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

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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Bris­tol My­ers pledges to sell its Ac­celeron shares as ac­tivist in­vestors cir­cle Mer­ck­'s $11.5B buy­out — re­port

Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.

The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.

Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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Some can­cer pa­tients now have to find oth­er op­tions as Bris­tol My­er­s' Abrax­ane falls in­to short­age from man­u­fac­tur­ing woes

When Beth Hogan, a metastatic pancreatic cancer patient, showed up for her infusion at Yale’s Smilow Cancer Hospital in New Haven, CT on Oct. 11, she said she was informed that day that she would not be receiving Bristol Myers Squibb’s Abraxane, part of her combo treatment, because of a shortage.

“I was told we don’t know when you can have it,” she told Endpoints News via email, adding that she doesn’t expect to receive any Abraxane this coming Monday at her treatment appointment either, and she doesn’t know when things will change.

Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Valeriano Di Domenico)

Up­dat­ed: Bio­gen sells just $300K worth of Aduhelm in Q3, as ques­tions on long-term vi­a­bil­i­ty re­main

Barely anyone is accessing Biogen’s controversial Alzheimer’s treatment, with the company reporting just $0.3 million in Aduhelm sales in the third quarter. Although investors will be looking to the longer term, when CMS may decide to cover the drug and open the floodgates for more reimbursement, use of the drug is currently stalled.

Since June, when the FDA first signed off on the drug under its accelerated pathway, Biogen said Wednesday that it’s sold a total of $2 million worth of Aduhelm. That’s a far cry from the peak Wall Street sales estimate of about $9 billion in annual sales, and even a ways away from the sell-side consensus of about $17 million in Q3 sales.

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Eli Lil­ly or­dered to pay roy­al­ties on block­buster di­a­betes drugs, though ex­act dam­ages are un­clear

A federal court found Eli Lilly in breach of a royalty agreement with an Arizona company, likely sending the case — which deals with Lilly’s blockbuster diabetes drugs — to a trial.

The Arizona District Court ordered Lilly to pay the royalties to Tucson, AZ-based Research Corporation Technologies, per an opinion delivered Tuesday, stemming from a 1990 agreement involving materials used in manufacturing Lilly’s insulin products. Lilly had agreed to pay a 2% royalty on worldwide sales, and the exact amount of damages will be determined in a trial, Judge Scott Rash wrote.