Pharmaceutical Technology Editors

Quotient Sciences, a UK-based drug development and manufacturing accelerator, announced on Feb. 9, 2021 that it has acquired Arcinova, a UK-based multiservice contract development and manufacturing organization. The acquisition expands Quotient’s service portfolio and will enable the integration of drug substance, drug product, and clinical testing capabilities under one organization.

The integration of capabilities is expected to further simply and accelerate outsourced development programs, the company stated in a press release. Under the deal, Arcinova’s minority equity partner, BGF, will exit the business.

“I’d like to congratulate the Arcinova team on building an exciting business, and I am thrilled to be joining forces. Both businesses are similar in culture and aspire to help customers accelerate molecules from candidate selection through development and on to commercial launch,” said Mark Egerton, PhD, CEO of Quotient Sciences, in the company press release. “I’d also like to take this moment to thank our private equity partner, Permira, for supporting our ambitious growth plans.”

“Since inception, we set out to build a unique organization that accelerates the development of new medicines for patients in need. We are delighted to move on to the next stage with Quotient as the perfect partner for Arcinova. Deep science, agility, flexibility, and the drive for customer service excellence are the cornerstones of both businesses. I look forward to working with the Quotient team and Permira to deliver even greater value for our customers,” said Professor Ian Shott, co-founder and executive chairman of Arcinova, in the press release.

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The acquisition will integrate drug substance, drug product, and clinical testing capabilities under Quotient.

Quotient Sciences Acquires CDMO Arcinova

Charles River Laboratories announced on Feb. 17, 2021 that it has acquired Cognate BioServices, a cell and gene therapy contract development and manufacturing organization (CDMO), for $875 million in cash.

The acquisition will allow Charles River to expand its cell and gene therapy development, testing, and manufacturing capabilities, while adding to its existing portfolio of non-clinical capabilities in order to offer clients integrated solutions from basic research and discovery through to CGMP production, Charles River said in a company press release. The deal is expected close during the first quarter of 2021.

“Cognate BioServices presents a unique opportunity to expand into a high-growth, value-added sector of the CDMO market and enhance our ability to meet our clients’ needs in emerging areas of scientific innovation,” said James C. Foster, chairman, president, and CEO of Charles River Laboratories, in the press release. “This acquisition will be an exceptional strategic fit, adding to our comprehensive suite of early stage research and manufacturing support solutions and enabling us to achieve our goal of establishing a single scientific partner to provide biopharmaceutical clients with an integrated solution to help accelerate their cell and gene therapy programs from discovery and non-clinical development through commercialization.”

The acquisition will allow Charles River to expand its cell and gene therapy development, testing, and manufacturing capabilities, while adding to its existing portfolio of non-clinical capabilities.

Charles River to Acquire Cognate BioServices for $875 Million

Novartis announced on Feb. 17, 2021 that it has entered into an agreement with the Bill & Melinda Gates Foundation under which the foundation will provide funding support for the discovery and development of a single-administration, 

 gene therapy to cure sickle cell disease (SCD), a hereditary blood disease.

Through the agreement, Novartis plans to develop an accessible 

 gene therapy to be administered one time, directly to the patient, without modifying the cells in a lab, which will potentially lessen the need for long or repeated hospital stays, Novartis said in a company press release. The Gates Foundation will provide funding support for a research team, while Novartis will offer up in-kind support and access to its suite of technologies and resources.

“Gene therapies might help end the threat of diseases like sickle cell, but only if we can make them far more affordable and practical for low-resource settings,” said Trevor Mundel, president of Global Health at the Gates Foundation, in the press release. “What’s exciting about this project is that it brings ambitious science to bear on that challenge. It’s about treating the needs of people in lower-income countries as a driver of scientific and medical progress, not an afterthought. It also holds the promise of applying lessons learned to help develop potentially curative options for other debilitating diseases affecting low-income populations, such as HIV.”

“Novartis is proud to lead this effort to find an accessible genetic therapy for sickle cell disease, with support from the Bill & Melinda Gates Foundation,” added Lutz Hegemann, group head of Corporate Affairs and Global Health for Novartis, in the press release. “In keeping with our purpose, we firmly believe we can use science and innovation to reimagine the way SCD is treated for patients around the world.”

The foundation will provide funding support for the discovery and development of a single-administration, in-vivo gene therapy to cure sickle cell disease, a hereditary blood disease.

Novartis and the Bill & Melinda Gates Foundation Team Up to Develop Gene Therapy for Sickle Cell Disease

The European Medicines Agency (EMA) announced that concerns regarding products containing amfepramone have been raised after its Pharmacovigilance Risk Assessment Committee (PRAC)

reviewed the periodic safety update report for amfepramone. The agency stated in a press release that these concerns—which include heart problems, high blood pressure in the lungs, longer than recommended use, using more than the recommended dose, and use during pregnancy—require further evaluation. The announcement came after PRAC’s February meeting held Feb. 8–11, 2021.

In some European Union countries, medicines containing amfepramone are used to treat obesity in patients that have not been able to reduce their weight with other methods. Because of the safety concerns the Romanian medicines agency has requested a review of these products.

EMA also announced in the press release that PRAC concluded its review of reports of acute kidney injury in patients with COVID-19 treated with Veklury (remdesivir) and found “there is no evidence indicating that the reported kidney problems are associated with the use of Veklury.” The agency said it will continue to monitor the risk of kidney injury. PRAC also is reviewing a safety signal raised by the Italian Medicines Agency regarding 11 cases of sinus bradycardia in patients treated with Veklury.

The European Medicines Agency announced it has started a review of drugs that contain amfepramone due to concerns that include heart problems and high blood pressure in the lungs.

EMA Reviews Amfepramone Medicines

 that gives recommendations to health care providers and investigators on the use of COVID-19 convalescent plasma or investigational convalescent plasma. Recommendations are also provided regarding blood collection.The document also discusses the agency’s interim compliance and enforcement policy for investigational new drug requirements for the use of investigational convalescent plasma.

The new guidance, which supersedes guidance issued in January 2021 and previous versions, includes revised recommendations for convalescent plasma donors. “The revisions address when individuals who have received an investigational COVID-19 monoclonal antibody therapy as a participant in a clinical trial, or received an authorized or licensed COVID-19 monoclonal antibody therapy, qualify as convalescent plasma donors,” the guidance states.

Recommendations for qualification and labeling of high titer COVID-19 convalescent plasma under the Emergency Use Authorization have also been revised. The guidance was also updated to “note that FDA intends to exercise enforcement discretion related to the investigational new drug requirements for use of convalescent plasma including when, among other circumstances, the donor meets the qualifications for individuals who have received a COVID-19 vaccine or COVID-19 monoclonal antibody therapy in accordance with section III.B.1 of this guidance.”

FDA published recommendations on the use of COVID-19 convalescent plasma or investigational convalescent plasma during the pandemic.

Guidance Issued on Investigational COVID-19 Convalescent Plasma

The European Commission (EC) has granted marketing authorization to Celltrion Healthcare for its adalimumab biosimilar, Yuflyma (CT-P17), for all 13 intended indications for the treatment of multiple chronic inflammatory diseases.

Celltrion Healthcare revealed the authorization notice in a Feb. 15, 2021 press release, in which the company stated that the approval had been based on the results of analytical, preclinical, and clinical studies that demonstrated that Yuflyma is comparable with adalimumab. The EC’s approval follows the recommendation for marketing authorization that had been issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), which was issued in December 2020.

“In Europe, according to IQVIA data, 60% of the whole adalimumab market has been taken by high concentration formulation and over 90% of the original adalimumab market has already been replaced with a high concentration version. With high concentration, low-volume, and consequently less pain, adalimumab can improve treatment adherence at the very least. Therefore, we focused on development of a high concentration biosimilar to provide a significant alternative to the adalimumab treatment category,” said Dr. HoUng Kim, head of Medical and Marketing Division at Celltrion Healthcare, in the press release. “In terms of the administration device, we have looked to ensure improved convenience for patients as well as providers with the inclusion of needle size (29G), latex-free to reduce allergy risk, and a long storage period or shelf life at room temperature for 30 days.”

Professor Rieke Alten, head of the Department of Internal Medicine, Rheumatology, Clinical Immunology, and Osteology at Schlosspark-Klinik, Teaching Hospital of Charité, Berlin, Germany added in the press release, “Over the past two decades, anti-tumor necrosis factor (TNF) biologics have revolutionized the management of chronic immune-mediated inflammatory diseases, but some of the features needed improvement for patients to reach their therapeutic goals. As a physician, we welcome these value-added features such as high concentration and low-volume formulations to reduce injection discomfort.”

The EC has granted marketing authorization to Celltrion Healthcare for its adalimumab biosimilar, Yuflyma (CT-P17).