Allergan CEO Brent Saunders (via AP images)

The list gets longer: Mer­ck, Al­ler­gan, No­var­tis is­sue 2020 drug price hikes — re­port

The price train con­tin­ues chug­ging in one di­rec­tion.

On Fri­day, a trio of drug­mak­ers — US-based Mer­ck, Ire­land-head­quar­tered Al­ler­gan and Swiss drug­mak­er No­var­tis — is­sued a round of hikes on more than 100 med­i­cines, vault­ing the to­tal num­ber of price rais­es on 445 drugs in 2020, Reuters re­port­ed, cit­ing health­care re­search firm 3 Ax­is Ad­vi­sors.

These spikes fol­low those by a cadre of drug­mak­ers in­clud­ing GSK, Pfiz­er, Gilead, Bris­tol-My­ers, Bio­gen, Lil­ly, and Te­va ear­li­er in the first week of 2020. In most cas­es, the stick­er price in­creas­es have been lim­it­ed to the mid-sin­gle-dig­it per­cent­ages. As the spot­light on drug pric­ing in­ten­si­fied, with pa­tients, pol­i­cy­mak­ers, and politi­cians de­cry­ing the mag­ni­tude and fre­quen­cy of hikes, a raft of drug­mak­ers — led by Al­ler­gan CEO Brent Saun­ders — pre­vi­ous­ly pledged to not raise their prices by more than 10% an­nu­al­ly.

“We don’t have all the da­ta yet,” 3 Ax­is Ad­vi­sors’ co-founder An­to­nio Ciac­cia not­ed in an in­ter­view with End­points News. His­tor­i­cal­ly, the bulk of the price in­creas­es for the year are typ­i­cal­ly is­sued by the sec­ond week of Jan­u­ary.

The biggest of­fend­er in terms of price in­creas­es is hard to iso­late not just be­cause all the price in­creas­es not been rev­e­lat­ed yet, but be­cause list prices are not re­li­able in­di­ca­tors of re­al, av­er­age, out-of-pock­et costs for in­sured Amer­i­cans.

“The amount of in­creas­es that we’ve seen so far are pret­ty well in line with pri­or years, at least over the last five years. It’s im­pos­si­ble to tell who the bad guy is,” Ciac­cia said. “Like if they raised the price by 7%, where that 7% is go­ing — is it go­ing back to…share­hold­ers or is it flowed back to the sup­ply chain in terms of a pro­pri­etary dis­count that’s go­ing to the in­sur­ers and the PBMs.”

In the lat­est round of hikes on Fri­day, both No­var­tis and Al­ler­gen (which is the process of be­ing swal­lowed by Ab­b­Vie) said the net prices on their price boost­ed med­i­cines would be ei­ther flat or low­er in 2020.

No­var­tis is lift­ing the prices of 7% of its US med­i­cines — but the drug­mak­er told Reuters that af­ter dis­counts and re­bates those net prices will de­crease by 2.5%. Mean­while, Al­ler­gan is boost­ing prices on 25 drugs by 5%, and on two more med­i­cines by 2-3%, but fol­low­ing dis­counts and re­bates, its net prices will work out flat-to-low­er in 2020, the com­pa­ny claimed to the wire ser­vice.

In ad­di­tion, Mer­ck el­e­vat­ed the stick­er price on 15 drugs — in­clud­ing its di­a­betes drugs Janu­via and Janu­met — by an av­er­age of 5%. The price of the drug­mak­er’s flag­ship im­munother­a­py, Keytru­da — which gen­er­at­ed near­ly $8 bil­lion in the first nine months of 2019 and is on track to be­come the world’s best sell­ing med­i­cine by 2024 — is go­ing up by 1.5%. Mer­ck’s hikes are “con­sis­tent with its com­mit­ment to not raise US net prices by more than in­fla­tion an­nu­al­ly,” the com­pa­ny told Reuters.

“I think over the last three, four years man­u­fac­tur­ers have rel­a­tive­ly speak­ing, tak­en their foot off the gas,” Ciac­cia said. “They’re lay­ing low, they’re keep­ing the in­creas­es un­der 10%. But for the most part, I feel like they’re keep­ing things with­in the realm that hope­ful­ly keeps them out of the news­pa­pers.”

As of Fri­day, Ciac­cia said there was one small drug­mak­er that boost­ed the price of its med­i­cine by more than 10%: Neos Ther­a­peu­tics lift­ed the price of its at­ten­tion deficit dis­or­der drug, Con­tem­pla XR, by 13.24%.

Some­times, drug­mak­ers don’t just take an­nu­al hikes — they al­so take ad­di­tion­al mid-year in­creas­es, al­though the prac­tice has grad­u­al­ly wilt­ed as the scruti­ny in­to pric­ing in­ten­si­fies.

“His­tor­i­cal­ly speak­ing, mid-year price heights have re­al­ly erod­ed…we’re not see­ing the amount of fig­ure price in­creas­es that we used to,” Ciac­cia said. “It’s hard to have a crys­tal ball, but if we’re, just judg­ing on past ex­pe­ri­ence, maybe price in­creas­es will like­ly go down again.

Surg­ing drug prices in the Unit­ed States are a thorny yet key bi­par­ti­san is­sue as an­oth­er pres­i­den­tial elec­tion beck­ons. While US Pres­i­dent Trump strug­gles to make good on his promise to low­er drug prices, the in­dus­try, which has long thrived pric­ing its prod­ucts with­out gov­ern­ment in­ter­fer­ence, per­sis­tent­ly ar­gues that any kind of in­ter­fer­ence will sti­fle in­no­va­tion.

Law­mak­ers left and right all ar­gue drug prices in the Unit­ed States are too high — and the in­dus­try holds the crown for the least fa­vored sec­tor by Amer­i­cans, falling be­hind the fed­er­al gov­ern­ment it­self — but so far no­body can agree on just how to make the US health care sys­tem great again. Last month, the HHS opened the door to a pol­i­cy that al­lows for the im­por­ta­tion of drugs from Cana­da.

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.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Jacob Van Naarden, Senior VP, CEO of Loxo Oncology at Lilly; President, Lilly Oncology

Eli Lil­ly bags FDA nod for Verzenio in ear­ly breast can­cer, but a con­tro­ver­sial di­ag­nos­tic could dog its roll­out

As Eli Lilly works to consolidate its internal and Loxo teams into an oncology powerhouse, the drug giant is putting high hopes on CDK 4/6 inhibitor Verzenio to help drive the portfolio into the future. Now, the drug has scored a paradigm-altering win in early breast cancer — but will a controversial companion diagnostic hamstring Lilly’s market plans?

The FDA on Wednesday approved CDK 4/6 inhibitor Verzenio in combination with physician’s-choice endocrine therapy to cut the risk of relapse in patients with high-risk HR-positive, HER2-negative breast cancer, Lilly said in a release.

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FDA ad­comm votes unan­i­mous­ly in sup­port of a J&J Covid-19 boost­er two months af­ter one-dose shot

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.

FDA ad­comm to de­cide on mol­nupi­ravir EUA; Can­cer at­las un­veils new po­ten­tial drug tar­get

The FDA has another adcomm coming down the pipeline — this time on Covid-19 oral antiviral molnupiravir.

The federal agency’s advisory committee will meet on November 30th to go over Merck and Ridgeback’s EUA request for their investigational antiviral drug, and discuss the available data supporting its use in Covid-19 patients.

This comes two weeks after Merck claimed that their antiviral pill reduced the chance that newly diagnosed Covid-19 patients would be hospitalized or die by 50%. The pharma made the announcement after interim data on 775 patients in their clinical trial showed the antiviral’s potential.