- Amgen and partner AstraZeneca revealed Monday that their experimental drug for asthma has succeeded in a large study of people with a severe form of the breathing condition.
- All of the study's nearly 1,100 participants received standard of care treatment and were monitored for one year. Those who also got Amgen's tezepelumab showed significant reductions in asthma exacerbations — sometimes called asthma attacks — compared to those who got a placebo. More detailed data will be presented at an upcoming medical meeting, Amgen said.
- Umer Raffat, an analyst at Evercore ISI, called the results a "best-case outcome" for Amgen and tezepelumab, especially considering the drug had failed as an eczema treatment a few years back. "I expect Amgen to be up nicely – in part given how much nervousness there was on this readout," Raffat wrote in a note to clients. Indeed, Amgen's share price rose 3% Tuesday morning, while AstraZeneca's was up 5%.
Amgen continues to rely on aging biologic drugs to support its business. Over the first nine months of this year, its drugs Enbrel, Neulasta and Prolia, which were first approved in 1998, 2002 and 2010, respectively, accounted for about 42% of the company's nearly $18 billion in product sales.
Though Amgen has established formidable patent defenses around its drugs, they're not impenetrable. Sales of Neulasta, for example, have declined significantly over the last two years due to the entry of biosimilar competitors.
Amgen has therefore been under pressure to bring new additions to its portfolio of marketed products. Last year, it shelled out $13 billion to acquire Celgene's anti-inflammation drug Otezla. Amgen has also identified a few of its own experimental drugs as potential growth drivers, with one being tezepelumab.
Tezepelumab is an engineered antibody meant to block a protein called TSLP, which plays a role in how the immune system responds to allergens. While the drug struggled to show merit as an eczema treatment, it's fared well in asthma. In 2017, the New England Journal of Medicine published results from a mid-stage study that found patients with uncontrolled asthma who received some dose of tezepelumab ended up having exacerbation rates which were 62% to 71% lower than patients who weren't treated with the drug.
For the more recent, late-stage results announced Monday, Amgen noted how its drug appeared to work in a variety of patients. Namely, researchers saw asthma exacerbation rates decline both for patients with high levels of eosinophils as well as patients with low levels. Eosinophils are a type of white blood cell that appear at elevated levels in patients with severe asthma.
Wall Street analysts claim that these results could lead to a broad label for tezepelumab should it come to market. If the data continue to hold up, Michael Yee of Jefferies argues that the drug may end up being a $2 billion or more franchise for Amgen. Notably, asthma approvals have led to big sales bumps for drugs like Sanofi and Regeneron's Dupixent.
Amgen is "scoring a key pipeline win that we think is important for [its] near-term growth," wrote Alethia Young, an analyst at Cantor Fitzgerald.
Young added, too, that the positive results are especially important given that another of Amgen's closely watched drugs, developed with partner Cytokinetics, recently delivered disappointing data. While that drug hit the main goal of a late-stage trial testing it in thousands of patients with a type of chronic heart failure, its performance was still weaker than what investors had hoped for.
Amgen has also received much attention for an experimental cancer drug that's successfully targeted a protein previously thought to be untouchable. But, while the drug has shown positive effects for some patients, it's far from perfect, which has left an opening for rival medicines from companies like Mirati Therapeutics, Johnson & Johnson and Roche.