Pharmaceutical Technology Editors

The United States Department of Justice announced on Feb. 9, 2021 that Fresenius Kabi Oncology Limited (FKOL), an oncology drug manufacturer, has agreed to plead guilty to concealing and destroying records preceding a 2013 FDA plant inspection and pay $50 million in fines and forfeiture.

According to a Department of Justice press release, court documents showed FKOL owned a manufacturing plant in Kalyani, West Bengal, India, that produced active pharmaceutical ingredients used in cancer drug products distributed to the US. Prior to a January 2013 FDA inspection of the facility, the documents report that FKOL plant management asked employees to remove specific records from the property and delete other records from computers that showed FKOL was manufacturing drug ingredients in violation of FDA requirements. Employees removed computers, hardcopy documents, and other materials and deleted spreadsheets that showed the plant’s violations, the press release said.

FKOL has pleaded guilty to violating the Federal Food, Drug, and Cosmetic Act by failing to provide certain records to FDA investigators and will pay a criminal fine of $30 million, and forfeit an additional $20 million, according to the press release. FKOL will also establish a compliance and ethics program for the prevention, detection, and correction of violations of US law in relation to the company’s manufacturing of cancer drugs for terminally ill patients.

“By hiding and deleting manufacturing records, FKOL sought to obstruct the FDA’s regulatory authority and prevent the FDA from doing its job of ensuring the purity and potency of drugs intended for US consumers,” said Acting Assistant Attorney General Brian Boynton of the Justice Department’s Civil Division, in the press release. “FKOL’s conduct put vulnerable patients at risk. The Department of Justice will continue to work with FDA to prosecute drug manufacturers who obstruct these inspections.”

“Pharmaceutical companies that obstruct FDA inspections jeopardize patient safety,” said US Attorney Nicholas A. Trutanich for the District of Nevada, in the press release. “Maintaining the integrity of records and data is a critical part of drug manufacturing, and our office will continue prosecuting those that obstruct FDA inspections by destroying records or other means.”

“FDA inspections of pharmaceutical manufacturing facilities help ensure the strength, quality, and purity of our medicines. Any attempt to obstruct or interfere with these inspections threatens the public health,” added Judy McMeekin, associate commissioner for Regulatory Affairs of the FDA. “We will continue to aggressively investigate and present any such obstruction for prosecution.”

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The company has pleaded guilty to violating the Federal Food, Drug and Cosmetic Act by failing to provide certain records to FDA investigators and will pay a criminal fine of $30 million, and forfeit an additional $20 million.

Fresenius Kabi Oncology Pleads Guilty to Concealing and Destroying Records Prior to FDA Inspection

Bristol Myers Squibb and Molecular Templates (MTEM), a US-based clinical-stagebiologic therapeutics company, announced on Feb. 11, 2021 that they have entered into a research collaboration to discover and develop multiple novel therapies designed for specific oncology targets.

Under the terms of the agreement, Bristol Myers Squibb will provide an upfront payment of $70 million to MTEM, who will also be eligible to receive near-term and development, regulatory, and sales milestone payments of up to $1.3 billion, MTEM said in a company press release. MTEM will handle research activities for the discovery of the next generation of engineered toxin bodies (ETBs) using its ETB platform, while Bristol Myers Squibb will obtain a license to develop and commercialize the ETBs.

“Bristol Myers Squibb is a leading global pharmaceutical company with a strong oncology franchise and a history of innovation, making them an ideal partner for the discovery and development of novel ETBs for the treatment of cancer,” said Eric Poma, PhD, Molecular Templates’ CEO and scientific officer, in the press release. “MTEM is excited to be working with Bristol Myers Squibb to focus on discovering and developing new ETBs against promising oncology targets. This collaboration provides further validation of our ETB platform while we continue to advance our wholly-owned product pipeline to offer promising therapeutic options for patients.”

MTEM will handle research activities for the discovery of the next generation of engineered toxin bodies using its ETB platform, while Bristol Myers Squibb will obtain a license to develop and commercialize the ETBs.

Bristol Myers Squibb and Molecular Templates Form $1.37-Billion R&D Collaboration

According to a Feb. 8, 2021 press release, 4D pharma has signed a clinical trial collaboration and supply agreement with Merck and Pfizer for Bavencio (avelumab)—an immunotherapy approved as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma.

4D pharma expects to commence clinical trials evaluating the combination of Bavencio—which is co-developed and co-commercialized by Merck and Pfizer—with its single strain live biotherapeutic product, MRx0518 in 2021. The aim of the clinical trial will be to evaluate the combination therapy as a first-line maintenance therapy for patients with local advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy.

“With this second clinical trial collaboration for MRx0518 with a leading immune checkpoint inhibitor, 4D is able to evaluate MRx0518 in a new combination and earlier treatment setting. Following the promising data already generated in combination with checkpoint inhibitor pembrolizumab in refractory patients, and MRx0518 monotherapy data demonstrating single agent immuno-modulation presented last year at SITC, this collaboration allows us to continue to build a broad understanding of the safety and efficacy of MRx0518 across a range of solid tumors and stages of disease,” said Duncan Peyton, CEO, 4D pharma, in the press release. “The combination of MRx0518 with BAVENCIO has the potential to further enhance the positive clinical outcomes achieved by BAVENCIO for the significant number of patients in this treatment setting.”

4D pharma has signed a clinical trial collaboration and supply agreement with Merck and Pfizer for Bavencio (avelumab).

4D pharma Signs Clinical Trial Collaboration and Supply Agreement with Merck and Pfizer

In a Feb. 11, 2021 press release, the Cell and Gene Therapy Catapult (CGT Catapult) and Rentschler Biopharma jointly announced that Rentschler Biopharma will establish its manufacturing capability for advanced therapy medicinal products (ATMPs) at the CGT Catapult site in Stevenage, United Kingdom.

As per the terms of the agreement, Rentschler Biopharma, a global contract and development organization (CDMO), will invest in the Stevenage site over the next five years to set up its manufacturing capabilities. These investments will be used to help meet the demand from UK and international researchers for suitable manufacturing capability and the site development is expected to strengthen the UK cell and gene therapy ecosystem.

“We are excited to take this next big step in our evolution and address the growing industry demand for ATMP manufacturing capacity and viral vector supply. With the largest industry cluster for cell and gene therapies outside the [United States], the UK is an ideal location for us to establish our Center of Excellence for cell and gene therapy,” said Dr. Frank Mathias, CEO of Rentschler Biopharma, in the press release. “We look forward to working with the CGT Catapult as we invest in this growing field. They are well established in this important market, enabling us to immediately tap into the organization’s network and utilise the UK’s strong expertise and supply chain in cell and gene therapy manufacturing.”

“We are very pleased that Rentschler Biopharma, a global CDMO, has chosen to build their ATMP capacity in the UK, bringing in their expertise and investment. This will build new capacity to benefit the international ATMP supply chain and meet growing academic and commercial demand across the industry,” added Matthew Durdy, CEO of the CGT Catapult, in the press release. “As more companies from around the globe come to the UK, it demonstrates and enhances the attractiveness of its cell and gene therapy ecosystem as a place to develop new technologies and capabilities.”

Rentschler Biopharma will establish its manufacturing capability for advanced therapy medicinal products at the CGT Catapult site in Stevenage, UK.

Rentschler Biopharma Establishes ATMP Manufacturing Capabilities in the UK

Optibrium, software developer for drug discovery, has raised investment from Kester Capital, a private equity firm, for the development of its business. The investment was announced in a Feb 10, 2021 press release.

Using the funds received from Kester Capital, Optibrium will drive commercial growth and develop new products for the improvement of speed, efficiency, and productivity of drug discovery. Lead products for Optibrium include StarDrop and Cerella. StarDrop is a suite of integrated software for small molecule design, optimization, and data analysis, and the Cerella platform delivers artificial intelligence technology that learns from complex drug discovery data to target high-potential chemical compounds.

“Optibrium is a cutting-edge software business that is driving some of the most exciting developments within computer-aided drug discovery,” said Adam Maidment, managing partner of Kester Capital, in the press release. “We had been tracking the business for some time and were really impressed by the team and the business’ achievements.”

Matt Segall, CEO of Optibrium, added in the press release, “We are delighted to have Kester Capital on board as an investment partner to continue the successful evolution of the business. Kester has extensive experience in the life sciences sector, and we are looking forward to working with them to capitalize on the substantial market opportunities.”

Optibrium, software developer for drug discovery, has raised investment from Kester Capital, a private equity firm, for the development of its business. 

Optibrium Raises Equity to Drive Development of the Business

Nanoparticle medicine enabling company, Nanoform, and clinical-stage biotech company, Herantis, have signed a biologics proof of concept agreement for formulation proof of concept projects (PoCs) aimed at improving nasal drug delivery to the brain.

The non-exclusive agreement is specifically pertaining to the enhancement of nasal delivery of Herantis’ cerebral dopamine neurotrophic factor (CDNF) therapies for Parkinson’s disease using Nanoform’s biological nanoparticle technology. Under the terms of the agreement, Nanoform will perform formulation PoCs on Herantis’ CDNF molecules for compensation on standard commercial terms.

“We are delighted to finalize the agreement with Herantis and initiate our partnership together. Brain delivery for biologicals and small molecules is a hugely challenging route of administration and we firmly believe nanoparticles have a key role to play in enhancing and hopefully enabling this,” said Christian Jones, chief commercial officer of Nanoform, in a Feb. 9, 2021 press release. “Since the launch of our Biologics nanoparticle technology platform, we have experienced a high level of interest from the industry in exploring how our nanoparticles can potentially enable drug delivery opportunities and solve challenges in this space and we look forward to onboarding further partners both on the biologics and small molecules side.”

“Intranasal delivery of CDNF is a key focus for Herantis. One of our important initiatives in this regard is the work with Nanoform to enhance and enable superior formulations of the pioneering new drugs we have developed and is a key and exciting opportunity for Herantis,” added Dr. Craig Cook, CEO of Herantis Pharma, in the press release. “Initiating this PoC formulation work is a solid start to 2021 and we look forward to evaluating Nanoform’s technologies to explore the potential enhancements of the drug delivery applications in this complex and challenging field. It is our hope that this collaboration will open up new possibilities for improving the lives of patients with Parkinson’s and other related diseases.”

Nanoform and Herantis have signed a biologics proof of concept agreement for formulation proof of concept projects aimed at improving nasal drug delivery to the brain.