The recent news that bapineuzumab, a treatment for Alzheimer’s disease, failed to meet two primary endpoints in a recent Phase III study isn’t great for development partners Pfizer and Johnson & Johnson. The new results show the drug fails to produce clinical significance in treating carriers of the APoE4 genotype. The drug had not performed up to expectations for this patient population in Phase2 either. Bapineuzumab will continue through trials in other patients who are more likely to show a strong response to the drug, according to pharmaceutical industry expert Ed Silverman in a recent Forbes piece.
By Jeremy Spivey,
Senior Research Analyst
For me, the high level of investment and interest in bapineuzumab points to the importance of portfolio management in the pharmaceutical industry. With over 26 million people suffering from Alzheimer’s disease worldwide – and the number likely to increase as the average age increases – a highly effective treatment line is sorely needed. While the current treatments for Alzheimer’s target some of the affected neurological systems, none yet treat the root cause of the disease – and none are entirely effective. If one of the therapies in clinical trials right now proves to be even moderately effective, the drug will be a blockbuster and generate handsome returns for the company pursuing marketing approval.
Developing the right product is very challenging, however. The biggest reason is that the root cause of Alzheimer’s hasn’t yet been established. Bapineuzumab was synthesized and investigated at a point when the presence of beta-amyloid plaques were thought to be a major cause of the disease. Now, many are looking to tau protein as a potential target. Ultimately, the root cause may be determined to be neither – they may both be visible effects, but not a direct cause, of the disease.
Several companies are pursuing treatments for Alzheimer’s disease, so even if the correct biological target is chosen, products will likely have strong competition within a year or two on the market. The gold standard treatment will be the one that works most effectively, with the least amount of side effects, and can do work with a reasonable dosing schedule. Dosing will be especially important in Alzheimer’s, as caregivers often assist with medication but aren’t always around 24 hours to ensure that multiple doses are taken throughout the day.
When dealing with problems like these, companies are best served if they have portfolio management teams looking into the future. These groups measure the market potential of products against the cost of developing or acquiring products. Then, presented with many options, they must consider which ones, if any, to pursue. In a recent study on portfolio management, Cutting Edge Information found that 66% of companies rely on the portfolio management group to align brand and corporate strategy. Other groups were involved in this as well – business development and marketing groups were involved at 41% of companies.
Selecting the best molecules to take through the development process is becoming more important than ever, with many European payers rewarding breakthrough products handsomely but looking less favorably upon incremental improvements. In these cases, having the best compound at the latest clinical stage could be the difference between strong profits and lagging sales.