Navigating life sciences M&A in 2023

There’s unprecedented firepower on the table

It’s an interesting year for M&A in the life sciences. The industry is emerging from a period of unprecedented turbulence, and there is currently approximately $1.4 trillion in firepower on the table – the highest amount of available capital for acquisitions recorded in the last decade. Analysts predict large-scale transformative dealmaking, and as life sciences organizations look to grow and future-proof their operations, strategic M&A will play an increasingly important role. 

Here’s a quick guide to navigating life sciences M&A in 2023.

M&A activity is on the rise in 2023

2022 saw a fairly muted year for M&A activity in the pharmaceutical industry. According to Bain & Company, strategic healthcare deals declined by over 30%, with average deal size dropping 15% despite some mega-deals in the fourth quarter. But so far, 2023 has delivered some key indicators that M&A is set to rebound. M&A activity increased by 43% in value terms in Q1 compared to the previous quarter’s total, a rise of 196% compared to Q1 2022. 

As the industry acclimatizes to macroeconomic uncertainties, analysts predict a number of factors will drive growth in this arena. The first is the surplus of cash on hand. The top 25 US firms had approximately $30 billion in cash on hand at the beginning of this year – enough to see some significant movement as the year progresses. To add to this, there are approximately $100 billion in patents set to expire by 2030, meaning pharma M&A activity is expected to rebound significantly in the immediate future as companies move to plug the gaps in their portfolios brought on by approaching patent cliffs. The looming patent cliff is estimated to put around $258 billion at risk as revenues are eroded by the introduction of lower-priced generics and biosimilars. 

The biggest deals of 2023 (so far)

There’s already been some significant M&A activity in the sector this year. 

In April, Merck acquired Prometheus Biosciences for $11 billion, adding an exciting experimental treatment for ulcerative colitis and Crohn’s disease to its portfolio.

In March, Pfizer bought Seagen for $43 billion in what analysts predict will be the biggest deal of the year. The Seattle-based biotech startup is set to broaden the pharmaceutical giant’s oncology capabilities significantly.

Lastly, AstraZeneca is set to acquire American clinical-stage biopharmaceutical company CinCor for $2 billion, looking to boost its cardiorenal pipeline. 

Three steps to successful M&A dealmaking in 2023

In a guest column for Life Science Leader, Arda Ural lays out three strategies for successful M&A dealmaking in 2023. 

  1. Attempt to de-risk deals as far as possible

50% of M&A deals targeted pre-Phase 3 assets in 2022, suggesting that companies are moving towards earlier-stage assets, as opposed to de-risking by targeting late-stage, well-validated clinical assets. Assets that are earlier in the R&D lifecycle come at a lower price, which offsets the higher risk of failure. 

  1. Assess which deals have worked historically, and why

Ural suggests analyzing historical trends to isolate the highest areas of return. For example, bolt-on transactions have higher yields when the target company is in an adjacent therapeutic arena to the primary portfolio of the purchasing company. This suggests that depth and specialization are more lucrative than breadth. 

  1. Ensure the right processes are in place to integrate new acquisitions

According to Ural, M&A doesn’t end when the funds have cleared. A robust change management infrastructure must be in place to ensure the success of the deal in the long term. This includes measures for facilitating cultural collaboration, change management, integration and new workflows.

For the latest in M&A news and insights, choose Similari

The M&A landscape changes by the minute, and to keep abreast of the latest developments, researchers need a tool that analyzes the bigger picture, while customizing granular, relevant insights to their area of immediate interest. 

Similari’s AI-enabled insights management platform brings you a live feed of all the latest M&A news and developments as they happen by monitoring millions of data points in your chosen arena of inquiry.

Reach out today to find out how Similari can help you spot trends as they’re shaped, sharpen your forecasting and keep absolutely up to date on competitor activity, minute by minute. 

How Real World Data (RWD) is modernizing the clinical trial

Big data is changing the trial game

As big data analysis capabilities have increased over the last five years, so have the possibilities for radically improving efficiency and success rates in clinical trials. Digital transformation at the level of general healthcare, including the prevalence of digitized records, the proliferation of data-capturing wearables market and other sources of patient-related information mean that researchers now have access to a range of invaluable data collected during patients’ normal course of care outside of the clinical trial setting. 

This Real World Data (RWD) presents a wealth of information about drug and treatment efficacy, and it’s changing the way clinical trials are designed and executed. Here’s why.

What is Real World Data?

The term Real World Data refers to health-related data generated during the course of a patient’s routine care or post-treatment life that relates to their health status. This data comes from sources outside of the clinical trial itself, such as healthcare records, insurance claims and billing activity, medication order records, or from the patient’s own data generation via wearables or other at-home medical devices. 

From Real World Data, researchers can synthesize Real World Evidence (RWE), which is the clinical evidence generated by the analysis of RWD that reflects the safety, efficiency, benefits and risks associated with the drug under testing.

What are the sources of Real World Data?

Real World Data can be sourced from any reliable point of origin outside of the clinical trial itself, many of which appear fairly unconventional. RWD sources include:

  • Clinical sources, including EHR records, pathology/histology data, discharge and progress reports. 
  • Medication sources, including order records, Point of Sale data, concomitant therapies and prescription refills. 
  • Claims, including medical and prescription drug claims, and other treatment usage data. 
  • Family history, including historical data on health conditions relating to the patient’s extended history, smoking in the household and alcohol use. 
  • Mobile health, including data gathered by fitness trackers and wearables delivering clinical-grade information on heart rate, PulseOx levels, sleep, calories and more. 
  • Social media, including patient support groups, blogs and posts. 
  • Environmental sources, including data on air quality, climate factors, community infections, and OHSA data. 

Real World Data applications

Real World Data is being applied in the drug discovery process in a number of important ways. 

Guiding pipeline and portfolio strategy

Pharmaceutical companies can use RWD to guide strategic decision-making, including estimating disease prevalence and incidence and predicting the scope of the potential patient population. Increasingly, researchers are bringing RWD into earlier phases of the product development process to help guide the allocation of resources and maximize the potential for success. 

Optimizing study design

Researchers can use RWD to optimize study design through advanced feasibility determinations, improved cohort recruitment and predictive enrichment, and lowering trial costs through the development of “synthetic” control arms built from pre-gathered RWD. Researchers are also using RWD to make more informed decisions regarding required enrollment sizes,  trial site selection and trial patient diversity. 

Post-launch safety and efficacy surveillance

RWD is emerging as an invaluable data source for post-launch drug safety and efficacy assessments. To assess the safety and efficacy of a drug, researchers need visibility of drug performance and potential associated risks across a longer period of time and against a broader scope of variables than possible during the limited time period of a trial.

How advanced data management is unlocking major value in the drug discovery pipeline

Clinical trials are producing more data than ever before, especially with the increasing use of RWD. The sheer volume of data being generated every day from clinical trials, M&A activity, press releases and publications has become impossible for human researchers to monitor and analyze effectively. 

Increasingly, pharmaceutical R&D teams are turning to AI-enabled data monitoring and insights management platforms to help them keep on top of the impenetrable data volume flooding their areas of research. Similari is one such platform. 

By monitoring millions of data points in a defined arena of inquiry, Similari is able to collate key insights which help inform data-driven decisions, identify true white spaces and avoid research duplication and dead ends. 

Find out how Similari can augment your R&D capabilities by trying a free demo today.

Drug repurposing: an emerging approach to lifesaving care

What is drug repurposing?

Drug repurposing, also known as drug repositioning, is emerging as a low-cost, low-risk, highly efficient means of capturing value in the drug discovery process. It involves finding new pharmacological or therapeutic indications for existing drugs that have already been approved by regulatory agencies. Not only does this circumvent the exorbitant costs and resources required to develop a new drug from scratch, it also means that, in an instance when an existing drug is found to have useful applications for other diseases, patients are able to access the benefits of effective care much faster than with traditional drug discovery processes. 

Over the last five years, drug repurposing has gained significant momentum, with the drug repurposing market estimated to grow to a value of $46 851.5 million by 2028, expanding at a CAGR of 5.4% year on year. There are approximately 10 000 known diseases, but only 2500 are paired with FDA-approved drugs. This presents a major opportunity for pharmaceutical organizations, particularly in the realm of rare diseases, diseases in children and pregnant women, and neglected tropical diseases – many of which could be addressed by existing drugs.

In this article, we’ll take a closer look at drug repurposing, and how it has the potential to deliver lifesaving care to patients across the globe, while delivering major returns to the pharmaceutical industry.

A doctor saves his own life

In the early 2010s, Dr. David Fajgenbaum, at the time a medical student at the University of Pennsylvania, became gravely ill with idiopathic multicentric Castleman disease. The disease is characterized by deadly cytokine storms – flares of immune-signaling cells which cause the immune system to attack the body. Determined to save his own life, Falgenbaum set out to find a new treatment approach, examining his own medical records. He noticed that a protein called vascular endothelial growth factor (VEGF) was spiking at 10 times the normal level. He consulted with his doctor and request a prescription for Sirolimus, an approved immunosuppressant usually prescribed to transplant patients. Years later, he remains relapse-free.

Since then, Fajgenbaum has founded a number of organizations dedicated to finding treatments for the 7000 rare diseases affecting over 400 million people around the world, using repurposed drugs.

Blockbusters-in-waiting

A number of repurposed drugs have gone on to become blockbusters in the pharmaceutical market. Most famously, Sildenafil, originally developed to treat angina pectoris and hypertension, was repurposed into Viagra, one of Pfizer’s most successful drugs of all time. Other examples include Minoxidil, which led to Rogaine, and Wellbutrin, which delivered the smoking cessation drug Zyban. 

The advantages of drug repurposing

Repurposing a drug has two main advantages over the traditional drug development process: faster time to market and significantly lower cost of development. The average drug development process takes approximately 10-16 years on average, as opposed to 3-12 years for a repurposed drug – a saving of about 5-7 years of average R&D time. It only costs about $1.6 billion to develop a new drug using a drug repositioning strategy, as opposed to the average $12 billion it costs to develop a new drug from scratch. Chances of success and approval are also much higher – 45% of the failure rate of traditional new drug discovery processes can be attributed to safety and toxicity concerns, a factor not relevant in already-approved drugs targeted for repurposing. Overall, about 30% of repurposed drugs make it through to patients – 20% more than new drugs. 

How AI is accelerating drug repurposing efforts

Researchers are increasingly deploying AI’s ability to process immense data sets and discover and examine complex relationships between data to identify and predict the success of repurposing candidates. In one recent example, researchers used AI to try and identify existing medications that may be effective for the treatment of COVID-19. In just 48 hours, the system had identified baricitinib, a rheumatoid arthritis drug, as the most likely candidate. The drug went on to gain FDA approval for the treatment of adult COVID-19.

Accelerating R&D through AI-enabled insights management

Drug repurposing is one example of how researchers use existing data to create major value in the drug discovery process. 

For R&D teams throughout the pharmaceutical industry, the need to monitor the ever-increasing volume of data emerging across the industry every day is mission-critical to research success. 

By monitoring millions of data points in real-time, many of which are invisible to traditional search methods, Similari’s AI-enabled insights management platform allows you to offload up to 90% of your manual data monitoring time, keeping you absolutely up to date with all the latest developments in your specific arena of inquiry, and allowing you to optimize decision-making, resource allocation and research efforts across the board. 

Find out how Similari will change the way you work by trying a free demo today.

Vaccines enter their golden era: 4 of the latest innovations in vaccine technology

A major leap for vaccine technology

The COVID-19 pandemic had a paradoxical effect on global vaccine progress. On the one hand, the crisis saw the world falling behind on immunizations against diseases other than COVID-19 – so much so that “The Big Catch-Up” was the theme of this year’s World Immunization Week. On the other hand, the unprecedented levels of firepower aimed at developing appropriate vaccines to curb the pandemic slingshotted vaccine tech years ahead and into what analysts are calling its “golden era”. Since then, there have been some fascinating and fast-moving developments in the world of vaccines. In this article, we will explore four of the latest vaccine innovations which are expected to have a major impact on public health in the near future.

  1. Shelf-Stable Malaria Vaccines

For a century, researchers have been trying to find a viable vaccine for malaria. This year, two are showing major promise. The R21/Matrix-M and RTS,S vaccines are both showing efficacy levels of up to 80% in small children between the ages of 5 and 17 months, and up to 75% efficacy in adults – a huge improvement on the only vaccine currently approved for malaria, Mosquirix, which only delivers a 56% efficacy rate after four doses. 

What’s more, both R21/Matrix-M and RTS,S are shelf-stable with a long shelf-life. Neither requires sub-zero temperatures for storage and transportation, and both are able to withstand temperatures of up to 104°F for up to two weeks – key features to overcome the infrastructure and distribution challenges common in more remote areas of Africa.

Ghana and Nigera have both approved the new vaccines – the first approvals in what’s expected to be a comprehensive roll-out.

  1. Microarray Patches

As the world’s experience of the COVID-19 pandemic proved, vaccine accessibility is an urgent humanitarian concern. One of the technologies with the potential to revolutionize vaccine accessibility is the microarray patch. According to Birgitte Giersing of the World Health Organization’s Immunization Department, last-mile costs are responsible for more than half the cost of a single child’s vaccination. On top of this, the costs of transportation, appropriate storage, mixing and administration by a professional are prohibitive for many lower-income communities. 

Microarray patches solve many of these problems, providing a cost-effective, simple and easy-to-distribute method of delivering vaccines to even the most remote areas. The small, coin-sized patches deliver dry vaccine via the skin painlessly, either through small needles on the patch or through a soluble formula that dissolves as the patch is held to the skin for a period of time. Microarray patches do not need to be kept at cold temperatures, do not require mixing and can be administered by anyone, removing the need for trained healthcare professionals to run vaccine administration programs. 

Currently, there are microarray patch vaccines in development for measles and rubella. 

  1. Personalized Cancer Vaccines

mRNA vaccines have been hailed as the next frontier for vaccine innovation. While researchers have been working on mRNA tech for decades, the pandemic brought about an estimated 15 years’ worth of progress in a matter of 12 months. One of the most exciting potentials unleashed by this wave of progress has been the possibility of personalized cancer vaccines. According to Dr. Paul Burton, Chief Medical Officer of Moderna, the firm hopes to offer “personalized cancer vaccines against multiple different tumor types to people around the world” by the end of the decade. 

  1. Maternal Vaccination

Maternal vaccination is emerging as a viable way to tackle infant mortality and morbidity, particularly in addressing RSV, Group B strep, herpes simplex and cytomegalovirus, which are common risk factors for newborns. Pfizer is currently developing a groundbreaking vaccine against RSV in infants. Through passive immunization, antibodies are passed from the mother to the fetus, delivering a 70-80% efficacy for up to 6 months after birth. 

The latest innovations, as they happen

From vaccines to biologics, drug discovery and beyond – no matter your arena of research, you can keep absolutely up to date with the latest developments and innovations using the powerful AI-enabled Similari insights management platform. 

By monitoring millions of data points in real-time, many of which are invisible to traditional search methods, Similari collates and presents a dynamic feed of all the latest news, clinical trial results, press releases, M&A activity and much more, allowing you to offload up to 90% of your manual data monitoring time. 

Find out how Similari is revolutionizing the way R&D teams work by trying a free demo today.