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Pharmaceutical portfolio management is challenging for many reasons, including a changing competitive landscape, the push and pull of clinical value, and development timelines that reduce long-term market predictability. In fact, between September 2019 and December 2021, 62% of new product launches fell short of expectations in the first year. Recent Analysis From industry consultant Trinity Life Sciences.
How can companies mitigate market entry failures and ensure their products reach their full potential? The battle is on. Before “There are many more challenges in the development process than most companies realize,” said Leslie Orne, Trinity’s president and CEO.
Leslie Orne, CEO, Trinity Life Sciences
With permission from Trinity
“Frankly, the bar for performance for these drugs is getting higher and higher, and there’s a lot of junk on the market,” Orne said. “When you look at the list of 50-plus FDA-approved drugs[in 2023]you see pattern recognition leading to winners and losers. And some people have to work harder to succeed. We’ve seen it get harder and harder to achieve success.”
The two main reasons assets end up on the “junk pile” are copycat science and a lack of data-driven rigor, Orne said, which is why pharma companies need to “reverse engineer” the go-to-market stratification that creates winners and losers and take a more forward-looking view of their portfolios from the get-go.
“Junk pile” invites
Copycat drugs entering an already thriving therapeutic landscape are less likely to live up to market potential: for example, the fifth PD-L1 inhibitor or sixth TNF-α inhibitor to enter the market is less likely to make a difference in an unmet medical need.
“If you rush to market to reach clinical standards and don’t think strategically about how to differentiate your asset, you’re going to end up with a lackluster launch even if the science has potential,” Orne said. “That’s where we want to focus most: how to take pretty good science, or even great science, and develop it in a way that’s acceptable for the commercial market.”
But being first can also lead to failure. Orne points to Biogen and Eisai’s debacle when they brought Alzheimer’s drug Aduherm to market. Despite being a highly sought-after asset and the first approved treatment theoretically designed to modify the disease, market prospects quickly faded as payers and physicians poked holes in Aduherm’s clinical evidence, ultimately leading both companies to pull it from shelves.
“I’m not saying they got the roadmap to success right, but they probably could have done a couple of things to articulate the value of that asset in a more realistic way and convince payers not to block it,” Orne said. “Biogen is doing great science in Alzheimer’s, but they stumbled with their first one, and they should have looked more at the commercial realities to prevent that.”
Orne said a focus on data could drive more successful launches, suggesting taking a more rigorous approach than traditional market research, leveraging tools such as AI and machine learning to provide an objective approach.
“We’re advocating for swift kills. We need more courage to do it the right way, but some of the best leaders I’ve seen say, ‘It’s time to look somewhere else.'”
Leslie Orne
CEO, Trinity Life Sciences
Building (and tearing down) pipelines
Big pharma is always looking for new areas to enter through big M&A, add-on acquisitions, partnerships and asset purchases, and after a multi-year drought during which pharma companies hunkered down in a volatile market, the sector is “bound to grow again,” said Arda Ural, life sciences leader at EY Americas.
“The pharmaceutical industry remains a $1.4 trillion war chest and targets are on the cheap,” Ural said, referring to the industry’s ability to make deals. Recent EY reports“Meanwhile, big pharma is losing $300 million (in patent losses) and there’s an offsetting effect of them having to somehow make up for that revenue with their pipeline.”
For example, J&J recently acquired a subsidiary of Numab Therapeutics. Approximately $1.3 billion It provides access to early-stage treatments for eczema in a portfolio that includes older immunotherapies that have reached the end of patent protection. next yearNumab CEO David Ureck told PharmaVoice that the bispecific antibody has also attracted interest from another “big pharma company,” highlighting the need to replenish pipelines across big pharma.
But while additional deals to bolster the pipeline fulfill big pharma’s immediate portfolio needs, the flip side of narrowing down candidates before committing too much money to costly development could prove just as important to their hit rate to market, Orne says.
Orne said big pharma companies have been heeding that need lately, with companies such as Sanofi, AstraZeneca and Takeda making deals earlier and reprioritizing their pipelines as a result. For example, Sanofi’s 2023 decision It said it withdrew its late-stage candidate for myasthenia gravis “after careful evaluation of the emerging competitive treatment landscape in MG.” Company Release.
“(Pharmaceutical companies) are trying to be accountable to the standards and norms that they set for themselves,” Orne said. “We’re advocating for a rapid closure. It takes more courage to do it the right way, but some of the best leaders I’ve seen are saying, ‘It’s time to look elsewhere.'”
