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20 years of stimulating columns. Thank you Moira!

Happy New Year

All Change Again for Pharma - Treating the Patient not the Disease

After almost 40 years writing about the pharma industry and almost 20 years writing this column I’ve decided to retire. So it’s time to bid you farewell, with a brief look at where we’ve been over these past years, where we are now, and where we might be going with drugs of the future.

Death of the Blockbuster?

Just a decade ago, with the expiry of the patent on Lipitor it was said we’d seen the death of the blockbuster. But did we? Biologicals were quick to take over, and single products such as Humira (adalimumab), which could treat a wide range of diseases, became the new blockbusters. But now that particular market has become much more competitive with biosimilars eating into the returns on top biological brands.

New Blockbusters

However, plenty of potential new blockbusters are waiting in the wings, many of which, like Humira, have a raft of indications. New immunotherapies are already making their mark - Merck’s Keytruda (pembrolizumab), for example, which is used to treat a range of cancers is forecast by Evaluate to be the top selling drug worldwide in 2026 with sales of $24.9 billion, almost double its predicted closest rival, BMS/Ono’s Opdivo (nivolumab), another immunotherapy indicated for several types of cancer.

Some specific classes of drug are already seeing rapid uptake as attention focuses on disease prevention - the DOACs, for example, for prevention of stroke as diagnoses of atrial fibrillation are being stepped up. BMS’ Eliquis (apixaban) is predicted by Evaluate to generate sales of $12.6 billion by 2026, just behind Opdivo.

Also, new drugs for hard-to-treat diseases and unmet medical needs are emerging rapidly, notably CFTR modulators for cystic fibrosis, although manufacturers have had a fight on their hands to get reimbursement approval for these products.

And of course there is the COVID-19 effect that has seen rapid regulatory approval for Merck/Ridgeway’s Lagevrio (molnupiravir), Pfizer’s Paxlovid (ritonavir), and GSK’s Xevudy (sotrovimab). However, as with the DOACs, an increasingly crowded therapeutic marketplace could eat into sales potential.

Getting Personal

Blockbusters aside, the pharmaceutical landscape is going through another transition. While patient centricity is now something of an overhyped buzzword, there’s no doubt that the patient voice has become more ‘central’ in recent years. Companies are engaging much more with increasingly knowledgeable patients, through online platforms for patient advocacy groups, for example. Like the medical profession, healthcare companies are having to take a less paternalistic attitude towards patients who have become greedier for more information about healthcare and medicines, especially since the COVID-19 pandemic. New ways will have to be found to meet this need without breaching the rules on advertising to the public. One suggestion is that pharma firms should set up advisory committees or boards that include patients who have experience with the company’s products.

“Treat the Patient not the Disease”

Medicine is set to get even more personal and the above quote from Canadian physician Sir Willian Osler, often described as the Father of Modern Medicine, seems particularly appropriate for the next chapter in the pharmaceutical story - precision medicine.

Personalised Medicine

Huge advances in genomics and technology are making it easier to develop precision/personalised medicines and targeted therapies. This will mean a shift from the ‘one size fits all’ approach of the traditional blockbuster to breakthrough new medicines that target smaller patient populations with specific genetic profiles. The therapies will come as a package with genomic biomarker testing. The rising prevalence of cancer will drive growth in the precision medicine market, with one out of every five individuals developing cancer at some point in their lives.

As you’d expect, most big pharma companies are developing personalised medicines and have teamed up with genomic/genetic and artificial intelligence (AI) research companies to do so. Here’s what some of them say about it.

“Precision medicine is where we want medicine to be. It is a key evolution – it used to be about making the patient fit the treatment, but now it is about making the treatment fit the patient.” Novartis

“Our investments in R&D are designed to generate the next generation of medicines that treat patients in a more precise, personalised way.” Amgen

By rooting our research process in the underlying clinical and molecular biology of disease, our goal is to develop medicines and vaccines with potentially transformational outcomes for patients. In short, it is about treating the right patients with the right medicines.” Pfizer

“Precision medicine is now applied in >90% of AstraZeneca’s clinical pipeline across all main therapy areas - oncology, CVRM, and respiratory disease.”

“Our current approach to delivering healthcare is not working. Every patient - and their disease - is unique, with many ‘one size fits all’ treatments benefiting only a minority. For example, current untargeted drugs are effective in around one-quarter of all cancer patients, three out of 10 people with Alzheimer’s disease and just over one-half of patients with diabetes.” Merck (Darmstadt)

Marketing and Reimbursement Challenges

Personalised medicine will pose interesting challenges for pharma marketers. Just as ‘one size fits all’ drugs can fall short, ‘one size fits all’ traditional marketing strategies ae unlikely to work. Precision medicines will require precision marketing. Patient engagement is likely to be more important in the marketing mix - perhaps through helping patients understand genomics and how the new therapies can manage their individual genetic complications.

Pricing and gaining reimbursement for these medicines will be a major challenge. Risk-sharing deals will have to be agreed with payers who will be looking for outcomes data and real-world evidence. (RWE) is already being built into registration as well as reimbursement requirements.

Unmet Medical Need

While targeted medicines, including gene and cell therapies, will help combat the growing scourge of cancer (and boost the pharmaceutical market), there is still little sign of real breakthroughs for neurogenerative diseases such as Alzheimer’s and Parkinson’s. If treatments can be found for these conditions, then reports of the death of the blockbuster will indeed have been grossly exaggerated.

I Wish You All the Compliments of the Season and a Safe, Healthy and Prosperous 2022.


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