Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Felicity Thomas

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On Feb 1, 2024, AbbVie announced that the United Kingdom’s National Institute for Health and Care Excellence (NICE) has recommended Tepkinly (epcoritamab) as a treatment option for eligible adults with diffuse large B-cell lymphoma (DLBCL).

The recommendation, which was based on data from a single-arm Phase I/II clinical trial, is that the subcutaneous therapy be used in adults with DLBCL whose cancer has either returned or has not responded to two or more lines of systemic therapy. Epcoritamab is a bispecific antibody that has been designed to attach simultaneously to two different cells—an immune T cell and a cancerous lymphoma cell. Once brought together by the bispecific antibody, the immune T cell is activated to destroy the cancerous cell.

“DLBCL is a type of blood cancer, and while most people go into remission after standard treatment, some people can see their cancer return. Like many that experience blood cancer, people with relapsed or refractory DLBCL experience anxiety around the prospect of not responding to treatment or the cancer once again returning,” said Rincy George, policy officer at Blood Cancer UK, in the press release. “Epcoritamab (Tepkinly) is an injectable bispecific antibody designed to recognise and attach to the cancer cells and immune cells, so that the body’s immune system can destroy them. [This] decision from NICE approving epcoritamab for eligible patients for use on the NHS [National Health Service] in England and Wales is a welcome step for many.”

“Despite recent therapeutic advances, treatment options for this hard-to-treat group of patients have been limited. This can mean many patients do not have suitably effective treatment options, resulting in a poor prognosis,” added Chris Fox, professor of Haematology, School of Medicine, University of Nottingham and Honorary Consultant Haematologist, Nottingham University Hospitals NHS Trust, in the press release. “Today’s decision by NICE on epcoritamab provides physicians with a second bispecific antibody as a treatment option for eligible patients with relapsed or refractory diffuse large B cell lymphoma after two or more lines of therapy.”

“AbbVie is committed to advancing care for people living with blood cancer,” stated Belinda Byrne, medical director, AbbVie UK, in the press release. “We are delighted that NICE has recognized the benefit that epcoritamab can have on the lives of people living with R/R [relapsed/refractory] DLBCL. We will continue working closely with the relevant authorities to provide equitable access across the UK for eligible R/R DLBCL patients in need.”

Articles

NICE has recommended the use of AbbVie's Tepkinly as a treatment option for eligible adults with diffuse large B-cell lymphoma.

AbbVie Gains Nod from NICE for Tepkinly

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ProductLife Group (PLG), a specialized provider of regulatory, scientific, quality, and digital transformation consulting services for the life sciences industry, announced in a Feb. 1, 2024 press release its acquisition of Australian company Commercial Eyes.

Commercial Eyes is a pharmaceutical and medical device commercialization company that specializes in regulatory affairs, pharmacovigilance, medical information, quality assurance, market access, market research, and patient programs. Through the acquisition, PLG will be able to combine its global presence and expertise with the regional knowledge and capabilities of Commercial Eyes to be able to deliver enhanced services and solutions to clients.

“Joining PLG is a major strategic move for Commercial Eyes, our people, and our clients. We will leverage the platform we have created over the last 22 years to expand our footprint globally,” said Andrew Carter, founder and managing director of Commercial Eyes in the press release. “This [expansion] will create significant professional development opportunities for our team members and enable us to better support our clients with global coverage of end-to-end life sciences consulting services.”

“This merger not only enables us to broaden our geographical footprint and expand our offerings to global markets but also empowers us to better serve our clients throughout their market and patient access strategy. The acquisition of Commercial Eyes marks an exciting new chapter in our journey. Together, we possess the collective strength, expertise, and passion to drive positive change and shape the future of the life sciences industry,” added Xavier Duburcq, CEO of PLG in the press release. “Our two companies share similar values: pioneering the way for innovation, client satisfaction, team spirit and a unique sense of purpose for life sciences. This common set of values forms a solid foundation for the seamless integration of the two organizations.”

ProductLife Group has announced its acquisition of Australian company Commercial Eyes.

Latest Acquisition Sees ProductLife Group Expand its Asia-Pacific Footprint

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Prior to COVID-19, mergers and acquisitions (M&A) activity within the biopharma industry was booming, managing to reach an all-time high level of US$414 billion (€384 billion) worth of deals in 2019 (1). When the pandemic hit, not only did company priorities shift to working on solutions to help prevent or even cure COVID-19 but there were also lockdowns and the need to work remotely, which has impacted the timings of potential deals.

However, in 2023, the industry rebounded somewhat in terms of M&A activity with deals reaching their highest level since 2019 at approximately US$152 billion (€141 billion) (2). During 2023, there was one ‘mega-deal’ in the form of Pfizer’s acquisition of Seagen, which was worth US$43 billion (€40 billion) alone, the next highest deal was worth US$14 billion (€13 billion) for Bristol Myers Squibb’s acquisition of Karuna Therapeutics (2).

This positive upswing, representing a 79% increase from the prior year (2022), seems to be continuing into 2024. In fact, on 5 Feb. 2024, Novo Holdings’ acquisition of Catalent for US$16.5 billion (€15.3 billion) was announced (3). Under the terms of this agreement, Novo will acquire Catalent in an all-cash transaction that is expected to close towards the end of 2024. Additionally, Novo has specified that it will sell three of Catalent’s fill/finish sites, with related assets, located in Anagni (Italy), Bloomington (Indiana, USA), and Brussels (Belgium) to Novo Nordisk.

Also, on 5 Feb. 2024, European industry giant, Novartis, revealed its plans to acquire German biopharmaceutical company focused on oncology medicines, MorphoSys, for €2.7 billion in cash (4). Once Novartis has acquired MorphoSys, it will own pelabresib—a late-stage oncology therapy designed to inhibit the function of bromodomain and extra-terminal domain (BET) proteins—which will complement Novartis’ oncology pipeline.

Good M&A deals can provide companies with substantial growth opportunities and given the current macroeconomic, pricing, and regulatory risks; inorganic growth will be depended upon. Add the looming ‘patent cliff’ to the mix and a surge in M&A activity seems a no-brainer for the near future (5).

1. Saikia, R. Is COVID-19 Changing the Rules of the Game for Biopharmaceuticals M&A? 

, Expert Briefing, January 2021.
2. Gores, M.; Harries, W. Biopharma M&A Outlook for 2024. 

, Blog, 12 Jan. 2024.
3. Catalent. Novo Holdings to Acquire Catalent. Press Release, 5 Feb. 2024.
4. Novartis. Novartis to Strengthen Oncology Pipeline with Agreement to Acquire MorphoSys AG for EUR 68 per Share or an Aggregate of EUR 2.7 bn in Cash. Press Release, 5 Feb. 2024.
5. Spence, P.; Baral, S.; Ural, A.; Boodhoo, A.; Evans, J. 

Life Sciences Deals are Back—Making the Right Deals in a Time of Change

. 2024 EY M&A Firepower Report, 8 Jan. 2024.

Felicity Thomas is the European/senior editor for Pharmaceutical Technology Group.

When referring to this article, please cite it as Thomas, F. On the Up and Up. 

The industry’s M&A activity is on the up and expected to continue to rise in 2024.

On the Up and Up

Agilent Technologies has revealed in a Jan. 30, 2024 press release that it has entered into an agreement with Incyte for the development of companion diagnostics (CDx) programs to support Incyte’s hematology and oncology portfolio.

According to the press release, the agreement will allow both companies to work together on CDx development programs, enabling Agilent to continue to expand its companion diagnostics portfolio with novel biomarkers while also allowing Incyte to leverage Agilent’s expertise across a range of functions to support clinical trials. Additionally, Incyte will take advantage of Agilent’s experience to achieve potential registration and commercialization of CDx in both the United States and Europe.

“Leveraging the power of companion diagnostics, we are strategically transforming the treatment paradigm for a broad spectrum of cancers,” said Paul Beresford, vice president and general manager of Agilent’s Companion Diagnostics Division, in the press release. “By working together, Agilent and Incyte hope to expedite the development of innovative precision medicine products, potentially paving the way for enhanced patient health outcomes.”

“Agilent’s expertise in the development of companion diagnostics is impressive, as is their regulatory and commercialization record,” added Jeff Jackson, group vice president of Translational Medicine at Incyte, in the press release. “We are excited about the collaboration and look forward to working together to innovate in support of patients.”

Companion diagnostics are used to evaluate expression of biomarkers and can identify patients that are more likely to respond to treatment with targeted therapeutics. As a result of their use and ability to inform treatment decisions, the companion diagnostics market is expected to grow in the near future.

Agilent Technologies and Incyte have signed an agreement to collaborate on the development of companion diagnostics programs.

Agilent and Incyte Collaborate on Development of CDx in Hematology and Oncology

Making the Grade: The Importance of Using the Correct Excipient Grade in Drug Products

In this exclusive Drug Digest video interview, Felicity Thomas, Europe/senior editor, 

Group, interviews a panel of experts from IPEC Americas about excipient grades. During the panel session, Nigel Langley, David Schoneker, Kathy Ulman, Priscilla Zawislak, and Joseph Zeleznik go into detail about the various excipient grades and why the use of the correct grade in pharmaceutical products is important; what ‘testing up’ of an excipient grade is and if it is possible to do so for drug products; where the responsibility lies in ensuring the correct grade of excipient is used in the manufacture of a drug product; if it is possible to use non-compendial grade excipients in drugs; excipient grade considerations in academic research; the importance of FRCs in formulation development; and considerations for companies looking to change excipient provider.

For a list of resources associated with this Drug Digest episode, please click 

Chair, IPEC-Americas
Global Technical Director, Life Sciences, Gaylord Chemical Company LLC

Nigel provides technical support to the pharmaceutical industry and helps solve drug formulation challenges. Prior to joining Gaylord Chemical Nigel has held various senior technical and marketing positions with BASF and Croda International PLC. Nigel has also worked in Japan and England with Croda. He gained his Chemistry (Hons) degree and PhD (liquid crystals) from the University of Hull (UK) and an MBA from Leeds University (UK). He also took a two-year Postdoctoral research position at Leeds University (UK) in natural product synthesis. He has over 100 scientific publications and has co-edited three books. Nigel is an adjunct professor at the University of Mississippi and a Fellow of the Royal Society of Chemistry (UK). In 2018 he was awarded the Industry Research Achievement Award in Excipient Technology by the IPEC Foundation. He has been a member of the Executive Committee at IPEC-Americas since 2010 and is currently Chair.

Executive Committee Member and QbD/Composition Committee Chair, IPEC-Americas
President/Owner, Black Diamond Regulatory Consulting, LLC

David has over 45 years of experience and has developed strong networks with trade associations, regulatory agencies and pharmacopeias around the world.He is also an Adjunct Professor at Temple University's School of Pharmacy in their RA/QA Master's Program teaching courses in Global Excipient Regulations and the Regulation of Dietary Supplements.

Prior to August 2019, David was the Global Regulatory Director—Strategic Relationships at Colorcon, Inc. His responsibilities included global coordination of Colorcon’s worldwide regulatory activities. He was at Colorcon from 1977 until 2019. David was the Chairman of IPEC-Americas during the period 2007-2009 and is currently a member of the Executive Committee, the Chair of the QbD/Composition Committee and is actively involved with the development of Regulatory, Safety, GMP and Supplier Qualification related guidelines to improve Excipient Quality and Safety.

Member/Consultant for IPEC-Americas
Owner and Primary for KLU Consulting, LLC

Katherine retired from Dow Corning Corporation after more than 40 years of employment. While at Dow Corning, she held positions as a global regulatory compliance manager for their Healthcare business as well as regulatory manager of the Dow Corning Healthcare Industries Materials Site. In addition to her regulatory role, she was an associate scientist at Dow Corning where she worked in the development and characterization of pharmaceutical excipient and medical device raw materials/components. Much of her early career was dedicated to the synthesis of novel silicone monomers and polymers/copolymers. Katherine has been a member of the ACS, AAPS, and CRS. She is currently an active member and support staff for IPEC-Americas. She has published and presented several papers in her field, developed and taught a college course in Organosilicone Polymer Chemistry and Technology through SDSM&T, and taught international courses on silicones for pharmaceutical/biomedical applications and medical adhesives through Technomic Publishing Co. Katherine earned her Bachelor of Science degree in chemistry from the South Dakota School of Mines and Technology in 1976.

Chair-Elect, IPEC-Americas
Technical Director, North America IMCD

Joseph has responsibility for product and technology training, conducting customer seminars, and advising with formulation development through excipient and process selection. Joe also collaborates with formulation prototype development, demonstrating IMCD’s product and technology benefits. Joe works closely with IMCD’s many principals to promote product awareness and coordinates joint meetings in those efforts. Joe has contributed to the development of several IPEC Guides and is a member of IPEC-Americas’ Executive Committee, serving as chair for the 2024-2025 term. Prior to joining IMCD US, Joe served as Manager, Technical and Regulatory Affairs with MEGGLE USA, Inc. and Associate Director, R&D with JRS PHARMA.

With a career spanning four decades, his interests are varied and include high-functionality excipient development and application, focusing on CPEs and other novel excipients, powder blending strategies, continuous manufacture, and advancing excipient knowledge.

President, IPEC Federation
Vice Chair, Science and Regulatory Policy, IPEC-Americas
Global Regulatory Affairs Advocacy Manager, IFF

Priscilla has over 35 years’ experience in Regulatory Affairs and Quality for excipients, food additives and ingredients for personal care products. Currently with IFF, she is responsible for regulatory advocacy for excipients, APIs, and food additives. Prior positions include Global Regulatory Affairs Manager for Ashland Specialty Ingredients’ Pharmaceutical and Nutrition business and Quality Manager at FMC Health and Nutrition.

Priscilla is currently President of the IPEC Federation, a global organization consisting of regional IPECs in the US, Europe, China, Japan, and India. She is also the Vice Chair of Science and Regulatory Policy for IPEC-Americas and is also a past Chair of the organization. She has been an active member of IPEC-Americas committees since 2001, is a member of the IPEC Americas Executive Committee and a member of the Board of Directors of EXCiPACT.

Priscilla earned her degrees in Biological Sciences and Chemistry from the University of Delaware.

This episode of Drug Digest is sponsored by:

Drug Digest is a tech talk video series with the 

 editors, who interview industry experts to discuss the emerging opportunities, obstacles, and advances in the pharmaceutical and biopharmaceutical industry for the research, development, formulation, analysis, upstream and downstream processing, manufacturing, supply chain, and packaging of drug products.

Videos

In this exclusive Drug Digest video interview, Felicity Thomas, Europe/senior editor, Pharmaceutical Technology Group, interviews an esteemed panel of experts from IPEC Americas about excipient grades.

Drug Digest: Making the Grade: The Importance of Using the Correct Excipient Grade in Drug Products

IMU Biosciences—a UK-based company that is using technology to gain an understanding of the human immune response—has closed its Series A financing round, securing a total of £11.5 million ($14.6 million). The financing round was led by European tech VC Molten Ventures and included LifeX Ventures among others, according to a Jan. 24, 2024 press release.

The company’s proprietary CytAtlas platform, which is an artificial intelligence (AI) platform combined with deep immune data profiling, is finding applications across a breadth of high-growth areas thanks to its ability to provide insights into the human immune system. For example, in immune-oncology, the platform is enabling rapid immunophenotyping to be performed from liquid biopsy samples, and in cell therapy the platform is being applied to the identification of immune signatures in donors, which is improving manufacturing efficiency.

"With our technology, we’re building the world's largest immune data assets across health and disease, which allows us to perform analyses with a level of depth and granularity that was previously unthinkable," said Dr. Adam Laing, CEO and co-founder of IMU Biosciences, in the press release. “This systems-level approach to understanding immune function enables us to look at the bigger picture rather than just focusing on individual disease-associated parameters. Our goal is to revolutionize precision medicine, improving its effectiveness, reducing failure rates in clinical trials, and making these therapies more viable in the long run.”

"Our technology could fundamentally change how we approach patient stratification for advanced therapies, disease monitoring, and diagnostics," explained Dr. Tom Hayday, CSO and co-founder of IMU Biosciences, in the press release. "We're talking about better patient outcomes, more effective therapies, and even cost reductions in healthcare over the long term. This potential is already being recognized by pharma and biotech companies as well as leading academic institutions, offering us multiple opportunities to create significant value from strategic collaborations that leverage our unique approach."

With the funds raised, IMU Biosciences will seek to accelerate its roadmap, which will include advancing its CytAtlas platform and expanding its operations into the Boston/Cambridge, Mass. area.

IMU Biosciences has secured £11.5 million in its Series A financing round.