I got this update on ESPR that I posted about some pages back.
Heart-pill developer Esperion Therapeutics (Nasdaq: ESPR) is about to get some big news...
Esperion has developed a cholesterol-lowering drug called bempedoic acid. Bempedoic acid is like a statin drug, but so far, it hasn't shown any of the same side effects.
That's great news because around 20% of people who take statins can't tolerate them.
Early data showed that when patients took bempedoic acid with Zetia (ezetimibe), another cholesterol lowering drug, bad cholesterol levels dropped as much as 50%. If patients were already taking the maximum statin dose, bempedoic acid lowered bad cholesterol by 32%.
The drug is now up for review with the U.S. Food and Drug Administration ("FDA"). The Prescription Drug User Fee Act ("PDUFA") date for the FDA to decide on bempedoic acid is February 21. The FDA has until February 26 to decide on the bempedoic acid/ezetimibe combination pill.
The FDA didn't even bother to consult its outside expert committee about this decision, which the company thinks is a bullish sign.
Here's why we agree...
The European Medicines Agency outside expert committee did review the drug and the combination pill. Both passed review and were recommended for approval on January 31 although actual market approval might not happen until the second quarter. As soon as that happens (at the first sale), Esperion will get a $150 million milestone payment from its European partner Daiichi Sankyo (4568). Esperion is also eligible to receive another $600 million in sales milestones, and then up to 25% in royalties.
Daiichi Sankyo is a Japanese firm, and Esperion has not yet sold Asian rights. So either Daiichi Sankyo is going to buy Esperion, or it's going to have to try to make a deal with a company it has to pay royalties to. It would be cheaper to buy Esperion.
The alternative scenario is that Esperion launches and sells the drug itself in the U.S. and gets milestones and royalties from Europe. Right now, Esperion is a cash rich firm, and although it's not a drug giant, this pill is a strong product (especially the combination). Merck (MRK) just announced that it's selling its Zetia factories before Esperion starts to compete. That should tell you something...
Pfizer (PFE) could also step in to buy Esperion since it has bought Esperion Founder Roger Newton's drugs twice before. The first was Lipitor which became a $10 billion statin pill. The next was a protein drug, also from Esperion. Pfizer let Roger and his team walk away with bempedoic acid... Pfizer thought it wasn't going to amount to anything!
The best play for Esperion is to put bempedoic acid, Zetia (ezetimibe), and a statin like Pfizer's into the same pill, to lower everyone's cholesterol to the new lower, safer standards. That could be a $20 pill with twice the reach of bempedoic acid and ezetimibe alone.
You might think all of this is conjecture but Novartis (NVS) just paid $9.7 billion for the Medicines Company (MDCO) to get a once-every-six-month injectable cholesterol-fighting drug called PCSK9. That deal closed a month ago... So Big Pharma understands what this market is worth.
Put simply, if the Medicines Company is worth nearly $10 billion, then Esperion is worth $10 billion. Lipitor was worth $10 billion PER YEAR a decade ago. So, a Lipitor/bempedoic acid/ezetimibe pill is worth $10 billion per year. Esperion would be a steal for Pfizer at $10 billion.
Now, any other Big Pharma could buy it or no one could buy it. Either way, this is a great time to own Esperion, as FDA approval and U.S. sales are imminent. And European approval plus a $150 milestone payment are very likely to follow.