The acquisition is expected to strengthen Romaco’s position as a turnkey supplier of processing technologies.

“With the takeover of Tecpharm and its patented high-tech tablet coating machines, we can decisively expand our portfolio,” said Jörg Pieper, CEO, Romaco Group, in the press release. “Tecpharm manufactures drum coaters that embody economic efficiency, reliability, and batch flexibility—and therefore perfectly fits the products and quality standards of Innojet and Kilian. This new constellation creates valuable synergistic effects, which we intend to leverage systematically in order to offer our customers state-of-the-art processing solutions.”

“I regard the exit to Romaco as a milestone in our relatively young company history,” added David Mateo, managing director of Tecpharm, S. L., in the press release. “Our integration into such a successful global player will create major growth opportunities for Tecpharm. The support we get from Romaco’s worldwide sales and service network will allow us to expand the reach of these products enormously and boost our sales accordingly. Moreover, Romaco is a very decentralised organization, which will ease our integration with our new sister companies at eye level.”

Romaco, supplier of processing and packaging equipment, has acquired STE Tecpharm, S. L., a Spanish manufacturer of processing technology. 