The Flop of the Decade: A PCSK9 Inhibitor with a Price Tag of $14,100

The cardiovascular disease is a lucrative market for many pharmaceutical and biotechnology companies to break in. It is estimated that the cardiovascular disease market is expected to grow from $129.3 billion in 2015 to $146.4 billion by 2022.

More than 50 million patients are living with atherosclerotic cardiovascular disease (ASCVD) or familial hypercholesterolemia (FH). Amgen tried to help patients with this condition with a drug they develop to lower the “bad” LDL cholesterol levels. So far they had a rough start in launching its PCSK9 inhibitor in 2015. Their decision to launch Repatha was a little late. Sanofi beat Amgen in earning an approval from the FDA. Sanofi’s Praluent was a competitor that Amgen needed to handle since both drugs mechanism of action was working on the same LDL receptors that Repatha targeted.

As Amgen was battling Sanofi in court, another Big Pharma, Pfizer, was trying enter the PCSK9 market thinking it will make money from these patients. Pfizer ended leaving their phase III drug because of concerns over their drug not being safe enough. A brilliant move that Pfizer took when you realized that the market wasn’t big for more than two drugs to be sold commercially. Repatha and Praluent were forecasted to be blockbuster drugs, meaning that these drugs were expected to generate a billion dollars each… but didn’t happen.

Even as analysts forecasted this drug to make billions in its first year, Amgen generated a lackluster of $10 million in their first year. So what happen? Well the drug was just too expensive that it priced itself out from insurers. Nobody could afford it or wanted to pay for it.

Amgen was forced to lower the cost of their PCSK9 inhibitor just so they could be considered by insurers. Hopefully patients that need this drug to treat FH are given the treatment for their cholesterol.

Even as Amgen is expected to make money, it has until 2028 to fight off generics. Generics is the plague in pharma and biotech companies, think of them as your competitors that are trying to price you out of the market. As repatha was cut more than half from its 2015 price, it will need to continue lowering its price t secure its position in the cardiovascular market. By lowering the price tag of $5,850 dollars to a more conservative number, it will allow them to fight off the generic market.

Amgen’s market is growing slowly with its PCSK9 inhibitor. Since the launch of its PCSK9 inhibitor it had a rough start for its cholesterol drug. It is estimated that by 2022, Amgen will generate $2.2 Billion from their cholesterol drug. Their drug might be a blockbuster. The ease of using low cost statins and Sanofi’s Praluent made it difficult for them to fill out prescriptions. Their decision to lower the cost of their cholesterol drug to push more prescriptions will lead to more revenue.

Novartis has decided to join the PCSK9 market with a more attractive contender . A small interference drug that treated patients suffering from high “bad” cholesterol was another “black sheep” that the executives and marketing team had to deal with. On November of 2019, Novartis acquired The Medicine Company for $9.7 billion dollar for its first in class small interference RNA (siRNA) drug, Inclisiran, a drug that blocks the production of protein convertase substilisen/kexin type 9.

Even as it is expected to benefit from a growing market, many of us are wondering will they be recouping the losses it took from 2015? A saturated market that will have a better PCSK9 inhibitor may need Amgen to lower its price even more to fend off a drug like Inclisiran.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

This site uses Akismet to reduce spam. Learn how your comment data is processed.