As talk of drug pric­ing takes cen­ter stage, Am­gen slash­es Repatha price by near­ly 60%

Biotech ma­jor Am­gen $AMGN has de­cid­ed to cut its loss­es, and the price, of its cho­les­terol drug Repatha in a scram­ble to claw back its com­pet­i­tive po­si­tion­ing ver­sus Re­gen­eron $REGN and Sanofi $SNY, the team be­hind its main ri­val treat­ment, Pralu­ent.

Fol­low­ing ap­provals in 2015 the two drugs were pegged to at­tain block­buster sta­tus for their abil­i­ty to dra­mat­i­cal­ly low­er lev­els of LDL cho­les­terol, but in­stead faced push­back from in­sur­ers for their high stick­er prices that led to low­er adop­tion than ex­pect­ed, de­spite lat­er tri­als that demon­strat­ed the PC­SK9 in­hibitors al­so sig­nif­i­cant­ly cut the risk of heart at­tacks and stroke.

On Wednes­day, Am­gen said it was low­er­ing Repatha’s list price by 60% to $5,850 from $14,100 per year in a bid to low­er co­pays, par­tic­u­lar­ly for pa­tients cov­ered by Medicare. An es­ti­mat­ed 75% of Medicare pa­tients pre­scribed a PC­SK9 in­hibitor nev­er ac­tu­al­ly fill their pre­scrip­tions, main­ly due to high out-of-pock­et costs, not­ed Am­gen CEO Robert Brad­way.  

Am­gen’s move fol­lows Re­gen­eron and Sanofi’s de­ci­sion to low­er the price of its Pralu­ent to a range of $4,500 – $8,000 from the orig­i­nal $14,600 per year.  This change did not mod­i­fy Pralu­ent’s list price, but rather was of­fered in the form of a larg­er re­bate to gi­ant phar­ma­cy ben­e­fit man­ag­er Ex­press Scripts $ES­RX, who re­ward­ed the ac­tion by po­si­tion­ing Pralu­ent as the pre­ferred PC­SK9 in­hibitor in their for­mu­la­ry. Un­like Repatha, Pralu­ent has al­so shown to low­er the risk of death.   

Last year, Repatha brought in $319 mil­lion, while Pralu­ent gen­er­at­ed $195 mil­lion.

Bri­an Sko­r­ney

Am­gen’s an­nounce­ment could “re­sult in some mar­ket seg­men­ta­tion, where Am­gen claims greater share of the Medicare mar­ket but Sanofi/Re­gen­eron dom­i­nates the pri­vate in­sur­ance mar­ket” not­ed Baird an­a­lyst Bri­an Sko­r­ney in a note. Ac­cord­ing to Jef­feries’ an­a­lyst Michael Yee, the cur­rent PC­SK9 mar­ket is half Medicare and half com­mer­cial, while 75% of Medicare scripts are ap­proved and have in­sur­ance ver­sus on­ly 40% for com­mer­cial pay­ors. But, 75% of Medicare-ap­proved pre­scrip­tions do not get filled and are even­tu­al­ly aban­doned due to an av­er­age $280-370/month co-pay, he said. “This is mon­ey lit­er­al­ly left on the ta­ble.”

Yee made some quick back-of-the-en­ve­lope cal­cu­la­tions:

If we tried to es­ti­mate and gross up cur­rent “lost rev­enue” now that be­come “booked rev­enue” over next year…we es­ti­mate the con­tri­bu­tion to­day could be up to a 25% boost – i.e. they do $200 mil­lion/year in medicare busi­ness but 75% is lost due to co-pay af­ford­abil­i­ty. If the co-pay drops to the new $25-150 then the $200 mil­lion in medicare grossed up could be $150 mil­lion+ tech­ni­cal­ly per year…ob­vi­ous­ly this is a longer term thing to say that half the busi­ness now should open up and get more ac­ces­si­bil­i­ty.

As po­lit­i­cal and pub­lic scruti­ny in­to drug pric­ing in­ten­si­fies, a host of Amer­i­can drug­mak­ers have made pledges to quell their ap­petite for drug price hikes. Am­gen in May al­so pledged not to take price in­creas­es planned for Ju­ly, and promised it would not do so for the rest of 2018.


Im­age: Am­gen CEO Robert Brad­way (cen­ter) at the White House short­ly af­ter Pres­i­dent Trump took of­fice in 2017 Get­ty

The Advance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

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Sanofi — which has been decoupling from Regeneron for more than a year now — bought in big in early 2013, back when Regeneron’s stock was going for around $165 a share. Small investors flocked to the deal, buzzing about an imminent takeover. The buyout chatter wound down long ago.

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Janet Woodcock, director of the Center for Drug Evaluation and Research (AP Images)

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Two weeks ago, FDA drug chieftain Janet Woodcock was assuring a top Wall Street analyst that any vaccine approved for combating Covid-19 would have to meet high agency standards on safety and efficacy before it’s approved. But over the weekend, after she and Peter Marks took top positions with the public-private operation meant to speed a new vaccine to lightning-fast approvals — they both recused themselves from the review process after an advocacy group argued their roles close to the White House could pose a conflict of interest.

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FDA ap­proves the first gener­ic for Amar­in's Vas­cepa — but is a fish oil price war im­mi­nent?

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Despite Amarin’s $AMRN pledge to appeal — a process that could take months — the ruling opened the door for generic competition. Hikma Pharmaceuticals, one of three challengers in the Nevada suit, on Friday said that its generic copy of pure EPA, the omega-3 fatty acid that constitutes Vascepa, has been approved by the FDA.

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BARDA has tapped a largely unknown startup to ramp up production of a list of drugs that may be at risk of running short in the US. And the deal, which comes with up to $812 million in federal funds, was inked by a CEO who found himself in the middle of an ugly price gouging controversy a few years ago.

The feds’ new partner — called Phlow — won a 4-year “base” contract of $354 million, with another $458 million that’s on the table in potential options to sustain the outfit. That would make it one of the largest awards in BARDA’s history.

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Prostate cancer patients have another PARP inhibitor option in a matter of days.

Clovis’ Rubraca won its prostate cancer approval on Friday, but data from AstraZeneca and Merck rival Lynparza put a damper on commercial expectations. Now, the FDA has approved Lynparza in the prostate cancer setting, months ahead of its expected decision date.

Lynparza has been approved for patients with metastatic castration-resistant prostate cancer (mCRPC), who carry BRCA or ATM mutations, which account for roughly 20-30% of patients with mCRPC. The approval was based on the late-stage PROfound trial, which found the drug eclipsed the impact of the androgen therapies at reducing the risk of disease progression or death by a sharp 66%.

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An­oth­er NASH de­lay for In­ter­cept frus­trates in­vestors, shares wilt

A previous FDA advisory committee delay for Intercept’s NASH drug may have dampened spirits, but investors perked up after French rival Genfit recently failed to best a placebo with its offering in a keenly anticipated pivotal study. In yet another twist on Friday, the New York drugmaker said the FDA is postponing its adcom again to accommodate the review of additional data it has asked the company to furnish.

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Ger­man Mer­ck bests US Mer­ck in UK copy­right tus­sle of Mer­ck v. Mer­ck

Before Merck and Merck, there was only Merck.

A single company was founded as a drugmaker in the pre-Bismarckian days of an industrializing Germany that, in 1891, decided to launch an outpost in New York. It was a successful idea, launching a smallpox vaccine just 7 years later, until World War I, when the US government seized the US branch under the Trading with the Enemy Act, splitting the global corporation in two and setting off a century of intercontinental brand confusion.