06Jun

In a report scoring the efforts of 20 global pharmaceutical companies in providing access to their medicines the industry came in for some rare praise, as well as a bit of scolding for too often putting poor countries last.

“After years of encouraging access planning, we are now seeing a strategic shift in this direction [of inclusion] by pharma companies,” said Jayasree K. Iyer, executive director of the Access to Medicine Foundation.

“This could radically change how fast access to new products is achieved – if company leadership is determined to ensure people living in low- and middle-income countries are not last in line.”

Iyer’s comments came in connection with the foundation’s release of Access to Medicine Index 2021, its biennial report ranking the largest pharma companies on how well they are doing to make drugs and vaccines accessible to the world’s poorest nations.

GlaxoSmithKline came in first, as it has in the previous 6 reports.

Access to meds rankings 2021 - blog.jpg

Close on its heels is Novartis. It ranked 2nd in the 2018 report, and 2nd again, but this year edged closer to the top spot on the strength of its product delivery. Of Novartis the report says, “Leading consistently across access strategies, it is the only company that applies equitable access strategies in low-income countries (LICs) for all its products.”

GSK, a mere 0.05 points ahead of Novartis, held onto the top position on the strength of its R&D performance. “Performance in R&D is a significant factor in its retention of the top spot,” the report explains. “It has access plans covering the largest proportion of late-stage projects.”

The highly detailed, 236 page report digs deep into each of the 20 companies, scoring them in three areas:

  1. Governance – The area looks at the governance, planning, implementation and integration of access to medicine initiatives into corporate strategy and the extent of staff incentivization towards fostering access. It also considers marketing and disclosure practices.
  2. R&D – Focus is placed on product development, access planning, and R&D capacity building. Affordability, accessibility, and availability are crucial aspects to be considered for the pipeline. Companies also need to contribute to local R&D capacity building, empowering local researchers to address relevant needs.
  3. Product Delivery  The report assesses post-development actions on the ground to ensure companies offer equitable access to their products and overcome any local barriers in accessing hard-to-reach markets and patient populations.

The purpose of ranking each company, explains the foundation, is to spur them “to compete and collaborate on priority access-to-medicine topics, while identifying best practices, areas of progress and gaps where more action is urgently needed.”

The report observes that the industry “continues to inch forward,” but laments that progress is largely due to a handful of companies that “account for the bulk of the R&D projects that the global health community considers a priority, underscoring a worrying dependency on just a few large players.”

Image by Arek Socha

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Jun 6, 2023

Most New Drugs Never Make it to Market

The amazing speed with which the pharmaceutical industry developed, tested and won emergency approval for the COVID-19 vaccine was not just surprising, but in at least one way, misleading.

As the new report, Clinical Development Success Rates and Contributing Factors 2011 – 2020 from Bio.org makes clear, the COVID vaccines and therapeutics that became available mere months into the pandemic were a dramatic and rare exception.

On average, the report tells us it takes almost 11 years to go from a Phase I program to regulatory approval. And that’s only for those drugs and therapies that make it through. Over the 10 years from 2011, the likelihood that a drug in a Phase I trial would ultimately win approval was 7.9%.

That may be better odds than winning the Powerball lottery, however, the investment in a drug’s development can dwarf all but the largest jackpots. Making it even more of a gamble for a pharmaceutical firm is that the average success rate has declined since Bio’s 2016 report. Then the average for the previous 10 years was 9.6%.

Heavy with tables, charts and graphs, the Bio.org report (in conjunction with Informa Pharma Intelligence and QLS Advisors) reviews success rates across 21 major diseases. It reports specifics on 14 of them, combining the balance into an “Other” category. The detailed diseases are: Allergy, Autoimmune, Cardiovascular, Endocrine, Gastroenterology (non-IBD), Hematology, Infectious disease, Metabolic, Neurology, Oncology, Ophthalmology, Psychiatry, Respiratory, and Urology.

Comparing the success rates in the current report to the previous one, Bio found 12 categories had a lower likelihood of progressing from Phase 1 to approval. The largest decline was in urology. In the 2016 report, therapeutics in this category averaged 11.4% success. In the recent report, the average fell to 3.6%.

Hematology has the highest likelihood of approval at 23.9%, though it too saw a decline from 26.1%.

Drugs to treat rare diseases fared better than other therapies. The report said these drugs had a 17% likelihood of success.

The decrease, explains a Bio.org discussion of the report, “Can be attributed to two main factors: A greater participation from smaller firms participating in drug candidate development and their willingness to disclose early failures.”

Said David Thomas, BIO VP, industry research, “That all ties into what we see, which is a lower success rate overall from our last paper in 2016.”

Drug development remains difficult with far less than 1 in 10 clinical drug programs ever reaching patients,” says the Bio.org account. “It usually takes 10 to 10.5 years to develop a vaccine, which makes the existing COVID-19 vaccines on the market all the more incredible.”

Success, adds Thomas, takes “many shots on goal.”

Photo by ThisisEngineering RAEng on Unsplash

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