Amgen doesn’t buy Esperion

Acquiring the private Dutch group Dezima Pharma makes perfect sense in terms of growing Amgen’s lipid-lowering franchise, but it also raises questions. For one, what does it mean for Esperion, a rival US biotech working on a related approach?

Some might, for instance, read sinister things into the fact that it was Dezima and not Esperion that Amgen bought. However, Dezima only cost $300m, and if Amgen’s move is a cheap bet on a new approach then any readacross is limited. It is also important to remember that Dezima was basically built to be acquired.

Dezima last year reported positive phase II data with its sole project, the CETP inhibitor TA-8995, but now needed someone to come in and finance a 12,000-patient cardiovascular outcomes study that stands between it and TA-8995’s approval (Interview – After Dezima’s Tulip blooms, a bigger task awaits, September 2, 2014).

Partnering was of course a possibility, but it was obvious why Amgen chose full ownership in preference to licensing. After all, Dezima is a one-asset business, without a complicated network of partners, that has only been in existence for three years; it was tailor-made for acquisition.

Merck and Lilly

Based on this fact there is probably also limited readacross to Merck & Co and Lilly’s rival CETP inhibitors, anacetrapib and evacetrapib respectively, though however small Amgen's bet it is still an endorsement. After the failures of Pfizer’s torcetrapib and Roche’s dalcetrapib the CETP approach was thought to have been dead and buried.

But what about Esperion, with its ACL inhibitor ETC-1002? This company had enjoyed a stunning share price uplift earlier this year on promise of an early launch in a narrow patient population, but since July its stock has halved; yesterday it was off another 2%, but rose 7% in early trade today.

Esperion’s troubles are hard to understand, especially as recent approvals of the anti-PCSK9s Repatha from Amgen and Praluent from Sanofi/Regeneron – again in an initial narrow patient population – had rekindled interest in cholesterol-lowering. Both Esperion and Dezima’s assets are oral – and thus cheaper and more convenient than the injectable anti-PCSK9 MAbs.

But maybe Esperion was not bought by Amgen simply because it was not for sale, at least not at the current valuation. And at a much higher premium it would have cost Amgen billions of dollars, which would have been much harder for the acquirer to justify than the $300m for Dezima.

Moreover, Esperion did not desperately need a buyer or licensee, seeing its initial route to market in statin-intolerant patients, a use that requires a relatively limited sales presence.

Dezima had floated a similar idea – in its case running a small phase II trial in 42 patients with asymptomatic, severely elevated lipoprotein(a), who it says have no specific available therapy. But this study was quietly completed in January with no results announced, so it is a safe bet that it failed – eliminating the last reason for Dezima’s solo existence.

Broad access

For any of these approaches – CETP inhibitors, anti-PCSK9s, ACL inhibition – to gain access to the broad patient population massive cardiovascular outcomes studies will be needed, and are in progress for Repatha and Praluent.

With TA-8995 this is no longer Dezima’s worry, though presumably much of the $1.25bn future milestones relates to the project’s broad use. It is Amgen’s problem that TA-8995 might not be launched before 2020, by which time anacetrapib and evacetrapib might be on the market, based on their respective massive cardiovascular trials, Reveal and Accelerate.

Esperion bulls could still view their company as being an acquisition target for Sanofi, which given the French firm’s tit-for-tat battle with Amgen in PCSK9s is not an outlandish suggestion. And if Amgen got a bargain, should Dezima have held out for more?

Sure, a flotation on Nasdaq would have given the Dutch company a much higher valuation, but it would have got it no nearer to funding a 12,000-patient trial solo. For Dezima’s private backers a $300m payout on a $19m investment three years ago is not bad going.

Project Mechanism Study Detail Trial ID
Praluent (Sanofi/Regeneron) Anti-PCSK9 Odyssey 18,000-pt CVOT; ends 2017 NCT01663402
Repatha (Amgen)  Anti-PCSK9 Fourier 27,564-pt CVOT; ends 2018 NCT01764633 
Evacetrapib (Lilly) CETP inhibitor Accelerate 12,000--t CVOT; ends 2016 NCT01687998
Anacetrapib (Merck & Co) CETP inhibitor Reveal 30,624-pt CVOT; ends 2017 NCT01252953
ETC-1002 (Esperion) ACL inhibitor 143 high cholesterol & hypertension pts NCT02178098  
ETC-1002 (Esperion) ACL inhibitor 133 pts; statin add-on NCT02072161
TA-8995 (Dezima) CETP inhibitor Tulip 364 pts with mild dyslipidaemia NCT01970215
TA-8995 (Dezima) CETP inhibitor 42 pts with elevated lipoprotein(a) NCT02241772

To contact the writer of this story email Jacob Plieth in London at [email protected] or follow @JacobPlieth on Twitter

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